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Sample records for 12-week randomized intervention-study

  1. Exercise and quality of life in patients with cystic fibrosis: A 12-week intervention study.

    PubMed

    Schmidt, Anne Mette; Jacobsen, Ulla; Bregnballe, Vibeke; Olesen, Hanne Vebert; Ingemann-Hansen, Thorsten; Thastum, Mikael; Oluf Schiøtz, Peter

    2011-11-01

    It was hypothesised that increased exercise capacity is related to improved quality of life (QoL) in patients with cystic fibrosis (CF). A 12-week individually tailored unsupervised aerobic exercise programme was offered to 42 patients with CF. At the start and at the end of the exercise programme, data on QoL, current exercise habits and preferences, anthropometric data, exercise test, and lung function test were collected. Adherence was observed by a heart rate (HR) monitor. A total of 24 patients accepted to be enrolled in the exercise programme and 14 completed the programme. Another 14 patients declined to be enrolled in the exercise programme but completed the Cystic Fibrosis Questionnaire for Adolescents and Adults (CFQ-R 14+). Four patients did not want to participate at all. The 14 patients completing the exercise programme had a significantly increased VO(2max), but they showed no significant change in total QoL score. However, the scores in the domain of treatment burden and emotional functioning increased significantly. There was no significant difference in QoL and lung function between patients participating in the exercise programme (n = 24) and non-participants (n = 14). A 12-week individually tailored unsupervised aerobic exercise programme where HR monitors were used significantly affected VO(2max). Improvement in QoL could not be demonstrated in this study. PMID:21722067

  2. Escitalopram for treatment of night eating syndrome: a 12-week, randomized, placebo-controlled trial.

    PubMed

    Vander Wal, Jillon S; Gang, Catherine H; Griffing, George T; Gadde, Kishore M

    2012-06-01

    The primary objective of this study was to examine the short-term effects of escitalopram on symptoms of night eating syndrome (NES) in a randomized controlled clinical trial. A total of 40 patients with NES were randomly assigned to double-blind treatment with escitalopram 20 mg (n = 20) or placebo (n = 20) for 12 weeks. Escitalopram was started at 10 mg/d with a dosage increase to 20 mg/d after 4 weeks; placebo dosing was identical. The primary end point was a mean change in total score of the Night Eating Questionnaire (NEQ). At 12 weeks, mean (SE) change in NEQ total score was -13.0 (1.6) and -10.6 (2.2) in the escitalopram and placebo groups, respectively (F(1,37) = 2.5, P = 0.124). There was a marginal interaction effect between response to escitalopram and race (F(1,34) = 4.0, P = 0.052), with a favorable effect for white patients (F(1,20) = 6.0, P = 0.024) but not for black patients (F(1,13) = 0.6, P = 0.453). Seven patients in the escitalopram group, compared with 6 patients in the placebo group, showed a 50% NEQ score reduction (P = 0.736). Sixteen patients in the escitalopram group and 12 patients in the placebo group no longer met NES criteria (P = 0.168). Twelve patients in the escitalopram group were classified as responders according to the Clinical Global Impression Improvement scale compared with 7 patients in the placebo group (P = 0.113). No significant between-group differences were found for weight, mood ratings, or adverse events. We conclude that escitalopram treatment for 12 weeks was not superior to placebo in reducing NES symptoms as measured by the NEQ.

  3. Efficacy of Olibra: A 12-Week Randomized Controlled Trial and a Review of Earlier Studies

    PubMed Central

    Rebello, Candida J; Martin, Corby K; Johnson, William D; O'Neil, Carol E; Greenway, Frank L

    2012-01-01

    Background Intervention strategies that harness the body's appetite and satiety regulating signals provide a means of countering excessive energy intake. Methods Eighty-two subjects were enrolled (18–60 years, body mass index: 25–40 kg/m2) in a randomized, placebo-controlled, double-blind, parallel trial. During a 12-week period, the effects of Olibra™ fat emulsion (2.1 g twice daily) on food intake, appetite, satiety, weight, and body composition were compared with those of a twice daily administered placebo (1.95 g milk fat). On days -7, 0, and 28, Olibra or the placebo added to 200 g of yogurt was served at breakfast and lunch. Food intake, appetite, and satiety were assessed after lunch and dinner. Body weight was measured on days -7, 0, 14, 28, 56, and 84. Body fat, waist circumference, and waist-hip ratio were determined on days 0 and 84. The Eating Inventory was administered at screening and on day 28. Data relating to 71 subjects were analyzed using analysis of covariance. Results At 12 weeks, body weight was reduced in the test group (2.17 ± 0.46 kg standard error of the mean, p < .0001) and the control group (1.68 ± 0.42 kg, p < .0001). Waist circumference decreased by 2.93 ± 0.85 cm in the test group (p = .001) and by 1.78 ± 0.74 cm in the control group (p = .02). Differential weight and waist circumference reductions were not significant. Hunger scores (Eating Inventory) decreased more in the test group (p = .0082). Differential group effects were not significant for body fat, waist-hip ratio, food intake, appetite, and satiety. Conclusions At this dose, Olibra did not exert a consistent effect on food intake, appetite regulation, body weight, or body composition. PMID:22768902

  4. Effect of a Brown Rice Based Vegan Diet and Conventional Diabetic Diet on Glycemic Control of Patients with Type 2 Diabetes: A 12-Week Randomized Clinical Trial

    PubMed Central

    Lee, Yu-Mi; Kim, Se-A; Lee, In-Kyu; Kim, Jung-Guk; Park, Keun-Gyu; Jeong, Ji-Yun; Jeon, Jae-Han; Shin, Ji-Yeon; Lee, Duk-Hee

    2016-01-01

    Objective Several intervention studies have suggested that vegetarian or vegan diets have clinical benefits, particularly in terms of glycemic control, in patients with type 2 diabetes (T2D); however, no randomized controlled trial has been conducted in Asians who more commonly depend on plant-based foods, as compared to Western populations. Here, we aimed to compare the effect of a vegan diet and conventional diabetic diet on glycemic control among Korean individuals. Materials and Methods Participants diagnosed with T2D were randomly assigned to follow either a vegan diet (excluding animal-based food including fish; n = 46) or a conventional diet recommended by the Korean Diabetes Association 2011 (n = 47) for 12 weeks. HbA1c levels were measured at weeks 0, 4, and 12, and the primary study endpoint was the change in HbA1c levels over 12 weeks. Results The mean HbA1c levels at weeks 0, 4, and 12 were 7.7%, 7.2%, and 7.1% in the vegan group, and 7.4%, 7.2%, and 7.2% in the conventional group, respectively. Although both groups showed significant reductions in HbA1C levels, the reductions were larger in the vegan group than in the conventional group (-0.5% vs. -0.2%; p-for-interaction = 0.017). When only considering participants with high compliance, the difference in HbA1c level reduction between the groups was found to be larger (-0.9% vs. -0.3%). The beneficial effect of vegan diets was noted even after adjusting for changes in total energy intake or waist circumference over the 12 weeks. Conclusion Both diets led to reductions in HbA1c levels; however, glycemic control was better with the vegan diet than with the conventional diet. Thus, the dietary guidelines for patients with T2D should include a vegan diet for the better management and treatment. However, further studies are needed to evaluate the long-term effects of a vegan diet, and to identify potential explanations of the underlying mechanisms. Trial Registration CRiS KCT0001771 PMID:27253526

  5. Linagliptin monotherapy compared with voglibose monotherapy in patients with type 2 diabetes undergoing hemodialysis: a 12-week randomized trial

    PubMed Central

    Mori, Katsuhito; Emoto, Masanori; Shoji, Tetsuo; Inaba, Masaaki

    2016-01-01

    Objective Focusing on efficacy and tolerability, we compared linagliptin monotherapy with voglibose monotherapy in patients with type 2 diabetes undergoing hemodialysis (HD). Research design and methods In this multicenter, randomized, open-label, parallel-group, active-controlled study, 78 patients were randomized (1:1) to receive a 12-week treatment with 5 mg linagliptin once daily or 0.2 mg voglibose three times a day. To assess whether linagliptin was superior to voglibose, the primary efficacy end point was the change in glycated hemoglobin (HbA1c) level between baseline and week 12. Secondary efficacy end points included changes between baseline and week 12 in glycated albumin (GA) and casual plasma glucose (PG) levels. Results At week 12, the adjusted mean HbA1c levels had decreased by −0.60% after treatment with linagliptin and by −0.20% after treatment with voglibose (treatment difference: −0.40%, 95% CI −0.74% to −0.06%, p=0.022). A significant reduction in casual PG level was also observed after treatment with linagliptin compared with treatment with voglibose. Relative to voglibose, linagliptin tended to elicit reductions in GA, although without statistical significance. No hypoglycemic symptoms or severe hypoglycemia occurred during the study. Conclusions In patients with type 2 diabetes undergoing HD, linagliptin monotherapy provided significantly better glycemic control without severe hypoglycemia than voglibose monotherapy. Linagliptin represents a promising agent for glycemic management in patients with type 2 diabetes undergoing HD. Trial registration number UMIN000007635; results. PMID:27547421

  6. Magnesium Replacement Does Not Improve Insulin Resistance in Patients With Metabolic Syndrome: A 12-Week Randomized Double-Blind Study

    PubMed Central

    Lima de Souza e Silva, Maria de Lourdes; Cruz, Thomaz; Rodrigues, Luiz Erlon; Ladeia, Ana Marice; Bomfim, Olivia; Olivieri, Lucas; Melo, Juliana; Correia, Raquel; Porto, Mirna; Cedro, Alexandre

    2014-01-01

    Background To evaluate the effect of magnesium (Mg) replacement on insulin resistance and cardiovascular risk factors in women with metabolic syndrome (MS) without diabetes. Methods This 12-week clinical randomized double-blind study compared the effects of 400 mg/day of Mg with those of a placebo (n = 72) on fasting glucose, insulin, HOMA-IR, lipid profile and CRP. Mg was measured in serum (SMg) and in mononuclear cells (MMg). Results Hypomagnesemia (SMg < 1.7 mg/dL) was seen in 23.2% of patients and intracellular depletion in 36.1% of patients. The MMg means were lower in patients with obesity (0.94 ± 0.54 μg/mg vs. 1.19 ± 0.6 μg/mg, P = 0.04), and insulin resistance (0.84 ± 0.33 μg/mg vs. 1.14 ± 0.69 µg/mg, P < 0.05). Mg replacement did not alter SMg (1.82 ± 0.14 mg/dL vs. 1.81 ± 0.16 mg/dL, P = 0.877) and tended to increment MMg (0.90 ± 0.40 μg/mg vs. 1.21 ± 0.73 μg/mg, P = 0.089). HOMA-IR did not alter in interventions nor in placebo group (3.2 ± 2.0 to 2.8 ± 1.9, P = 0.368; 3.6 ± 1.9 to 3.2 ± 1.8, respectively), neither did other metabolic parameters. Conclusion Serum and intracellular Mg depletion is common in patients with MS; however, Mg replacement in recommended dosage did not increase significantly Mg levels, neither reduced insulin resistance or metabolic control. PMID:25247020

  7. Oral Microbiota Shift after 12-Week Supplementation with Lactobacillus reuteri DSM 17938 and PTA 5289; A Randomized Control Trial

    PubMed Central

    Romani Vestman, Nelly; Chen, Tsute; Lif Holgerson, Pernilla; Öhman, Carina; Johansson, Ingegerd

    2015-01-01

    Background Lactobacillus spp. potentially contribute to health by modulating bacterial biofilm formation, but their effects on the overall oral microbiota remain unclear. Methods and Findings Oral microbiota was characterized via 454-pyrosequencing of the 16S rDNA hypervariable region V3-V4 after 12 weeks of daily Lactobacillus reuteri DSM 17938 and PTA 5289 consumption. Forty-four adults were assigned to a test group (n = 22) that received lactobacilli lozenges (108 CFU of each strain/lozenge) or a control group that received placebo (n = 22). Presence of L. reuteri was confirmed by cultivation and species specific PCR. Tooth biofilm samples from 16 adults before, during, and after exposure were analyzed by pyrosequencing. A total of 1,310,292 sequences were quality filtered. After removing single reads, 257 species or phylotypes were identified at 98.5% identity in the Human Oral Microbiome Database. Firmicutes, Bacteroidetes, Fusobacteria, Proteobacteria, and Actinobacteria were the most abundant phyla. Streptococcus was the most common genus and the S. oralis/S. mitis/S. mitis bv2/S. infantis group comprised the dominant species. The number of observed species was unaffected by L. reuteri exposure. However, subjects who had consumed L. reuteri were clustered in a principal coordinates analysis relative to scattering at baseline, and multivariate modeling of pyrosequencing microbiota, and culture and PCR detected L. reuteri separated baseline from 12-week samples in test subjects. L. reuteri intake correlated with increased S. oralis/S. mitis/S. mitis bv2/S. infantis group and Campylobacter concisus, Granulicatella adiacens, Bergeyella sp. HOT322, Neisseria subflava, and SR1 [G-1] sp. HOT874 detection and reduced S. mutans, S. anginosus, N. mucosa, Fusobacterium periodicum, F. nucleatum ss vincentii, and Prevotella maculosa detection. This effect had disappeared 1 month after exposure was terminated. Conclusions L. reuteri consumption did not affect species

  8. A 12-week randomized double-blind parallel pilot trial of Sinetrol XPur on body weight, abdominal fat, waist circumference, and muscle metabolism in overweight men.

    PubMed

    Cases, Julien; Romain, Cindy; Dallas, Constantin; Gerbi, Alain; Rouanet, Jean Max

    2015-01-01

    Overweight and obesity are associated to increased risk of developing non-communicable diseases that might dramatically affect life expectancy according World Health Organization. Overweight, obesity, and decline in physical activity are correlated to a significant propensity to lose skeletal muscle mass as a result of prolonged inflammation and oxidative stress whereas cohort surveys and clinical investigations have demonstrated health benefits of Citrus-based polyphenols to reverse such regression. Overweight men were included in a double-blind, randomized, parallel pilot trial where they received daily for a 12-week period 900 mg of a Citrus-based polyphenol extract, Sinetrol® XPur. Body composition, anthropometric, and blood parameters were assessed before and at the end of the intervention period. After 12 weeks, while the silhouette slimmed down, metabolic parameters were significantly improved and skeletal muscle catabolism held back. These data suggest that over a 12-week period, the efficacy of the supplement improve both overweight process and correlated skeletal muscle mass metabolism. PMID:26037199

  9. Swahili 12 Weeks Course.

    ERIC Educational Resources Information Center

    Defense Language Inst., Washington, DC.

    This 12-weeks course in basic Swahili comprises 55 lesson units in five volumes. The general course format consists of (1) perception drills for comprehension, oral production, and association using "situational picture" illustrations; (2) dialogs in English and Swahili, with cartoon guides; (3) sequenced pattern and recombination drills, and (4)…

  10. Low-dose memantine attenuated methadone dose in opioid-dependent patients: a 12-week double-blind randomized controlled trial.

    PubMed

    Lee, Sheng-Yu; Chen, Shiou-Lan; Chang, Yun-Hsuan; Chen, Po See; Huang, San-Yuan; Tzeng, Nian-Sheng; Wang, Liang-Jen; Lee, I Hui; Wang, Tzu-Yun; Chen, Kao Chin; Yang, Yen Kuang; Hong, Jau-Shyong; Lu, Ru-Band

    2015-05-19

    Low-dose memantine might have anti-inflammatory and neurotrophic effects mechanistically remote from an NMDA receptor. We investigated whether add-on memantine reduced cytokine levels and benefitted patients with opioid dependence undergoing methadone maintenance therapy (MMT) in a randomized, double-blind, controlled 12-week study. Patients were randomly assigned to a group: Memantine (5 mg/day) (n = 53) or Placebo (n = 75). The methadone dose required and retention in treatment were monitored. Plasma tumor necrosis factor (TNF)-α, C-reactive protein (CRP), interleukin (IL)-6, IL-8, transforming growth factor (TGF)-β1, and brain-derived neurotrophic factor (BDNF) levels were examined during weeks 0, 1, 4, 8, and 12. General linear mixed models were used to examine therapeutic effect. After 12 weeks, Memantine-group required a somewhat lower methadone dose than did Placebo-group (P = 0.039). They also had significantly lower plasma TNF-α and significantly higher TGF-β1 levels. We provide evidence of the benefit of add-on memantine in opioid dependent patients undergoing MMT.

  11. Improvement in subjective and objective neurocognitive functions in patients with major depressive disorder: a 12-week, multicenter, randomized trial of tianeptine versus escitalopram, the CAMPION study.

    PubMed

    Jeon, Hong Jin; Woo, Jong-Min; Lee, Seung-Hwan; Kim, Eui-Joong; Chung, Seockhoon; Ha, Jee Hyun; Fava, Maurizio; Mischoulon, David; Kim, Ji-Hae; Heo, Jung-Yoon; Yu, Bum-Hee

    2014-04-01

    Although many patients with major depressive disorder (MDD) complain of neurocognitive impairment, the effects of antidepressant medications on neurocognitive functions remain unclear. This study compares neurocognitive effects of tianeptine and escitalopram in MDD. Patients with MDD (N = 164) were randomly assigned in a 1:1 ratio to either tianeptine (37.5 mg/d) or escitalopram (10 mg/d) for 12 weeks. Outcome measures included clinical improvement, subjective cognitive impairment on memory and concentration, the Mini-Mental State Examination, the Continuous Performance Test, the Verbal Learning Test, and the Raven Progressive Matrices, assessed every 4 weeks. After 12 weeks, the tianeptine group showed significant improvement in commission errors (P = 0.002), verbal immediate memory (P < 0.0001), Mini-Mental State Examination (P < 0.0001), delayed memory (P < 0.0001), and reasoning ability (P = 0.0010), whereas the escitalopram group improved in delayed memory and reasoning ability but not in the other measures. Both groups significantly improved in subjective cognitive impairment in memory (P < 0.0001) and concentration (P < 0.0001). Mixed effects model repeated measures analyses revealed that the tianeptine group had a significant improvement in scores of commission errors (F = 6.64, P = 0.011) and verbal immediate memory (F = 4.39, P = 0.038) from baseline to 12 weeks, compared with the escitalopram group, after controlling for age, sex, education years, baseline scores, and changes of depression severity. The treatment of MDD with tianeptine led to more improvements in neurocognitive functions, especially in commission errors and verbal immediate memory, compared with escitalopram, after controlling for changes in depression severity. Both drugs improved subjective cognitive impairment of memory and concentration.

  12. Improvement in subjective and objective neurocognitive functions in patients with major depressive disorder: a 12-week, multicenter, randomized trial of tianeptine versus escitalopram, the CAMPION study.

    PubMed

    Jeon, Hong Jin; Woo, Jong-Min; Lee, Seung-Hwan; Kim, Eui-Joong; Chung, Seockhoon; Ha, Jee Hyun; Fava, Maurizio; Mischoulon, David; Kim, Ji-Hae; Heo, Jung-Yoon; Yu, Bum-Hee

    2014-04-01

    Although many patients with major depressive disorder (MDD) complain of neurocognitive impairment, the effects of antidepressant medications on neurocognitive functions remain unclear. This study compares neurocognitive effects of tianeptine and escitalopram in MDD. Patients with MDD (N = 164) were randomly assigned in a 1:1 ratio to either tianeptine (37.5 mg/d) or escitalopram (10 mg/d) for 12 weeks. Outcome measures included clinical improvement, subjective cognitive impairment on memory and concentration, the Mini-Mental State Examination, the Continuous Performance Test, the Verbal Learning Test, and the Raven Progressive Matrices, assessed every 4 weeks. After 12 weeks, the tianeptine group showed significant improvement in commission errors (P = 0.002), verbal immediate memory (P < 0.0001), Mini-Mental State Examination (P < 0.0001), delayed memory (P < 0.0001), and reasoning ability (P = 0.0010), whereas the escitalopram group improved in delayed memory and reasoning ability but not in the other measures. Both groups significantly improved in subjective cognitive impairment in memory (P < 0.0001) and concentration (P < 0.0001). Mixed effects model repeated measures analyses revealed that the tianeptine group had a significant improvement in scores of commission errors (F = 6.64, P = 0.011) and verbal immediate memory (F = 4.39, P = 0.038) from baseline to 12 weeks, compared with the escitalopram group, after controlling for age, sex, education years, baseline scores, and changes of depression severity. The treatment of MDD with tianeptine led to more improvements in neurocognitive functions, especially in commission errors and verbal immediate memory, compared with escitalopram, after controlling for changes in depression severity. Both drugs improved subjective cognitive impairment of memory and concentration. PMID:24525660

  13. Effects of 12-week oral supplementation of Ecklonia cava polyphenols on anthropometric and blood lipid parameters in overweight Korean individuals: a double-blind randomized clinical trial.

    PubMed

    Shin, Hyeon-Cheol; Kim, Seong Ho; Park, Yongju; Lee, Bong Ho; Hwang, Hye Jeong

    2012-03-01

    The effects of 12-week supplementation with a polyphenol extract from Ecklonia cava (ECP) on anthropometry, serum biochemistry and hematology have been investigated. Ninety-seven overweight male and female adults (average age 40.5 ± 9.2 yr and body mass index (BMI) of 26.5 ± 1.6 kg/m²) were enrolled in a randomized, double-blind, placebo-controlled trial with parallel-group design. Subjects were randomly allocated into three groups designated as PC (placebo), LD (low-dose, 72 mg-ECP/day) and HD (high-dose, 144 mg-ECP/day). Both LD and HD groups showed significant decreases in BMI, body fat ratio, waist circumference, waist/hip ratio, total cholesterol, low-density lipoprotein (LDL) cholesterol, total cholesterol/high-density lipoprotein (HDL) cholesterol and atherogenic index (AI) after 12 weeks, as compared with the placebo group. The HD group also showed a significant increase in serum HDL cholesterol as compared with the placebo group. Only the HD group showed significant decreases in serum glucose and systolic blood pressure after 12 weeks. There was no significant adverse event related with ingestion of ECP, and serum biochemical and hematological parameters were maintained within normal range during the intervention period. In conclusion, these results demonstrated that ECP supplementation significantly contributed to lowering body fat and serum lipid parameters such as total and LDL cholesterols with dose dependence. Further studies using different populations, dosages or biological markers are highly recommended to better understand the physiological features of this polyphenol.

  14. A 12-week medical exercise therapy program leads to significant improvement in knee function after degenerative meniscectomy: a randomized controlled trial with one year follow-up.

    PubMed

    Østerås, Håvard

    2014-07-01

    There is no consensus in the postoperative rehabilitation regimen for patients who have undergone surgery for medial meniscus damage. The aim of this study was to examine whether it is necessary to undergo postoperative physiotherapy treatment these patients. A prospective randomized controlled clinical trial was performed. 42 participants (26 males, 16 women) were randomly assigned into an exercise group (EG) (n = 22) or a control group (CG) (n = 20). Prognostic variables were similar between the groups at baseline. The EG achieved significantly better outcome effects than the CG at pain (VAS reduced 1.9 in TG and 0.6 in CG, p < 0.01) and function (KOOS decreased 18.0 in TG and only 6.5 in CG, p < 0.01) during the 12 week intervention period. The results after a 12-month follow-up indicated the same results as at posttest 3 months postoperatively. In patients with surgery for degenerative meniscus damage, postoperative medical exercise therapy - as a model of physiotherapy - is an efficient treatment alternative compared to no systematic rehabilitation.

  15. Bimatoprost 0.01% or 0.03% in patients with glaucoma or ocular hypertension previously treated with latanoprost: two randomized 12-week trials

    PubMed Central

    Myers, Jonathan S; Vold, Steven; Zaman, Fiaz; Williams, Julia M; Hollander, David A

    2014-01-01

    Background The purpose of this study was to evaluate the intraocular pressure (IOP)-lowering efficacy and safety of bimatoprost 0.01% or 0.03% as monotherapy in patients treated with latanoprost 0.005% monotherapy who require additional IOP lowering for their ocular hypertension or open-angle glaucoma. Methods Two prospective, investigator-masked, randomized, parallel-group, multicenter studies enrolled patients with baseline IOP ≥20 mmHg after ≥30 days of latanoprost 0.005% monotherapy. Patients were randomized to 12 weeks of study treatment (study 1, bimatoprost 0.01% once daily or bimatoprost 0.01% once daily plus brimonidine 0.1% three times daily; study 2, bimatoprost 0.03% once daily or bimatoprost 0.03% once daily plus fixed-combination brimonidine 0.2%/timolol 0.5% twice daily). Patient evaluations at weeks 4 and 12 included IOP at 8 am, 10 am, and 4 pm and safety assessments. Results in the monotherapy study arms (bimatoprost 0.01% or 0.03%) are presented. Results Latanoprost-treated baseline mean diurnal IOP (± standard error of the mean) was 22.2±0.3 mmHg and 22.1±0.4 mmHg in the bimatoprost 0.01% and bimatoprost 0.03% treatment arms, respectively (P=0.957). In both treatment arms, mean (± standard error of the mean) reduction in IOP from latanoprost-treated baseline was statistically significant at each time point at both follow-up visits (P<0.001), ranging from 3.7±0.4 (17.0%) mmHg to 4.4±0.4 (19.9%) mmHg with bimatoprost 0.01% and from 2.8±0.5 (12.8%) mmHg to 3.9±0.5 (16.7%) mmHg with bimatoprost 0.03%. Mean percentage IOP reduction from latanoprost-treated baseline was numerically greater with bimatoprost 0.01% than with bimatoprost 0.03% throughout follow-up. The incidence of conjunctival hyperemia of mild or greater severity increased from latanoprost baseline after 12 weeks of treatment only in the bimatoprost 0.03% treatment arm. Conclusion Many patients who do not reach their target IOP on latanoprost can achieve additional IOP

  16. Effectiveness and tissue compatibility of a 12-week treatment of chronic venous leg ulcers with an octenidine based antiseptic--a randomized, double-blind controlled study.

    PubMed

    Vanscheidt, Wolfgang; Harding, Keith; Téot, Luc; Siebert, Jörg

    2012-06-01

    The aim of this study was to evaluate the cytotoxic effect of octenidine dihydrochloride/phenoxyethanol (OHP) found in vitro by conducting a randomized, double-blind controlled clinical study focusing on its safe and effective use in chronic venous leg ulcers. In total, 126 male and female patients were treated with either OHP (n = 60) or Ringer solution (n = 66). The treatment lasted over a period of maximum 12 weeks. For the assessment of the wound-healing process, clinical outcome parameters were employed, that is, time span until 100% epithelization, wound status and the wound surface area were analysed. Side effects were recorded during the study period. The median time to complete ulcer healing was comparable between the OHP and Ringer solution groups (92 versus 87 days; P = 0·952), without being influenced by wound size or duration of the target ulcer (P-values: 0·947/0·978). In patients treated with OHP, fewer adverse events (AEs) were observed compared with the Ringer group (17% versus 29% of patients reported 20 versus 38 AEs). OHP is well suitable for the treatment of chronic wounds without cytotoxic effects. Furthermore, OHP does not impair the wound healing in chronic venous ulcers.

  17. The effect of 12 weeks Anethum graveolens (dill) on metabolic markers in patients with metabolic syndrome; a randomized double blind controlled trial

    PubMed Central

    2012-01-01

    Background The clustering of metabolic abnormalities defined as metabolic syndrome is now both a public health and a clinical problem .While interest in herbal medicine has greatly increased, lack of human evidence to support efficacies shown in animals does exist. This clinical trial study designed to investigate whether herbal medicine, Anethum graveolens (dill) extract, could improve metabolic components in patients with metabolic syndrome. Methods A double-blind, randomized, placebo-controlled trial using a parallel design was conducted. 24 subjects who had metabolic syndrome diagnostic criteria (update of ATP III) were randomly assigned to either dill extract (n = 12) or placebo (n = 12) for 3 months. Results Across lipid component of metabolic syndrome, no significant differences in triglyceride (TG) concentration and high density lipoprotein cholesterol were seen between the two groups. However TG improved significantly from baseline (257.0 vs. 201.5p = 0.01) with dill treatment but such a significant effect was not observed in placebo group. Moreover, no significant differences in waist circumference, blood pressure and fasting blood sugar were seen between two groups after 3 months follow up period. Conclusion In this small clinical trial in patients with metabolic syndrome, 12 weeks of dill extract treatment had a beneficial effect in terms of reducing TG from baseline. However dill treatment was not associated with a significant improvement in metabolic syndrome related markers compared to control group. Larger studies might be required to prove the efficacy and safety of long-term administration of dill to resolve metabolic syndrome components. PMID:23351341

  18. Onion peel extract reduces the percentage of body fat in overweight and obese subjects: a 12-week, randomized, double-blind, placebo-controlled study

    PubMed Central

    Lee, Ji-Sook; Cha, Yong-Jun; Lee, Kyung-Hea

    2016-01-01

    BACKGROUND/OBJECTIVES The anti-obesity effect of quercetin-rich onion peel extract (OPE) was suggested in rats, but information from human studies is limited. This study aimed to investigate the effects of OPE on the body composition of overweight and obese subjects. MATERIALS/METHODS In this 12-week, randomized, double-blind, placebo-controlled study, parallel clinical trials were performed in overweight and obese Korean subjects. Randomly assigned subjects were instructed to take daily either the placebo (male, 6 and female, 30) or OPE capsules containing 100 mg of quercetin (male, 5 and female, 31). Body composition was measured by using bioimpedance and dual-energy X-ray absorptiometry (DXA). Resting energy expenditure (REE) and respiratory quotient (RQ) were evaluated by using indirect calorie measurement methods. Fasting blood levels of glucose, insulin, lipids, and leptin were determined. RESULTS Quercetin-rich OPE supplementation significantly reduced the weight and percentage of body fat as measured by DXA (P = 0.02). These effects were not shown in the control group. Levels of blood glucose (P = 0.04) and leptin (P = 0.001 for placebo, P = 0.002 for OPE) decreased in both groups. Significant increases in REE and RQ were observed in both groups (P = 0.003 for placebo, P = 0.006 for OPE) and in the OPE group alone (P = 0.02), respectively. CONCLUSIONS Quercetin-rich OPE supplementation changed the body composition of the overweight and obese subjects. This result suggests a beneficial role of the anti-obesity effect of OPE human subjects. PMID:27087901

  19. Implementation of a 12-week disease management program improved clinical outcomes and quality of life in adults with asthma in a rural district hospital: pre- and post-intervention study.

    PubMed

    Chamnan, Parinya; Boonlert, Kittipa; Pasi, Wanit; Yodsiri, Songkran; Pong-on, Sirinya; Khansa, Bhoonsab; Yongkulwanitchanan, Pichapat

    2010-03-01

    Despite the availability of effective medical treatment and disease management guidelines, asthma remains a poorly controlled disease in developing countries. There is little evidence of the effectiveness of disease management guidelines in rural clinical practice. The effect of disease management guidelines on clinical outcomes and quality of life in asthmatic patients in a rural community hospital was examined. Fifty-seven patients aged > or = 16 years with physician-diagnosed asthma from a hospital outpatient clinic in Ubon-ratchathani, Thailand, were recruited. Asthma diagnosis was confirmed by reviewing clinical records. We implemented a 12-week disease management program, including the use of written asthma treatment plan and asthma action plan tailored to individual patients. Using one-group pre- and post-intervention design, we compared the average number of emergency visits and hospitalizations from acute asthmatic attacks before and after the implementation of interventions using the Wilcoxon matched-pairs signed-rank test. We also compared patient's asthma quality of life (AQL) scores, measured using the 7-point scaled Mini Asthma Quality of Life Questionnaire. It was found that among the 57 patients, 38 (67%) were women, and the mean age (SD) of the patients was 47.6 (17.0) years. Sixteen patients (28%) had a family history of asthma. Emergency visits decreased from 0.48 (SD = 0.83) per patient before implementation of interventions to 0.11 (0.37) per patient after implementation of interventions (p = 0.003). Hospitalizations with acute asthma attacks reduced from 0.14 (0.35) per patient to 0.04 (0.27) per patient (p = 0.034). Overall AQL scores increased significantly from 3.7 to 5.4 (p < 0.001), with most improvement observed in symptoms and emotions. It was concluded that implementation of a 12-week asthma disease management program could reduce emergency visits and hospitalizations, and improve patients' quality of life in a rural practice setting.

  20. Efficacy and safety of tofacitinib as monotherapy in Japanese patients with active rheumatoid arthritis: a 12-week, randomized, phase 2 study

    PubMed Central

    Tanaka, Yoshiya; Takeuchi, Tsutomu; Yamanaka, Hisashi; Nakamura, Hiroyuki; Toyoizumi, Shigeyuki; Zwillich, Samuel

    2015-01-01

    Abstract Objectives. To evaluate oral tofacitinib versus placebo for treatment of active rheumatoid arthritis in Japanese patients with inadequate response to disease-modifying antirheumatic drugs. Methods. In this double-blind, placebo-controlled, randomized, parallel-group, 12-week, phase 2 study (clinicaltrials.gov NCT00687193), 317 patients received tofacitinib: 1, 3, 5, 10, or 15 mg as monotherapy or placebo twice daily (BID). Primary endpoint: response rate by American College of Rheumatology (ACR) ≥ 20% improvement criteria (ACR20) at week 12. Results. ACR20 response rates: 37.7% (20/53), 67.9% (36/53), 73.1% (38/52), 84.9% (45/53), and 90.7% (49/54) with tofacitinib: 1, 3, 5, 10, and 15 mg BID, respectively, versus 15.4% (8/52) with placebo (p < 0.01; all doses). Dose-dependent ACR20 responses with tofacitinib versus placebo occurred from week 2 onward (p < 0.05). Changes from baseline in 28-joint disease activity score using erythrocyte sedimentation rate improved with tofacitinib versus placebo from week 4 (p < 0.01; all doses). Six tofacitinib patients experienced treatment-related serious adverse events (AEs). Most common treatment-emergent AEs: nasopharyngitis (10% vs 12%) and hyperlipidemia (5% vs 0%). Serum creatinine, hemoglobin, and total-, low-, and high-density lipoprotein-cholesterol levels increased with tofacitinib. Conclusions. Tofacitinib produced dose-dependent ACR20 responses and reduced disease activity. The safety profile was consistent with that reported from global monotherapy trials. PMID:25496464

  1. Portuguese Special Course: 12 Weeks.

    ERIC Educational Resources Information Center

    Defense Language Inst., Washington, DC.

    This 12-week course in beginning Portuguese comprises four volumes of student text (Lessons 1-55) and a fifth volume of Portuguese-English/English-Portuguese vocabulary. Lesson materials consist of basic dialogs with English translation, recombination dialogs, readings and comprehension questions, oral exercises, and in later units, additional…

  2. Efficacy and safety of canagliflozin in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, 12-week study†

    PubMed Central

    Inagaki, N; Kondo, K; Yoshinari, T; Maruyama, N; Susuta, Y; Kuki, H

    2013-01-01

    Aims We examined the efficacy, safety and tolerability of canagliflozin, a sodium glucose co-transporter 2 inhibitor, in Japanese patients with type 2 diabetes (T2DM) undergoing diet and exercise therapy. Methods Patients aged 20–80 years with T2DM diagnosed ≥3 months previously, and HbA1c of 6.9–9.9% were randomized to 50, 100, 200 or 300 mg canagliflozin or placebo once daily for 12 weeks. The primary and secondary endpoints were changes in HbA1c, fasting plasma glucose (FPG), urinary glucose/creatinine and postprandial glycaemic parameters following a meal test. The safety assessments included adverse events (AEs) and clinical laboratory tests. Results Overall, 383 patients were randomized to receive either placebo (n = 75), or 50 mg (n = 82), 100 mg (n = 74), 200 mg (n = 77) or 300 mg canagliflozin (n = 75). At week 12, significant reductions in HbA1c were observed in all canagliflozin groups relative to placebo (−0.61, –0.80, –0.79 and −0.88% for 50, 100, 200 and 300 mg, respectively, versus +0.11% for placebo; all, p < 0.01). FPG and postprandial glycaemic parameters improved significantly in the canagliflozin groups. Body weight was significantly decreased by canagliflozin. No deaths or drug-related serious AEs were reported. There was no dose-dependent increase in the incidence of AEs in the canagliflozin groups. The incidence of hypoglycaemia was low; episodes were not severe or dose dependent. Canagliflozin did not affect serum creatinine levels or the urinary albumin/creatinine ratio. Conclusions Treatment with canagliflozin for 12 weeks significantly improved glycaemic control and reduced body weight in Japanese patients with T2DM. Canagliflozin was well tolerated. PMID:23782594

  3. Effect of an integrated community-based package for maternal and newborn care on feeding patterns during the first 12 weeks of life: a cluster-randomized trial in a South African township

    PubMed Central

    Ijumba, Petrida; Doherty, Tanya; Jackson, Debra; Tomlinson, Mark; Sanders, David; Swanevelder, Sonja; Persson, Lars-Åke

    2015-01-01

    Objective To analyse the effect of community-based counselling on feeding patterns during the first 12 weeks after birth, and to study whether the effect differs by maternal HIV status, educational level or household wealth. Design Cluster-randomized trial with fifteen clusters in each arm to evaluate an integrated package providing two pregnancy and five postnatal home visits delivered by community health workers. Infant feeding data were collected using 24 h recall of nineteen food and fluid items. Setting A township near Durban, South Africa. Subjects Pregnant women (1894 intervention and 2243 control) aged 17 yearsor more. Results Twelve weeks after birth, 1629 (intervention) and 1865 (control) mother–infant pairs were available for analysis. Socio-economic conditions differed slightly across intervention groups, which were considered in the analyses. There was no effect on early initiation of breast-feeding. At 12 weeks of age the intervention doubled exclusive breast-feeding (OR=2·29; 95 % CI 1·80, 2·92), increased exclusive formula-feeding (OR=1·70; 95 % CI 1·28, 2·27), increased predominant breast-feeding (OR=1·71; 95 % CI 1·34, 2·19), decreased mixed formula-feeding (OR=0·68; 95 % CI 0·55, 0·83) and decreased mixed breast-feeding (OR=0·54; 95 % CI 0·44, 0·67). The effect on exclusive breast-feeding at 12 weeks was stronger among HIV-negative mothers than HIV-positive mothers (P=0·01), while the effect on mixed formula feeding was significant only among HIV-positive mothers (P=0·03). The effect on exclusive feeding was not different by household wealth or maternal education levels. Conclusions A perinatal intervention package delivered by community health workers was effective in increasing exclusive breast-feeding, exclusive formula feeding and decreasing mixed feeding. PMID:25660465

  4. Effect of ginger powder supplementation on nitric oxide and C-reactive protein in elderly knee osteoarthritis patients: A 12-week double-blind randomized placebo-controlled clinical trial.

    PubMed

    Naderi, Zahra; Mozaffari-Khosravi, Hassan; Dehghan, Ali; Nadjarzadeh, Azadeh; Huseini, Hassan Fallah

    2016-07-01

    There is limited evidence that ginger ( shēng jiāng) powder consumption can relieve pain and inflammation because of its special phytochemical properties. This study is aimed at investigating the effect of ginger powder supplementation on some inflammatory markers in patients suffering from knee osteoarthritis. This is a double-blind randomized placebo-controlled clinical trial with a follow-up period of 3 months that was conducted on 120 outpatients with moderately painful knee osteoarthritis. Patients were randomly divided up into two groups: ginger group (GG) or placebo group (PG). Both groups received two identical capsules on a daily basis for 3 months. Each ginger capsule contained 500 mg of ginger powder; the placebo capsules had 500 mg of starch in them. Serum samples were collected prior to and after the intervention and were stored at -70 °C until the end of the study. Serum concentration of nitric oxide (NO) and hs-C reactive protein (hs-CRP) were measured using enzyme-linked immunosorbent assay kits. There was no significant difference between the two groups in terms of inflammatory markers (i.e., NO and hs-CRP) prior to the intervention. However, after 3 months of supplementation, serum concentration of NO and hs-CRP decreased in the GG. After 12 weeks, the concentration of these markers declined more in the GG than in the PG. Ginger powder supplementation at a dose of 1 g/d can reduce inflammatory markers in patients with knee osteoarthritis, and it thus can be recommended as a suitable supplement for these patients. PMID:27419081

  5. Doenjang, a Korean fermented soy food, exerts antiobesity and antioxidative activities in overweight subjects with the PPAR-γ2 C1431T polymorphism: 12-week, double-blind randomized clinical trial.

    PubMed

    Cha, Youn-Soo; Park, Yongsoon; Lee, Myoungsook; Chae, Soo-Wan; Park, Kungmin; Kim, Yeonsoo; Lee, Haeng-Shin

    2014-01-01

    We examined the antiobesity and antioxidant effects of supplementation with doenjang, a fermented soybean paste, in overweight Koreans with the PPAR-γ2 C1431T polymorphism. Sixty overweight subjects were randomly assigned to consume either 9.8 g/day of doenjang or placebo for 12 weeks. Before and after the intervention, anthropometric and metabolic parameters, along with abdominal fat distribution and PPAR-γ2 polymorphisms, were measured. Fifty-one subjects completed the study, doenjang (n=26) and placebo (n=25) groups. Relative frequencies of the PPAR-γ2 genotypes CC, TC, and TT were 70% (n=41), 25.9% (15), and 3.4% (2), whereas those of the PPAR-γ2 alleles C and T were 81.6% and 18.4%. Visceral fat area (VFA) was significantly decreased by doenjang supplementation in subjects with a mutant T allele of PPAR-γ2 compared to those with a C allele after adjusting for age, sex, and body mass index. Plasma free fatty acid, insulin, and homeostatic model assessment insulin resistance (HOMA-IR) levels were also significantly increased in the doenjang group. Doenjang pills significantly activated radical clearance capacity (ORAC and DNA tail length) in subjects with the C allele. The catalase (CAT) activity was increased twofold in the doenjang-treated group with the C allele, but this phenomenon was reversed in those with the T allele. Doenjang-treated subjects tended to have low dietary carbohydrate and sodium intakes compared with those given placebo. We found that doenjang supplementation decreased visceral fat accumulation and aging most effectively in subjects with PPAR-γ polymorphisms. This study suggests that doenjang has antiobesity and antioxidative effects in overweight individuals with mutant alleles of PPAR-γ2. PMID:24456362

  6. Improving Parental Stress Levels Among Mothers Living with HIV: A Randomized Control Group Intervention Study

    PubMed Central

    Johnson, Erica R.; Davies, Susan L.; Aban, Inmaculada; Mugavero, Michael J.; Shrestha, Sadeep

    2015-01-01

    Abstract Limited knowledge exists regarding parenting efficacy interventions for mothers living with HIV (MLH). This study evaluated the impact of a supportive group intervention on lowering parenting stress among MLH. Eighty MLH were randomized to a parenting (N=34) or health focused (control) (N=46) group intervention. Pre- and post-intervention stress levels were assessed using the Parental Stress Index-Short Form (PSI/SF). Differences in PSI/SF scores were examined using ANOVA, and predictors of PSI/SF scores were evaluated using multivariable linear regression. Findings indicate that both groups experienced significant decreases in parenting stress from baseline to post-intervention (p=0.0001), with no significant differences between interventions. At baseline, 41% of participants were identified as highly stressed and 30% as clinically stressed, with PSI/SF scores above the 85th and 90th percentile, respectively. Amongst the highly stressed subpopulation, significant improvements in PSI/SF scores for Parental Distress PSI/SF (p=0.039), Difficult Child PSI/SF (p=0.048), and total PSI/SF (p=0.036) were seen, with greater improvements in the parenting intervention. Among the clinically stressed subpopulation, significant improvements in total post-intervention PSI/SF scores were seen (p=0.049), with greater improvements in the parenting intervention. Results indicate that screening for high levels of stress should be considered in clinical practice to effectively implement stress-reducing interventions among MLH. PMID:25734870

  7. Attachment-Focused Integrative Reminiscence with Older African-Americans: A Randomized Controlled Intervention Study

    PubMed Central

    Henderson, Charles R.; Kang, Suk-Young; Pillemer, Karl

    2015-01-01

    Objectives Prior integrative reminiscence interventions have had a limited focus on attachment themes. The Attachment-Focused Integrative Reminiscence (AFIR) intervention differs from these in its central emphasis on attachment themes. The wide range of health benefits resulting from integrative reminiscence may be due in part to reminiscing about, mourning, and integrating unresolved attachment experiences. Method Participants were randomized into treatment and wait-list control conditions; completed a pre-test; met for 8 consecutive weekly 2-hour sessions of largely attachment-focused reminiscence; then completed post-tests immediately following the intervention and again 6 months later. Results Results show treatment effects for depression (p = .01 and .05 at 8 weeks and 6 months), perceived stress (p = .01 and .04), and emergency room (ER) visits at 6 months (p = .04), with the intervention group showing lower depression and stress and fewer ER visits. Conclusion Integrative reminiscence interventions are cost-effective, have rapid impact, and carry a certain appeal to older adults. Augmenting such interventions with a focus on attachment experiences may reduce perceived stress, an important health risk factor. Wider application of AFIRs may further reduce health disparities among U.S. older adults. PMID:25812080

  8. Radon balneotherapy and physical activity for osteoporosis prevention: a randomized, placebo-controlled intervention study.

    PubMed

    Winklmayr, Martina; Kluge, Christian; Winklmayr, Wolfgang; Küchenhoff, Helmut; Steiner, Martina; Ritter, Markus; Hartl, Arnulf

    2015-03-01

    Low-dose radon hyperthermia balneo treatment (LDRnHBT) is applied as a traditional measure in the non-pharmacological treatment of rheumatic diseases in Europe. During the last decades, the main approach of LDRnHBT was focused on the treatment of musculoskeletal disorders, but scientific evidence for the biological background of LDRnHBT is weak. Recently, evidence emerged that LDRnHBT influences bone metabolism. We investigated, whether combined LDRnHBT and exercise treatment has an impact on bone metabolism and quality of life in a study population in an age group at risk for developing osteoporosis. This randomized, double-blind, placebo-controlled trial comprised guided hiking tours and hyperthermia treatment in either radon thermal water (LDRnHBT) or radon-free thermal water (PlaceboHBT). Markers of bone metabolism, quality of life and somatic complaints were evaluated. Statistics was performed by linear regression and a linear mixed model analysis. Significant changes over time were observed for most analytes investigated as well as an improvement in self-assessed health in both groups. No significant impact from the LDRnHBT could be observed. After 6 months, the LDRnHBT group showed a slightly stronger reduction of the osteoclast stimulating protein receptor activator of nuclear kB-ligand compared to the PlaceboHBT group, indicating a possible trend. A combined hyperthermia balneo and exercise treatment has significant immediate and long-term effects on regulators of bone metabolism as well as somatic complaints. LDRnHBT and placeboHBT yielded statistically equal outcomes.

  9. Protocol: the effect of 12 weeks of Tai Chi practice on anxiety in healthy but stressed people compared to exercise and wait-list comparison groups: a randomized controlled trial.

    PubMed

    Zheng, Shuai; Lal, Sara; Meier, Peter; Sibbritt, David; Zaslawski, Chris

    2014-06-01

    Stress is a major problem in today's fast-paced society and can lead to serious psychosomatic complications. The ancient Chinese mind-body exercise of Tai Chi may provide an alternative and self-sustaining option to pharmaceutical medication for stressed individuals to improve their coping mechanisms. The protocol of this study is designed to evaluate whether Tai Chi practice is equivalent to standard exercise and whether the Tai Chi group is superior to a wait-list control group in improving stress coping levels. This study is a 6-week, three-arm, parallel, randomized, clinical trial designed to evaluate Tai Chi practice against standard exercise and a Tai Chi group against a nonactive control group over a period of 6 weeks with a 6-week follow-up. A total of 72 healthy adult participants (aged 18-60 years) who are either Tai Chi naïve or have not practiced Tai Chi in the past 12 months will be randomized into a Tai Chi group (n = 24), an exercise group (n = 24) or a wait-list group (n = 24). The primary outcome measure will be the State Trait Anxiety Inventory with secondary outcome measures being the Perceived Stress Scale 14, heart rate variability, blood pressure, Short Form 36 and a visual analog scale. The protocol is reported using the appropriate Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) items.

  10. Changes in Physical Activity and Sedentary Behavior in a Randomized Trial of an Internet-Based Versus Workbook-Based Family Intervention Study

    PubMed Central

    Catenacci, Victoria; Barrett, Christopher; Odgen, Lorraine; Browning, Ray; Schaefer, Christine Adele; Hill, James; Wyatt, Holly

    2015-01-01

    Background The America on the Move (AOM) Family Intervention Program has been shown to prevent excess weight gain in overweight children. Providing intervention materials via the internet would have the potential to reach more families but may increase sedentary behavior. The purpose was to evaluate whether delivering the AOM Family Intervention via the internet versus printed workbook would have a similar impact on sedentary behaviors in children. Methods 131 children (age 8–12) were randomized to receive the AOM Family Intervention via the internet or workbook for 12 weeks. Changes in objectively measured sedentary time and moderate-to vigorous physical activity (MVPA) as well as self-reported screen time were compared between groups. Results There were no significant differences between groups in screen time, sedentary time, or MVPA at the end of the 12 week intervention. Families receiving the intervention via the internet were more likely to remain in the study (98% vs. 82%, P = .016). Conclusions Using the internet to deliver the lifestyle intervention did not increase sedentary behavior in children. Attrition rates were lower when the program was delivered by internet versus via printed materials. These results provide support for using the internet to deliver healthy lifestyle programs for children. PMID:23364318

  11. Effect of 12 weeks of wrist and forearm training on high school baseball players.

    PubMed

    Szymanski, David J; Szymanski, Jessica M; Molloy, Joseph M; Pascoe, David D

    2004-08-01

    This study examined the effect of 12 weeks of wrist and forearm training on male high school baseball players (mean age = 15.3 +/- 1.1 years). Participants (N = 43) were tested for 10 repetition maximum (RM) wrist barbell flexion, wrist barbell extension, dominant (D) and nondominant (ND) hand-forearm supination, D and ND forearm pronation, D and ND wrist radial deviation, D and ND wrist ulnar deviation, D and ND grip strength, and a 3RM parallel squat (PS) and bench press (BP). Group 1 (n = 23) and group 2 (n = 20), randomly assigned by a stratified sampling technique, performed the same resistance exercises while training 3 days a week for 12 weeks according to a stepwise periodized model. Group 2 also performed wrist and forearm exercises 3 days a week for 12 weeks to determine if additional wrist and forearm training provided further wrist and forearm strength improvements. All wrist and forearm strength variables were measured before and after 12 weeks of training. The 3RM PS and BP were measured at 0 and after 4, 8, and 12 weeks of training. Both groups significantly increased wrist and forearm strength (kg +/- SD) except 10RM D and ND forearm supination for group 1 (p < 0.05). Group 2 showed statistically greater improvements (p < 0.05) in all wrist and forearm strength variables than did group 1 except for D and ND grip strength. Predicted 1RM (kg +/- SD) PS and BP increased significantly (p < 0.05) after weeks 4, 8, and 12 for both groups. These data indicate that a 12-week stepwise periodized training program can significantly increase wrist, forearm, PS, and BP strength for both groups. Additionally, group 2 had further wrist and forearm strength gains.

  12. Factors Associated with High Use of a Workplace Web-Based Stress Management Program in a Randomized Controlled Intervention Study

    ERIC Educational Resources Information Center

    Hasson, H.; Brown, C.; Hasson, D.

    2010-01-01

    In web-based health promotion programs, large variations in participant engagement are common. The aim was to investigate determinants of high use of a worksite self-help web-based program for stress management. Two versions of the program were offered to randomly selected departments in IT and media companies. A static version of the program…

  13. A Randomized Intervention Study to Evaluate Whether Electronic Messaging Can Increase Human Papillomavirus Vaccine Completion and Knowledge among College Students

    ERIC Educational Resources Information Center

    Richman, Alice R.; Maddy, LaDonna; Torres, Essie; Goldberg, Ellen J.

    2016-01-01

    Objective: To evaluate an intervention aimed at increasing human papillomavirus (HPV) vaccine completion of the 3-dose series and knowledge. Participants: Two hundred sixty-four male and female US college students 18-26 years old who were receiving HPV vaccine dose 1. Methods: Students were randomly assigned to the intervention or control group.…

  14. Improving the Design of Science Intervention Studies: An Empirical Investigation of Design Parameters for Planning Group Randomized Trials

    ERIC Educational Resources Information Center

    Westine, Carl; Spybrook, Jessaca

    2013-01-01

    The capacity of the field to conduct power analyses for group randomized trials (GRTs) of educational interventions has improved over the past decade (Authors, 2009). However, a power analysis depends on estimates of design parameters. Hence it is critical to build the empirical base of design parameters for GRTs across a variety of outcomes and…

  15. Prevention of gestational diabetes through lifestyle intervention: study design and methods of a Finnish randomized controlled multicenter trial (RADIEL)

    PubMed Central

    2014-01-01

    Background Maternal overweight, obesity and consequently the incidence of gestational diabetes are increasing rapidly worldwide. The objective of the study was to assess the efficacy and cost-effectiveness of a combined diet and physical activity intervention implemented before, during and after pregnancy in a primary health care setting for preventing gestational diabetes, later type 2 diabetes and other metabolic consequences. Methods RADIEL is a randomized controlled multi-center intervention trial in women at high risk for diabetes (a previous history of gestational diabetes or prepregnancy BMI ≥30 kg/m2). Participants planning pregnancy or in the first half of pregnancy were parallel-group randomized into an intervention arm which received lifestyle counseling and a control arm which received usual care given at their local antenatal clinics. All participants visited a study nurse every three months before and during pregnancy, and at 6 weeks, 6 and 12 months postpartum. Measurements and laboratory tests were performed on all participants with special focus on dietary and exercise habits and metabolic markers. Of the 728 women [mean age 32.5 years (SD 4.7); median parity 1 (range 0-9)] considered to be eligible for the study 235 were non-pregnant and 493 pregnant [mean gestational age 13 (range 6 to 18) weeks] at the time of enrollment. The proportion of nulliparous women was 29.8% (n = 217). Out of all participants, 79.6% of the non-pregnant and 40.4% of the pregnant women had previous gestational diabetes and 20.4% of the non-pregnant and 59.6% of the pregnant women were recruited because of a prepregnancy BMI ≥30 kg/m2. Mean BMI at first visit was 30.1 kg/m2 (SD 6.2) in the non-pregnant and 32.7 kg/m2 (SD 5.6) in the pregnant group. Discussion To our knowledge, this is the first randomized lifestyle intervention trial, which includes, besides the pregnancy period, both the prepregnancy and the postpartum period. This study design also

  16. Efficacy of a Multicomponent Positive Psychology Self-Help Intervention: Study Protocol of a Randomized Controlled Trial

    PubMed Central

    Drossaert, Constance HC; Pieterse, Marcel E; Walburg, Jan A; Bohlmeijer, Ernst T

    2015-01-01

    Background Positive psychology interventions have been found to enhance well-being and decrease clinical symptomatology. However, it is still unknown how flourishing can also be increased. Although multicomponent interventions seem to be necessary for this purpose, different formats can be used. A cost-effective approach could be a positive psychology-based self-help book with tailored email support to reach large target groups and to prevent dropout. Objective This study will evaluate the efficacy of a comprehensive multicomponent self-help intervention with or without email support on well-being and flourishing, and will seek to determine the working mechanisms underlying the intervention. Methods In this 3-armed, parallel, randomized controlled trial, 396 participants with low or moderate levels of well-being and without clinical symptomatology will be randomly assigned to (1) a self-help book condition with weekly email support, (2) a self-help book condition without email support but with a weekly information email, or (3) a waiting list control condition. Online measurements will be assessed at baseline, at post-test (3 months after baseline), and at 6 and 12 months after baseline. Results The primary outcomes are well-being and flourishing (ie, high levels of well-being). Secondary outcomes are the well-being components included in the intervention: positive emotion, use of strengths, optimism, self-compassion, resilience, and positive relations. Other measures include depressive and anxiety symptoms, personality traits, direct medical and non-medical costs, life-events, and client satisfaction. Conclusions This study will add knowledge to the efficacy and cost-effectiveness of a multicomponent positive psychology intervention. We will also explore who can benefit most from this intervention. If the intervention is found to be effective, our results will be especially relevant for public mental health services, governments, and primary care. Trial

  17. Effects of a Randomized Reading Intervention Study Aimed at 9-Year-Olds: A 5-Year Follow-up.

    PubMed

    Wolff, Ulrika

    2016-05-01

    The present paper reports on a 5-year follow-up of a randomized reading intervention in grade 3 in Sweden. An intervention group (n = 57) received daily training for 12 weeks in phoneme/grapheme mapping, reading comprehension and reading speed, whereas a control group (n = 55) participated in ordinary classroom activities. The main aim was to investigate if there were remaining effects of the intervention on reading-related skills. Previous analyses showed that the intervention group performed significantly better than the control group on spelling, reading speed, reading comprehension and phoneme awareness at the immediate post-test with sustained effects 1 year later. Results from the 5-year follow-up show that the only significant difference between the intervention (n = 47) and the control group (n = 37) was on word decoding. There was also a significant interaction effect of group assignment and initial word decoding, in the way that the lowest-performing students benefitted the most from the intervention. Another aim was to examine if the children identified in a screening (n = 2212) as poor readers in grade 2 still performed worse than typical readers. The analyses showed that the typically developing students (n = 66) outperformed the students identified as poor readers in grade 2 on working memory, spelling, reading comprehension and word decoding. Copyright © 2016 John Wiley & Sons, Ltd. PMID:27146373

  18. Factors associated with high use of a workplace web-based stress management program in a randomized controlled intervention study.

    PubMed

    Hasson, H; Brown, C; Hasson, D

    2010-08-01

    In web-based health promotion programs, large variations in participant engagement are common. The aim was to investigate determinants of high use of a worksite self-help web-based program for stress management. Two versions of the program were offered to randomly selected departments in IT and media companies. A static version of the program including health screening tool, diary and information about stress was offered to the control group. Additional materials, i.e. interactive, cognitive-based and classical stress management exercises and a chat room, were offered to the intervention group. Baseline data regarding participants' demographics, health (self-ratings and biological measures), lifestyle, work-related factors and group membership were analyzed to study determinants of employees' participation in the program during a period of 12 months. Multiple logistic regression analysis was used and found intervention group membership, being a woman, having at most a secondary education, regular physical exercise habits and having positive expectations of the program were significant predictors of high use. The findings demonstrate that the interactivity of a web-based program is an important factor for determining participation in a web-based worksite stress management program. Implications for those developing and implementing future web-based health promotion activities are discussed. PMID:20150531

  19. The First Intervention Study in Elder Self-Neglect: A Randomized Clinical Trial to Improve Vitamin D Levels

    NASA Technical Reports Server (NTRS)

    Burnett, Jason; Hochschild, Ann; Smith, Scott M.; Diamond, Pam; Stotts, Angela; Dyer, Carmel

    2011-01-01

    Despite high mortality rates, elder self-neglect is characterized by refusal of medical and social interventions. To date there have been no tested clinical interventions in elders who self-neglect. Previous research from the TEAM Institute has shown significantly low vitamin D levels in this population. This study aimed to determine the feasibility of a clinical intervention. Replacement of vitamin D was chosen because of its ease of administration and favorable safety profile. Methods: A randomized clinical trial using directly observed therapy of vitamin D was conducted using 50 elders, >65 years of age, with Adult Protective Services (APS) validated self-neglect. A staggered intervention with waiting controls was used to maximize statistical power. One-third (n=17) of the group was administered 50,000 IU vitamin D2 (ergocalciferol) monthly and the remainder (n=33) were administered 400 IU monthly. Serum 25-OH vitamin D was assessed at baseline and 5-months. Results: 69% agreed to participate in the study and of those n=40 (80%) remained at 5-months. At baseline, 12% (n=7) were deficient in vitamin D (<30nmol/L) and approximately 38% (n=22) had inadequate vitamin D levels (<50nmol/L). The baseline 25-OH vitamin D level was 59 nmol/L +25 (mean SD), and increased significantly to 72nmol/L +21 nmol/L at 5-months. Conclusion: These data are the first to provide evidence that clinical interventions are feasible in elders who self-neglect. The increase in vitamin D levels confirmed that the study personnel were able to successfully intervene community-dwelling elders with self-neglect. This study sets the precedent for future intervention and prevention studies

  20. Recruitment and baseline characteristics of participants in the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER)-a randomized controlled lifestyle trial.

    PubMed

    Ngandu, Tiia; Lehtisalo, Jenni; Levälahti, Esko; Laatikainen, Tiina; Lindström, Jaana; Peltonen, Markku; Solomon, Alina; Ahtiluoto, Satu; Antikainen, Riitta; Hänninen, Tuomo; Jula, Antti; Mangialasche, Francesca; Paajanen, Teemu; Pajala, Satu; Rauramaa, Rainer; Strandberg, Timo; Tuomilehto, Jaakko; Soininen, Hilkka; Kivipelto, Miia

    2014-09-10

    Our aim is to describe the study recruitment and baseline characteristics of the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) study population. Potential study participants (age 60-77 years, the dementia risk score ≥ 6) were identified from previous population-based survey cohorts and invited to the screening visit. To be eligible, cognitive performance measured at the screening visit had to be at the mean level or slightly lower than expected for age. Of those invited (n = 5496), 48% (n = 2654) attended the screening visit, and finally 1260 eligible participants were randomized to the intervention and control groups (1:1). The screening visit non-attendees were slightly older, less educated, and had more vascular risk factors and diseases present. The mean (SD) age of the randomized participants was 69.4 (4.7) years, Mini-Mental State Examination 26.7 (2.0) points, systolic blood pressure 140.1 (16.2) mmHg, total serum cholesterol 5.2 (1.0) mmol/L for, and fasting glucose 6.1 (0.9) mmol/L for, with no difference between intervention and control groups. Several modifiable risk factors were present at baseline indicating an opportunity for the intervention. The FINGER study will provide important information on the effect of lifestyle intervention to prevent cognitive impairment among at risk persons.

  1. Chronic flexibility improvement after 12 week of stretching program utilizing the ACSM recommendations: hamstring flexibility.

    PubMed

    Sainz de Baranda, P; Ayala, F

    2010-06-01

    The ACSM flexibility training recommendations emphasize proper stretching of muscles supporting the major joints, but there is a little evidence to support this recommendation in terms of effectiveness, and which stretching parameters (technique and single stretch duration) are more adequate. A randomized controlled clinical trial design was use to investigate whether the ACSM flexibility training recommendation parameters improve hip flexion range of motion. A total of 173 subjects, 122 men (21.3+/-2.5 years; 176.33+/-8.35 cm; 74.42+/-10.80 kg) and 51 women (20.7+/-1.6 years; 163.43+/-6.57 cm; 60.12+/-7.88 kg), classified as recreationally active young adult university students were randomly assigned to 1 of 7 groups: 1 control group (no stretching) or 1 of 6 stretching groups. All stretching groups performed 12 weeks of flexibility training with a consistent stretch daily dose (180 s) and frequency (3 days per week) parameters and different stretch technique (passive or active) and single stretch duration (15, 30, or 45 s). Hip flexion passive range of motion (PROM) was determined through the bilateral straight-leg raise test before, during (at 4 and 8 weeks), and after the program (12 weeks). All stretching groups performed hip flexion PROM after flexibility training. A significant improvement was identified in mean PROM for each stretching group, but no significant differences were found between stretch technique and single stretch duration (p>0.05). The control group's mean PROM decreased (Delta PROM: -0.08 degrees, 95% confidence interval [CI]=-2.3 to 5.3), whereas all stretching groups increased PROM (Delta PROM: 15.14 degrees, 95% CI=10.19 to 23.56) in hip flexion after 12 weeks of stretching (p<0.05). The present study suggests that the current ACSM flexibility training recommendations are effective for improving hip flexion ROM in recreationally active young adults.

  2. A Cluster-Randomized Controlled Intervention Study to Assess the Effect of a Contact Intervention in Reducing Leprosy-Related Stigma in Indonesia

    PubMed Central

    Peters, Ruth M. H.; Dadun; Zweekhorst, Marjolein B. M.; Bunders, Joske F. G.; Irwanto; van Brakel, Wim H.

    2015-01-01

    Background Can deliberate interaction between the public and persons affected by leprosy reduce stigmatization? The study described in this paper hypothesises that it can and assesses the effectiveness of a ‘contact intervention’. Methods/Principal Findings This cluster-randomized controlled intervention study is part of the Stigma Assessment and Reduction of Impact (SARI) project conducted in Cirebon District, Indonesia. Testimonies, participatory videos and comics given or made by people affected by leprosy were used as methods to facilitate a dialogue during so-called ‘contact events’. A mix of seven quantitative and qualitative methods, including two scales to assess aspects of stigma named the SDS and EMIC-CSS, were used to establish a baseline regarding stigma and knowledge of leprosy, monitor the implementation and assess the impact of the contact events. The study sample were community members selected using different sampling methods. The baseline shows a lack of knowledge about leprosy, a high level of stigma and contrasting examples of support. In total, 91 contact events were organised in 62 villages, directly reaching 4,443 community members (mean 49 per event). The interview data showed that knowledge about leprosy increased and that negative attitudes reduced. The adjusted mean total score of the EMIC-CSS reduced by 4.95 points among respondents who had attended a contact event (n = 58; p <0.001, effect size = 0.75) compared to the score at baseline (n = 213); for the SDS this was 3.56 (p <0.001, effect size = 0.81). About 75% of those attending a contact event said they shared the information with others (median 10 persons). Conclusions/Significance The contact intervention was effective in increasing knowledge and improving public attitudes regarding leprosy. It is relatively easy to replicate elsewhere and does not require expensive technology. More research is needed to improve scalability. The effectiveness of a contact intervention to

  3. Randomized intervention study of solar disinfection of drinking water in the prevention of dysentery in Kenyan children aged under 5 years.

    PubMed

    du Preez, Martella; Conroy, Ronan M; Ligondo, Sophie; Hennessy, James; Elmore-Meegan, Michael; Soita, Allan; McGuigan, Kevin G

    2011-11-01

    We report the results of a randomized controlled intervention study (September 2007 to March 2009) investigating the effect of solar disinfection (SODIS) of drinking water on the incidence of dysentery, nondysentery diarrhea, and anthropometric measurements of height and weight among children of age 6 months to 5 years living in peri-urban and rural communities in Nakuru, Kenya. We compared 555 children in 404 households using SODIS with 534 children in 361 households with no intervention. Dysentery was recorded using a pictorial diary. Incidence rate ratios (IRR) for both number of days and episodes of dysentery and nondysentery diarrhea were significantly (P < 0.001) reduced by use of solar disinfection: dysentery days IRR = 0.56 (95% CI 0.40 to 0.79); dysentery episodes IRR = 0.55 (95% CI 0.42 to 0.73); nondysentery days IRR = 0.70 (95% CI 0.59 to 0.84); nondysentery episodes IRR = 0.73 (95% CI 0.63 to 0.84). Anthropometry measurements of weight and height showed median height-for-age was significantly increased in those on SODIS, corresponding to an average of 0.8 cm over a 1-year period over the group as a whole (95% CI 0.7 to 1.6 cm, P = 0.031). Median weight-for-age was higher in those on SODIS, corresponding to a 0.23 kg difference in weight over the same period; however, the confidence interval spanned zero and the effect fell short of statistical significance (95% CI -0.02 to 0.47 kg, P = 0.068). SODIS and control households did not differ in the microbial quality of their untreated household water over the follow-up period (P = 0.119), but E. coli concentrations in SODIS bottles were significantly lower than those in storage containers over all follow-up visits (P < 0.001). This is the first trial to show evidence of the effect of SODIS on childhood anthropometry, compared with children in the control group and should alleviate concerns expressed by some commentators that the lower rates of dysentery associated with SODIS are the product of biased

  4. Intake of Novel Red Clover Supplementation for 12 Weeks Improves Bone Status in Healthy Menopausal Women

    PubMed Central

    Thorup, Anne Cathrine; Lambert, Max Norman; Kahr, Henriette Strøm; Bjerre, Mette; Jeppesen, Per Bendix

    2015-01-01

    Objective. To investigate the effect by which daily consumption of a novel red clover (RC) extract influences bone health, inflammatory status, and cardiovascular health in healthy menopausal women. Design. A 12-week randomized, double-blinded, placebo-controlled trial involving 60 menopausal women receiving a daily dose of 150 mL RC extract containing 37.1 mg isoflavones (33.8 mg as aglycones) or placebo. Methods. Bone parameters were changes in bone mineral density (BMD), bone mineral content (BMC), and T-score at the lumbar spine and femoral neck. Bone turnover (CTx) and inflammatory markers were measured in plasma and finally blood pressure (BP) was evaluated. Results. RC extract had positive effect on bone health, and only the women receiving the placebo experienced a decline in BMD (p < 0.01) at the lumbar spine. T-score at the lumbar spine only decreased in the placebo group (p < 0.01). CTx decreased in the RC group with −9.94 (±4.93)%, although not significant. Conclusion. Daily consumption of RC extract over a 12-week period was found to have a beneficial effect on bone health in menopausal women based on BMD and T-score at the lumbar spine and plasma CTx levels. No changes in BP or inflammation markers were found and no side effects were observed. PMID:26265926

  5. The efficacy of 12 weeks supervised exercise in obesity management.

    PubMed

    Herring, L Y; Wagstaff, C; Scott, A

    2014-08-01

    The objective of this randomized controlled trial was to investigate the effect of adding either aerobic training (AT) or resistance training (RT) to a multidisciplinary teamed (MDT) educational weight management programme on the health-related fitness of morbidly obese individuals. Males (n = 9) and females (n = 24) aged between 24 and 68 years with a body mass index (BMI) of ≥40 kg m(2) (≥35 kg m(2) with comorbidities) undertaking a weight management programme were recruited (Completion: M = 8, F = 19). Participants were randomly allocated to either AT (n = 12), RT (n = 11) or CON (n = 10). AT and RT undertook three structured ∼60 min moderate intensity sessions weekly, two supervised gym-based and one structured home-based session for 12 weeks; CON undertook usual care alone. Anthropometric, psychological and functional capacity measures were obtained pre- and post-intervention. Both exercise interventions elicited improvements compared with CON in the: shuttle walk test (AT [Δ 207.0 ± 123.0 metres, 68.0%, P = 0.04], RT [Δ 165.0 ± 183.3 m, 48.8%, P = 0.06], CON [Δ -14.3 ± 38.7 m, -6.2%]), triceps skin-fold (P ≤ 0.001), self-efficacy (P = 0.005) and interest/enjoyment (P = 0.006). RT displayed additional improvements compared with CON in BMI (RT [Δ -1.02 ± 0.91 kg·m(2) , -2.5%, P = 0.033], AT [Δ -1.84 ± 2.70 kg·m(2) , -4.3%, P = 0.142], CON [Δ -0.31 ± 1.47 kg·m(2) , -0.6%]), waist circumference (P = 0.022), competence (P = 0.019), biceps skin-fold (P = 0.012) and medial calf skin-fold (P = 0.013). No significant differences were observed between exercise modalities. Regardless of exercise mode, the addition of supervised and structured exercise to a MDT weight management programme significantly improved anthropometric, functional and psychological measures in obese participants with a BMI of ≥35 kg·m(2) . PMID

  6. The efficacy of 12 weeks supervised exercise in obesity management.

    PubMed

    Herring, L Y; Wagstaff, C; Scott, A

    2014-08-01

    The objective of this randomized controlled trial was to investigate the effect of adding either aerobic training (AT) or resistance training (RT) to a multidisciplinary teamed (MDT) educational weight management programme on the health-related fitness of morbidly obese individuals. Males (n = 9) and females (n = 24) aged between 24 and 68 years with a body mass index (BMI) of ≥40 kg m(2) (≥35 kg m(2) with comorbidities) undertaking a weight management programme were recruited (Completion: M = 8, F = 19). Participants were randomly allocated to either AT (n = 12), RT (n = 11) or CON (n = 10). AT and RT undertook three structured ∼60 min moderate intensity sessions weekly, two supervised gym-based and one structured home-based session for 12 weeks; CON undertook usual care alone. Anthropometric, psychological and functional capacity measures were obtained pre- and post-intervention. Both exercise interventions elicited improvements compared with CON in the: shuttle walk test (AT [Δ 207.0 ± 123.0 metres, 68.0%, P = 0.04], RT [Δ 165.0 ± 183.3 m, 48.8%, P = 0.06], CON [Δ -14.3 ± 38.7 m, -6.2%]), triceps skin-fold (P ≤ 0.001), self-efficacy (P = 0.005) and interest/enjoyment (P = 0.006). RT displayed additional improvements compared with CON in BMI (RT [Δ -1.02 ± 0.91 kg·m(2) , -2.5%, P = 0.033], AT [Δ -1.84 ± 2.70 kg·m(2) , -4.3%, P = 0.142], CON [Δ -0.31 ± 1.47 kg·m(2) , -0.6%]), waist circumference (P = 0.022), competence (P = 0.019), biceps skin-fold (P = 0.012) and medial calf skin-fold (P = 0.013). No significant differences were observed between exercise modalities. Regardless of exercise mode, the addition of supervised and structured exercise to a MDT weight management programme significantly improved anthropometric, functional and psychological measures in obese participants with a BMI of ≥35 kg·m(2) .

  7. Clinical pharmacology study of cariprazine (MP-214) in patients with schizophrenia (12-week treatment)

    PubMed Central

    Nakamura, Tadakatsu; Kubota, Tomoko; Iwakaji, Atsushi; Imada, Masayoshi; Kapás, Margit; Morio, Yasunori

    2016-01-01

    Purpose Cariprazine is a potent dopamine D3-preferring D3/D2 receptor partial agonist in development for the treatment of schizophrenia, bipolar mania, and depression. Pharmacokinetics of cariprazine and the two clinically relevant metabolites (desmethyl- and didesmethyl-cariprazine) was evaluated in a clinical pharmacology study. Methods This was a multicenter, randomized, open-label, parallel-group, fixed-dose (3, 6, or 9 mg/day) study of 28-week duration (≤4-week observation, 12-week open-label treatment, and 12-week follow-up). Once-daily cariprazine was administered to 38 adult patients with schizophrenia. The pharmacokinetics of cariprazine, metabolites, and total active moieties (sum of cariprazine and two metabolites) was evaluated; efficacy and safety were also assessed. Results Steady state was reached within 1–2 weeks for cariprazine and desmethyl-cariprazine, 4 weeks for didesmethyl-cariprazine, and 3 weeks for total active moieties. Cariprazine and desmethyl-cariprazine levels decreased >90% within 1 week after the last dose, didesmethyl-cariprazine decreased ~50% at 1 week, and total active moieties decreased ~90% within 4 weeks. Terminal half-lives of cariprazine, desmethyl-cariprazine, and didesmethyl-cariprazine ranged from 31.6 to 68.4, 29.7 to 37.5, and 314 to 446 hours, respectively. Effective half-life (calculated from time to steady state) of total active moieties was ~1 week. Incidence of treatment-emergent adverse events was 97.4%; 15.8% of patients discontinued due to adverse events. No abnormal laboratory values or major differences from baseline in extrapyramidal symptoms were observed. Conclusion Cariprazine and its active metabolites reached steady state within 4 weeks, and exposure was dose proportional over the range of 3–9 mg/day. Once-daily cariprazine was generally well tolerated in adult patients with schizophrenia. PMID:26834462

  8. Improved cognitive function in postmenopausal women after 12 weeks of consumption of a soya extract containing isoflavones.

    PubMed

    Duffy, Rosanna; Wiseman, Helen; File, Sandra E

    2003-06-01

    We previously reported that a high soya diet improved memory and frontal lobe function in young volunteers, and since soya isoflavones are agonists at oestrogen receptors, they may improve these functions in postmenopausal women. Thirty-three postmenopausal women (50-65 years) not receiving conventional hormone replacement therapy (HRT) were randomly allocated in a double-blind parallel study to receive a soya supplement (60 mg total isoflavone equivalents/day) or placebo for 12 weeks. They received a battery of cognitive tests and completed analogue rating scales of mood and sleepiness, and a menopausal symptoms questionnaire before the start of treatment and then after 12 weeks of treatment. Those receiving the isoflavone supplement showed significantly greater improvements in recall of pictures and in a sustained attention task. The groups did not differ in their ability to learn rules, but the isoflavone supplement group showed significantly greater improvements in learning rule reversals. They also showed significantly greater improvement in a planning task. There was no effect of treatment on menopausal symptoms, self-ratings of mood, bodily symptoms or sleepiness. Thus, significant cognitive improvements in postmenopausal women can be gained from 12 weeks of consumption of a supplement containing soya isoflavones that are independent of any changes in menopausal symptoms, mood or sleepiness.

  9. Effects of 12 weeks combined aerobic and resistance exercise on heart rate variability in type 2 diabetes mellitus patients.

    PubMed

    Kang, Seol-Jung; Ko, Kwang-Jun; Baek, Un-Hyo

    2016-07-01

    [Purpose] This study evaluated the effects of 12 weeks combined aerobic and resistance exercise on heart rate variability in patients with Type 2 diabetes mellitus. [Subjects and Methods] The subjects were 16 female patients with Type 2 diabetes mellitus selected among the participants of a chronic disease management exercise class at C Region Public Health Center in South Korea. Subjects were randomly assigned to the exercise group (n=8; age, 55.97 ± 7.37) or the control group (n=8; age, 57.53 ± 4.63) The exercise group performed aerobic and resistance exercises for 60 minutes per day, 3 times per week for 12 weeks. Anthropometric measurements, biochemical markers, physical fitness, and heart rate variability were examined. [Results] After 12 weeks of exercise, weight, body fat percentage, waist circumference, blood glucose, insulin resistance, glycated hemoglobin level, systolic blood pressure, and diastolic blood pressure significantly decreased and cardiorespiratory fitness and muscular strength significantly increased in the exercise group. Although heart rate variability measures showed favorable changes with the exercise program, none were significant. [Conclusion] Although the exercise program did not show notable changes in heart rate variability in patients with Type 2 diabetes within the timeframe of the study, exercise may contribute to the prevention and control of cardiovascular autonomic neuropathy. PMID:27512271

  10. Effects of 12 weeks combined aerobic and resistance exercise on heart rate variability in type 2 diabetes mellitus patients

    PubMed Central

    Kang, Seol-Jung; Ko, Kwang-Jun; Baek, Un-Hyo

    2016-01-01

    [Purpose] This study evaluated the effects of 12 weeks combined aerobic and resistance exercise on heart rate variability in patients with Type 2 diabetes mellitus. [Subjects and Methods] The subjects were 16 female patients with Type 2 diabetes mellitus selected among the participants of a chronic disease management exercise class at C Region Public Health Center in South Korea. Subjects were randomly assigned to the exercise group (n=8; age, 55.97 ± 7.37) or the control group (n=8; age, 57.53 ± 4.63) The exercise group performed aerobic and resistance exercises for 60 minutes per day, 3 times per week for 12 weeks. Anthropometric measurements, biochemical markers, physical fitness, and heart rate variability were examined. [Results] After 12 weeks of exercise, weight, body fat percentage, waist circumference, blood glucose, insulin resistance, glycated hemoglobin level, systolic blood pressure, and diastolic blood pressure significantly decreased and cardiorespiratory fitness and muscular strength significantly increased in the exercise group. Although heart rate variability measures showed favorable changes with the exercise program, none were significant. [Conclusion] Although the exercise program did not show notable changes in heart rate variability in patients with Type 2 diabetes within the timeframe of the study, exercise may contribute to the prevention and control of cardiovascular autonomic neuropathy. PMID:27512271

  11. Feasibility, acceptability and findings from a pilot randomized controlled intervention study on the impact of a book designed to inform patients about cancer clinical trials.

    PubMed

    Carney, Patricia A; Tucker, Erin K; Newby, Timothy A; Beer, Tomasz M

    2014-03-01

    This study was conducted to assess the feasibility, acceptability, and changes in knowledge among cancer patients assigned to receive a 160-page book on experimental cancer therapies and clinical trials. We enrolled 20 patients with cancer who had never participated in a clinical trial and randomly assigned them to receive the book either during week 1 or week 4 of the study. We collected baseline patient demographic and cancer-related information as well as knowledge about cancer clinical trials at week 0. Follow-up surveys were administered at weeks 3 and 6 for both study groups. Comparisons were made within and between groups randomized to receive the book early (at week 1) to those who received it later (at week 4). One hundred percent of data were captured in both groups at baseline, which decreased to 77.8% by week 6. The vast majority of participants found the book moderately or very useful (89% in the Early Group at week 3 and 95.5% in the Late Group at week 6). Within group pairwise comparisons found significant difference between baseline and week 6 in content-specific knowledge scores among participants in the Late Group [79% versus 92.1%, p = 0.01). Global knowledge scores increased significantly for variables reflecting knowledge that promotes decisions to participate in clinical trials. Providing published reading material to patients with cancer is both feasible and acceptable. Offering information to patients about cancer clinical trials, using a book designed for patients with cancer may influence knowledge related to decision to participate in clinical trials.

  12. A randomized double-blind intervention study on the effect of calcium supplementation on esophageal precancerous lesions in a high-risk population in China.

    PubMed

    Wang, L D; Qiu, S L; Yang, G R; Lipkin, M; Newmark, H L; Yang, C S

    1993-01-01

    To determine whether dietary calcium supplementation affects esophageal precancerous lesions, 200 subjects with esophageal lesions in a high-risk area for esophageal cancer in China (Huixian, Henan) were randomly divided into 2 groups (100 subjects/group). Subjects in one group received an oral supplementation of calcium carbonate tablets (1200 mg of calcium daily), and subjects in the other group received placebo pills for 11 months. At the entry and the end of the trial, esophagoscopy was performed, and 2 or 3 biopsy specimens were taken from the middle and lower thirds of the esophagus and from macroscopic lesions, if any, of each subject for histopathology and cell proliferation analysis with deoxythymidine labeling. In comparison to normal epithelium, increased proliferative compartment size was observed in epithelia with hyperplasia or dysplasia. After the intervention, the percentage of individuals with "normal epithelium," "basal cell hyperplasia," "basal cell hyperplasia II," and "basal cell hyperplasia III and dysplasia" were 44, 31, 13, and 11% in the calcium group and 35, 39, 17, and 6% in the placebo group, respectively. The labeling index was 0.046 in the calcium group and 0.044 in the placebo group. After the intervention, the labeling index in basal cell layers 1 to 5, the major zone of cell proliferation, fell 38% in the calcium group and 44% in the placebo group from before the intervention. Therefore, in this study, calcium supplementation was not shown to have beneficial effects in alleviating precancerous lesions and abnormal cell proliferation patterns.

  13. Skeletal muscle contractility, self-reported pain and tissue sensitivity in females with neck/shoulder pain and upper Trapezius myofascial trigger points– a randomized intervention study

    PubMed Central

    2012-01-01

    Background In relation to Myofascial Triggerpoints (MFTrPs) of the upper Trapezius, this study explored muscle contractility characteristics, the occurrence of post-intervention muscle soreness and the effect of dry needling on muscle contractile characteristics and clinical outcomes. Methods Seventy-seven female office workers (25-46yrs) with and without neck/shoulder pain were observed with respect to self-reported pain (NRS-101), pressure-pain threshold (PPT), maximum voluntary contraction (Fmax) and rate of force development (RFD) at baseline (pre-intervention), immediately post-intervention and 48 hours post-intervention. Symptomatic and asymptomatic participant groups were each randomized into two treatment sub-groups (superficial (SDN) and deep dry needling (DDN)) after baseline testing. At 48 hours post-intervention participants were asked whether delayed onset muscle soreness (DOMS) and/or post-needling soreness had developed. Results Muscle contractile characteristics did not differ between groups at baseline. Forty-six individuals developed muscle soreness (39 from mechanical testing and seven from needling). No inter-group differences were observed post-intervention for Fmax or RFD for the four sub-groups. Over the observation period, symptomatic participants reported less pain from both SDN (p= 0.003) and DDN (p=0.011). However, PPT levels were reduced for all participants (p=0.029). Those reporting DOMS experienced significant decreases in PPT, irrespective of symptom state or intervention (p=0.001). Conclusions In selected female neck/shoulder pain sufferers, maximum voluntary contraction and rapid force generation of the upper Trapezius was not influenced by clinically relevant self-reported pain or the presence of diagnostically relevant MFTrPs. Dry needling, deep or superficial, did not affect measured functional outcomes over the 48-hour observation period. DOMS affected participants uniformly irrespective of pain, MFTrP status or intervention

  14. Paraneoplastic (non-metastatic) adrenal insufficiency preceded the onset of primary lung cancer by 12 weeks.

    PubMed

    Shantha, Ghanshyam Palamaner Subash; Kumar, Anita A; Jeyachandran, Vijay; Rajamanickam, Deepan; Bhaskar, Emmanuel; Paniker, Vinod K; Abraham, Georgi

    2009-01-01

    Clinically evident adrenal insufficiency associated with lung cancer is a rare entity. Among reported cases, adrenal insufficiency has occurred with or succeeded the primary lung cancer. Adrenal insufficiency has also been secondary to metastasis to the adrenal gland. The present report concerns a 61-year-old man, a chronic smoker, who presented to us with symptomatic adrenal insufficiency. He had no evidence of lung cancer during this visit. The primary lung cancer was only identified 12 weeks later. Additionally, his adrenals showed no evidence of metastasis. Hence his adrenal insufficiency had been a paraneoplastic manifestation of the lung cancer, and it had also preceded the primary by 12 weeks.

  15. Paraneoplastic (non-metastatic) adrenal insufficiency preceded the onset of primary lung cancer by 12 weeks

    PubMed Central

    Shantha, Ghanshyam Palamaner Subash; Kumar, Anita A; Jeyachandran, Vijay; Rajamanickam, Deepan; Bhaskar, Emmanuel; Paniker, Vinod K; Abraham, Georgi

    2009-01-01

    Clinically evident adrenal insufficiency associated with lung cancer is a rare entity. Among reported cases, adrenal insufficiency has occurred with or succeeded the primary lung cancer. Adrenal insufficiency has also been secondary to metastasis to the adrenal gland. The present report concerns a 61-year-old man, a chronic smoker, who presented to us with symptomatic adrenal insufficiency. He had no evidence of lung cancer during this visit. The primary lung cancer was only identified 12 weeks later. Additionally, his adrenals showed no evidence of metastasis. Hence his adrenal insufficiency had been a paraneoplastic manifestation of the lung cancer, and it had also preceded the primary by 12 weeks. PMID:21686682

  16. Effects of 12-week medicine ball training on muscle strength and power in young female handball players.

    PubMed

    Ignjatovic, Aleksandar M; Markovic, Zivorad M; Radovanovic, Dragan S

    2012-08-01

    The purpose of this study was to examine the effects of medicine ball training on the strength and power in young female handball athletes. Twenty-one young female handball players (age, 16.9 ± 1.2 years) were randomly assigned to experimental and control groups. Experimental group (n = 11) participated in a 12-week medicine ball training program incorporated into the regular training session, whereas controls (n = 10) participated only in the regular training. Performance in the medicine ball throws in standing and sitting positions, 1 repetition maximum (1RM) bench and shoulder press, and power test at 2 different loads (30 and 50% of 1RM) on bench and shoulder press were assessed at pre- and posttraining testing. The athletes participating in the medicine ball training program made significantly greater gains in all medicine ball throw tests compared with the controls (p < 0.01). Also, the experimental group made significantly greater gains in bench and shoulder press power than control group (p < 0.05). Both training groups (E) and (C) significantly (p < 0.05) increased 1RM bench and shoulder strength, with no differences observed between the groups. Additionally, medicine ball throw tests showed stronger correlation with power tests, than with 1RM tests. These data suggest that 12-week medicine ball training, when incorporated into a regular training session, can provide greater sport-specific training improvements in the upper body for young female handball players. PMID:22027860

  17. The Effects of a 12-Week Walking Program on Community-Dwelling Older Adults

    ERIC Educational Resources Information Center

    Cheng, Shun-Ping; Tsai, Tzu-I; Lii, Yun-Kung; Yu, Shu; Chou, Chen-Liang; Chen, I-Ju

    2009-01-01

    Walking is a popular and easily accessible form of physical activity. However, walking instruction for older adults is based on the evidence gathered from younger populations. This study evaluated walking conditions, strength, balance, and subjective health status after a 12-week walking-training program in community-dwelling adults greater than…

  18. The Treatment for Adolescents with Depression Study (TADS): Methods and Message at 12 Weeks

    ERIC Educational Resources Information Center

    March, John; Silva, Susan; Vitiello, Benedetto

    2006-01-01

    Funded by the National Institute of Mental Health, the Treatment for Adolescents With Depression Study (TADS) is intended to evaluate the short-term (12 weeks) and longer-term (36 weeks) effectiveness of four treatments for adolescents with DSM-IV major depressive disorder: clinical management with fluoxetine (FLX), cognitive-behavioral therapy…

  19. Achondrogenesis type 2 diagnosed by transvaginal ultrasound at 12 weeks' gestation.

    PubMed

    Soothill, P W; Vuthiwong, C; Rees, H

    1993-06-01

    Ultrasound examination at 12 weeks' gestation revealed severe generalised subcutaneous oedema in a pregnancy at risk for achondrogenesis type II. Transvaginal scanning confirmed the oedema and suggested abnormal limb development. The prenatal diagnosis was confirmed by X-ray examination after transvaginal termination. PMID:8372079

  20. Early management of type 2 diabetes based on a SMBG strategy: the way to diabetes regression--the St Carlos study : a 3-year, prospective, randomized, clinic-based, interventional study with parallel groups.

    PubMed

    García de la Torre, Nuria; Durán, Alejandra; Del Valle, Laura; Fuentes, Manuel; Barca, Idoya; Martín, Patricia; Montañez, Carmen; Perez-Ferre, Natalia; Abad, Rosario; Sanz, Fuencisla; Galindo, Mercedes; Rubio, Miguel A; Calle-Pascual, Alfonso L

    2013-08-01

    The aims are to define the regression rate in newly diagnosed type 2 diabetes after lifestyle intervention and pharmacological therapy based on a SMBG (self-monitoring of blood glucose) strategy in routine practice as compared to standard HbA1c-based treatment and to assess whether a supervised exercise program has additional effects. St Carlos study is a 3-year, prospective, randomized, clinic-based, interventional study with three parallel groups. Hundred and ninety-five patients were randomized to the SMBG intervention group [I group; n = 130; Ia: SMBG (n = 65) and Ib: SMBG + supervised exercise (n = 65)] and to the HbA1c control group (C group) (n = 65). The primary outcome was to estimate the regression rate of type 2 diabetes (HbA1c <6 % on metformin treatment). After 3 years of follow-up, diabetes regression was achieved by 56 patients, 6 (9.2 %) from the C group, 21 (32.3 %) from the Ia group and 29 (44.6 %) from the Ib group. RR (95 % CI) for diabetes regression in the intervention group (Ia + Ib) was 4.5 (2.1-9); p < 0.001 and remained after stratification by gender, age and BMI. This difference was associated with healthier changes in lifestyle and greater weight loss. RR for a weight loss >4 kg was 3.6 (1.8-7); p < 0.001. This study shows that the use of SMBG in an educational program effectively increases the regression rate in newly diagnosed type 2 diabetic patients after 3 years of follow-up. These data suggest that SMBG-based programs should be extended to primary care settings where diabetic patients are usually attended.

  1. Lateralization of infant holding by mothers: A longitudinal evaluation of variations over the first 12 weeks.

    PubMed

    Todd, Brenda K; Banerjee, Robin

    2016-01-01

    The maternal preference to hold infants on the left rather than right side of the body was examined longitudinally, with attention to 4 explanations: maternal monitoring of infant state, maternal handedness, infant proximity to the mother's heartbeat, and preferred infant head position. The side and site of holding were measured over the first 12 weeks of the lives of 24 infants. Information about group and individual consistency in holding side allowed novel evaluation of the theories. A strong bias to hold on the left dropped below significance when the infants were aged 12 weeks and was limited to specific holding positions. Findings were generally consistent with the monitoring hypothesis, and little support was found for the 3 alternative explanations.

  2. The effect of 12-week Pilates exercises on wellness in the elderly.

    PubMed

    Roh, Su Yeon

    2016-04-01

    The purpose of this study is to examine the efficiency of 12-week Pilates exercises on wellness in the elderly. Before Pilates exercises training, the 88 elderly (63 females, 25 males) were given and completed a Wellness Scale. Then, the elderly participated in Pilates exercises and completed the same scale afterwards. Results of paired t-test showed that participants in 12-week Pilates exercises experienced significant improvement in physical (t=2.762, P<0.01), social (t=3.362, P<0.001), spiritual (t=2.307, P<0.05), and emotional wellness (t=2.489, P<0.05). Consequently, Pilates exercises helped improve wellness of the elderly. PMID:27162774

  3. The effect of 12-week Pilates exercises on wellness in the elderly

    PubMed Central

    Roh, Su Yeon

    2016-01-01

    The purpose of this study is to examine the efficiency of 12-week Pilates exercises on wellness in the elderly. Before Pilates exercises training, the 88 elderly (63 females, 25 males) were given and completed a Wellness Scale. Then, the elderly participated in Pilates exercises and completed the same scale afterwards. Results of paired t-test showed that participants in 12-week Pilates exercises experienced significant improvement in physical (t=2.762, P<0.01), social (t=3.362, P<0.001), spiritual (t=2.307, P<0.05), and emotional wellness (t=2.489, P<0.05). Consequently, Pilates exercises helped improve wellness of the elderly. PMID:27162774

  4. 12 Weeks of Daclatasvir in Combination With Sofosbuvir for HIV-HCV Coinfection (ALLY-2 Study): Efficacy and Safety by HIV Combination Antiretroviral Regimens

    PubMed Central

    Luetkemeyer, Anne F.; McDonald, Cheryl; Ramgopal, Moti; Noviello, Stephanie; Bhore, Rafia; Ackerman, Peter

    2016-01-01

    Background. Highly effective hepatitis C virus (HCV) direct-acting antiviral therapies that do not require modification of human immunodeficiency virus (HIV) antiretroviral regimens are needed. We evaluated the efficacy and safety of daclatasvir + sofosbuvir (DCV + SOF) for 12 weeks by antiretroviral (ARV) regimen in HIV-HCV-coinfected patients. Methods. In the randomized, open-label ALLY-2 study, HIV-HCV-coinfected patients received 8 or 12 weeks of once-daily DCV 60 mg (dose-adjusted as-necessary for concomitant ARVs) + SOF 400 mg. Results were stratified by ARV class for the 151 patients who received 12 weeks of DCV + SOF. Results. Fifty-one patients were HCV treatment experienced, 100 were treatment naive, 89% male and 33% black. HCV genotypes were: genotype 1a (GT1a; 69%), GT1b (15%), GT2 (8%), GT3 (6%), and GT4 (2%). Sustained virologic response 12 weeks post-treatment (SVR12) was 97% and was similar across ARV regimens (P = .774): protease inhibitor-based, 97% (95% confidence interval [CI], 90%-99.7%); nonnucleoside reverse transcriptase inhibitor-based, 100% (95% CI, 91%-100%); and integrase inhibitor based, 95% (95% CI, 83%-99.4%). SVR12 among patients receiving either tenofovir disoproxil fumarate or abacavir as part of their antiretroviral therapy regimen was 98% (95% CI, 93%-99.5%) and 100% (95% CI, 85%-100%), respectively. Age, gender, race, cirrhosis, HCV treatment history, GT , and baseline HCV RNA did not affect SVR12. No discontinuations were attributed to treatment-related adverse events. Conclusions. DCV + SOF x12 weeks is a highly efficacious, all-oral, pan-GT HCV treatment for HIV-HCV coinfected patients across a broad range of ARV regimens. Clinical Trials Registration. NCT02032888. PMID:27025835

  5. Immune Function Alterations during 12 Weeks of Abstinence in Heroin Users.

    PubMed

    Wang, Z; Yang, X-R; Song, H; Cao, B-R; Yin, F; An, Z-M; Kang, L; Li, J

    2015-01-01

    The intent of the study was to evaluate immune system changes during 12 weeks of abstinence in heroin users. We recruited men (N = 65) aged 18-45 years and collected demographic and heroin use pattern data. Serum blood levels of total interleukin 2 (IL-2), interferon γ (IFN-γ), immunoglobulin (Ig) A, IgG, and IgM were assessed at five time points. The IL-2 level was increased on day 84 as compared to that in healthy controls. The IFN-γ level was higher in heroin users than in healthy controls between days 0 and 28, and was decreased on day 84. IgG and IgM levels in heroin users were higher than those in healthy controls in our 12-week study, and were in positive correlation with the way of using the drug, duration of heroin dependence, and daily heroin intake. Our data revealed that the immune system was not restored during the 12 weeks of heroin withdrawal. PMID:26789146

  6. Initial response as a predictor of 12-week buprenorphine-naloxone treatment response in a prescription opioid dependent population

    PubMed Central

    McDermott, Katherine A.; Griffin, Margaret L.; Connery, Hilary S.; Hilario, E. Yvette; Fiellin, David A.; Fitzmaurice, Garrett M.; Weiss, Roger D.

    2015-01-01

    Objective Initial medication response has been shown to predict treatment outcome across a variety of substance use disorders, but no studies have examined the predictive power of initial response to buprenorphine-naloxone in the treatment of prescription opioid dependence. We therefore conducted a secondary analysis of data from the Prescription Opioid Addiction Treatment Study to determine whether initial response to buprenorphine-naloxone predicted 12-week treatment outcome in a prescription opioid-dependent population. Method Using data from a multi-site, randomized controlled trial of buprenorphine-naloxone plus counseling for DSM-IV prescription opioid dependence (June 2006–July 2009), we conducted a secondary analysis to investigate the relationship between initial medication response and 12-week treatment outcome to establish how soon the efficacy of buprenorphine-naloxone could be predicted. Outcomes were determined from the Substance Use Report, a self-report measure of substance use, and confirmatory urinalysis. Predictive values were calculated to determine the importance of abstinence vs. use at various time points within the first month of treatment (week 1, weeks 1–2, 1–3, or 1–4) in predicting successful vs. unsuccessful treatment outcome (based on abstinence or near-abstinence from opioids) in the last 4 weeks of buprenorphine-naloxone treatment (weeks 9–12). Results Outcome was best predicted by medication response after two weeks of treatment. Two weeks of initial abstinence was moderately predictive of treatment success (positive predictive value = 71%), while opioid use in both of the first two weeks was strongly predictive of unsuccessful treatment outcome (negative predictive value (NPV) = 84%), especially when successful outcome was defined as total abstinence from opioids in weeks 9–12 (NPV = 94%). Conclusion Evaluating prescription opioid-dependent patients after two weeks of buprenorphine-naloxone treatment may help determine

  7. Using Social Media While Waiting in Pain: A Clinical 12-Week Longitudinal Pilot Study

    PubMed Central

    Gray, Kathleen; Martin-Sanchez, Fernando; Mantopoulos, Steven; Hogg, Malcolm

    2015-01-01

    Background Chronic pain places an enormous burden on health care systems. Multidisciplinary pain management services are well documented as an effective means to improve patient outcomes. However, waiting lists to access these services are long and outcomes deteriorate. Innovative solutions such as social media are gaining attention as a way to decrease this burden and improve outcomes. It is a challenge to design research that demonstrates whether social media are acceptable to patients and clinically effective. Objective The aim was to conduct a longitudinal pilot study to understand what aspects of research design are key to the success of running a larger-scale study of social media use in the clinical management of chronic pain. Methods A 12-week study examined social media use by patients on the waiting list for the Royal Melbourne Hospital Pain Management Service. Selected social media resources were suggested for use by patients waiting for an appointment at the clinic. Patients filled out measures for pain interference and pain self-efficacy before and after the study. Follow-up was conducted at monthly intervals via telephone semistructured interviews to discuss engagement and garner individual perceptions towards social media use. A social media-use instrument was also administered as part of the after-study questionnaire. Results Targeted recruitment refined 235 patient referrals to 138 (58.7%) suitable potential participants. Contact was made with 84 out of 138 (60.9%) patients. After a further exclusion of 54 out of 84 (64%) patients for various reasons, this left 30 out of 84 (36%) patients fitting the inclusion criteria and interested in study participation. A final study cohort of 17 out of 30 (57%) was obtained. Demographics of the 17 patients were mixed. Low back pain was the primary condition reported as leading to chronic pain. Semistructured interviews collected data from 16 out of 17 (94%) patients who started the trial, and at final follow

  8. Gincosan (a combination of Ginkgo biloba and Panax ginseng): the effects on mood and cognition of 6 and 12 weeks' treatment in post-menopausal women.

    PubMed

    Hartley, D E; Elsabagh, S; File, S E

    2004-01-01

    As memory and concentration impairments are a frequent complaint in post-menopausal women, this well-defined population was selected to investigate the effect on mood and cognition of chronic treatment with Gincosan. In a double-blind placebo controlled study, post-menopausal women aged 51-66 were randomly assigned to 12 weeks' treatment with Gincosan (320mg/day), containing 120mg Ginkgo biloba, and 200mg Panax ginseng (n = 30), or matched placebo (n = 27). They were given measurements of mood, somatic anxiety, sleepiness, and menopausal symptoms and a battery of cognitive tests before treatment and after 6 and 12 weeks of treatment. There were no significant effects of Gincosan treatment on ratings of mood, bodily symptoms of somatic anxiety, menopausal symptoms, or sleepiness or on any of the cognitive measures of attention, memory or frontal lobe function. Thus, after chronic administration, Gincosan appeared to have no beneficial effects in post-menopausal women.

  9. [Uterine rupture in a patient with bicornuate uterus at 12 weeks of amenorrhea: about a case].

    PubMed

    Itchimouh, Sanaa; Khabtou, Karima; Mahdaoui, Sakher; Boufettal, Houssine; Samouh, Naima

    2016-01-01

    The incidence of uterine malformations affecting reproduction is difficult to assess. Their identification requires a specific assessment (hysterosalpingography, hysteroscopy, laparoscopy). Spontaneous fertility can be affected depending on the type of uterine abnormality. All these abnormalities can affect the evolution of pregnancy causing early and late miscarriage, ectopic pregnancy, threat of premature labour, premature labour, vascular pathologies during pregnancy and inadequate intra-uterine growth. Bicornuate uterus is the most common uterine malformation and represents about half of all uterine anomalies The occurrence of this type of pregnancy is associated with an increased risk of maternal mortality, but early diagnosis and proper monitoring can lead pregnancies to term on malformed uterus. Ultrasound screening should allow for a systematic identification of such cases in order to take the necessary preventive measures. We report a case of uterine rupture in a patient with unicervical bicornuate uterus at 12 weeks of amenorrhea.

  10. [Uterine rupture in a patient with bicornuate uterus at 12 weeks of amenorrhea: about a case].

    PubMed

    Itchimouh, Sanaa; Khabtou, Karima; Mahdaoui, Sakher; Boufettal, Houssine; Samouh, Naima

    2016-01-01

    The incidence of uterine malformations affecting reproduction is difficult to assess. Their identification requires a specific assessment (hysterosalpingography, hysteroscopy, laparoscopy). Spontaneous fertility can be affected depending on the type of uterine abnormality. All these abnormalities can affect the evolution of pregnancy causing early and late miscarriage, ectopic pregnancy, threat of premature labour, premature labour, vascular pathologies during pregnancy and inadequate intra-uterine growth. Bicornuate uterus is the most common uterine malformation and represents about half of all uterine anomalies The occurrence of this type of pregnancy is associated with an increased risk of maternal mortality, but early diagnosis and proper monitoring can lead pregnancies to term on malformed uterus. Ultrasound screening should allow for a systematic identification of such cases in order to take the necessary preventive measures. We report a case of uterine rupture in a patient with unicervical bicornuate uterus at 12 weeks of amenorrhea. PMID:27642490

  11. Inflammatory suppression by endodontic sealers after aging 12 weeks In vitro.

    PubMed

    Brackett, Martha Goël; Marshall, Aksana; Lockwood, Petra E; Lewis, Jill B; Messer, Regina L W; Bouillaguet, Serge; Wataha, John C

    2009-11-01

    Dental endodontic sealers are in intimate contact with tissues around the root apex (periapical area) for extended periods. New endodontic sealers have been developed in the past decade, but the biological responses to many new products are not well documented. In this study, we assessed in vitro monocytic cytotoxic and inflammatory responses to several contemporary endodontic sealers. AH-Plus (AH), Pulp Canal Sealer (PC), Epiphany (EPH), Endo-Rez (ER), and an experimental Endo-Rez (ERx) were initially placed in buffered-saline for 12 weeks to simulate in vivo use. After "aging," specimens were placed in direct contact with THP1 monocytes for 72 h and their cytotoxicity (mitochondrial response; MTT) or ability to trigger or suppress cytokine secretion (ELISA; TNFalpha, IL1beta, IL=6; +/- lipopolysaccharide (LPS) exposure) were measured relative to Teflon (Tf) negative controls. Cellular responses among conditions were compared with ANOVA and Tukey post-hoc analysis (alpha = 0.05). Two of the five sealers, EPH and PC, still suppressed cell mitochondrial activity by 70% or more after 12 weeks of conditioning in saline. No sealer alone activated monocytic TNFalpha, IL1beta, or IL6 secretion (p > 0.05 vs. +LPS controls). When THP1 were activated by LPS after exposure to the sealers, differential suppression of TNFalpha, IL1beta, and IL6 secretion was observed for two of the five sealers tested. (EPH and PC) This data suggest that common endodontic sealers do not activate monocytic TNFalpha, IL1beta, and IL6 secretion in vitro by themselves, but degradation products of the sealers may suppress activation of monocytes.

  12. Do 12-week yoga program influence respiratory function of elderly women?

    PubMed

    Bezerra, Lídia Aguiar; de Melo, Helton Fabrício; Garay, Ana Paula; Reis, Victor Machado; Aidar, Felipe José; Bodas, Ana Rita; Garrido, Nuno Domingos; de Oliveira, Ricardo Jacó

    2014-09-29

    Aging produces several respiratory limitations and reduces tolerance to physical efforts, sometimes leading to pulmonary diseases in the elderly. The literature draws attention to the possible benefits of Yoga practice among the elderly, presenting evidence for significant improvements in quality of life. It was hypothesized that yoga practice can improve respiratory function in the elderly. The effects of a yoga program on pulmonary volumes and respiratory muscle strength were verified in 36 elderly women divided into a yoga group [YG] (63.1 ± 13.3 years of age) and a control group (61.0 ± 6.9 years of age). Maximal inspiratory and expiratory pressure (MIP and MEP) were assessed by a manovacuometer and tidal volume (VT), vital capacity (VC) and minute ventilation (VE) were measured by a ventilometer. The program comprised 65 min sessions, 3 times/week during 12 weeks. The heart rate and respiratory rate decreased significantly in the YG (76-39 ± 8-03 vs. 74-61±10.26 bpm and 18.61 ± 3.15 vs. 16.72 ± 3.12 resp/min, respectively). In the YG, VT and VE increased significantly (0.55 ± 0.22 vs. 0.64 ± 0.2 ml and 9.19 ± 2.39 vs. 10.05 ± 2.11 ml, respectively), as well as VC (1.48 ± 0.45 vs. 2.03 ± 0.72 ml). Improvements were also found in MIP and MEP in the YG (62.17 ± 14.77 vs. 73.06 ± 20.16 cmH2O and 80.56 ± 23.94 vs. 86.39 ± 20.16 cmH2O, respectively). It was concluded that a 12-week yoga program significantly improves pulmonary function of aged women. PMID:25713658

  13. Effects of a 12-week resistance exercise program on physical self-perceptions in college students.

    PubMed

    Moore, Justin B; Mitchell, Nathanael G; Bibeau, Wendy S; Bartholomew, John B

    2011-06-01

    There is an increase in literature suggesting exercise can promote positive changes in physical self-perceptions that can manifest as an increase in global self-esteem. In the present study, we assessed self-esteem using the hierarchical framework of the Exercise and Self-Esteem Model (EXSEM) along with cognitive facets at the subdomain level (e.g., competence, certainty, importance, and ideal self-discrepancy). This allowed for an analysis of cognitive facets as possible contributors to changes in physical self-perceptions. We addressed these aims with a sample of 120 college-age adults who completed a 12-week resistance exercise program. Results indicated significant improvements in self-perception constructs at all levels of the EXSEM. The hierarchical structure of the EXSEM was partially supported, as we observed successively smaller improvements at each level of the model (e.g., self-esteem showed lesser improvements than physical self-worth). In addition, a path model developed to explain the impact of strength changes on self-esteem proved a good fit for the data. Results are discussed in terms of contemporary models of self-perception, potential mediators of exercise on self-esteem, and the need to consider cognitive facets of self-perception. PMID:21699109

  14. Predictors of adherence to a 12-week exercise program among men treated for prostate cancer: ENGAGE study.

    PubMed

    Craike, Melinda; Gaskin, Cadeyrn J; Courneya, Kerry S; Fraser, Steve F; Salmon, Jo; Owen, Patrick J; Broadbent, Suzanne; Livingston, Patricia M

    2016-05-01

    Understanding the factors that influence adherence to exercise programs is necessary to develop effective interventions for people with cancer. We examined the predictors of adherence to a supervised exercise program for participants in the ENGAGE study - a cluster randomized controlled trial that assessed the efficacy of a clinician-referred 12-week exercise program among men treated for prostate cancer. Demographic, clinical, behavioral, and psychosocial data from 52 participants in the intervention group were collected at baseline through self-report and medical records. Adherence to the supervised exercise program was assessed through objective attendance records. Adherence to the supervised exercise program was 80.3%. In the univariate analyses, cancer-specific quality of life subscales (role functioning r = 0.37, P = 0.01; sexual activity r = 0.26, P = 0.06; fatigue r = -0.26, P = 0.06, and hormonal symptoms r = -0.31, P = 0.03) and education (d = -0.60, P = 0.011) were associated with adherence. In the subsequent multivariate analysis, role functioning (B = 0.309, P = 0.019) and hormonal symptoms (B = -0.483, P = 0.054) independently predicted adherence. Men who experienced more severe hormonal symptoms had lower levels of adherence to the exercise program. Those who experienced more positive perceptions of their ability to perform daily tasks and leisure activities had higher levels of adherence to the exercise program. Hormonal symptoms and role functioning need to be considered when conducting exercise programs for men who have been treated for prostate cancer. PMID:26872005

  15. Changes in weight control behaviors and hedonic hunger during a 12-week commercial weight loss program.

    PubMed

    O'Neil, Patrick M; Theim, Kelly R; Boeka, Abbe; Johnson, Gail; Miller-Kovach, Karen

    2012-12-01

    Greater use of key self-regulatory behaviors (e.g., self-monitoring of food intake and weight) is associated with greater weight loss within behavioral weight loss treatments, although this association is less established within widely-available commercial weight loss programs. Further, high hedonic hunger (i.e., susceptibility to environmental food cues) may present a barrier to successful behavior change and weight loss, although this has not yet been examined. Adult men and women (N=111, body mass index M±SD=31.5±2.7kg/m(2)) were assessed before and after participating in a 12-week commercial weight loss program. From pre- to post-treatment, reported usage of weight control behaviors improved and hedonic hunger decreased, and these changes were inversely associated. A decrease in hedonic hunger was associated with better weight loss. An improvement in reported weight control behaviors (e.g., self-regulatory behaviors) was associated with better weight loss, and this association was even stronger among individuals with high baseline hedonic hunger. Findings highlight the importance of specific self-regulatory behaviors within weight loss treatment, including a commercial weight loss program developed for widespread community implementation. Assessment of weight control behavioral skills usage and hedonic hunger may be useful to further identify mediators of weight loss within commercial weight loss programs. Future interventions might specifically target high hedonic hunger and prospectively examine changes in hedonic hunger during other types of weight loss treatment to inform its potential impact on sustained behavior change and weight control.

  16. The effect of 12 weeks Prop Pilates Exercise Program (PPEP) on body stability and pain for fruit farmers with MSDs.

    PubMed

    Kim, Hye-Jin; Nam, Sang-Nam; Bae, Ung Ryel; Hwang, Ryong; Lee, Jong-Bok; Kim, Jong-Hyuck

    2014-01-01

    The purpose of this study was to determine possible effects of 12-week Prop Pilates Exercise Program (PPEP) for the fruit farmers (grape, tomato, apple) with musculoskeletal disorders (MSD) on body stability and pain. 131 fruit farmers with MSD were selected and asked to join a 12-week Prop Pilates Exercise Program (PPEP) from 2009 to 2012. The subjects (female=74, male=57) aged 50 to 65 years old voluntarily participated. As a result, it was found that lateral-medial and anterior-posterior of body stability significantly improved in male and female fruit farmers. It was found that pain index (VAS) after 12-week Prop Pilates Exercise Program (PPEP) showed a significant decrease. PMID:24704650

  17. A 12-week Interdisciplinary Intervention Program for Children who are Obese

    PubMed Central

    Taylor, Laura; Williamson, Megan; Robinson, Chris

    2011-01-01

    Childhood obesity is a growing problem, for which multi-disciplinary interventions are needed. Purpose: This interdisciplinary intervention program was designed to improve the health of children who were obese. Methods: Twenty-five children, mean age 8.1 (1.5) years; body mass index (BMI)> 98th percentile, and their parents completed the 12-week (3 days/wk) intervention consisting of aerobic and resistance exercise appropriate to age and developmental levels. Baseline and posttest measures of blood values, fitness, and cardiovascular risk factors were performed. Data were analyzed using paired t-tests with significance accepted at P ≤ .05. Results: Significant differences between means (SD) for pre- and post-measurements were, respectively: BMI 30.31 (4.56), 27.80 (4.54), body-fat percent 43.7 (11.5), 40.7 (10.9), waist circumference 82.1 (7.1), 80.4(6.1) cm, calf circumference 34.2 (3.1), 35.2 (3.1) cm; step-test heart rate 137 (20), 126 (12) bpm, push-ups 1.0 (1.8), 5.6 (3.8), sit-ups 23.6 (12.7), 33.2 (13.8), sit-and-reach 35.1 (7.4), 41.2 (5.8) cm; systolic BP 102 (10), 108 (9) mmHg, glucose 4.9(0.3), 4.8 (0.4) mmol/L, total cholesterol 4.6 (1.0), 4.2 (0.8) mmol/L, ALT 41 (9), 35 (8) U/L, bilirubin 6.3 (2.4), 5.6 (2.1) μmol/L, and BUN 4.9 (1.1), 4.3 (0.9) mmol/L. Conclusions: This interdisciplinary intervention program positively affected the fitness and health status of children who were obese by involving the children and parents. PMID:22163176

  18. A Mixed Methods Evaluation of a 12-Week Insurance-Sponsored Weight Management Program Incorporating Cognitive-Behavioral Counseling

    ERIC Educational Resources Information Center

    Abildso, Christiaan; Zizzi, Sam; Gilleland, Diana; Thomas, James; Bonner, Daniel

    2010-01-01

    Physical activity is critical in healthy weight loss, yet there is still much to be learned about psychosocial mechanisms of physical activity behavior change in weight loss. A sequential mixed methods approach was used to assess the physical and psychosocial impact of a 12-week cognitive-behavioral weight management program and explore factors…

  19. Multi-component access to a community-based weight loss program: 12 week results

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The current study examined weight loss between a comprehensive lifestyle modification program (Weight Watchers PointsPlus program) that included three ways to access and a self-help (SH) condition. A total of 293 participants were randomized to either a Weight Watchers condition (WW) (n=148) or a SH...

  20. Effect of a 12-week complex training on the body composition and cardiorespiratory system of female college students

    PubMed Central

    Kim, Seungsuk; Han, Gunsoo

    2016-01-01

    [Purpose] The aim of this study was to examine the effects of a complex exercise program on the body composition and cardiorespiratory system of female college students. [Subjects and Methods] This study included 20 female college students who had not participated in any particular sports in the last 3 months. The complex exercise program consisted of two parts, aerobic exercise and weight training. First, aerobic exercise was implemented (30 min 5 times a week for 12 weeks) according to the participants’ exercise tolerance. Second, weight training was implemented (40 min 5 times a week for 12 weeks) with 60% of 1 repetition maximum (RM). [Results] The t-test results showed significant differences in body composition between the before and after the complex exercise program. The subjects’ body weights and body fat percentages were decreased, and their skeletal muscle masses were increased. Increased levels of maximal oxygen uptake (VO2max), maximal expiratory volume (VEmax), and maximal heart rate (HRmax) were also observed. [Conclusion] In conclusion, the 12-week complex exercise program, including aerobic and weight training, had positive effects on the body composition and cardiorespiratory system of the female college students. PMID:27630436

  1. Effect of a 12-week complex training on the body composition and cardiorespiratory system of female college students.

    PubMed

    Kim, Seungsuk; Han, Gunsoo

    2016-08-01

    [Purpose] The aim of this study was to examine the effects of a complex exercise program on the body composition and cardiorespiratory system of female college students. [Subjects and Methods] This study included 20 female college students who had not participated in any particular sports in the last 3 months. The complex exercise program consisted of two parts, aerobic exercise and weight training. First, aerobic exercise was implemented (30 min 5 times a week for 12 weeks) according to the participants' exercise tolerance. Second, weight training was implemented (40 min 5 times a week for 12 weeks) with 60% of 1 repetition maximum (RM). [Results] The t-test results showed significant differences in body composition between the before and after the complex exercise program. The subjects' body weights and body fat percentages were decreased, and their skeletal muscle masses were increased. Increased levels of maximal oxygen uptake (VO2max), maximal expiratory volume (VEmax), and maximal heart rate (HRmax) were also observed. [Conclusion] In conclusion, the 12-week complex exercise program, including aerobic and weight training, had positive effects on the body composition and cardiorespiratory system of the female college students. PMID:27630436

  2. Effect of a 12-week complex training on the body composition and cardiorespiratory system of female college students

    PubMed Central

    Kim, Seungsuk; Han, Gunsoo

    2016-01-01

    [Purpose] The aim of this study was to examine the effects of a complex exercise program on the body composition and cardiorespiratory system of female college students. [Subjects and Methods] This study included 20 female college students who had not participated in any particular sports in the last 3 months. The complex exercise program consisted of two parts, aerobic exercise and weight training. First, aerobic exercise was implemented (30 min 5 times a week for 12 weeks) according to the participants’ exercise tolerance. Second, weight training was implemented (40 min 5 times a week for 12 weeks) with 60% of 1 repetition maximum (RM). [Results] The t-test results showed significant differences in body composition between the before and after the complex exercise program. The subjects’ body weights and body fat percentages were decreased, and their skeletal muscle masses were increased. Increased levels of maximal oxygen uptake (VO2max), maximal expiratory volume (VEmax), and maximal heart rate (HRmax) were also observed. [Conclusion] In conclusion, the 12-week complex exercise program, including aerobic and weight training, had positive effects on the body composition and cardiorespiratory system of the female college students.

  3. Clinical Application of Revised Laboratory Classification Criteria for Antiphospholipid Antibody Syndrome: Is the Follow-Up Interval of 12 Weeks Instead of 6 Weeks Significantly Useful?

    PubMed Central

    Park, Sang Hyuk; Park, Chan-Jeoung; Chi, Hyun-Sook

    2016-01-01

    Background. According to revised classification criteria of true antiphospholipid antibody syndrome, at least one of three antiphospholipid antibodies should be present on two or more occasions at least 12 weeks apart. However, it can be inconvenient to perform follow-up tests with interval of 12 weeks. We investigated clinical application of follow-up tests with interval of 12 weeks. Method. Totals of 67, 199, and 332 patients tested positive initially for the lupus anticoagulants confirm, the anti-β2 glycoprotein-I antibody, and the anti-cardiolipin antibody test, respectively, from Jan 2007 to Jul 2009. We investigated clinical symptoms of patients, follow-up interval, and results of each test. Results. Among patients with initial test positive, 1.5%–8.5% were subjected to follow-up tests at interval of more than 12 weeks. Among 25 patients with negative conversion in tests, patients with interval of more than 12 weeks showed clinical symptom positivity of 33.3%, which was higher than that of 12.5% with 6–12 weeks. Among 34 patients with persistent test positive, clinical symptoms positivity trended to be more evident in patients at interval of 6–12 weeks (47.4% versus 26.7%, P = 0.191) than more than 12 weeks. Conclusion. Less than 10% of patients with initial test positive had follow-up tests at interval of more than 12 weeks and the patients with persistent test positive at interval of more than 12 weeks showed trends toward having lower clinical symptoms than 6–12 weeks. More research is needed focused on the evidence that follow-up test at interval of more than 12 weeks should be performed instead of 6 weeks. PMID:27610369

  4. Clinical Application of Revised Laboratory Classification Criteria for Antiphospholipid Antibody Syndrome: Is the Follow-Up Interval of 12 Weeks Instead of 6 Weeks Significantly Useful?

    PubMed

    Park, Sang Hyuk; Jang, Seongsoo; Park, Chan-Jeoung; Chi, Hyun-Sook

    2016-01-01

    Background. According to revised classification criteria of true antiphospholipid antibody syndrome, at least one of three antiphospholipid antibodies should be present on two or more occasions at least 12 weeks apart. However, it can be inconvenient to perform follow-up tests with interval of 12 weeks. We investigated clinical application of follow-up tests with interval of 12 weeks. Method. Totals of 67, 199, and 332 patients tested positive initially for the lupus anticoagulants confirm, the anti-β 2 glycoprotein-I antibody, and the anti-cardiolipin antibody test, respectively, from Jan 2007 to Jul 2009. We investigated clinical symptoms of patients, follow-up interval, and results of each test. Results. Among patients with initial test positive, 1.5%-8.5% were subjected to follow-up tests at interval of more than 12 weeks. Among 25 patients with negative conversion in tests, patients with interval of more than 12 weeks showed clinical symptom positivity of 33.3%, which was higher than that of 12.5% with 6-12 weeks. Among 34 patients with persistent test positive, clinical symptoms positivity trended to be more evident in patients at interval of 6-12 weeks (47.4% versus 26.7%, P = 0.191) than more than 12 weeks. Conclusion. Less than 10% of patients with initial test positive had follow-up tests at interval of more than 12 weeks and the patients with persistent test positive at interval of more than 12 weeks showed trends toward having lower clinical symptoms than 6-12 weeks. More research is needed focused on the evidence that follow-up test at interval of more than 12 weeks should be performed instead of 6 weeks. PMID:27610369

  5. Asenapine as adjunctive treatment for acute mania associated with bipolar disorder: results of a 12-week core study and 40-week extension.

    PubMed

    Szegedi, Armin; Calabrese, Joseph R; Stet, Let; Mackle, Mary; Zhao, Jun; Panagides, John

    2012-02-01

    In a 12-week randomized, placebo-controlled study evaluating the efficacy and safety of adjunctive asenapine, bipolar I disorder patients experiencing manic or mixed episodes despite pretreatment with lithium or valproate monotherapy were treated with flexible-dose, twice-daily asenapine 5 or 10 mg (n = 158) or placebo (n = 166). The primary efficacy end point was change from baseline Young Mania Rating Scale (YMRS) total score at week 3. Secondary outcomes included YMRS response and remission and Clinical Global Impression for Bipolar Disorder and Montgomery-Asberg Depression Rating Scale score changes. Patients completing the core study were eligible for a 40-week double-blind extension assessing safety and tolerability. Adjunctive asenapine significantly improved mania versus placebo at week 3 (primary end point) and weeks 2 to 12. The YMRS response rates were similar at week 3 but significantly better with asenapine at week 12. The YMRS remission rates and changes from baseline on Clinical Global Impression for Bipolar Disorder for mania and overall illness were significantly better with asenapine at weeks 3 and 12. No other statistically significant differences on secondary outcomes were observed. Only a small number of patients entered the extension, making firm statistical conclusions on efficacy difficult. Treatment-emergent adverse events reported by 5% or more of asenapine patients and at twice the incidence of placebo were sedation, somnolence, depression/depressive symptoms, oral hypoesthesia, and increased weight in the 12-week core study. Adjunctive asenapine to lithium or valproate was more effective than mood stabilizer monotherapy in the core study and was well tolerated for up to 52 weeks.

  6. Adding Memantine to Rivastigmine Therapy in Patients With Mild-to-Moderate Alzheimer's Disease: Results of a 12-Week, Open-Label Pilot Study

    PubMed Central

    Riepe, Matthias W.; Adler, Georg; Ibach, Bernd; Weinkauf, Birgit; Gunay, Ibrahim; Tracik, Ferenc

    2006-01-01

    Objective: At present, inhibition of cholines-terase is the treatment of choice for subjects with mild-to-moderate Alzheimer's disease (AD). Memantine, a noncompetitive antagonist at N-methyl-d-aspartate receptors, is currently used to treat subjects with moderate-to-severe AD. The goal of this multicenter, open-label pilot study was to investigate whether combination therapy with memantine added to rivastigmine is safe and beneficial in subjects with mild-to-moderate AD. Method: Patients with a DSM-IV diagnosis of dementia of the Alzheimer's type (N = 95), who were treated with rivastigmine (6–12 mg/day) for a maximum duration of 24 weeks prior to baseline, received memantine (5–20 mg/day) in combination with rivastigmine for 12 weeks. The primary efficacy variable was the change in the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) total score at the end of 12 weeks compared with baseline. The study was conducted between September 15, 2003, and May 27, 2004. Results: There was a statistically significant difference between baseline and week 12 for the ADAS-cog total score, showing a positive effect of combination therapy. Combination therapy did not evidence any unexpected safety concerns and was well-tolerated by most patients. Conclusion: Memantine in combination with rivastigmine appears to be safe and beneficial in patients with mild-to-moderate AD. Our results need to be confirmed in a large, long-term, randomized, double-blind, placebo-controlled clinical trial. PMID:17235381

  7. The relation between anthropometric and physiological variables and bat velocity of high-school baseball players before and after 12 weeks of training.

    PubMed

    Szymanski, David J; Szymanski, Jessica M; Schade, Ryan L; Bradford, T Jason; McIntyre, Joseph S; DeRenne, Coop; Madsen, Nels H

    2010-11-01

    The purpose of this article was to investigate the relation between anthropometric and physiological variables to linear bat swing velocity (BV) of 2 groups of high-school baseball players before and after completing a 12-week periodized resistance exercise program. Participants were randomly assigned to 1 of 2 training groups using a stratified sampling technique. Group 1 (n = 24) and group 2 (n = 25) both performed a stepwise periodized resistance exercise program and took 100 swings a day, 3 d·wk-1, for 12 weeks with their normal game bat. Group 2 performed additional rotational and full-body medicine ball exercises 3 d·wk-1 for 12 weeks. Fourteen variables were measured or calculated before and after 12 weeks of training. Anthropometric and physiological variables tested were height, body mass, percent body fat, lean body mass (LBM), dominant torso rotational strength (DTRS) and nondominant torso rotational strength (NDTRS), sequential hip-torso-arm rotational strength measured by a medicine ball hitter's throw (MBHT), estimated 1 repetition maximum parallel squat (PS) and bench press (BP), vertical jump (VJ), estimated peak power, angular hip velocity (AHV), and angular shoulder velocity (ASV). The baseball-specific skill of linear BV was also measured. Statistical analysis indicated a significant moderately high positive relationship (p ≤ 0.05) between prelinear BV and pre-NDTRS for group 1, pre-LBM, DTRS, NDTRS, peak power, and ASV for group 2; moderate positive relationship between prelinear BV and preheight, LBM, DTRS, peak power, BP, PS, and ASV for group 1, preheight, body mass, MBHT, BP, and PS for group 2. Significantly high positive relationships were indicated between postlinear BV and post-NDTRS for group 1, post-DTRS and NDTRS for group 2; moderately high positive relationships between postlinear BV and post-LBM, DTRS, peak power, BP, and PS for group 1, postheight, LBM, VJ, peak power for group 2; moderate positive relationships between

  8. The relation between anthropometric and physiological variables and bat velocity of high-school baseball players before and after 12 weeks of training.

    PubMed

    Szymanski, David J; Szymanski, Jessica M; Schade, Ryan L; Bradford, T Jason; McIntyre, Joseph S; DeRenne, Coop; Madsen, Nels H

    2010-11-01

    The purpose of this article was to investigate the relation between anthropometric and physiological variables to linear bat swing velocity (BV) of 2 groups of high-school baseball players before and after completing a 12-week periodized resistance exercise program. Participants were randomly assigned to 1 of 2 training groups using a stratified sampling technique. Group 1 (n = 24) and group 2 (n = 25) both performed a stepwise periodized resistance exercise program and took 100 swings a day, 3 d·wk-1, for 12 weeks with their normal game bat. Group 2 performed additional rotational and full-body medicine ball exercises 3 d·wk-1 for 12 weeks. Fourteen variables were measured or calculated before and after 12 weeks of training. Anthropometric and physiological variables tested were height, body mass, percent body fat, lean body mass (LBM), dominant torso rotational strength (DTRS) and nondominant torso rotational strength (NDTRS), sequential hip-torso-arm rotational strength measured by a medicine ball hitter's throw (MBHT), estimated 1 repetition maximum parallel squat (PS) and bench press (BP), vertical jump (VJ), estimated peak power, angular hip velocity (AHV), and angular shoulder velocity (ASV). The baseball-specific skill of linear BV was also measured. Statistical analysis indicated a significant moderately high positive relationship (p ≤ 0.05) between prelinear BV and pre-NDTRS for group 1, pre-LBM, DTRS, NDTRS, peak power, and ASV for group 2; moderate positive relationship between prelinear BV and preheight, LBM, DTRS, peak power, BP, PS, and ASV for group 1, preheight, body mass, MBHT, BP, and PS for group 2. Significantly high positive relationships were indicated between postlinear BV and post-NDTRS for group 1, post-DTRS and NDTRS for group 2; moderately high positive relationships between postlinear BV and post-LBM, DTRS, peak power, BP, and PS for group 1, postheight, LBM, VJ, peak power for group 2; moderate positive relationships between

  9. Impact of maternal education about complementary feeding on their infants' nutritional outcomes in low- and middle-income households: a community-based randomized interventional study in Karachi, Pakistan.

    PubMed

    Saleem, Ali Faisal; Mahmud, Sadia; Baig-Ansari, Naila; Zaidi, Anita K M

    2014-12-01

    This cluster-randomized interventional trial at periurban settings of Karachi was conducted to evaluate the impact of maternal educational messages regarding appropriate complementary feeding (CF) on the nutritional status of their infants after 30 weeks of educational interventions delivered by trained community health workers. Mothers in the intervention group received three education modules about breastfeeding (BF) and appropriate CF at a baseline visit and two subsequent visits 10 weeks apart. The control group received advice about BF according to national guidelines. Infants' growth [weight, length, and mid-upper arm-circumference (MUAC), stunting, wasting, and underweight] were measured at four time points. At the end of the study, infants in the intervention group had a higher mean weight of 350 g (p=0.001); length of 0.66 cm (p=0.001), and MUAC of 0.46 cm (p=0.002) compared to the controls; proportionate reduction of stunting and underweight were 10% (84% vs. 74%; OR(adj) 8.36 (5.6-12.42) and 5% (25% vs. 20%; OR(adj) 0.75 (0.4-1.79) in the intervention compared to the control group. For relatively food-secure populations, educational interventions about appropriate CF to mothers had a direct positive impact on linear growth of their infants.

  10. Effects of 12-week proprioception training program on postural stability, gait, and balance in older adults: a controlled clinical trial.

    PubMed

    Martínez-Amat, Antonio; Hita-Contreras, Fidel; Lomas-Vega, Rafael; Caballero-Martínez, Isabel; Alvarez, Pablo J; Martínez-López, Emilio

    2013-08-01

    The purpose of this study was to evaluate the effect of a 12-week-specific proprioceptive training program on postural stability, gait, balance, and fall prevention in adults older than 65 years. The present study was a controlled clinical trial. Forty-four community dwelling elderly subjects (61-90 years; mean age, 78.07 ± 5.7 years) divided into experimental (n = 20) and control (n = 24) groups. The participants performed the Berg balance test before and after the training program, and we assessed participants' gait, balance, and the risk of falling, using the Tinetti scale. Medial-lateral plane and anterior-posterior plane displacements of the center of pressure, Sway area, length and speed, and the Romberg quotient about surface, speed, and distance were calculated in static posturography analysis (EPS pressure platform) under 2 conditions: eyes open and eyes closed. After a first clinical evaluation, patients were submitted to 12 weeks proprioception training program, 2 sessions of 50 minutes every week. This program includes 6 exercises with the BOSU and Swiss ball as unstable training tools that were designed to program proprioceptive training. The training program improved postural balance of older adults in mediolateral plane with eyes open (p < 0.05) and anterior-posterior plane with eyes closed (p < 0.01). Significant improvements were observed in Romberg quotient about surface (p < 0.05) and speed (p < 0.01) but not about distance (p > 0.05). After proprioception training, gait (Tinetti), and balance (Berg) test scores improved 14.66% and 11.47% respectively. These results show that 12 weeks proprioception training program in older adults is effective in postural stability, static, and dynamic balance and could lead to an improvement in gait and balance capacity, and to a decrease in the risk of falling in adults aged 65 years and older.

  11. The Ontogeny of Face Recognition: Eye Contact and Sweet Taste Induce Face Preference in 9- and 12-Week-Old Human Infants.

    ERIC Educational Resources Information Center

    Blass, Elliott M.; Camp, Carole A.

    2001-01-01

    Calm or crying 9- and 12-week-olds sat facing a researcher who gazed into their eyes or at their forehead and delivered either a sucrose solution or pacifier or delivered nothing. Found that combining sweet taste and eye contact was necessary and sufficient for calm 9- and 12-week-olds to form a preference for the researcher, but not for crying…

  12. Effects of Charitable Versus Monetary Incentives on the Acceptance of and Adherence to a Pedometer-Based Health Intervention: Study Protocol and Baseline Characteristics of a Cluster-Randomized Controlled Trial

    PubMed Central

    Kramer, Jan-Niklas; Kehr, Flavius; Wahle, Fabian; Elser, Niklas; Fleisch, Elgar

    2016-01-01

    Background Research has so far benefited from the use of pedometers in physical activity interventions. However, when public health institutions (eg, insurance companies) implement pedometer-based interventions in practice, people may refrain from participating due to privacy concerns. This might greatly limit the applicability of such interventions. Financial incentives have been successfully used to influence both health behavior and privacy concerns, and may thus have a beneficial effect on the acceptance of pedometer-based interventions. Objective This paper presents the design and baseline characteristics of a cluster-randomized controlled trial that seeks to examine the effect of financial incentives on the acceptance of and adherence to a pedometer-based physical activity intervention offered by a health insurance company. Methods More than 18,000 customers of a large Swiss health insurance company were allocated to a financial incentive, a charitable incentive, or a control group and invited to participate in a health prevention program. Participants used a pedometer to track their daily physical activity over the course of 6 months. A Web-based questionnaire was administered at the beginning and at the end of the intervention and additional data was provided by the insurance company. The primary outcome of the study will be the participation rate, secondary outcomes will be adherence to the prevention program, physical activity, and health status of the participants among others. Results Baseline characteristics indicate that residence of participants, baseline physical activity, and subjective health should be used as covariates in the statistical analysis of the secondary outcomes of the study. Conclusions This is the first study in western cultures testing the effectiveness of financial incentives with regard to a pedometer-based health intervention offered by a large health insurer to their customers. Given that the incentives prove to be effective

  13. Effects of supplementing n-3 fatty acid enriched eggs and walnuts on cardiovascular disease risk markers in healthy free-living lacto-ovo-vegetarians: a randomized, crossover, free-living intervention study

    PubMed Central

    2014-01-01

    Background Plant and marine n-3 fatty acids (FA) may favorably modify select markers of cardiovascular disease risk. Whether supplementing the habitual diet of lacto-ovo-vegetarians (LOV) with walnuts (containing α-linolenic acid, ALA) and n-3 FA enriched eggs (containing primarily docosahexaenoic acid, DHA and ALA) would have equivalent effects on CVD risk factors is explored in this study. Methods In this study, 20 healthy free-living LOVs following their habitual diet were randomly assigned in a crossover design to receive one of three supplements: n-3 FA enriched egg (6/week), walnuts (28.4 g, 6/week) or a standard egg, 6/week (control) for 8 weeks each with 4-wk washout between treatments. Erythrocyte membrane fatty acids, serum lipids and inflammatory markers were measured at the end of each treatment. Results Dietary compliance was observed by an expected increase in erythrocyte membrane ALA following the walnut treatment and in DHA following the n-3 FA enriched egg treatment. Walnut treatment lowered serum triacylglycerol, total cholesterol and Apo B (p < 0.05) compared to the standard egg but not the n-3 FA enriched egg treatment. However, walnut treatment significantly reduced total: HDL cholesterol ratio compared to both egg treatments. There were no differences between treatments for any of the inflammatory markers. Conclusions For LOV, a direct source of DHA such as n-3 FA enriched eggs seems necessary to increase membrane levels of DHA. However for producing an overall favorable blood lipid profile, daily consumption of a handful of walnuts rich in ALA may be a preferred option for lacto-ovo vegetarian. PMID:24673793

  14. Does school-based physical activity decrease overweight and obesity in children aged 6–9 years? A two-year non-randomized longitudinal intervention study in the Czech Republic

    PubMed Central

    2012-01-01

    Background Globally, efforts aimed at the prevention of childhood obesity have led to the implementation of a range of school-based interventions. This study assessed whether augmenting physical activity (PA) within the school setting resulted in increased daily PA and decreased overweight/obesity levels in 6-9-year-old children. Methods Across the first to third primary school years, PA of 84 girls and 92 boys was objectively monitored five times (each for seven successive days) using Yamax pedometer (step counts) and Caltrac accelerometer (activity energy expenditure AEE - kcal/kg per day). Four schools were selected to participate in the research (2 intervention, 2 controls), comprising intervention (43 girls, 45 boys) and control children (41 girls, 47 boys). The study was non-randomized and the intervention schools were selected on the basis of existing PA-conducive environment. Analyses of variance (ANOVA) for repeated measures examined the PA programme and gender effects on the step counts and AEE. Logistic regression (Enter method) determined the obesity and overweight occurrence prospect over the course of implementation of the PA intervention. Results There was a significant increase of school-based PA during schooldays in intervention children (from ≈ 1718 to ≈ 3247 steps per day; and from 2.1 to ≈ 3.6 Kcal/Kg per day) in comparison with the control children. Increased school-based PA of intervention children during schooldays contributed to them achieving >10,500 steps and >10.5 Kcal/Kg per school day across the 2 years of the study, and resulted in a stop of the decline in PA levels that is known to be associated with the increasing age of children. Increased school-based PA had also positive impact on leisure time PA of schooldays and on PA at weekends of intervention children. One year after the start of the PA intervention, the odds of being overweight or obese in the intervention children was almost three times lower than that of

  15. A Double-Blind, 12-Week Study to Evaluate the Antiaging Efficacy of a Cream Containing the NFκB Inhibitor 4-Hexyl-1, 3-Phenylenediol and Ascorbic Acid-2 Glucoside in Adult Females.

    PubMed

    Roure, Romain; Nollent, Virginie; Dayan, Liliane; Camel, Etienne; Bertin, Christiane

    2016-06-01

    The 5 main physical manifestations of aged skin are wrinkles, uneven tone, brown spots, loss of elasticity, and dryness. One mechanism resulting in these physical manifestations is increased activity of the nuclear factor kappa B (NFκB) protein. This 12-week, double-blind, placebo-controlled, randomized split-face study compared the antiaging effect and safety of a face cream containing 4-Hexyl-1, 3-phenylenediol, an NFκB inhibitor, and ascorbic acid-2 glucoside versus placebo in adult females aged 45-70 years old. Subjects (n=42) applied active treatment or placebo to the same half face twice daily at home for 12 weeks. Clinical evaluation was carried out by a dermatologist. Subjects carried out similar self-grading assessments. Colorimetric measurements analyzed skin color, and biomechanical skin properties were evaluated. Clinical grading showed that most wrinkle parameters were significantly improved after 8 weeks of active treatment compared with baseline and placebo (P≤.05), with improvements maintained after 12 weeks. Only Marionette wrinkles did not show a significant improvement. Brown spots (color intensity/number), overall photodamage, and most complexion parameters improved significantly after 8 and 12 weeks compared with baseline and placebo (P≤.05). Self-grading yielded similar results compared with baseline. Self-grading did not demonstrate improvements with active treatment versus placebo, except for skin firmness at 8 and 12 weeks (P≤.05). A significant difference was seen with active treatment compared with placebo in all colorimetric parameters (L*, b*, and ITA°) after 8 weeks, and in spot coloration (b*) after 12 weeks (P<.05). Improvements in skin elasticity were not significantly different between treatments. Overall tolerability of active treatment was judged as good. In conclusion, a cream containing 4-Hexyl-1, 3-phenylenediol and ascorbic acid-2 glucoside improves the clinical appearance of aged

  16. Effect of 12 Weeks of Accelerated Rehabilitation Exercise on Muscle Function of Patients with ACL Reconstruction of the Knee Joint.

    PubMed

    Lee, Joong-Chul; Kim, Ji Youn; Park, Gi Duck

    2013-12-01

    [Purpose] To examine changes in the knee joint's isokinetic muscle functions following systematic and gradual rehabilitation exercises lasting for 12 weeks for male and female patients who underwent anterior cruciate ligament (ACL) reconstruction. Differences in muscle functions between the uninvolved side (US) and the involved side (IS) before surgery, differences in muscle functions between US and IS after rehabilitation exercises lasting for 12 weeks, and changes in muscle functions on US and IS between before and after surgery were analyzed to examine the effects of accelerated rehabilitation exercises after ACL reconstruction. [Subjects] The study subjects were 10 patients, five females and five males, who underwent ACL reconstruction performed by the same surgeon. [Methods] As a measuring tool, a Biodex Multi-joint system 3pro (USA), which is an isokinetic measuring device, was used to examine the flexion and extension forces of the knee joint. During isokinetic muscle strength evaluation, the ROM of US was set to be the same as that of IS for consistency of measurement. [Results] At 60°/s, the isokinetic muscle functions of the females did not show any significant change between before and after surgery in any of the variables on both US and IS. At 60°/s, the isokinetic muscle functions of the males did not show any significant change between before and after surgery in the peak torque, average power, and entire work done on US. In extension, peak torque on IS did not show any significant change.

  17. Self-presentation in exercise: changes over a 12-week cardiovascular programme for overweight and obese sedentary females.

    PubMed

    Pearson, Erin S; Hall, Craig R; Gammage, Kimberley L

    2013-01-01

    Self-presentational concerns, shown to influence exercise-related cognitions and behaviours, are evaluated frequently in the absence of exercise or following a single bout of physical activity. The purpose of the present study was to examine longitudinally, the extent to which participating in a structured 12-week cardiovascular exercise intervention elicited changes in self-presentational efficacy expectancy (SPEE) and social physique anxiety (SPA). Participants were 80 sedentary women with overweight or obesity (mean body mass index 29.02 kg/m(2), SD=4.71) between the ages of 19 and 45 wanting to begin an exercise programme (mean age 33.4 years, SD=7.6). The Self-Presentational Efficacy Scale (SPES) and the Social Physique Anxiety Scale (SPAS) were completed by each participant prior to commencing the study, and at the 6- and 12-week time points. For those who completed the programme, repeated measures ANOVAs indicated significant increases in SPEE between baseline and week 6 (P<0.001, η(2)=0.37), and week 6 to 12 (P<0.05, η(2)=0.10), while SPA decreased significantly between baseline and week 6 (P<0.01, η(2)=0.16). Bivariate correlation analyses revealed that length of participation in the study was positively related to SPEE and negatively related to SPA. Implications of focusing on these variables within a physical activity intervention are discussed with respect to exercise behaviour, programme development and adherence. PMID:23834547

  18. Turkish 12 Week Course.

    ERIC Educational Resources Information Center

    Defense Language Inst., Washington, DC.

    This audiolingual beginner's course has been prepared for the Defense Language Institute intensive program in modern spoken Turkish. The course, consisting of six volumes of basic text in 55 units begins with an introductory section which presents the linguistic background, phonology, and distinguishing features of Turkish. The lesson format…

  19. Lung function profiles and aerobic capacity of adult cigarette and hookah smokers after 12 weeks intermittent training

    PubMed Central

    Koubaa, Abdessalem; Triki, Moez; Trabelsi, Hajer; Masmoudi, Liwa; Zeghal, Khaled N.; Sahnoun, Zouhair; Hakim, Ahmed

    2015-01-01

    Introduction Pulmonary function is compromised in most smokers. Yet it is unknown whether exercise training improves pulmonary function and aerobic capacity in cigarette and hookah smokers and whether these smokers respond in a similar way as do non-smokers. Aim To evaluate the effects of an interval exercise training program on pulmonary function and aerobic capacity in cigarette and hookah smokers. Methods Twelve cigarette smokers, 10 hookah smokers, and 11 non-smokers participated in our exercise program. All subjects performed 30 min of interval exercise (2 min of work followed by 1 min of rest) three times a week for 12 weeks at an intensity estimated at 70% of the subject's maximum aerobic capacity (V.O2max). Pulmonary function was measured using spirometry, and maximum aerobic capacity was assessed by maximal exercise testing on a treadmill before the beginning and at the end of the exercise training program. Results As expected, prior to the exercise intervention, the cigarette and hookah smokers had significantly lower pulmonary function than the non-smokers. The 12-week exercise training program did not significantly affect lung function as assessed by spirometry in the non-smoker group. However, it significantly increased both forced expiratory volume in 1 second and peak expiratory flow (PEF) in the cigarette smoker group, and PEF in the hookah smoker group. Our training program had its most notable impact on the cardiopulmonary system of smokers. In the non-smoker and cigarette smoker groups, the training program significantly improved V.O2max (4.4 and 4.7%, respectively), v V.O2max (6.7 and 5.6%, respectively), and the recovery index (7.9 and 10.5%, respectively). Conclusions After 12 weeks of interval training program, the increase of V.O2max and the decrease of recovery index and resting heart rate in the smoking subjects indicated better exercise tolerance. Although the intermittent training program altered pulmonary function only partially, both

  20. Effects of 12-Week Bacopa monnieri Consumption on Attention, Cognitive Processing, Working Memory, and Functions of Both Cholinergic and Monoaminergic Systems in Healthy Elderly Volunteers

    PubMed Central

    Peth-Nui, Tatimah; Wattanathorn, Jintanaporn; Muchimapura, Supaporn; Tong-Un, Terdthai; Piyavhatkul, Nawanant; Rangseekajee, Poonsri; Ingkaninan, Kornkanok; Vittaya-areekul, Sakchai

    2012-01-01

    At present, the scientific evidence concerning the effect of Bacopa monnieri on brain activity together with working memory is less available. Therefore, we aimed to determine the effect of B. monnieri on attention, cognitive processing, working memory, and cholinergic and monoaminergic functions in healthy elderly. A randomized double-blind placebo-controlled design was utilized. Sixty healthy elderly subjects (mean age 62.62 years; SD 6.46), consisting of 23 males and 37 females, received either a standardized extract of B. monnieri (300 and 600 mg) or placebo once daily for 12 weeks. The cholinergic and monoaminergic systems functions were determined using AChE and MAO activities. Working memory was assessed using percent accuracy and reaction time of various memory tests as indices, whereas attention and cognitive processing were assessed using latencies and amplitude of N100 and P300 components of event-related potential. All assessments were performed before treatment, every four weeks throughout study period, and at four weeks after the cessation of intervention. B. monnieri-treated group showed improved working memory together with a decrease in both N100 and P300 latencies. The suppression of plasma AChE activity was also observed. These results suggest that B. monnieri can improve attention, cognitive processing, and working memory partly via the suppression of AChE activity. PMID:23320031

  1. A 12-week placebo-controlled double-blind study of prazosin in the treatment of prostatic obstruction due to benign prostatic hyperplasia.

    PubMed

    Chapple, C R; Stott, M; Abrams, P H; Christmas, T J; Milroy, E J

    1992-09-01

    A series of 93 normotensive patients with benign prostatic hyperplasia and maximum urinary flow rates < 15 ml/s, treated at 2 hospital centres using an identical protocol, was randomly assigned to receive a 12-week course of treatment with prazosin or placebo in a double-blind parallel group trial. A total of 75 patients completed the study and were suitable for the final analysis. Prazosin was administered orally in doses of 0.5 mg and then 1 mg twice daily for 4 days and 2 mg twice daily for the remainder of the trial. Patients on treatment with prazosin exhibited a significantly increased maximum urinary flow rate as compared with placebo, with a significant reduction in maximum voiding detrusor pressure. Prazosin therapy did not produce a significant effect on either frequency or standard parameters of detrusor instability. A double-blind overall assessment of drug efficacy and tolerance significantly favoured prazosin therapy. A total of 30 patients receiving prazosin and 28 receiving placebo reported varied adverse effects. Eighteen patients were excluded from the final analysis, 10 being withdrawn because of adverse effects, 7 on treatment with prazosin and 3 in the placebo group. In long-term usage oral prazosin was well tolerated and appeared to improve obstructed voiding in patients with benign prostatic hyperplasia.

  2. A 12-week comparison regarding symptom improvement in an urban university-based outpatient child psychiatry clinic.

    PubMed

    Adams, Adrienne L; Meaden, Patricia

    2014-01-01

    To compare the efficacy of pharmacotherapy versus combination pharmacotherapy and psychotherapy for externalizing, conduct, and aggressive behaviors in children aged 6 through 18 years in an urban academic outpatient facility. Data from a child psychiatry outpatient population whose scores were identified as "at risk" or "clinically significant" based on a validated and standardized assessment tool were assessed at baseline and 12 weeks or more after treatment. Conduct symptoms worsened with medication management alone but improved with combination treatment (P < 0.05). Females and older youth were more likely to have therapy included in their treatment. Conduct problems that can be seen in a variety of youth disorders, such as disruptive behaviors, mood, and anxiety disorders, have a better probability of improving with treatment that includes psychotherapy versus medication management alone.

  3. The influence of maternal age on the outcomes of pregnancies complicated by bleeding at less than 12 weeks.

    PubMed

    Mbugua Gitau, Godfrey; Liversedge, Helen; Goffey, Dawn; Hawton, Annemarie; Liversedge, Neil; Taylor, Myles

    2009-01-01

    The effect of maternal age on the outcome of threatened miscarriage after ultrasound has confirmed fetal heart (FH) pulsation was assessed. At a university teaching hospital, 138 women presenting with bleeding before 12 weeks' gestation were followed up until delivery or pregnancy loss. Those with multiple or ectopic pregnancy, social termination of pregnancy, assisted conception and temporary residence were excluded. Outcome measures were pregnancy loss, fetal abnormalities, preterm delivery, low birthweight and cesarean delivery. Age over 35 years was significantly associated with reduced live-birth and increased miscarriage rates. Women over 35 years of age had higher cesarean section and pregnancy loss rates than the younger women. The combination of bleeding in early pregnancy and advanced age increases risk of pregnancy loss even after ultrasound has confirmed FH pulsation. PMID:19140048

  4. Child Support Grant access and receipt among 12-week-old infants in an urban township setting in South Africa

    PubMed Central

    Zembe-Mkabile, Wanga; Doherty, Tanya; Sanders, David; Jackson, Debra

    2014-01-01

    Background Cash transfers (CTs) are increasingly used as a strategy to alleviate poverty and improve child health outcomes in low- and middle-income countries. The Child Support Grant (CSG) is the largest CT programme in South Africa, and on the continent, targeting poor children from birth until the age of 18 with a monthly sum of R300 (USD30). Evidence on the CSG shows that early receipt of the grant is associated with improved child health outcomes. Since its implementation, one of the major concerns about the grant has been take-up rates, particularly for younger children. This paper reports results on take-up rates for 12-week-old infants residing in an urban township in South Africa. Methods This is a descriptive study utilising data from a community-based, cluster-randomised trial which evaluated a programme providing pregnancy and post-natal home visits by community health workers to 3,494 mothers in Umlazi township, South Africa. Results At the 12-week visit, half (52%) of the mothers who had enrolled in the study had applied for the CSG on behalf of their children, while 85% of the mothers who had not applied were still planning to apply. Only 38% (1,327) of all children had received the CSG. Conclusions In this study, many mothers had not applied for the CSG in the first few months after delivery, and only a third of children had accessed the grant. Further research is needed to understand what the current barriers are that prevent mothers from applying for this important form of social protection in the early months after delivery. PMID:25160516

  5. Psychological correlates of performance in female athletes during a 12-week off-season strength and conditioning program.

    PubMed

    Jones, Margaret T; Matthews, Tracey D; Murray, Mimi; Van Raalte, Judy; Jensen, Barbara E

    2010-03-01

    Examination of the relationship between performance testing and psychological measures before and after a 12-week strength and conditioning program was the study's purpose. Female NCAA Division-III soccer (n = 28), field hockey (n = 28), and softball (n = 19) athletes completed pre- and post-testing held 12 weeks apart. On day 1, athletes completed informed consent, 3 psychological measures (Profile of Mood States [POMS], Physical Self Perception Profile [PSPP], and Athlete's Self Perception of Physical Abilities [ASPPA]), and 2 strength tests (1 repetition maximum [1RM] bench, 1RM back squat). Day 2 consisted of the 30-yd sprint, pro agility run (PRO), vertical jump (VJ), and standing long jump (SLJ). All sports improved (p < 0.01) in 1RM bench and squat and reported increases in perceived Physical Strength on the PSPP (p < 0.01). Soccer athletes improved (p < 0.01) in VJ, SLJ, and PRO (p < 0.05). No differences were found in POMS scores. The POMS scores indicated that the athletes were not overtrained or experiencing staleness. A series of correlations showed relationships between physical and psychological measures. Specifically, Physical Strength was correlated with 1RM upper-body (r = 0.49, p < 0.01) and lower-body (r = 0.42, p < 0.01) strength. The PSPP Physical Strength was correlated with ASPPA ratings of upper-body (r = 0.68, p < 0.01) and lower-body (r = 0.57, p < 0.01) strength. The PSPP Sport Competence correlated with ASPPA ratings of power (r = 0.45, p < 0.01) and PRO (r = 0.38, p < 0.05). The study's results highlight the benefits of strength and conditioning. Furthermore, these results demonstrate how physical changes are related to athletes' physical self-perceptions and self-assessment of ability within their teams.

  6. 12-week, placebo-controlled trial of add-on riluzole in the treatment of childhood-onset obsessive-compulsive disorder.

    PubMed

    Grant, Paul J; Joseph, Lisa A; Farmer, Cristan A; Luckenbaugh, David A; Lougee, Lorraine C; Zarate, Carlos A; Swedo, Susan E

    2014-05-01

    Many children with childhood-onset obsessive-compulsive disorder (OCD) fail to respond adequately to standard therapies. Evidence from preclinical and clinical studies suggests that the glutamatergic neurotransmitter system might be an alternative treatment target. This study examined the efficacy of riluzole, a glutamatergic modulator, as an adjunctive therapy for children with treatment-resistant OCD. In a 12-week, double-blind, placebo-controlled study, 60 treatment-resistant children and adolescents (mean age=14.5 ± 2.4 years), with moderate to severe OCD (mean Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)=28.2 ± 3.7), 17 of whom also had concomitant autism spectrum disorder, were randomized to receive riluzole (final dose of 100 mg/day) or placebo in addition to the existing treatment regimen. Fifty-nine subjects completed the randomized trial. Primary outcome measures were changes on the CY-BOCS, the Clinical Global Impressions Scale, and the Children's Global Assessment Scale. Riluzole was fairly well tolerated, although it was associated with one case of pancreatitis and five instances of slight increases in transaminases. All subjects showed significant reductions in CY-BOCS scores during treatment; however, there was no significant difference between placebo and riluzole on any of the primary or secondary outcome measures. The study failed to demonstrate superiority of riluzole over placebo as an adjunctive treatment for children with childhood-onset OCD. However, future studies may show benefits for less treatment-refractory children with fewer concomitant medications.

  7. Utility of imaging for nutritional intervention studies in Alzheimer's disease.

    PubMed

    de Wilde, Martijn C; Kamphuis, Patrick J G H; Sijben, John W C; Scheltens, Phillip

    2011-09-01

    Alzheimer's disease (AD) is a multi-factorial neurodegenerative disorder and the leading cause of dementia, wherein synapse loss is the strongest structural correlate with cognitive impairment. Basic research has shown that dietary supply of precursors and co-factors for synthesis of neuronal membranes enhances the formation of synapses. Daily intake of a medical food containing a mix of these nutrients for 12 weeks in humans improved memory, measured as immediate and delayed verbal recall by the Wechsler Memory Scale-revised, in patients with very mild AD (MMSE 24-26). An improvement of immediate verbal recall was noted following 24 weeks of intervention in an exploratory extension of the study. These data suggest that the intervention may improve synaptic formation and function in early AD. Here we review emerging technologies that help identify changes in pathological hallmarks in AD, including synaptic function and loss of connectivity in the early stages of AD, before cognitive and behavioural symptoms are observable. These techniques include the detection of specific biomarkers in the cerebrospinal fluid, as well as imaging procedures such as fluorine-18 fluorodeoxyglucose positron emission tomography (FDG-PET), amyloid PET, structural/functional magnetic resonance imaging, diffusion tensor imaging, magnetoencephalography (MEG) and electroencephalography (EEG). Such techniques can provide new insights into the functional and structural changes in the brain over time, and may therefore help to develop more effective AD therapies. In particular, nutritional intervention studies that target synapse formation and function may benefit from these techniques, especially FDG-PET and EEG/MEG employed in the preclinical or early stages of the disease. PMID:21816137

  8. The effect of complex rehabilitation training for 12 weeks on trunk muscle function and spine deformation of patients with SCI

    PubMed Central

    Sung, Dong-Hun; Yoon, Seong-Deok; Park, Gi Duck

    2015-01-01

    [Purpose] It is important for patients with incomplete spinal cord injury (SCI) to strengthen their muscle strength and return to the work force one of the ultimate objectives of rehabilitation. This study reports how a single patient with SCI became stabilized in terms of abdominal muscles and back extension muscles, as well as returning the back to the neutral position from spinal deformation, as result of complex exercises performed for 12 weeks. [Subjects] The degree of damage of the subject was rated as C grade. The subject of this study had unstable posture due to paralysis in the lower extremities of the left side after removal of a malignant tumor by surgical operation, and tilting and torsion in the pelvis increased followed by increase of kyphosis in the thoracolumbar spine. The subject was more than two years since diagnosis of incomplete SCI after surgery. [Methods] Using isokinetic lumbar muscle strength measurement equipment, peak torque/weight, total work and average power in flexion and extension of the lumbar region were measured. A trunk measurement system (Formetric 4D, DIERS, Germany), which is a 3D image processing apparatus with high resolution for vertebrae, was used in order to measure 3D vertebrae and pelvis deformation as well as static balance abilities. As an exercise method, a foam roller was used to conduct fascia relaxation massage for warming-up, and postural kyphosis was changed into postural lordosis by lat pull-down using equipment, performed in 5 sets of 15 times preset at 60% intensity of 1RM 4 set of 10 crunch exercises per set using Togu’s were done while sitting at the end of Balance pad, and 4 sets of 15 bridge exercises. [Results] All angular speed tests showed a gradual increase in muscle strength. Flexion and extension showed 10% and 3% improvements, respectively. The spine deformation test showed that isokinetic exercise and lat pull-down exercise for 12 weeks resulted in improved spinal shape. [Conclusion] In this

  9. Effects of 12 weeks of aerobic training on autonomic modulation, mucociliary clearance, and aerobic parameters in patients with COPD

    PubMed Central

    Leite, Marceli Rocha; Ramos, Ercy Mara Cipulo; Kalva-Filho, Carlos Augusto; Freire, Ana Paula Coelho Figueira; de Alencar Silva, Bruna Spolador; Nicolino, Juliana; de Toledo-Arruda, Alessandra Choqueta; Papoti, Marcelo; Vanderlei, Luiz Carlos Marques; Ramos, Dionei

    2015-01-01

    Introduction Patients with chronic obstructive pulmonary disease (COPD) exhibit aerobic function, autonomic nervous system, and mucociliary clearance alterations. These parameters can be attenuated by aerobic training, which can be applied with continuous or interval efforts. However, the possible effects of aerobic training, using progressively both continuous and interval sessions (ie, linear periodization), require further investigation. Aim To analyze the effects of 12-week aerobic training using continuous and interval sessions on autonomic modulation, mucociliary clearance, and aerobic function in patients with COPD. Methods Sixteen patients with COPD were divided into an aerobic (continuous and interval) training group (AT) (n=10) and a control group (CG) (n=6). An incremental test (initial speed of 2.0 km·h−1, constant slope of 3%, and increments of 0.5 km·h−1 every 2 minutes) was performed. The training group underwent training for 4 weeks at 60% of the peak velocity reached in the incremental test (vVO2peak) (50 minutes of continuous effort), followed by 4 weeks of sessions at 75% of vVO2peak (30 minutes of continuous effort), and 4 weeks of interval training (5×3-minute effort at vVO2peak, separated by 1 minute of passive recovery). Intensities were adjusted through an incremental test performed at the end of each period. Results The AT presented an increase in the high frequency index (ms2) (P=0.04), peak oxygen uptake (VO2peak) (P=0.01), vVO2peak (P=0.04), and anaerobic threshold (P=0.02). No significant changes were observed in the CG (P>0.21) group. Neither of the groups presented changes in mucociliary clearance after 12 weeks (AT: P=0.94 and CG: P=0.69). Conclusion Twelve weeks of aerobic training (continuous and interval sessions) positively influenced the autonomic modulation and aerobic parameters in patients with COPD. However, mucociliary clearance was not affected by aerobic training. PMID:26648712

  10. The effect of complex rehabilitation training for 12 weeks on trunk muscle function and spine deformation of patients with SCI.

    PubMed

    Sung, Dong-Hun; Yoon, Seong-Deok; Park, Gi Duck

    2015-03-01

    [Purpose] It is important for patients with incomplete spinal cord injury (SCI) to strengthen their muscle strength and return to the work force one of the ultimate objectives of rehabilitation. This study reports how a single patient with SCI became stabilized in terms of abdominal muscles and back extension muscles, as well as returning the back to the neutral position from spinal deformation, as result of complex exercises performed for 12 weeks. [Subjects] The degree of damage of the subject was rated as C grade. The subject of this study had unstable posture due to paralysis in the lower extremities of the left side after removal of a malignant tumor by surgical operation, and tilting and torsion in the pelvis increased followed by increase of kyphosis in the thoracolumbar spine. The subject was more than two years since diagnosis of incomplete SCI after surgery. [Methods] Using isokinetic lumbar muscle strength measurement equipment, peak torque/weight, total work and average power in flexion and extension of the lumbar region were measured. A trunk measurement system (Formetric 4D, DIERS, Germany), which is a 3D image processing apparatus with high resolution for vertebrae, was used in order to measure 3D vertebrae and pelvis deformation as well as static balance abilities. As an exercise method, a foam roller was used to conduct fascia relaxation massage for warming-up, and postural kyphosis was changed into postural lordosis by lat pull-down using equipment, performed in 5 sets of 15 times preset at 60% intensity of 1RM 4 set of 10 crunch exercises per set using Togu's were done while sitting at the end of Balance pad, and 4 sets of 15 bridge exercises. [Results] All angular speed tests showed a gradual increase in muscle strength. Flexion and extension showed 10% and 3% improvements, respectively. The spine deformation test showed that isokinetic exercise and lat pull-down exercise for 12 weeks resulted in improved spinal shape. [Conclusion] In this study

  11. Effect of 12 Weeks High Oleic Peanut Consumption on Cardio-Metabolic Risk Factors and Body Composition.

    PubMed

    Barbour, Jayne A; Howe, Peter R C; Buckley, Jonathan D; Bryan, Janet; Coates, Alison M

    2015-09-01

    Epidemiological evidence indicates an inverse association between nut consumption and obesity, inflammation, hyperlipidaemia and glucose intolerance. We investigated effects of high oleic peanut consumption vs. a nut free diet on adiposity and cardio-metabolic risk markers. In a randomised cross-over design, 61 healthy subjects (65 ± 7 years, body mass index (BMI) 31 ± 4 kg/m²) alternated either high oleic peanuts (15%-20% of energy) or a nut free diet for 12 weeks. Body composition and mass, waist circumference, C-reactive protein (CRP), lipids, glucose and insulin were assessed at baseline and after each phase. Repeated measures analysis of variance (ANOVA) compared the two diets. Consistent with other nut studies, there were no differences in lipids, CRP, glucose and insulin with peanut consumption. In contrast, some reports have demonstrated benefits, likely due to differences in the study cohort. Energy intake was 10% higher (853 kJ, p < 0.05), following peanut consumption vs. control, attributed to a 30% increase in fat intake (p < 0.001), predominantly monounsaturated (increase 22 g, p < 0.05). Despite greater energy intake during the peanut phase, there were no differences in body composition, and less than predicted increase (0.5 kg) in body weight for this additional energy intake, possibly due to incomplete nutrient absorption and energy utilisation.

  12. Effect of 12 Weeks High Oleic Peanut Consumption on Cardio-Metabolic Risk Factors and Body Composition

    PubMed Central

    Barbour, Jayne A.; Howe, Peter R. C.; Buckley, Jonathan D.; Bryan, Janet; Coates, Alison M.

    2015-01-01

    Epidemiological evidence indicates an inverse association between nut consumption and obesity, inflammation, hyperlipidaemia and glucose intolerance. We investigated effects of high oleic peanut consumption vs. a nut free diet on adiposity and cardio-metabolic risk markers. In a randomised cross-over design, 61 healthy subjects (65 ± 7 years, body mass index (BMI) 31 ± 4 kg/m2) alternated either high oleic peanuts (15%–20% of energy) or a nut free diet for 12 weeks. Body composition and mass, waist circumference, C-reactive protein (CRP), lipids, glucose and insulin were assessed at baseline and after each phase. Repeated measures analysis of variance (ANOVA) compared the two diets. Consistent with other nut studies, there were no differences in lipids, CRP, glucose and insulin with peanut consumption. In contrast, some reports have demonstrated benefits, likely due to differences in the study cohort. Energy intake was 10% higher (853 kJ, p < 0.05), following peanut consumption vs. control, attributed to a 30% increase in fat intake (p < 0.001), predominantly monounsaturated (increase 22 g, p < 0.05). Despite greater energy intake during the peanut phase, there were no differences in body composition, and less than predicted increase (0.5 kg) in body weight for this additional energy intake, possibly due to incomplete nutrient absorption and energy utilisation. PMID:26404365

  13. Knee Extension Range of Motion at 4 Weeks Is Related to Knee Extension Loss at 12 Weeks After Anterior Cruciate Ligament Reconstruction

    PubMed Central

    Noll, Sarah; Garrison, J. Craig; Bothwell, James; Conway, John E.

    2015-01-01

    Background: The anterior cruciate ligament (ACL) is commonly torn, and surgical reconstruction is often required to allow a patient to return to their prior level of activity. Avoiding range of motion (ROM) loss is a common goal, but little research has been done to identify when ROM loss becomes detrimental to a patient’s future function. Purpose: To determine whether there is a relationship between early knee side-to-side extension difference after ACL reconstruction and knee side-to-side extension difference at 12 weeks. The hypothesis was that early (within the first 8 weeks) knee side-to-side extension difference will be predictive of knee side-to-side extension difference seen at 12 weeks. Study Design: Cohort study; Level of evidence, 3. Methods: Knee side-to-side extension difference measures were taken on 74 patients undergoing ACL reconstruction rehabilitation at the initial visit and 4, 8, and 12 weeks postoperatively. Visual analog scores (VAS) and International Knee Documentation Committee (IKDC) scores were also recorded at these time frames. Results: There was a strong relationship between knee extension ROM at 4 and 12 weeks (r = 0.639, P < .001) and 8 and 12 weeks (r = 0.742, P < .001). When the variables of knee extension ROM at initial visit and 4 and 8 weeks were entered into a regression analysis, the predictor variable explained 61% (R2 = 0.611) of variance for knee extension ROM at 12 weeks, with 4 weeks (R2 = 0.259) explaining the majority of this variance. Conclusion: This study found that a patient’s knee extension at 4 weeks was strongly correlated with knee extension at 12 weeks. Clinical Relevance: This information may be useful for clinicians treating athletic patients who are anxious for return to sport by providing them an initial goal to work toward in hopes of ensuring successful rehabilitation of their knee. PMID:26675061

  14. Cutoff Designs for Community-Based Intervention Studies

    PubMed Central

    Pennell, Michael L.; Hade, Erinn M.; Murray, David M.; Rhoda, Dale A.

    2011-01-01

    Summary Public health interventions are often designed to target communities defined either geographically (e.g., cities, counties) or socially (e.g., schools or workplaces). The group randomized trial (GRT) is regarded as the gold standard for evaluating these interventions. However, community leaders may object to randomization as some groups may be denied a potentially beneficial intervention. Under a regression discontinuity design (RDD), individuals may be assigned to treatment based on the levels of a pretest measure, thereby allowing those most in need of the treatment to receive it. In this article, we consider analysis, power, and sample size issues in applying the RDD and related cutoff designs in community-based intervention studies. We examine the power of these designs as a function of intraclass correlation, number of groups, and number of members per group and compare results to the traditional GRT. PMID:21500240

  15. Effects of a 12-week intervention period with football and running for habitually active men with mild hypertension.

    PubMed

    Knoepfli-Lenzin, C; Sennhauser, C; Toigo, M; Boutellier, U; Bangsbo, J; Krustrup, P; Junge, A; Dvorak, J

    2010-04-01

    The present study examined the effect of football (F, n=15) training on the health profile of habitually active 25-45-year-old men with mild hypertension and compared it with running (R, n=15) training and no additional activity (controls, C, n=17). The participants in F and R completed a 1-h training session 2.4 times/week for 12 weeks. Systolic and diastolic blood pressure decreased in all groups but the decrease in diastolic blood pressure in F (-9 +/- 5 (+/- SD) mmHg) was higher than that in C (-4 +/- 6 mmHg). F was as effective as R in decreasing body mass (-1.6 +/- 1.8 vs-1.5 +/- 2.1 kg) and total fat mass (-2.0 +/- 1.5 vs -1.6 +/- 1.5 kg) and in increasing supine heart rate variability, whereas no changes were detected for C. Maximal stroke volume improved in F (+13.1%) as well as in R (+10.1%) compared with C (-4.9%). Total cholesterol decreased in F (5.8 +/- 1.2 to 5.5 +/- 0.9 mmol/L) but was not altered in R and C. We conclude that football training, consisting of high-intensity intermittent exercise, results in positive effects on blood pressure, body composition, stroke volume and supine heart rate variability, and elicits at least the same cardiovascular health benefits as continuous running exercise in habitually active men with mild hypertension.

  16. Agomelatine versus Sertraline: An Observational, Open-labeled and 12 Weeks Follow-up Study on Efficacy and Tolerability

    PubMed Central

    Akpınar, Esma; Cerit, Cem; Talas, Anıl; Tural, Ümit

    2016-01-01

    Objective In this open-labeled, 12 weeks follow-up study, we aimed to compare the efficacy and tolerability of agomelatine with sertraline Methods The outpatients of adult psychiatry clinic who have a new onset of depression and diagnosed as ‘major depressive episode’ by clinician according to the Diagnostic and Statistical Manual of Mental Disorders 4th edition and prescribed agomelatine (25 mg/day) or sertraline (50 mg/day) were included in the study. Results The decline of mean Montgomery-Asberg Depression Rating Scale (MADRS) scores of agomelatine group was significantly higher than the sertraline group at the end of 2nd week; however, the difference was not significant at the end of 3 months. Mean Clinical Global Impression-Improvement scale (CGI-I) scores of agomelatine group was lower than sertraline group at first week. Mean CGI-Severity scale and CGI-I scores were favour to sertraline group at the end of the study. Remission rates were 46.7% for sertraline group and 33.3% for agomelatine group while response rates were 76.7% for both groups. Any patient from agomelatine group dropped-out due to adverse effects. The amount of side effects was also less with agomelatine. Conclusion Agomelatine has a rapid onset efficacy on depressive symptoms and this can be beneficial for some critical cases. Considering MADRS scores, agomelatine seems to have similar efficacy with sertraline but we also point the need for long term studies since CGI scores were favour to sertraline group at the end of the study. Agomelatine has a favourable tolerability profile both in terms of discontinuation and the amount of side effects compared to sertraline. PMID:27776387

  17. A 12-Week Exercise Program for Pregnant Women with Obesity to Improve Physical Activity Levels: An Open Randomised Preliminary Study

    PubMed Central

    Alméras, Natalie; Dufresne, Sébastien S.; Robitaille, Julie; Rhéaume, Caroline; Bujold, Emmanuel; Frenette, Jérôme; Tremblay, Angelo

    2015-01-01

    Objective To evaluate whether a 12-week supervised exercise program promotes an active lifestyle throughout pregnancy in pregnant women with obesity. Methods In this preliminary randomised trial, pregnant women (body mass index ≥ 30 kg/m2) were allocated to either standard care or supervised training, from 15 to 27 weeks of gestation. Physical activity was measured by accelerometry at 14, 28 and 36 weeks, while fitness (oxygen consumption (VO2) at the anaerobic threshold), nutrition (caloric intake and macronutrients percentage) and anthropometry were assessed at 14 and 28 weeks of gestation. Analyses were performed using repeated measures ANOVA. Results A total of fifty (50) women were randomised, 25 in each group. There was no time-group interaction for time spent at moderate and vigorous activity (pinteraction = 0.064), but the exercise group’s levels were higher than controls’ at all times (pgroup effect = 0.014). A significant time-group interaction was found for daily physical activity (p = 0.023); similar at baseline ((22.0 ± 6.7 vs 21.8 ± 7.3) x 104 counts/day) the exercise group had higher levels than the control group following the intervention ((22.8 ± 8.3 vs 19.2 ± 4.5) x 104 counts/day, p = 0.020) and at 36 weeks of gestation ((19.2 ± 1.5 vs 14.9 ± 1.5) x 104 counts/day, p = 0.034). Exercisers also gained less weight than controls during the intervention period despite similar nutritional intakes (difference in weight change = -0.1 kg/week, 95% CI -0.2; -0.02, p = 0.016) and improved cardiorespiratory fitness (difference in fitness change = 8.1%, 95% CI 0.7; 9.5, p = 0.041). Conclusions Compared with standard care, a supervised exercise program allows pregnant women with obesity to maintain fitness, limit weight gain and attenuate the decrease in physical activity levels observed in late pregnancy. Trial Registration ClinicalTrials.gov NCT01610323 PMID:26375471

  18. Differential therapeutic effects of 12-week treatment of atomoxetine and methylphenidate on drug-naïve children with attention deficit/hyperactivity disorder: A counting Stroop functional MRI study.

    PubMed

    Chou, Tai-Li; Chia, Seng; Shang, Chi-Yung; Gau, Susan Shur-Fen

    2015-12-01

    Methylphenidate and atomoxetine are effective in treating attention-deficit/hyperactivity disorder (ADHD) with underlying distinct pharmacological mechanisms. To relate neural mechanisms to clinical response, we conducted a comparative trial to differentiate the changes in brain activation of drug-naïve children with ADHD when performing neuropsychological tasks after 12 weeks of pharmacotherapy. We randomized 50 drug-naïve children with ADHD, aged 7-17, to treatment with methylphenidate (n=25) or atomoxetine (n=25). These children were scanned twice with functional magnetic resonance imaging (fMRI) during the counting Stroop task before and after treatment. Focused attention and impulsivity were assessed twice by using the Conner's Continuous Performance Test (CCPT). The final sample for fMRI analysis comprised 20 in the methylphenidate group and 22 in the atomoxetine group. Atomoxetine decreased activations in the dorsal anterior cingulate cortex and dorsolateral prefrontal cortex, which correlated with improvement in focused attention assessed by the CCPT. In contrast, methylphenidate increased activations in the inferior frontal gyrus, which correlated with the decreasing severity of impulsivity assessed by the CCPT. The current findings suggest that differential therapeutic effects on neuronal changes induced by 12-week treatment atomoxetine and methylphenidate may contribute to behavioral improvement.

  19. Differential therapeutic effects of 12-week treatment of atomoxetine and methylphenidate on drug-naïve children with attention deficit/hyperactivity disorder: A counting Stroop functional MRI study.

    PubMed

    Chou, Tai-Li; Chia, Seng; Shang, Chi-Yung; Gau, Susan Shur-Fen

    2015-12-01

    Methylphenidate and atomoxetine are effective in treating attention-deficit/hyperactivity disorder (ADHD) with underlying distinct pharmacological mechanisms. To relate neural mechanisms to clinical response, we conducted a comparative trial to differentiate the changes in brain activation of drug-naïve children with ADHD when performing neuropsychological tasks after 12 weeks of pharmacotherapy. We randomized 50 drug-naïve children with ADHD, aged 7-17, to treatment with methylphenidate (n=25) or atomoxetine (n=25). These children were scanned twice with functional magnetic resonance imaging (fMRI) during the counting Stroop task before and after treatment. Focused attention and impulsivity were assessed twice by using the Conner's Continuous Performance Test (CCPT). The final sample for fMRI analysis comprised 20 in the methylphenidate group and 22 in the atomoxetine group. Atomoxetine decreased activations in the dorsal anterior cingulate cortex and dorsolateral prefrontal cortex, which correlated with improvement in focused attention assessed by the CCPT. In contrast, methylphenidate increased activations in the inferior frontal gyrus, which correlated with the decreasing severity of impulsivity assessed by the CCPT. The current findings suggest that differential therapeutic effects on neuronal changes induced by 12-week treatment atomoxetine and methylphenidate may contribute to behavioral improvement. PMID:26409297

  20. Effects of 12-week exercise training on osteocalcin, high-sensitivity C-reactive protein concentrations, and insulin resistance in elderly females with osteoporosis.

    PubMed

    Ahn, Nayoung; Kim, Kijin

    2016-08-01

    [Purpose] This study examined the effects of exercise training on bone metabolism markers, inflammatory markers, and physical fitness in patients with osteoporosis from an osteoporosis-related immunological perspective. [Subjects and Methods] Twenty-nine elderly female subjects (age, 74.2 ± 3.2 years) were classified into normal, osteopenia, and osteoporosis groups based on the T-score measured using dual-energy X-ray absorptiometry. The exercise was performed voluntarily by the patients for 1 hour per day, three times per week, for 12 weeks. [Results] The differences between bone mineral content, bone mineral density, and osteocalcin concentrations increased significantly in the osteoporosis group after 12 weeks of exercise and were significantly higher than those in the normal and osteopenia groups. However, the homeostatic model assessment of insulin resistance score decreased significantly in the osteoporosis group after 12 weeks of exercise. High-sensitivity C-reactive protein concentrations tended to decrease in all groups after 12 weeks of exercise and showed an inverse correlation with osteocalcin concentration; however, no statistical significance was observed. [Conclusion] Our findings suggest that an exercise program in patients with osteopenia and osteoporosis effectively reduces the risk of osteoporotic fracture and related diseases since it improves bone density and physical fitness and reduces inflammatory marker levels. PMID:27630402

  1. A 12 Week, Open Label, Phase I/IIa Study Using Apatone® for the Treatment of Prostate Cancer Patients Who Have Failed Standard Therapy

    PubMed Central

    Tareen, Basir; Summers, Jack L.; Jamison, James M.; Neal, Deborah R.; McGuire, Karen; Gerson, Lowell; Diokno, Ananias

    2008-01-01

    Purpose: To evaluate the safety and efficacy of oral Apatone® (Vitamin C and Vitamin K3) administration in the treatment of prostate cancer in patients who failed standard therapy. Materials and Methods: Seventeen patients with 2 successive rises in PSA after failure of standard local therapy were treated with (5,000 mg of VC and 50 mg of VK3 each day) for a period of 12 weeks. Prostate Specific Antigen (PSA) levels, PSA velocity (PSAV) and PSA doubling times (PSADT) were calculated before and during treatment at 6 week intervals. Following the initial 12 week trial, 15 of 17 patients opted to continue treatment for an additional period ranging from 6 to 24 months. PSA values were followed for these patients. Results: At the conclusion of the 12 week treatment period, PSAV decreased and PSADT increased in 13 of 17 patients (p ≤ 0.05). There were no dose-limiting adverse effects. Of the 15 patients who continued on Apatone after 12 weeks, only 1 death occurred after 14 months of treatment. Conclusion: Apatone showed promise in delaying biochemical progression in this group of end stage prostate cancer patients. PMID:18392145

  2. Effects of 12-week exercise training on osteocalcin, high-sensitivity C-reactive protein concentrations, and insulin resistance in elderly females with osteoporosis.

    PubMed

    Ahn, Nayoung; Kim, Kijin

    2016-08-01

    [Purpose] This study examined the effects of exercise training on bone metabolism markers, inflammatory markers, and physical fitness in patients with osteoporosis from an osteoporosis-related immunological perspective. [Subjects and Methods] Twenty-nine elderly female subjects (age, 74.2 ± 3.2 years) were classified into normal, osteopenia, and osteoporosis groups based on the T-score measured using dual-energy X-ray absorptiometry. The exercise was performed voluntarily by the patients for 1 hour per day, three times per week, for 12 weeks. [Results] The differences between bone mineral content, bone mineral density, and osteocalcin concentrations increased significantly in the osteoporosis group after 12 weeks of exercise and were significantly higher than those in the normal and osteopenia groups. However, the homeostatic model assessment of insulin resistance score decreased significantly in the osteoporosis group after 12 weeks of exercise. High-sensitivity C-reactive protein concentrations tended to decrease in all groups after 12 weeks of exercise and showed an inverse correlation with osteocalcin concentration; however, no statistical significance was observed. [Conclusion] Our findings suggest that an exercise program in patients with osteopenia and osteoporosis effectively reduces the risk of osteoporotic fracture and related diseases since it improves bone density and physical fitness and reduces inflammatory marker levels.

  3. Effects of a 12-week healthy-life exercise program on oxidized low-density lipoprotein cholesterol and carotid intima-media thickness in obese elderly women.

    PubMed

    Park, Jong-Hwan; Park, Hyuntae; Lim, Seung-Taek; Park, Jin-Kee

    2015-05-01

    [Purpose] This study examined the effects of a 12-week exercise program on plasma level of oxidized low-density lipoprotein cholesterol in obese elderly women, who are at increased risk of heart disease morbidity. [Subjects and Methods] Twenty participants were assigned into either a control (n = 10) or a supervised exercise program (n = 10) group. The 12-week exercise intervention was performed 3 days per week and involved combined aerobic exercise, resistance exercise, and traditional Korean dance. [Results] Two-factor analysis of variance revealed significant group × time interactions for body mass, diastolic blood pressure, appendicular muscle mass. For high-density lipoprotein cholesterol, oxidized low-density lipoprotein cholesterol, and the ratio of oxidized low-/high-density lipoprotein cholesterol, two-factor analysis of variance revealed significant interactions (group × time), indicating responses differed significantly between the control and exercise groups after 12 weeks. [Conclusion] A 12-week low- to moderate-intensity exercise program appears to be beneficial for obese elderly women by improving risk factors for cardiovascular disease.

  4. Effects of 12-week exercise training on osteocalcin, high-sensitivity C-reactive protein concentrations, and insulin resistance in elderly females with osteoporosis

    PubMed Central

    Ahn, Nayoung; Kim, Kijin

    2016-01-01

    [Purpose] This study examined the effects of exercise training on bone metabolism markers, inflammatory markers, and physical fitness in patients with osteoporosis from an osteoporosis-related immunological perspective. [Subjects and Methods] Twenty-nine elderly female subjects (age, 74.2 ± 3.2 years) were classified into normal, osteopenia, and osteoporosis groups based on the T-score measured using dual-energy X-ray absorptiometry. The exercise was performed voluntarily by the patients for 1 hour per day, three times per week, for 12 weeks. [Results] The differences between bone mineral content, bone mineral density, and osteocalcin concentrations increased significantly in the osteoporosis group after 12 weeks of exercise and were significantly higher than those in the normal and osteopenia groups. However, the homeostatic model assessment of insulin resistance score decreased significantly in the osteoporosis group after 12 weeks of exercise. High-sensitivity C-reactive protein concentrations tended to decrease in all groups after 12 weeks of exercise and showed an inverse correlation with osteocalcin concentration; however, no statistical significance was observed. [Conclusion] Our findings suggest that an exercise program in patients with osteopenia and osteoporosis effectively reduces the risk of osteoporotic fracture and related diseases since it improves bone density and physical fitness and reduces inflammatory marker levels.

  5. Effects of 12-week exercise training on osteocalcin, high-sensitivity C-reactive protein concentrations, and insulin resistance in elderly females with osteoporosis

    PubMed Central

    Ahn, Nayoung; Kim, Kijin

    2016-01-01

    [Purpose] This study examined the effects of exercise training on bone metabolism markers, inflammatory markers, and physical fitness in patients with osteoporosis from an osteoporosis-related immunological perspective. [Subjects and Methods] Twenty-nine elderly female subjects (age, 74.2 ± 3.2 years) were classified into normal, osteopenia, and osteoporosis groups based on the T-score measured using dual-energy X-ray absorptiometry. The exercise was performed voluntarily by the patients for 1 hour per day, three times per week, for 12 weeks. [Results] The differences between bone mineral content, bone mineral density, and osteocalcin concentrations increased significantly in the osteoporosis group after 12 weeks of exercise and were significantly higher than those in the normal and osteopenia groups. However, the homeostatic model assessment of insulin resistance score decreased significantly in the osteoporosis group after 12 weeks of exercise. High-sensitivity C-reactive protein concentrations tended to decrease in all groups after 12 weeks of exercise and showed an inverse correlation with osteocalcin concentration; however, no statistical significance was observed. [Conclusion] Our findings suggest that an exercise program in patients with osteopenia and osteoporosis effectively reduces the risk of osteoporotic fracture and related diseases since it improves bone density and physical fitness and reduces inflammatory marker levels. PMID:27630402

  6. Effect of 12-Week Vitamin D Supplementation on 25[OH]D Status and Performance in Athletes with a Spinal Cord Injury.

    PubMed

    Flueck, Joelle Leonie; Schlaepfer, Max Walter; Perret, Claudio

    2016-09-22

    (1) BACKGROUND: studies with able-bodied athletes showed that performance might possibly be influenced by vitamin D status. Vitamin D seems to have a direct impact on neuromuscular function by docking on vitamin D receptors in the muscle tissue. Additionally, a high prevalence of vitamin D deficiency was shown not only in infants and in the elderly but also in healthy adults and spinal cord injured individuals. Therefore, the aim of our study was to investigate whether a vitamin D dose of 6000 IU daily over 12 weeks would be sufficient to increase vitamin D status in indoor wheelchair athletes to a normal or optimal vitamin D level and whether vitamin D deficiency is associated with an impairment in muscle performance in these individuals; (2) METHODS: vitamin D status was assessed in indoor elite wheelchair athletes in order to have a baseline measurement. If vitamin D status was below 75 nmol/L, athletes were supplemented with 6000 IU of vitamin D daily over 12 weeks. A vitamin D status over 75 nmol/L was supplemented with a placebo supplement. Vitamin D status, as well as a Wingate test and an isokinetic dynamometer test, were performed at baseline and after six and 12 weeks; (3) RESULTS: 20 indoor elite wheelchair athletes participated in this double-blind study. All of these athletes showed an insufficient vitamin D status at baseline and were, therefore, supplemented with vitamin D. All athletes increased vitamin D status significantly over 12 weeks and reached an optimal level. Wingate performance was not significantly increased. Isokinetic dynamometer strength was significantly increased but only in the non-dominant arm in isometric and concentric elbow flexion; (4) CONCLUSION: a dose of 6000 IU of vitamin D daily over a duration of 12 weeks seems to be sufficient to increase vitamin D status to an optimal level in indoor wheelchair athletes. It remains unclear, whether upper body performance or muscle strength and vitamin D status are associated with each

  7. Cardiovascular, renal and gastrointestinal effects of incretin-based therapies: an acute and 12-week randomised, double-blind, placebo-controlled, mechanistic intervention trial in type 2 diabetes

    PubMed Central

    Smits, Mark M; Tonneijck, Lennart; Muskiet, Marcel H A; Hoekstra, Trynke; Kramer, Mark H H; Pieters, Indra C; Cahen, Djuna L; Diamant, Michaela; van Raalte, Daniël H

    2015-01-01

    Introduction Incretin-based therapies, that is, glucagon-like peptide (GLP)-1 receptor agonists and dipeptidyl peptidase (DPP)-4 inhibitors, are relatively novel antihyperglycaemic drugs that are frequently used in type 2 diabetes management. Apart from glucose-lowering, these agents exhibit pleiotropic actions that may have favourable and unfavourable clinical consequences. Incretin-based therapies have been associated with heart rate acceleration, heart failure, acute renal failure and acute pancreatitis. Conversely, these agents may reduce blood pressure, glomerular hyperfiltration, albuminuria and hepatic steatosis. While large-sized cardiovascular safety trials can potentially identify the clinical significance of some of these pleiotropic actions, small-sized mechanistic studies are important to understand the (patho)physiological rationale of these findings. The current protocol describes a mechanistic study to assess cardiovascular, renal and gastrointestinal effects, and mechanisms of incretin-based therapies in type 2 diabetes. Methods and analyses 60 patients with type 2 diabetes will undergo acute and prolonged randomised, double-blind, intervention studies. The acute intervention will consist of intravenous administration of the GLP-1 receptor agonist exenatide or placebo. For the prolonged intervention, patients will be randomised to 12-week treatment with the GLP-1 receptor agonist liraglutide, the DPP-4 inhibitor sitagliptin or matching placebos. For each examined organ system, a primary end point is defined. Primary cardiovascular end point is change in resting heart rate variability assessed by beat-to-beat heart rate monitor and spectral analyses software. Primary renal end point is change in glomerular filtration rate assessed by the classic inulin clearance methodology. Primary gastrointestinal end points are change in pancreatic exocrine function assessed by MRI-techniques (acute intervention) and faecal elastase-1 levels (12-week intervention

  8. Effects of a 12-Week Hatha Yoga Intervention on Metabolic Risk and Quality of Life in Hong Kong Chinese Adults with and without Metabolic Syndrome

    PubMed Central

    Lau, Caren; Yu, Ruby; Woo, Jean

    2015-01-01

    Objective To determine the efficacy of a 12-week Hatha yoga intervention to improve metabolic risk profiles and health-related quality of life (HRQoL) in Chinese adults with and without metabolic syndrome (MetS). Methods We conducted a controlled trial within an university-affiliated hospital. 173 Chinese men and women aged 18 or above were assigned to either the yoga intervention group (n = 87) or the control group (n = 86). Primary outcomes included 12-week change in metabolic risk factors and MetS z score. Secondary outcome was HRQoL (Medical Outcomes Short Form Survey at 12 weeks). Results The mean age of participants was 52.0 (SD 7.4, range 31-71) years. Analysis involving the entire study population revealed that the yoga group achieved greater decline in waist circumference (p<0.001), fasting glucose (p<0.01), triglycerides (p<0.05), and MetS z score (p<0.01). Yoga training also improved general health perceptions (p<0.01), physical component score (p<0.01), and social functioning (p<0.01) domains score of HRQoL. However, no significant differences between groups were observed in the mean change of systolic/diastolic blood pressures or high-density lipid protein cholesterol (all p>0.05). There were no significant differences in the intervention effects on waist circumference and MetS z score between the MetS subgroups (both p>0.05). Conclusion A 12-week Hatha yoga intervention improves metabolic risk profiles and HRQoL in Chinese adults with and without MetS. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12613000816752 PMID:26111165

  9. Effects of 12-week Vegetarian Diet on the Nutritional Status, Stress Status and Bowel Habits in Middle School Students and Teachers

    PubMed Central

    Lee, Bo Ra; Ko, Yu Mi; Cho, Mi Hee; Yoon, Young Ran

    2016-01-01

    This study investigated the effect of switching normal diet to vegetarian diet rich in vegetables and fruits for school foodservice and home meal on the nutritional status, bowel habit improvement and stress reduction of teachers and adolescents. A total of 40 research subjects (26 students, 14 teachers) from one middle school voluntarily participated in the research. Questionnaire surveys and blood analysis were conducted before and after a 12-week vegetarian diet period. The participants were asked on their dietary habit, bowel habit and stress measurement. After 12 weeks, reduction of BMI (kg/m2) in the students (p < 0.05) and reduction of TC (mg/dL) in both teachers and students (p < 0.05) were observed. Also reduction of LDL-C (mg/dL) was observed in the teachers (p < 0.05) whereas serum calcium and Vitamin B12 was increased in the students and teachers (p < 0.005). The teacher's stress level was reduced (p < 0.05) after the 12-week vegetarian diet. As for the changes in bowel habit, the number of the students and teachers classified as experiencing functional constipation was decreased respectively from 10 to 7, from 7 to 5. Based on the result, it is considered that the vegetarian diet rich in fruits and vegetables improved general health status of study subjects suggesting that such a dietary habit would substantially contribute to improving nutritional status and bowel habit. PMID:27152300

  10. Effects of 12-week Vegetarian Diet on the Nutritional Status, Stress Status and Bowel Habits in Middle School Students and Teachers.

    PubMed

    Lee, Bo Ra; Ko, Yu Mi; Cho, Mi Hee; Yoon, Young Ran; Kye, Seung Hee; Park, Yoo Kyoung

    2016-04-01

    This study investigated the effect of switching normal diet to vegetarian diet rich in vegetables and fruits for school foodservice and home meal on the nutritional status, bowel habit improvement and stress reduction of teachers and adolescents. A total of 40 research subjects (26 students, 14 teachers) from one middle school voluntarily participated in the research. Questionnaire surveys and blood analysis were conducted before and after a 12-week vegetarian diet period. The participants were asked on their dietary habit, bowel habit and stress measurement. After 12 weeks, reduction of BMI (kg/m(2)) in the students (p < 0.05) and reduction of TC (mg/dL) in both teachers and students (p < 0.05) were observed. Also reduction of LDL-C (mg/dL) was observed in the teachers (p < 0.05) whereas serum calcium and Vitamin B12 was increased in the students and teachers (p < 0.005). The teacher's stress level was reduced (p < 0.05) after the 12-week vegetarian diet. As for the changes in bowel habit, the number of the students and teachers classified as experiencing functional constipation was decreased respectively from 10 to 7, from 7 to 5. Based on the result, it is considered that the vegetarian diet rich in fruits and vegetables improved general health status of study subjects suggesting that such a dietary habit would substantially contribute to improving nutritional status and bowel habit.

  11. The influence of a 12-week program of physical activity on changes in body composition and lipid and carbohydrate status in postmenopausal women

    PubMed Central

    Pilch, Wanda Barbara; Mucha, Dariusz Mikołaj; Pałka, Tomasz Adam; Suder, Agnieszka Ewa; Tyka, Anna Katarzyna; Tota, Łukasz Marcin; Ambroży, Tadeusz

    2015-01-01

    Introduction For years there have been studies on what kind of physical activity is optimal for maintaining proper health condition. Besides well known and approved endurance training of moderate intensity, an importance of interval exercise where short term, sudden intensification of work is performed at low endurance load is emphasized. The aim of the work was to assess the effects of a program of physical activity applied to postmenopausal women regarding improvement of their body composition and biochemical indices of lipid and carbohydrate status. Material and methods The program of physical activity contained 12-week trainings of Nordic walking (NW) and gymnastic-dance classes (G-D). The intensity of effort during the NW training was at the level of 60% HRmax, whereas intensity of G-D exercises was selected based on a subjective assessment of effort according to the scale of American College of Sports Medicine. Results The 12-week program of physical activity resulted in statistically significant lowering of total cholesterol and low density lipoprotein (LDL) fraction levels. An increase in high density lipoprotein (HDL) cholesterol level was observed, whereas the values of triacylglycerols (TG) did not change. The average fasting blood glucose level decreased significantly. Similar changes were noted for the insulin level. The analysed body biometrical-structural indices did not change significantly. Conclusions The applied 12-week program of physical activity without changes of dietary habits contributed to an improvement in plasma lipid profile and an increased insulin sensitivity, but it did not affect significantly body composition. PMID:26848294

  12. Effects of 12-week Vegetarian Diet on the Nutritional Status, Stress Status and Bowel Habits in Middle School Students and Teachers.

    PubMed

    Lee, Bo Ra; Ko, Yu Mi; Cho, Mi Hee; Yoon, Young Ran; Kye, Seung Hee; Park, Yoo Kyoung

    2016-04-01

    This study investigated the effect of switching normal diet to vegetarian diet rich in vegetables and fruits for school foodservice and home meal on the nutritional status, bowel habit improvement and stress reduction of teachers and adolescents. A total of 40 research subjects (26 students, 14 teachers) from one middle school voluntarily participated in the research. Questionnaire surveys and blood analysis were conducted before and after a 12-week vegetarian diet period. The participants were asked on their dietary habit, bowel habit and stress measurement. After 12 weeks, reduction of BMI (kg/m(2)) in the students (p < 0.05) and reduction of TC (mg/dL) in both teachers and students (p < 0.05) were observed. Also reduction of LDL-C (mg/dL) was observed in the teachers (p < 0.05) whereas serum calcium and Vitamin B12 was increased in the students and teachers (p < 0.005). The teacher's stress level was reduced (p < 0.05) after the 12-week vegetarian diet. As for the changes in bowel habit, the number of the students and teachers classified as experiencing functional constipation was decreased respectively from 10 to 7, from 7 to 5. Based on the result, it is considered that the vegetarian diet rich in fruits and vegetables improved general health status of study subjects suggesting that such a dietary habit would substantially contribute to improving nutritional status and bowel habit. PMID:27152300

  13. A 12-week rehabilitation program improves body composition, pain sensation, and internal/external torques of baseball pitchers with shoulder impingement symptom.

    PubMed

    Cha, Jun-Youl; Kim, Jae-Hak; Hong, Ju; Choi, Young-Tae; Kim, Min-Ho; Cho, Ji-Hyun; Ko, Il-Gyu; Jee, Yong-Seok

    2014-02-01

    The aim of this study was to investigate the effects of a 12-week rehabilitation program on body composition, shoulder pain, and isokinetic internal/external torques of pitchers with impingement syndrome. A total of 30 pitchers were divided into 2 groups: experimental group (EG, n = 16) and control group (CG, n= 14). The rehabilitation program consisted of physical therapy, warm-up, work-out, and cool-down. As results, body weight and fat mass of EG were decreased whereas muscle mass of EG was significantly increased after the experiment. The pain degrees in resting, normal daily activity, and strenuous activity on the numeric pain rating scale were significantly decreased in the EG. The internal and external peak torques (PTs) of uninvolved and involved sides of EG were increased in EG after 12 weeks. Such results provide a deficit ratio of both sides in EG close to normal values. The ratios of internal/external PTs in EG were also close to the reference values. The internal and external total works of both sides in EG were similar to the values of PT. The fatigue indices of internal and external rotators of both sides in EG were decreased. As a conclusion, a 12-week rehabilitation program reduced the shoulder pain, improved the body composition and enhanced the isokinetic shoulder internal/external rotators in EG with impingement symptoms. Also the study suggested that the rehabilitation program evened out the ratio between internal and external rotators and lowered the fatigue level after the experiment.

  14. Effect of 12-Week Vitamin D Supplementation on 25[OH]D Status and Performance in Athletes with a Spinal Cord Injury.

    PubMed

    Flueck, Joelle Leonie; Schlaepfer, Max Walter; Perret, Claudio

    2016-01-01

    (1) BACKGROUND: studies with able-bodied athletes showed that performance might possibly be influenced by vitamin D status. Vitamin D seems to have a direct impact on neuromuscular function by docking on vitamin D receptors in the muscle tissue. Additionally, a high prevalence of vitamin D deficiency was shown not only in infants and in the elderly but also in healthy adults and spinal cord injured individuals. Therefore, the aim of our study was to investigate whether a vitamin D dose of 6000 IU daily over 12 weeks would be sufficient to increase vitamin D status in indoor wheelchair athletes to a normal or optimal vitamin D level and whether vitamin D deficiency is associated with an impairment in muscle performance in these individuals; (2) METHODS: vitamin D status was assessed in indoor elite wheelchair athletes in order to have a baseline measurement. If vitamin D status was below 75 nmol/L, athletes were supplemented with 6000 IU of vitamin D daily over 12 weeks. A vitamin D status over 75 nmol/L was supplemented with a placebo supplement. Vitamin D status, as well as a Wingate test and an isokinetic dynamometer test, were performed at baseline and after six and 12 weeks; (3) RESULTS: 20 indoor elite wheelchair athletes participated in this double-blind study. All of these athletes showed an insufficient vitamin D status at baseline and were, therefore, supplemented with vitamin D. All athletes increased vitamin D status significantly over 12 weeks and reached an optimal level. Wingate performance was not significantly increased. Isokinetic dynamometer strength was significantly increased but only in the non-dominant arm in isometric and concentric elbow flexion; (4) CONCLUSION: a dose of 6000 IU of vitamin D daily over a duration of 12 weeks seems to be sufficient to increase vitamin D status to an optimal level in indoor wheelchair athletes. It remains unclear, whether upper body performance or muscle strength and vitamin D status are associated with each

  15. Effect of 12-Week Vitamin D Supplementation on 25[OH]D Status and Performance in Athletes with a Spinal Cord Injury

    PubMed Central

    Flueck, Joelle Leonie; Schlaepfer, Max Walter; Perret, Claudio

    2016-01-01

    (1) Background: studies with able-bodied athletes showed that performance might possibly be influenced by vitamin D status. Vitamin D seems to have a direct impact on neuromuscular function by docking on vitamin D receptors in the muscle tissue. Additionally, a high prevalence of vitamin D deficiency was shown not only in infants and in the elderly but also in healthy adults and spinal cord injured individuals. Therefore, the aim of our study was to investigate whether a vitamin D dose of 6000 IU daily over 12 weeks would be sufficient to increase vitamin D status in indoor wheelchair athletes to a normal or optimal vitamin D level and whether vitamin D deficiency is associated with an impairment in muscle performance in these individuals; (2) Methods: vitamin D status was assessed in indoor elite wheelchair athletes in order to have a baseline measurement. If vitamin D status was below 75 nmol/L, athletes were supplemented with 6000 IU of vitamin D daily over 12 weeks. A vitamin D status over 75 nmol/L was supplemented with a placebo supplement. Vitamin D status, as well as a Wingate test and an isokinetic dynamometer test, were performed at baseline and after six and 12 weeks; (3) Results: 20 indoor elite wheelchair athletes participated in this double-blind study. All of these athletes showed an insufficient vitamin D status at baseline and were, therefore, supplemented with vitamin D. All athletes increased vitamin D status significantly over 12 weeks and reached an optimal level. Wingate performance was not significantly increased. Isokinetic dynamometer strength was significantly increased but only in the non-dominant arm in isometric and concentric elbow flexion; (4) Conclusion: a dose of 6000 IU of vitamin D daily over a duration of 12 weeks seems to be sufficient to increase vitamin D status to an optimal level in indoor wheelchair athletes. It remains unclear, whether upper body performance or muscle strength and vitamin D status are associated with each

  16. Comparison of metabolic effects of aripiprazole, quetiapine and ziprasidone after 12 weeks of treatment in first treated episode of psychosis.

    PubMed

    Pérez-Iglesias, Rocio; Ortiz-Garcia de la Foz, Victor; Martínez García, Obdulia; Amado, Jose Antonio; Garcia-Unzueta, M Teresa; Ayesa-Arriola, Rosa; Suarez-Pinilla, Paula; Tabares-Seisdedos, Rafael; Crespo-Facorro, Benedicto

    2014-10-01

    This randomized open-label study compared the incidence of metabolic side effects of aripiprazole, ziprasidone and quetiapine in a population of medication-naïve first-episode psychosis patients. A total of 202 subjects were enrolled. Body weight, body mass index, leptin, fasting lipids and fasting glycaemic parameters were measured at baseline and at 3 months follow-up. A hundred and sixty-six patients completed the follow-up and were included in the analyses. A high proportion of patients experienced a significant weight increase (>7% of their baseline weight): 23% ziprasidone (n=12), 32% with quetiapine (n=16) and 45% with aripiprazole (n=31). Patients treated with aripiprazole gained significantly more weight than the patients in the ziprasidone group (1.2 kg [SD=4.1] versus 4.3 kg [SD=4.8], respectively). The increase in leptin levels was greater in women treated with aripiprazole than in those treated with ziprasidone (p=0.030). Mean prolactin levels significantly increased in patients treated with quetiapine and ziprasidone but not in those treated with aripiprazole. Patients treated with quetiapine and aripiprazole showed a significant increase in total cholesterol and LDL-cholesterol plasma levels. Quetiapine-treated patients resulted in a higher increase in LDL-cholesterol than patients treated with ziprasidone (p=0.021). No other significant differences between groups were found. No significant changes in glycaemic parameters were observed. Our results suggest that ziprasidone has a lower liability for inducing weight gain and lipid abnormalities than aripiprazole or quetiapine.

  17. Effects of a12-week endurance exercise program on adiposity and flexibility of Nigerian perimenopausal and postmenopausal women.

    PubMed

    Ogwumike, O O; Arowojolu, A O; Sanya, A O

    2011-12-20

    Menopause is a sign of aging in the woman. Loss of ovarian function induces a reduction in resting metabolic rate, physical energy expenditure, fat-free mass and abdominal adipose tissue accumulation. Location of adipose tissue deposit in abdominal region plays an important role in occurrence of hyperlipidemia, diabetes, hypertension and atherosclerosis. Although regular participation in physical exercise have been suggested to improve adiposity and body flexibility which are important health related components of physical fitness, few published studies are available on the effect of exercise on Nigerian menopausal women. This study investigated effects of a twelve-week endurance exercise program (EEP) on central and abdominal obesity as well as flexibility of perimenopausal and postmenopausal Nigerian women. The study employed a pretest- posttest control group design comprising a sample of 175 apparently healthy, literate, sedentary women within age range 40-59 years. They were workers in state and federal establishments in Ibadan North Local Government Area of Oyo State, Nigeria. Based on history of their last menstrual period, women with regular or irregular menstrual cycle status were allocated into perimenopausal group and those who no longer menstruated into postmenopausal group. A table of random numbers was used for further allocation into perimenopausal exercise group (PEMEG, 45), postmenopausal exercise group (POMEG, 45) perimenopausal control group (PEMCG, 42) and postmenopausal control group (POMCG, 43). Waist Hip Ratio (WHR), Body Mass Index (BMI) as well as Hip and Trunk Flexibility (HTF) were evaluated at baseline and 4weekly intervals until end of 12th week. EEP consisted of a 10-station circuit of cardiovascular endurance, flexibility, coordination, abdominal and pelvic floor muscle exercises. Data were analyzed using descriptive and inferential statistics. Mean age of participants was 52.3±4.1 years, 95% C.I (51.64-52.88) years. Significant

  18. Improving the Quality of Students' Academic Writing: An Intervention Study

    ERIC Educational Resources Information Center

    Boscolo, Pietro; Arfe, Barbara; Quarisa, Mara

    2007-01-01

    An intervention aimed at improving academic writing--in particular, synthesis writing - was conducted with 52 undergraduate students of psychology of the University of Padua (Italy). Before and after the intervention, which lasted 12 weeks, participants were administered a questionnaire on beliefs about writing and a synthesis writing task. During…

  19. Incidence of gastroduodenal ulcers in patients with rheumatoid arthritis after 12 weeks of rofecoxib, naproxen, or placebo: a multicentre, randomised, double blind study

    PubMed Central

    Hawkey, C J; Laine, L; Simon, T; Quan, H; Shingo, S; Evans, J

    2003-01-01

    Background: Previous studies in patients with osteoarthritis have suggested that the selective cyclooxygenase (COX)-2 inhibitor rofecoxib results in less gastrointestinal damage than non-selective non-steroidal antiinflammatory drugs (NSAIDs). This study compared the incidence of endoscopically detected gastroduodenal ulcers in rheumatoid arthritis patients treated with rofecoxib or a non-selective NSAID. Methods: In this multicentre, randomised, double blind, 12 week study, patients with rheumatoid arthritis were allocated to rofecoxib 50 mg once daily (n=219), naproxen 500 mg twice daily (n=220), or placebo (n=221). Endoscopy was performed at baseline and at six and 12 weeks. Lifetable analysis and log rank tests were used to analyse the incidence of gastroduodenal ulcers ≥3 mm. Gastric or duodenal ulcers ≥5 mm and erosions were also evaluated as secondary end points. Tolerability was assessed by adverse events. Results: The cumulative incidence of ulcers ≥3 mm at 12 weeks was significantly higher in patients on naproxen (25.5%) than in patients receiving rofecoxib (6.8%; difference 18.7% (95% confidence interval (CI) 11.7%, 25.7%); p<0.001) or placebo (2.9%; difference 22.6% (95% CI 16.1%, 29.1%); p<0.001). The difference between rofecoxib (6.8%) and placebo (2.9%) did not reach statistical significance (p=0.066). Results were similar for ulcers ≥5 mm and for mean changes from baseline in the number of gastroduodenal erosions. The overall incidence of clinical adverse events was similar among treatment groups (61% of patients on placebo, 62% in patients on rofecoxib, and 66% in patients on naproxen). Conclusions: Rofecoxib 50 mg daily (twice the dose recommended for this patient population) resulted in a lower incidence of endoscopically detected gastroduodenal ulcers and erosions than treatment with naproxen 500 mg twice daily. PMID:12740337

  20. Sofosbuvir with peginterferon-ribavirin for 12 weeks in previously treated patients with hepatitis C genotype 2 or 3 and cirrhosis

    PubMed Central

    Lawitz, Eric; Poordad, Fred; Brainard, Diana M; Hyland, Robert H; An, Di; Dvory-Sobol, Hadas; Symonds, William T; McHutchison, John G; Membreno, Fernando E

    2015-01-01

    Sofosbuvir (SOF) in combination with ribavirin (RBV) for 12 or 24 weeks is the current standard of care for patients infected with hepatitis C virus (HCV) genotypes 2 and 3, respectively. However, in clinical trials treatment-experienced patients, particularly those with cirrhosis, had suboptimal sustained virological response (SVR) rates. We assessed the efficacy and safety of sofosbuvir plus peginterferon and ribavirin (SOF+Peg-IFN+RBV) administered for 12 weeks to treatment-experienced patients with HCV genotypes 2 and 3, with and without cirrhosis. We enrolled 47 patients in this open-label, nonrandomized, uncontrolled phase 2 study. The primary endpoint was the proportion of patients with SVR at 12 weeks after cessation of study treatment (SVR12). The overall rate of SVR12 was 89% (95% confidence interval [CI]: 77-97). Rates of SVR12 were higher in patients with genotype 2 than in those with genotype 3, 96% (95% CI: 78-100) and 83% (95% CI: 62-95), respectively. Rates of SVR12 were similar in patients with and without cirrhosis: for genotype 2, 93% of patients with cirrhosis and 100% of patients without cirrhosis achieved SVR12, and for genotype 3, the SVR12 rate was 83% in patients both with and without cirrhosis. One patient discontinued study treatment because of an adverse event and four patients experienced serious adverse events. The most common adverse events were influenza-like illness, fatigue, anemia, and neutropenia. Conclusion: In treatment-experienced patients with HCV genotypes 2 and 3, 12-week administration of SOF+Peg-IFN+RBV provided high SVR rates, irrespective of cirrhosis status. No safety concerns were identified. (Hepatology 2015;61:769–775) PMID:25322962

  1. Residual {sup 18}F-FDG-PET Uptake 12 Weeks After Stereotactic Ablative Radiotherapy for Stage I Non-Small-Cell Lung Cancer Predicts Local Control

    SciTech Connect

    Bollineni, Vikram Rao; Widder, Joachim; Pruim, Jan; Langendijk, Johannes A.; Wiegman, Erwin M.

    2012-07-15

    Purpose: To investigate the prognostic value of [{sup 18}F]fluorodeoxyglucose positron emission tomography (FDG-PET) uptake at 12 weeks after stereotactic ablative radiotherapy (SABR) for stage I non-small-cell lung cancer (NSCLC). Methods and Materials: From November 2006 to February 2010, 132 medically inoperable patients with proven Stage I NSCLC or FDG-PET-positive primary lung tumors were analyzed retrospectively. SABR consisted of 60 Gy delivered in 3 to 8 fractions. Maximum standardized uptake value (SUV{sub max}) of the treated lesion was assessed 12 weeks after SABR, using FDG-PET. Patients were subsequently followed at regular intervals using computed tomography (CT) scans. Association between post-SABR SUV{sub max} and local control (LC), mediastinal failure, distant failure, overall survival (OS), and disease-specific survival (DSS) was examined. Results: Median follow-up time was 17 months (range, 3-40 months). Median lesion size was 25 mm (range, 9-70 mm). There were 6 local failures: 15 mediastinal failures, 15 distant failures, 13 disease-related deaths, and 16 deaths from intercurrent diseases. Glucose corrected post-SABR median SUV{sub max} was 3.0 (range, 0.55-14.50). Using SUV{sub max} 5.0 as a cutoff, the 2-year LC was 80% versus 97.7% for high versus low SUV{sub max}, yielding an adjusted subhazard ratio (SHR) for high post-SABR SUV{sub max} of 7.3 (95% confidence interval [CI], 1.4-38.5; p = 0.019). Two-year DSS rates were 74% versus 91%, respectively, for high and low SUV{sub max} values (SHR, 2.2; 95% CI, 0.8-6.3; p = 0.113). Two-year OS was 62% versus 81% (hazard ratio [HR], 1.6; 95% CI, 0.7-3.7; p = 0.268). Conclusions: Residual FDG uptake (SUV{sub max} {>=}5.0) 12 weeks after SABR signifies increased risk of local failure. A single FDG-PET scan at 12 weeks could be used to tailor further follow-up according to the risk of failure, especially in patients potentially eligible for salvage surgery.

  2. Decreasing cardiovascular risk factors in obese individuals using a combination of PGX® meal replacements and PGX® granules in a 12-week clinical weight modification program.

    PubMed

    Reichert, Ronald G; Lyon, Michael R; Kacinik, Veronica; Gahler, Roland J; Manjoo, Priya; Purnama, Monica; Wood, Simon

    2013-05-07

    In this open, clinically based, weight modification program, we determined in six sedentary obese adults (five women; one male; age range 30-62 years) that the combination of a modified calorie diet plus PGX® meal replacement and PGX® supplementation resulted in a significant reduction in several cardiovascular risk factors over a 12-week time period. This included a significant improvement in lipids (-0.98 mmol/l LDL-C), reduction in average weight (-9.2 kg), mean reduction in fat (-4.1%) and an increase in fat-free mass (2.8%).

  3. Decreasing cardiovascular risk factors in obese individuals using a combination of PGX® meal replacements and PGX® granules in a 12-week clinical weight modification program.

    PubMed

    Reichert, Ronald G; Lyon, Michael R; Kacinik, Veronica; Gahler, Roland J; Manjoo, Priya; Purnama, Monica; Wood, Simon

    2013-01-01

    In this open, clinically based, weight modification program, we determined in six sedentary obese adults (five women; one male; age range 30-62 years) that the combination of a modified calorie diet plus PGX® meal replacement and PGX® supplementation resulted in a significant reduction in several cardiovascular risk factors over a 12-week time period. This included a significant improvement in lipids (-0.98 mmol/l LDL-C), reduction in average weight (-9.2 kg), mean reduction in fat (-4.1%) and an increase in fat-free mass (2.8%). PMID:23652638

  4. The design and methodology of premature ejaculation interventional studies

    PubMed Central

    2016-01-01

    Large well-designed clinical efficacy and safety randomized clinical trials (RCTs) are required to achieve regulatory approval of new drug treatments. The objective of this article is to make recommendations for the criteria for defining and selecting the clinical trial study population, design and efficacy outcomes measures which comprise ideal premature ejaculation (PE) interventional trial methodology. Data on clinical trial design, epidemiology, definitions, dimensions and psychological impact of PE was reviewed, critiqued and incorporated into a series of recommendations for standardisation of PE clinical trial design, outcome measures and reporting using the principles of evidence based medicine. Data from PE interventional studies are only reliable, interpretable and capable of being generalised to patients with PE, when study populations are defined by the International Society for Sexual Medicine (ISSM) multivariate definition of PE. PE intervention trials should employ a double-blind RCT methodology and include placebo control, active standard drug control, and/or dose comparison trials. Ejaculatory latency time (ELT) and subject/partner outcome measures of control, personal/partner/relationship distress and other study-specific outcome measures should be used as outcome measures. There is currently no published literature which identifies a clinically significant threshold response to intervention. The ISSM definition of PE reflects the contemporary understanding of PE and represents the state-of-the-art multi-dimensional definition of PE and is recommended as the basis of diagnosis of PE for all PE clinical trials. PMID:27652224

  5. The design and methodology of premature ejaculation interventional studies.

    PubMed

    McMahon, Chris G

    2016-08-01

    Large well-designed clinical efficacy and safety randomized clinical trials (RCTs) are required to achieve regulatory approval of new drug treatments. The objective of this article is to make recommendations for the criteria for defining and selecting the clinical trial study population, design and efficacy outcomes measures which comprise ideal premature ejaculation (PE) interventional trial methodology. Data on clinical trial design, epidemiology, definitions, dimensions and psychological impact of PE was reviewed, critiqued and incorporated into a series of recommendations for standardisation of PE clinical trial design, outcome measures and reporting using the principles of evidence based medicine. Data from PE interventional studies are only reliable, interpretable and capable of being generalised to patients with PE, when study populations are defined by the International Society for Sexual Medicine (ISSM) multivariate definition of PE. PE intervention trials should employ a double-blind RCT methodology and include placebo control, active standard drug control, and/or dose comparison trials. Ejaculatory latency time (ELT) and subject/partner outcome measures of control, personal/partner/relationship distress and other study-specific outcome measures should be used as outcome measures. There is currently no published literature which identifies a clinically significant threshold response to intervention. The ISSM definition of PE reflects the contemporary understanding of PE and represents the state-of-the-art multi-dimensional definition of PE and is recommended as the basis of diagnosis of PE for all PE clinical trials. PMID:27652224

  6. Optimized design and analysis of preclinical intervention studies in vivo

    PubMed Central

    Laajala, Teemu D.; Jumppanen, Mikael; Huhtaniemi, Riikka; Fey, Vidal; Kaur, Amanpreet; Knuuttila, Matias; Aho, Eija; Oksala, Riikka; Westermarck, Jukka; Mäkelä, Sari; Poutanen, Matti; Aittokallio, Tero

    2016-01-01

    Recent reports have called into question the reproducibility, validity and translatability of the preclinical animal studies due to limitations in their experimental design and statistical analysis. To this end, we implemented a matching-based modelling approach for optimal intervention group allocation, randomization and power calculations, which takes full account of the complex animal characteristics at baseline prior to interventions. In prostate cancer xenograft studies, the method effectively normalized the confounding baseline variability, and resulted in animal allocations which were supported by RNA-seq profiling of the individual tumours. The matching information increased the statistical power to detect true treatment effects at smaller sample sizes in two castration-resistant prostate cancer models, thereby leading to saving of both animal lives and research costs. The novel modelling approach and its open-source and web-based software implementations enable the researchers to conduct adequately-powered and fully-blinded preclinical intervention studies, with the aim to accelerate the discovery of new therapeutic interventions. PMID:27480578

  7. Optimized design and analysis of preclinical intervention studies in vivo.

    PubMed

    Laajala, Teemu D; Jumppanen, Mikael; Huhtaniemi, Riikka; Fey, Vidal; Kaur, Amanpreet; Knuuttila, Matias; Aho, Eija; Oksala, Riikka; Westermarck, Jukka; Mäkelä, Sari; Poutanen, Matti; Aittokallio, Tero

    2016-01-01

    Recent reports have called into question the reproducibility, validity and translatability of the preclinical animal studies due to limitations in their experimental design and statistical analysis. To this end, we implemented a matching-based modelling approach for optimal intervention group allocation, randomization and power calculations, which takes full account of the complex animal characteristics at baseline prior to interventions. In prostate cancer xenograft studies, the method effectively normalized the confounding baseline variability, and resulted in animal allocations which were supported by RNA-seq profiling of the individual tumours. The matching information increased the statistical power to detect true treatment effects at smaller sample sizes in two castration-resistant prostate cancer models, thereby leading to saving of both animal lives and research costs. The novel modelling approach and its open-source and web-based software implementations enable the researchers to conduct adequately-powered and fully-blinded preclinical intervention studies, with the aim to accelerate the discovery of new therapeutic interventions. PMID:27480578

  8. The design and methodology of premature ejaculation interventional studies

    PubMed Central

    2016-01-01

    Large well-designed clinical efficacy and safety randomized clinical trials (RCTs) are required to achieve regulatory approval of new drug treatments. The objective of this article is to make recommendations for the criteria for defining and selecting the clinical trial study population, design and efficacy outcomes measures which comprise ideal premature ejaculation (PE) interventional trial methodology. Data on clinical trial design, epidemiology, definitions, dimensions and psychological impact of PE was reviewed, critiqued and incorporated into a series of recommendations for standardisation of PE clinical trial design, outcome measures and reporting using the principles of evidence based medicine. Data from PE interventional studies are only reliable, interpretable and capable of being generalised to patients with PE, when study populations are defined by the International Society for Sexual Medicine (ISSM) multivariate definition of PE. PE intervention trials should employ a double-blind RCT methodology and include placebo control, active standard drug control, and/or dose comparison trials. Ejaculatory latency time (ELT) and subject/partner outcome measures of control, personal/partner/relationship distress and other study-specific outcome measures should be used as outcome measures. There is currently no published literature which identifies a clinically significant threshold response to intervention. The ISSM definition of PE reflects the contemporary understanding of PE and represents the state-of-the-art multi-dimensional definition of PE and is recommended as the basis of diagnosis of PE for all PE clinical trials.

  9. Effects of a 12-week Rehabilitation Program with Music & Exercise Groups on Range of Motion in Young Children with Severe Burns

    PubMed Central

    Neugebauer, Christine Tuden; Serghiou, Michael; Herndon, David N.; Suman, Oscar E.

    2013-01-01

    Previous studies indicate that rehabilitation programs supplemented with a strength and endurance-based exercise program improve lean body mass, pulmonary function, endurance, strength, and functional outcomes in severely burned children over the age of 7-years when compared to standard of care. To date, supplemental exercise programming for severely burned children under the age of 7-years has not yet been explored. The purpose of this study was to determine if a 12-week rehabilitation program supplemented with music & exercise, was more effective in improving functional outcomes than the standard of care alone. METHODS This is a descriptive study that measured elbow and knee range of motion (ROM) in 24 severely burned children between ages two and six years. Groups were compared for demographics as well as active and passive ROM to bilateral elbows and knees. A total of 15 patients completed the rehabilitation with supplemental music and exercise, and data was compared to 9 patients who received standard of care. RESULTS Patients receiving the 12-week program significantly improved ROM in all joints assessed except for one. Patients receiving standard of care showed a significant improvement in only one of the joints assessed. CONCLUSION Providing a structured supplemental music and exercise program in conjunction with occupational and physical therapy seems to improve both passive and active ROM to a greater extent than the standard of care alone. PMID:18849852

  10. Cardiovascular Risk Evaluation through Heart Rate Variability (HRV) Analysis in Patients with Psoriasis before and after 12 Weeks of Etanercept Therapy: A Preliminary Prospective Study.

    PubMed

    Potenza, Concetta; Raimondi, Gianfranco; Pampena, Riccardo; Bernardini, Nicoletta; La Viola, Giorgio; Tolino, Ersilia; Zuber, Sara; Scordamaglia, Beatrice; Skroza, Nevena

    2016-08-01

    The association between psoriasis and cardiovascular diseases has been indicated by epidemiological studies. The sub-inflammatory systemic state that characterizes both psoriasis and atherosclerosis has been proposed as the link between these conditions; it cannot, however, explain the increased incidence of sudden cardiac death reported in young patients with severe psoriasis without common cardiovascular risk factors. In a previous study, we reported higher levels of autonomic dysregulation in patients with psoriasis, concluding that the prevalence of the sympathetic arm over the parasympathetic could increase cardiovascular risk. Objective of this study was to assess the influence of etanercept on autonomic cardiovascular regulation in young patients with moderate-to-severe psoriasis without cardiovascular risk factors. Five-minute ECG recordings were collected at rest before and after 12 weeks of therapy with etanercept in 19 young patients with psoriasis without cardiovascular risk factors. The Cardiolab CE pocket PC ECG system was used for linear methods of heart rate variability (HRV) analysis. No significant change in HRV analysis parameters was apparent after 12 weeks of etanercept therapy. Our data suggest that treatment with etanercept in patients with moderate-to-severe psoriasis does not affect cardiovascular autonomic regulation and cardiovascular risk. PMID:27663918

  11. Effects of a 12-Week Hatha Yoga Intervention on Cardiorespiratory Endurance, Muscular Strength and Endurance, and Flexibility in Hong Kong Chinese Adults: A Controlled Clinical Trial

    PubMed Central

    Lau, Caren; Yu, Ruby; Woo, Jean

    2015-01-01

    Objective. To examine the effects of a 12-week Hatha yoga intervention on cardiorespiratory endurance, muscular strength and endurance, and flexibility in Chinese adults. Methods. 173 adults (aged 52.0 ± 7.5 years) were assigned to either the yoga intervention group (n = 87) or the waitlist control group (n = 86). 19 dropped out from the study. Primary outcomes were changes in cardiorespiratory endurance (resting heart rate (HR) and maximal oxygen uptake (VO2max)), muscular strength and endurance (curl-up and push-up tests), and lower back and hamstring flexibility (the modified back-saver sit-and-reach (MBS) test). Results. Compared to controls, the yoga group achieved significant improvements in VO2max (P < 0.01), curl-up (P < 0.05) and push-up (P < 0.001) tests, and the MBS left and right leg tests (both P < 0.001) in both genders. Significant change was also found for resting HR between groups in women (P < 0.05) but not in men. Further analysis comparing participants between younger and older subgroups yielded similar findings, except that the older participants in the yoga group failed to improve resting HR or the curl-up test versus control. Adherence (89%) and attendance (94%) were high. No serious adverse events occurred. Conclusion. A 12-week Hatha yoga intervention has favorable effects on cardiorespiratory endurance, muscular strength and endurance, and flexibility in Chinese adults. PMID:26167196

  12. The effects of 12-week psyllium fibre supplementation or healthy diet on blood pressure and arterial stiffness in overweight and obese individuals.

    PubMed

    Pal, Sebely; Khossousi, Alireza; Binns, Colin; Dhaliwal, Satvinder; Radavelli-Bagatini, Simone

    2012-03-01

    Endothelial dysfunction and increased arterial stiffness occur early in the pathogenesis of the metabolic syndrome and they are both powerful independent predictors of cardiovascular risk. A high-fibre diet has been correlated with lower BMI and a lower incidence of hyperlipidaemia, CVD, hypertension and diabetes. The present randomised, parallel-design study compared the effects of fibre intake from a healthy diet v. fibre supplement diets on blood pressure (BP) and vascular function over 12 weeks. Overweight and obese adults were randomised to one of three groups: control (with placebo), fibre supplement (FIB) or healthy eating group with placebo (HLT). Systolic blood pressure (SBP) was lower in the FIB group compared with the control group at week 6, but not at week 12. However, SBP was lower in the HLT group compared with control group at week 12. At week 6, the FIB group presented lower diastolic blood pressure and augmentation index compared with the control group, but this result did not persist to the end of the study. The present study did not show any improvements in BP or vascular function in overweight and obese individuals with psyllium fibre supplementation over 12 weeks of intervention. However, a healthy diet provided the greatest improvements in BP in overweight and obese subjects. Further research with hypertensive individuals is necessary to elucidate whether increased fibre consumption in the form of psyllium supplementation may provide a safe and acceptable means to reduce BP, vascular function and the risk of developing CVD.

  13. Efficacy and tolerability of carbamazepine for the treatment of painful diabetic neuropathy in adults: a 12-week, open-label, multicenter study

    PubMed Central

    Saeed, Tariq; Nasrullah, Muhammad; Ghafoor, Adnan; Shahid, Riaz; Islam, Nadeem; Khattak, Mohammad Usman; Maheshwary, Neeta; Siddiqi, Ahson; Khan, Muhammad Athar

    2014-01-01

    Objective Anticonvulsants are increasingly being used in the symptomatic management of several neuropathic pain disorders. The present observational study was designed to evaluate the efficacy, tolerability, and quality of life (QoL) of carbamazepine use for 12 weeks in patients with painful diabetic neuropathy, in Pakistan. Methods This was a 12-week, multicenter, open-label, uncontrolled trial in adult type 2 diabetic patients (aged 18–65 years) suffering from clinically confirmed neuropathic pain (Douleur Neuropathique en 4 [DN4] score ≥4). Change in neuropathic pain at week 12 compared with baseline was assessed using the Brief Pain Inventory Scale–Short Form (pain severity score and pain interference score). QoL was determined by the American Chronic Pain Association QoL scale. Safety was assessed based on patient reported adverse events (AEs) and serious AEs. Results Of the total 500 screened patients, 452 enrolled and completed the study. The mean (± standard deviation [SD]) pain interference score decreased from 4.5±2.0 at baseline to 3.1±1.9 at week 12 (P<0.001). The mean (± SD) pain severity score decreased from 5.8±2.0 at baseline to 3.6±2.2 at week 12 (P<0.001). There was a decrease of ≥30% in the pain severity score between visits. The mean (± SD) QoL scale score improved from 5.9±1.6 at baseline to 8.0±1.7 at week 12. A total of ten (2.2%) patients reported AEs during the study period. No patient discontinued the study due to AEs. Conclusion In this real-life experience study, carbamazepine, when prescribed for 12 weeks to adult diabetic patients suffering from neuropathic pain, showed pain-relief effect, with reduced mean pain severity and mean pain interference scores and with improved QoL and good tolerability profile. PMID:25061334

  14. Changes of Achilles tendon properties via 12-week PNF based robotic rehabilitation of ankle joints with spasticity and/or contracture.

    PubMed

    Zhou, Zhihao; Zhou, Yuan; Wang, Ninghua; Gao, Fan; Wang, Long; Wei, Kunlin; Wang, Qining

    2014-01-01

    Ankle joint with spasticity and/or contracture can severely affect mobility and independence of stroke survivors. Due to that, the Achilles tendon(AT) is affected. In this paper, we aim to study changes of AT properties via proprioceptive neuromuscular facilitation (PNF) treatment. A robotic ankle-foot rehabilitation system has been proposed, which consists of a robotic ankle-foot platform and a graphic user interface. In this pilot study, two post-stroke patients participated and carried out a 12-week PNF treatment with the robotic system. The treatment is evaluated quantitatively in AT properties. The evaluation shows that after the PNF treatment, the average decrease of AT length is 4.1 mm (6.5%) and the recovery ratio is 30.4%, while the thickness has no change. The results indicate that the PNF based robotic rehabilitation for ankle joints with spasticity and/or contracture is effective to improve the ankle spasticity/contracture.

  15. Concentration- and time-dependent genomic changes in the mouse urinary bladder following exposure to arsenate in drinking water for up to 12 weeks.

    PubMed

    Clewell, H J; Thomas, R S; Kenyon, E M; Hughes, M F; Adair, B M; Gentry, P R; Yager, J W

    2011-10-01

    Inorganic arsenic (As(i)) is a known human bladder carcinogen. The objective of this study was to examine the concentration dependence of the genomic response to As(i) in the urinary bladders of mice. C57BL/6J mice were exposed for 1 or 12 weeks to arsenate in drinking water at concentrations of 0.5, 2, 10, and 50 mg As/l. Urinary bladders were analyzed using gene expression microarrays. A consistent reversal was observed in the direction of gene expression change: from predominantly decreased expression at 1 week to predominantly increased expression at 12 weeks. These results are consistent with evidence from in vitro studies of an acute adaptive response that is suppressed on longer exposure due to downregulation of Fos. Pathways with the highest enrichment in gene expression changes were associated with epithelial-to-mesenchymal transition, inflammation, and proliferation. Benchmark dose (BMD) analysis determined that the lowest median BMD values for pathways were above 5 mg As/l, despite the fact that pathway enrichment was observed at the 0.5 mg As/l exposure concentration. This disparity may result from the nonmonotonic nature of the concentration-responses for the expression changes of a number of genes, as evidenced by the much fewer gene expression changes at 2 mg As/l compared with lower or higher concentrations. Pathway categories with concentration-related gene expression changes included cellular morphogenesis, inflammation, apoptosis/survival, cell cycle control, and DNA damage response. The results of this study provide evidence of a concentration-dependent transition in the mode of action for the subchronic effects of As(i) in mouse bladder cells in the vicinity of 2 mg As(i)/l.

  16. Effect of an herbal/botanical supplement on strength, balance, and muscle function following 12-weeks of resistance training: a placebo controlled study

    PubMed Central

    2014-01-01

    Background StemSport (SS; StemTech International, Inc. San Clemente, CA) contains a proprietary blend of the botanical Aphanizomenon flos-aquae and several herbal antioxidant and anti-inflammatory substances. SS has been purported to accelerate tissue repair and restore muscle function following resistance exercise. Here, we examine the effects of SS supplementation on strength adaptations resulting from a 12-week resistance training program in healthy young adults. Methods Twenty-four young adults (16 males, 8 females, mean age = 20.5 ± 1.9 years, mass = 70.9 ± 11.9 kg, stature = 176.6 ± 9.9 cm) completed the twelve week training program. The study design was a double-blind, placebo controlled parallel group trial. Subjects either received placebo or StemSport supplement (SS; mg/day) during the training. 1-RM bench press, 1-RM leg press, vertical jump height, balance (star excursion and center of mass excursion), isokinetic strength (elbow and knee flexion/extension) and perception of recovery were measured at baseline and following the 12-week training intervention. Results Resistance training increased 1-RM strength (p < 0.008), vertical jump height (p < 0.03), and isokinetic strength (p < 0.05) in both SS and placebo groups. No significant group-by-time interactions were observed (all p-values >0.10). Conclusions These data suggest that compared to placebo, the SS herbal/botanical supplement did not enhance training induced adaptations to strength, balance, and muscle function above strength training alone. PMID:24910543

  17. School, Community, and Family Working Together to Address Childhood Obesity: Perceptions from the KOALA Lifestyle Intervention Study

    ERIC Educational Resources Information Center

    Smibert, Asa; Abbott, Rebecca; Macdonald, Doune; Hogan, Anna; Leong, Gary

    2010-01-01

    Epidemiological data on childhood obesity has prompted a significant response from both governments and academics seeking to recommend solutions to the reported "crisis". The "Kinder Overweight Active Living Action" (KOALA) healthy lifestyle programme is a randomized obesity prevention and intervention study designed to provide an understanding of…

  18. The Importance of Parenting in the Development of Disorganized Attachment: Evidence from a Preventive Intervention Study in Adoptive Families

    ERIC Educational Resources Information Center

    Juffer, Femmie; Bakermans-Kranenburg, Marian J.; van IJzendoorn, Marinus H.

    2005-01-01

    Background: As infant disorganized attachment is a serious risk factor for later child psychopathology, it is important to examine whether attachment disorganization can be prevented or reduced. Method: In a randomized intervention study involving 130 families with 6-month-old adopted infants, two attachment-based intervention programs were…

  19. Effects of 12-Week Endurance Training at Natural Low Altitude on the Blood Redox Homeostasis of Professional Adolescent Athletes: A Quasi-Experimental Field Trial.

    PubMed

    Tong, Tomas K; Kong, Zhaowei; Lin, Hua; He, Yeheng; Lippi, Giuseppe; Shi, Qingde; Zhang, Haifeng; Nie, Jinlei

    2016-01-01

    This field study investigated the influences of exposure to natural low altitude on endurance training-induced alterations of redox homeostasis in professional adolescent runners undergoing 12-week off-season conditioning program at an altitude of 1700 m (Alt), by comparison with that of their counterparts completing the program at sea-level (SL). For age-, gender-, and Tanner-stage-matched comparison, 26 runners (n = 13 in each group) were selected and studied. Following the conditioning program, unaltered serum levels of thiobarbituric acid reactive substances (TBARS), total antioxidant capacity (T-AOC), and superoxide dismutase accompanied with an increase in oxidized glutathione (GSSG) and decreases of xanthine oxidase, reduced glutathione (GSH), and GSH/GSSG ratio were observed in both Alt and SL groups. Serum glutathione peroxidase and catalase did not change in SL, whereas these enzymes, respectively, decreased and increased in Alt. Uric acid (UA) decreased in SL and increased in Alt. Moreover, the decreases in GSH and GSH/GSSG ratio in Alt were relatively lower compared to those in SL. Further, significant interindividual correlations were found between changes in catalase and TBARS, as well as between UA and T-AOC. These findings suggest that long-term training at natural low altitude is unlikely to cause retained oxidative stress in professional adolescent runners.

  20. Changes in Antioxidant Defense Capability and Lipid Profile after 12-Week Low- Intensity Continuous Training in Both Cigarette and Hookah Smokers: A Follow-Up Study

    PubMed Central

    Koubaa, Abdessalem; Triki, Moez; Trabelsi, Hajer; Masmoudi, Liwa; Sahnoun, Zouhair; Hakim, Ahmed

    2015-01-01

    To examine the impact of low-intensity continuous training program on antioxidant defense capability and lipid profile in male cigarette or hookah smokers. Forty-three male adults participated in a 12-week continuous training program at an intensity of 40% of VO2max. All subjects were subjected to anthropometric, physical and biochemical tests before and after the training program. The increase of Glutathione reductase (GR) and Superoxide dismutase (SOD) is significant only for cigarette smokers (CS) and hookah smokers (HS) groups. The Malondialdehyde (MDA) decrease and α-tocopherol increase are significant only for HS group. GPx was increased in NS, CS and HS by 2.6% (p< 0.01), 2% (p< 0.05) and 1.7% (p< 0.05) respectively. Likewise, significant improvements of high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and TC / HDL-C ratio were observed in three groups. En contrast no significant changes were recorded in triglycerides (TG). Also, significant reduction of total cholesterol (TC) for CS group (p< 0.01) and HS groups (p< 0.05). This continuous training program appears to have an important role in lipid levels improving and oxidative stress attenuation. PMID:26121249

  1. Motivation and ability to walk for a food reward in fast- and slow-growing broilers to 12 weeks of age.

    PubMed

    Bokkers, Eddie A M; Koene, Paul

    2004-09-30

    Poor physical abilities of broilers may prevent them from performing behaviours for which they are motivated. The aim of this study was to measure the influence of physical ability and motivation on the performance of broilers in short physical tasks. We tested birds from a fast- and a slow-growing broiler strain in a runway to 12 weeks of age. To manipulate motivation, half of the birds of each strain was feed deprived for 3h and the other half for 24h before testing. Each bird was tested in a control and a slalom runway test once a week. With a similar motivation, slow growers had a shorter latency to start walking and walked faster through the runway than fast growers in both tests. In fast growers walking speed decreased faster with age than in slow growers. Slow growers vocalised more in both tests. In the slalom test, 24h deprived birds vocalised more than 3h deprived birds. Although the fast and slow growers have a different genetic background, the results indicated that motivation is the dominant determinative factor for walking in birds with a low body weight, while physical ability is the dominant determinative factor for walking in birds with a high body weight.

  2. The Effect of a 12-Week Moderate Intensity Interval Training Program on the Antioxidant Defense Capability and Lipid Profile in Men Smoking Cigarettes or Hookah: A Cohort Study

    PubMed Central

    Koubaa, Abdessalem; Triki, Moez; Trabelsi, Hajer; Baati, Hamza; Sahnoun, Zouhair; Hakim, Ahmed

    2015-01-01

    Aim. To examine the impact of interval training program on the antioxidant defense capability and lipid profile in men smoking cigarettes or hookah unable or unwilling to quit smoking. Methods. Thirty-five participants performed an interval training (2 : 1 work : rest ratio) 3 times a week for 12 weeks at an intensity of 70% of VO2max. All subjects were subjected to a biochemical test session before and after the training program. Results. The increase of total antioxidant status (TAS), glutathione peroxidase (GPx), and α-tocopherol, is significant only for cigarette smokers (CS) and hookah smokers (HS) groups. The decrease of malondialdehyde (MDA) and the increase of glutathione reductase (GR) are more pronounced in smokers groups compared to those of nonsmokers (NS). Superoxide dismutase (SOD) increases in NS, CS, and HS groups by 10.1%, 19.5%, and 13.3%, respectively (P < 0.001). Likewise, a significant improvement of high-density lipoprotein cholesterol (HDL-C) and TC/HDL-C ratio was observed in CS and HS groups (P < 0.05). Conclusion. Although the interval training program does not have a significant effect on blood lipid levels, it seems to be very beneficial in the defense and prevention programs of oxidative stress. PMID:25664340

  3. Effects of 12-Week Endurance Training at Natural Low Altitude on the Blood Redox Homeostasis of Professional Adolescent Athletes: A Quasi-Experimental Field Trial

    PubMed Central

    Tong, Tomas K.; Kong, Zhaowei; Lin, Hua; He, Yeheng; Lippi, Giuseppe; Shi, Qingde; Zhang, Haifeng

    2016-01-01

    This field study investigated the influences of exposure to natural low altitude on endurance training-induced alterations of redox homeostasis in professional adolescent runners undergoing 12-week off-season conditioning program at an altitude of 1700 m (Alt), by comparison with that of their counterparts completing the program at sea-level (SL). For age-, gender-, and Tanner-stage-matched comparison, 26 runners (n = 13 in each group) were selected and studied. Following the conditioning program, unaltered serum levels of thiobarbituric acid reactive substances (TBARS), total antioxidant capacity (T-AOC), and superoxide dismutase accompanied with an increase in oxidized glutathione (GSSG) and decreases of xanthine oxidase, reduced glutathione (GSH), and GSH/GSSG ratio were observed in both Alt and SL groups. Serum glutathione peroxidase and catalase did not change in SL, whereas these enzymes, respectively, decreased and increased in Alt. Uric acid (UA) decreased in SL and increased in Alt. Moreover, the decreases in GSH and GSH/GSSG ratio in Alt were relatively lower compared to those in SL. Further, significant interindividual correlations were found between changes in catalase and TBARS, as well as between UA and T-AOC. These findings suggest that long-term training at natural low altitude is unlikely to cause retained oxidative stress in professional adolescent runners. PMID:26783415

  4. Effects of 12-Week Endurance Training at Natural Low Altitude on the Blood Redox Homeostasis of Professional Adolescent Athletes: A Quasi-Experimental Field Trial.

    PubMed

    Tong, Tomas K; Kong, Zhaowei; Lin, Hua; He, Yeheng; Lippi, Giuseppe; Shi, Qingde; Zhang, Haifeng; Nie, Jinlei

    2016-01-01

    This field study investigated the influences of exposure to natural low altitude on endurance training-induced alterations of redox homeostasis in professional adolescent runners undergoing 12-week off-season conditioning program at an altitude of 1700 m (Alt), by comparison with that of their counterparts completing the program at sea-level (SL). For age-, gender-, and Tanner-stage-matched comparison, 26 runners (n = 13 in each group) were selected and studied. Following the conditioning program, unaltered serum levels of thiobarbituric acid reactive substances (TBARS), total antioxidant capacity (T-AOC), and superoxide dismutase accompanied with an increase in oxidized glutathione (GSSG) and decreases of xanthine oxidase, reduced glutathione (GSH), and GSH/GSSG ratio were observed in both Alt and SL groups. Serum glutathione peroxidase and catalase did not change in SL, whereas these enzymes, respectively, decreased and increased in Alt. Uric acid (UA) decreased in SL and increased in Alt. Moreover, the decreases in GSH and GSH/GSSG ratio in Alt were relatively lower compared to those in SL. Further, significant interindividual correlations were found between changes in catalase and TBARS, as well as between UA and T-AOC. These findings suggest that long-term training at natural low altitude is unlikely to cause retained oxidative stress in professional adolescent runners. PMID:26783415

  5. Effects of a 12-week Pilates course on lower limb muscle strength and trunk flexibility in women living in the community.

    PubMed

    Kao, Yu-Hsiu; Liou, Tsan-Hon; Huang, Yi-Ching; Tsai, Ya-Wen; Wang, Kuo-Ming

    2015-01-01

    Researchers in Taiwan studying regular adult physical activity found that among married women aged 26 to 55 years, 56% participated in physical activity, and that the convenience and safety of the activity were major factors contributing to their willingness to exercise. Muscle weakness and poor trunk flexibility are closely related to some chronic diseases in women. In this cross-sectional survey, we used the Polestar Pilates™ method to explore the effects of a 12-week Pilates course on the physical fitness of women living in the community. Fifty-three members of the experimental group (mean age: 42.30 ± 9.97) and 43 of the control group (mean age: 41.23 ± 9.83) were included. We confirm that a convenient Pilates exercise intervention can significantly improve muscle strength and trunk flexibility in women. Our findings serve as an important reference for health authorities in Taiwan and provide higher awareness of women's health and physical fitness, which can help prevent chronic and cardiovascular diseases. PMID:24611630

  6. Effects of a 12-week Pilates course on lower limb muscle strength and trunk flexibility in women living in the community.

    PubMed

    Kao, Yu-Hsiu; Liou, Tsan-Hon; Huang, Yi-Ching; Tsai, Ya-Wen; Wang, Kuo-Ming

    2015-01-01

    Researchers in Taiwan studying regular adult physical activity found that among married women aged 26 to 55 years, 56% participated in physical activity, and that the convenience and safety of the activity were major factors contributing to their willingness to exercise. Muscle weakness and poor trunk flexibility are closely related to some chronic diseases in women. In this cross-sectional survey, we used the Polestar Pilates™ method to explore the effects of a 12-week Pilates course on the physical fitness of women living in the community. Fifty-three members of the experimental group (mean age: 42.30 ± 9.97) and 43 of the control group (mean age: 41.23 ± 9.83) were included. We confirm that a convenient Pilates exercise intervention can significantly improve muscle strength and trunk flexibility in women. Our findings serve as an important reference for health authorities in Taiwan and provide higher awareness of women's health and physical fitness, which can help prevent chronic and cardiovascular diseases.

  7. Exercise-training intervention studies in competitive swimming.

    PubMed

    Aspenes, Stian Thoresen; Karlsen, Trine

    2012-06-01

    Competitive swimming has a long history and is currently one of the largest Olympic sports, with 16 pool events. Several aspects separate swimming from most other sports such as (i) the prone position; (ii) simultaneous use of arms and legs for propulsion; (iii) water immersion (i.e. hydrostatic pressure on thorax and controlled respiration); (iv) propulsive forces that are applied against a fluctuant element; and (v) minimal influence of equipment on performance. Competitive swimmers are suggested to have specific anthropometrical features compared with other athletes, but are nevertheless dependent on physiological adaptations to enhance their performance. Swimmers thus engage in large volumes of training in the pool and on dry land. Strength training of various forms is widely used, and the energetic systems are addressed by aerobic and anaerobic swimming training. The aim of the current review was to report results from controlled exercise training trials within competitive swimming. From a structured literature search we found 17 controlled intervention studies that covered strength or resistance training, assisted sprint swimming, arms-only training, leg-kick training, respiratory muscle training, training the energy delivery systems and combined interventions across the aforementioned categories. Nine of the included studies were randomized controlled trials. Among the included studies we found indications that heavy strength training on dry land (one to five repetitions maximum with pull-downs for three sets with maximal effort in the concentric phase) or sprint swimming with resistance towards propulsion (maximal pushing with the arms against fixed points or pulling a perforated bowl) may be efficient for enhanced performance, and may also possibly have positive effects on stroke mechanics. The largest effect size (ES) on swimming performance was found in 50 m freestyle after a dry-land strength training regimen of maximum six repetitions across three

  8. Exercise-training intervention studies in competitive swimming.

    PubMed

    Aspenes, Stian Thoresen; Karlsen, Trine

    2012-06-01

    Competitive swimming has a long history and is currently one of the largest Olympic sports, with 16 pool events. Several aspects separate swimming from most other sports such as (i) the prone position; (ii) simultaneous use of arms and legs for propulsion; (iii) water immersion (i.e. hydrostatic pressure on thorax and controlled respiration); (iv) propulsive forces that are applied against a fluctuant element; and (v) minimal influence of equipment on performance. Competitive swimmers are suggested to have specific anthropometrical features compared with other athletes, but are nevertheless dependent on physiological adaptations to enhance their performance. Swimmers thus engage in large volumes of training in the pool and on dry land. Strength training of various forms is widely used, and the energetic systems are addressed by aerobic and anaerobic swimming training. The aim of the current review was to report results from controlled exercise training trials within competitive swimming. From a structured literature search we found 17 controlled intervention studies that covered strength or resistance training, assisted sprint swimming, arms-only training, leg-kick training, respiratory muscle training, training the energy delivery systems and combined interventions across the aforementioned categories. Nine of the included studies were randomized controlled trials. Among the included studies we found indications that heavy strength training on dry land (one to five repetitions maximum with pull-downs for three sets with maximal effort in the concentric phase) or sprint swimming with resistance towards propulsion (maximal pushing with the arms against fixed points or pulling a perforated bowl) may be efficient for enhanced performance, and may also possibly have positive effects on stroke mechanics. The largest effect size (ES) on swimming performance was found in 50 m freestyle after a dry-land strength training regimen of maximum six repetitions across three

  9. A search strategy for occupational health intervention studies

    PubMed Central

    Verbeek, J; Salmi, J; Pasternack, I; Jauhiainen, M; Laamanen, I; Schaafsma, F; Hulshof, C; van Dijk, F

    2005-01-01

    Background: As a result of low numbers and diversity in study type, occupational health intervention studies are not easy to locate in electronic literature databases. Aim: To develop a search strategy that facilitates finding occupational health intervention studies in Medline, both for researchers and practitioners. Methods: A gold standard of articles was created by going through two whole volumes of 19 biomedical journals, both occupational health specialty and non-occupational health journals. Criteria for occupational health intervention studies were: evaluating an intervention with an occupational health outcome and a study design with a control group. Each journal was searched independently by two of the authors. Search terms were developed by asking specialists and counting word frequencies in gold standard articles. Results: Out of 11 022 articles published we found 149 occupational health intervention studies. The most sensitive single terms were work*[tw] (sensitivity 71%, specificity 88%) and effect*[tw] (sensitivity 75%, specificity 63%). The most sensitive string was (effect*[tw] OR control*[tw] OR evaluation*[tw] OR program*[tw]) AND (work*[tw] OR occupation*[tw] OR prevention*[tw] OR protect*[tw]) (sensitivity 89%, specificity 78%). The most specific single terms were "occupational health"[tw] (sensitivity 22%, specificity 98%) and effectiveness[tw] (sensitivity 22%, specificity 98%). The most specific string was (program[tw] OR "prevention and control"[sh]) AND (occupational[tw] OR worker*[tw]) (sensitivity 47%, specificity 98%). Conclusion: No single search terms are available that can locate occupational health intervention studies sufficiently. The authors' search strings have acceptable sensitivity and specificity to be used by researchers and practitioners respectively. Redefinition and elaboration of keywords in Medline could greatly facilitate the location of occupational health intervention studies. PMID:16169913

  10. The Importance of Risk and Subgroup Analysis of Nonparticipants in a Geriatric Intervention Study

    PubMed Central

    Poulsen, Ingrid; Hendriksen, Carsten

    2016-01-01

    Background. A major concern in intervention studies is the generalizability of the findings due to refusal of intended participants to actually take part. In studies including ill older people the number of those declining to participate may be large and the concern is therefore relevant. Objectives. To compare patients characteristics, rates of acute readmission, and mortality after one and six months among older persons who agreed and those who declined to participate in a randomized controlled trial and to describe subgroups of nonparticipants. Design. Comparative study based on a randomized controlled trial. Setting. University hospital in the Capital Region of Denmark. Participants. Patients ≥70 years discharged home after a short Emergency Department stay. 399 were requested to participate; 271 consented, whereas 128 refused. Results. Refusers were more likely to be readmitted (p < 0.001) or die (p = 0.006). The largest subgroup of refusers described as “too ill” had the highest risk of readmission (OR = 3.00, 95% CI = 1.61–5.47, p = 0.001) and of mortality within six months (OR = 3.50, 95% CI = 1.64–7.49, p = 0.002). However, this seems not to have affected the results of our randomized study. Conclusion. We recommend that intervention studies among older people or other fragile patient groups include analysis of relevant risk and subgroup analyses of refusers. PMID:27446634

  11. [The PreFord Study. A prospective cohort study to evaluate the risk of a cardiovascular event (overall-collective) as well as a prospective, randomized, controlled, multicentre clinical intervention study (high-risk-collective) on primary prevention of cardiovascular diseases in the Ford Motor Company employees in Germany].

    PubMed

    Gysan, D B; Latsch, J; Bjarnason-Wehrens, B; Albus, C; Falkowski, G; Herold, G; Mey, E; Heinzler, R; Montiel, G; Schneider, C A; Stützer, H; Türk, S; Weisbrod, M; Predel, H G

    2004-02-01

    evidence based treatment. Group III: high risk, (> 1.5% per year or >15% within the next 10 years) will be randomised into two interventional groups. The first one, the intervention-group "PreFord" will perform an occupational integrated rehabilitation program (2,5-3 hours twice a week, for 15 weeks according to the BAR guidelines) with a following engagement in heart-groups and an annual repetition of the check-ups. The second group, the "classic" intervention-group will be treated evidence based in cooperation with their GP. As a result of this long term interventional study efficient, area wide implementable and economically feasible prevention concepts with special regards to operational healthcare will be developed and evaluated. Core elements will be exercise- and lifestyle-oriented concepts as well as guideline-based pharmacotherapy. PMID:14963679

  12. Morphology in Malay-English Biliteracy Acquisition: An Intervention Study

    ERIC Educational Resources Information Center

    Zhang, Dongbo

    2016-01-01

    This intervention study examined the effect of English morphological instruction on the development of English as well as Malay morphological awareness and word reading abilities among Malay-English bilingual fourth graders in Singapore, where English is the medium of instruction. The intervention group experienced semester-long instruction in…

  13. Designing Intervention Studies: Selected Populations, Range Restrictions, and Statistical Power

    ERIC Educational Resources Information Center

    Miciak, Jeremy; Taylor, W. Pat; Stuebing, Karla K.; Fletcher, Jack M.; Vaughn, Sharon

    2016-01-01

    An appropriate estimate of statistical power is critical for the design of intervention studies. Although the inclusion of a pretest covariate in the test of the primary outcome can increase statistical power, samples selected on the basis of pretest performance may demonstrate range restriction on the selection measure and other correlated…

  14. A Systematic Review Comparing Antiretroviral Adherence Descriptive and Intervention Studies

    PubMed Central

    Sandelowski, Margarete; Voils, Corrine I.; Chang, Yunkyung; Lee, Eun-Jeong

    2009-01-01

    We examined the extent to which studies aimed at testing interventions to improve antiretroviral adherence have targeted the facilitators of and barriers known to affect adherence. Of the 88 reports reviewed, 41 were reports of descriptive studies conducted with U.S. HIV-positive women and 47 were reports of intervention studies conducted with U.S. HIV-positive persons. We extracted from the descriptive studies all findings addressing any factor linked to antiretroviral adherence and from the intervention studies, information on the nature of the intervention, the adherence problem targeted, the persons targeted for the intervention, and the intervention outcomes desired. We discerned congruence between the prominence of substance abuse as a factor identified in the descriptive studies as a barrier to adherence and its prominence as the problem most addressed in those reports of intervention studies that specified the problems targeted for intervention. We also discerned congruence between the prominence of family and provider support as factors identified in the descriptive studies as facilitators of adherence and the presence of social support as an intervention component and outcome variable. Less discernible in the reports of intervention studies was specific attention to other factors prominent in the descriptive studies, which may be due to the complex nature of the problem, individualistic and rationalist slant of interventions, or simply the ways interventions were presented. Our review raises issues about niche standardization and intervention tailoring, targeting, and fidelity. PMID:20024751

  15. Academic Vocabulary and Middle School English Learners: An Intervention Study

    ERIC Educational Resources Information Center

    Townsend, Dianna; Collins, Penny

    2009-01-01

    The goal of this experimental intervention study was to determine if evidence-based instructional strategies for general vocabulary words are effective with middle school English learner (EL) students and academic vocabulary words. Participants showed significantly more growth in their knowledge of academic vocabulary during the treatment…

  16. Estimates of endemic waterborne risks from community-intervention studies.

    PubMed

    Calderon, Rebecca L; Craun, Gunther F

    2006-01-01

    The nature and magnitude of endemic waterborne disease are not well characterized in the United States. Epidemiologic studies of various designs can provide an estimate of the waterborne attributable risk along with other types of information. Community drinking water systems frequently improve their operations and may change drinking water treatment and their major source of water. In the United States, many of these treatment changes are the result of regulations promulgated under the Safe Drinking Water Act. A community-intervention study design takes advantage of these "natural" experiments to assess changes in health risks. In this paper, we review the community-intervention studies that have assessed changes in waterborne gastroenteritis risks among immunocompetent populations in industrialized countries. Published results are available from two studies in Australia, one study in the United Kingdom, and one study in the United States. Preliminary results from two other US studies are also available. Although the current information is limited, the risks reported in these community-intervention studies can help inform the national estimate of endemic waterborne gastroenteritis. Information is provided about endemic waterborne risks for unfiltered surface water sources and a groundwater under the influence of surface water. Community-intervention studies with recommended study modifications should be conducted to better estimate the benefits associated with improved drinking water treatment. PMID:16895087

  17. Commentary: The Challenge of Nonexperimental Interventions Studies in Social Work

    ERIC Educational Resources Information Center

    Schilling, Robert

    2010-01-01

    The challenging context of social work interventions require that most intervention studies will be derived from nonexperimental research designs. Two evaluation studies in this special issue employed nonrandomized designs to examine the efficacy of two programs--a police crisis intervention team designed to enhance officers' responses to mental…

  18. A Pilot Study Exploring the Effects of a 12-Week T'ai Chi Intervention on Somatic Symptoms of Depression in Patients with Heart Failure

    PubMed Central

    Tsuang, Ming; Rusiewicz, Anna; Pandzic, Ines; Cammarata, Stephanie; Rutledge, Thomas; Hong, Suzi; Linke, Sarah; Mills, Paul J.

    2012-01-01

    Abstract Background Patients with chronic heart failure (HF) and with elevated depression symptoms are at greater risk of morbidity and mortality. Somatic symptoms of depression are particularly prevalent in HF and are related to worse disease prognosis. T'ai chi practice is related to increased emotional well-being in various clinical populations; however, relatively little is known about t'ai chi's effects on somatic versus cognitive symptom dimensions of depression in HF. Purpose The objective of the study was to measure whether a t'ai chi intervention effectively reduces somatic and/or cognitive symptoms of depression in patients with HF. Methods Patients with HF were assigned to either t'ai chi training (n=16) or a usual-care group (n=12). At baseline and after the 12-week intervention period, participants were evaluated for changes in depressive symptoms using Beck Depression Inventory (BDI) total scores (BDI-t) and subcategorized scores of BDI-somatic (BDI-s) and BDI-cognitive (BDI-c), and for symptoms of fatigue using the Multidimensional Fatigue Symptom Inventory–Short Form. Results Patients with HF in the t'ai chi group compared to the usual-care group had reduced BDI-s (p≤0.017), but not BDI-c (p=0.50) scores from pre- to postintervention. Although t'ai chi did not significantly reduce fatigue, changes in physical fatigue (p≤0.05) were independently associated with changes in BDI-t scores. Conclusions T'ai chi practice reduced somatic symptoms of depression, which have been linked to worse prognosis in HF. Reductions in fatigue appear to explain some but not all of the reductions in somatic symptoms of depression. PMID:22845485

  19. Investigation of Peri-Implant Bone Healing Using Autologous Plasma Rich in Growth Factors in the Canine Mandible After 12 Weeks: A Pilot Study

    PubMed Central

    Birang, Reza; Tavakoli, Mohammad; Shahabouei, Mohammad; Torabi, Alireza; Dargahi, Ali; Soolari, Ahmad

    2011-01-01

    Introduction: Faster reconstruction of patients’ masticatory systems is the aim of modern dentistry. A number of studies have indicated that application of growth factors to the surface of a dental implant leads to accelerated and enhanced osseointegration. The objective of the present study was to investigate the effect of plasma rich in growth factors on peri-implant bone healing. Materials and Methods: For the purpose of this study, two healthy, mixed-breed canines were selected, and the premolars were extracted from both sides of the mandible. Three months after premolar removal, 12 implants, each 5 mm in diameter and 10 mm in length, were placed in osteotomy sites on both sides of the mandible. Prior to placement, plasma rich in growth factors was applied to the surfaces of six implants, while the other six were used without plasma rich in growth factors. The implants were removed after 12 weeks along with the bone surrounding the sites using a trephine bur. One mesiodistal section containing the surrounding bone from each implant block, 50 µm in diameter, was prepared for histologic and histomorphometric investigation with an optical microscope. Results: The sites with implants treated with plasma rich in growth factors showed more bone-to-implant contact compared to control sites. Also, higher values for bone trabecular thickness and bone maturity were recorded for the PRGF-treated sites than for the control sites. Conclusion: Application of plasma rich in growth factors to the surface of an implant may enhance the bone healing process as well as bone-to-implant contact, thereby helping to achieve faster osseointegration. PMID:22145011

  20. Effect of a fermented dietary supplement containing chromium and zinc on metabolic control in patients with type 2 diabetes: a randomized, placebo-controlled, double-blind cross-over study

    PubMed Central

    Lee, Yu-Mi; Wolf, Petra; Hauner, Hans; Skurk, Thomas

    2016-01-01

    Background For the increasing development of type 2 diabetes dietary habits play an important role. In this regard, dietary supplements are of growing interest to influence the progression of this disease. Objective The aim of this study was to investigate the effect of a cascade-fermented dietary supplement based on fruits, nuts, and vegetables fortified with chromium and zinc on metabolic control in patients with type 2 diabetes mellitus. Methods This was a randomized, placebo-controlled, double-blind, intervention study under free-living conditions using a cross-over design. Thirty-six patients with type 2 diabetes mellitus were enrolled and randomized either to receive a cascade-fermented dietary supplement enriched with chromium (100 µg/d) and zinc (15 mg/d) or a placebo similar in taste but without supplements, over a period of 12 weeks. After a wash-out period of 12 weeks, the patients received the other test product. The main outcome variable was the levels of glycated hemoglobin (HbA1c). Other outcome variables were fasting blood glucose, fructosamine, and lipid parameters. Results Thirty-one patients completed the study. HbA1c showed no relevant changes during both treatment periods, nor was there a relevant difference between the two treatments (HbA1c: p=0.48). The same results were found for fructosamine and fasting glucose (fructosamine: p=0.9; fasting glucose: p=0.31). In addition, there was no effect on lipid metabolism. Conclusion This intervention study does not provide evidence that a cascade-fermented plant-based dietary supplement enriched with a combination of chromium and zinc improves glucose metabolism in patients with type 2 diabetes mellitus under free-living conditions. PMID:27343205

  1. An Open-Label Trial of 12-Week Simeprevir plus Peginterferon/Ribavirin (PR) in Treatment-Naïve Patients with Hepatitis C Virus (HCV) Genotype 1 (GT1)

    PubMed Central

    Asselah, Tarik; Moreno, Christophe; Sarrazin, Christoph; Gschwantler, Michael; Foster, Graham R.; Craxí, Antonio; Buggisch, Peter; Ryan, Robert; Lenz, Oliver; Scott, Jane; Van Dooren, Gino; Lonjon-Domanec, Isabelle; Schlag, Michael; Buti, Maria

    2016-01-01

    Background Shortening duration of peginterferon-based HCV treatment reduces associated burden for patients. Primary objectives of this study were to assess the efficacy against the minimally acceptable response rate 12 weeks post-treatment (SVR12) and safety of simeprevir plus PR in treatment-naïve HCV GT1 patients treated for 12 weeks. Additional objectives included the investigation of potential associations of rapid viral response and baseline factors with SVR12. Methods In this Phase III, open-label study in treatment-naïve HCV GT1 patients with F0–F2 fibrosis, patients with HCV-RNA <25 IU/mL (detectable/undetectable) at Week 2, and undetectable HCV-RNA at Weeks 4 and 8, stopped all treatment at Week 12. All other patients continued PR for a further 12 weeks. Baseline factors significantly associated with SVR12 were identified through logistic regression. Results Of 163 patients who participated in the study, 123 (75%) qualified for 12-week treatment; of these, 81 (66%) achieved SVR12. Baseline factors positively associated with SVR12 rates in patients receiving the 12-week regimen were: IL28B CC genotype: (94% SVR12); HCV RNA ≤800,000 IU/mL (82%); F0–F1 fibrosis (74%). Among all 163 patients, 94% experienced ≥1 adverse event (AE), 4% a serious AE, and 2.5% discontinued due to an AE. Reduced impairment in patient-reported outcomes was observed in the 12-week vs >12-week regimen. Conclusions Overall SVR12 rate (66%) was below the target of 80%, indicating that shortening of treatment with simeprevir plus PR to 12 weeks based on very early response is not effective. However, baseline factors associated with higher SVR12 rates were identified. Therefore, while Week 2 response alone is insufficient to predict efficacy, GT1 patients with favourable baseline factors may benefit from a shortened simeprevir plus PR regimen. Trial Registration ClinicalTrials.gov NCT01846832 PMID:27428331

  2. Effects of a 12-Week Physical Activity Protocol Delivered by YMCA After-School Counselors (Youth Fit for Life) on Fitness and Self-Efficacy Changes in 5-12-Year-Old Boys and Girls

    ERIC Educational Resources Information Center

    Annesi, James J.; Westcott, Wayne L.; Faigenbaum, Avery D.; Unruh, Jennifer L.

    2005-01-01

    To address reduced physical education (PE) in elementary schools, a 12-week physical activity protocol was tested on 5-12-year-old, primarily African American, girls (n = 226) and boys (n = 344) at 14 YMCA after-school care sites. The 3 times/week, 45-min session curriculum included cardiovascular, resistance, and flexibility training, in which…

  3. Differences between men and women in dietary intakes and metabolic profile in response to a 12-week nutritional intervention promoting the Mediterranean diet.

    PubMed

    Leblanc, Vicky; Hudon, Anne-Marie; Royer, Marie-Michelle; Corneau, Louise; Dodin, Sylvie; Bégin, Catherine; Lemieux, Simone

    2015-01-01

    Few studies have compared men and women in response to nutritional interventions but none has assessed differences between men and women in the response to a nutritional intervention programme based on the self-determination theory (SDT) and using the Mediterranean diet (MedDiet) as a model of healthy eating, in a context of CVD prevention and within a non-Mediterranean population. The present study aimed to document differences between men and women in changes in dietary, anthropometric and metabolic variables, in response to a nutritional intervention programme promoting the adoption of the MedDiet and based on the SDT. A total of sixty-four men and fifty-nine premenopausal women presenting risk factors for CVD were recruited through different media advertisements in the Québec City Metropolitan area (Canada). The 12-week nutritional programme used a motivational interviewing approach and included individual and group sessions. A validated FFQ was administered to evaluate dietary intakes from which a Mediterranean score (Medscore) was derived. Both men and women significantly increased their Medscore in response to the intervention (P < 0·0001). Men showed a significantly greater decrease in red and processed meat (-0·4 (95 % CI -0·7, -0·1) portions per d) and a greater increase in fruit (0·9 (95 % CI 0·2, 1·6) portions per d) intakes than women. Significant decreases were observed for BMI and waist circumference in both men and women (P ≤ 0·04). Significant greater decreases were found for total cholesterol (total-C):HDL-cholesterol (HDL-C) (-0·2; 95 % CI -0·4, -0·03) and TAG:HDL-C (-0·2; 95 % CI -0·4, -0·04) ratios in men than in women. When adjusting for the baseline value of the response variable, differences between men and women became non-significant for red and processed meat and fruit intakes whereas significant differences between men and women (i.e. larger increases in men than women) were observed for legumes, nuts and seeds (0·6

  4. Differences between men and women in dietary intakes and metabolic profile in response to a 12-week nutritional intervention promoting the Mediterranean diet.

    PubMed

    Leblanc, Vicky; Hudon, Anne-Marie; Royer, Marie-Michelle; Corneau, Louise; Dodin, Sylvie; Bégin, Catherine; Lemieux, Simone

    2015-01-01

    Few studies have compared men and women in response to nutritional interventions but none has assessed differences between men and women in the response to a nutritional intervention programme based on the self-determination theory (SDT) and using the Mediterranean diet (MedDiet) as a model of healthy eating, in a context of CVD prevention and within a non-Mediterranean population. The present study aimed to document differences between men and women in changes in dietary, anthropometric and metabolic variables, in response to a nutritional intervention programme promoting the adoption of the MedDiet and based on the SDT. A total of sixty-four men and fifty-nine premenopausal women presenting risk factors for CVD were recruited through different media advertisements in the Québec City Metropolitan area (Canada). The 12-week nutritional programme used a motivational interviewing approach and included individual and group sessions. A validated FFQ was administered to evaluate dietary intakes from which a Mediterranean score (Medscore) was derived. Both men and women significantly increased their Medscore in response to the intervention (P < 0·0001). Men showed a significantly greater decrease in red and processed meat (-0·4 (95 % CI -0·7, -0·1) portions per d) and a greater increase in fruit (0·9 (95 % CI 0·2, 1·6) portions per d) intakes than women. Significant decreases were observed for BMI and waist circumference in both men and women (P ≤ 0·04). Significant greater decreases were found for total cholesterol (total-C):HDL-cholesterol (HDL-C) (-0·2; 95 % CI -0·4, -0·03) and TAG:HDL-C (-0·2; 95 % CI -0·4, -0·04) ratios in men than in women. When adjusting for the baseline value of the response variable, differences between men and women became non-significant for red and processed meat and fruit intakes whereas significant differences between men and women (i.e. larger increases in men than women) were observed for legumes, nuts and seeds (0·6

  5. Effects of feeding transgenic corn with mCry1Ac or maroACC gene to laying hens for 12 weeks on growth, egg quality and organ health.

    PubMed

    Zhong, R Q; Chen, L; Gao, L X; Zhang, L L; Yao, B; Yang, X G; Zhang, H F

    2016-08-01

    The objective of the present study was to investigate the effect of feeding two transgenic corn lines containing the mCry1Ac gene from Bacillus thuringiensis strain (BT-799) and the maroACC gene from Agrobacterium tumefaciens strain (CC-2), respectively, on growth, egg quality and organ health indicators. Expression of the mCry1Ac gene confers resistance to Pyrausta nubilalis and the maroACC gene confers tolerance to herbicides. Healthy hens (n=96 placed in cages; 3 hens/cage) were randomly assigned to one of four corn-soybean meal dietary treatments (8 cages/treatment) formulated with the following corn: non-transgenic near-isoline control corn (control), BT-799 corn, CC-2 corn and commercially available non-transgenic reference corn (reference). The experiment was divided into three 4-week phases (week 1 to 4, week 5 to 8 and week 9 to 12), during which hens were fed mash diets. Performance (BW, feed intake and egg production) and egg quality were determined. Following slaughter at the end of 12 weeks of feeding (n=8/treatment), carcass yield and organ weights (heart, liver, spleen, lung, kidneys, stomach and ovary) were recorded; organs and intestines were sampled for histological analysis. Analysis of serum biochemistry parameters to assess the liver and kidney function were performed. No differences in BW, egg production and production efficiency were observed between hens consuming the control diet and hens consuming the BT-799 or CC-2 diet. Haugh unit measures and egg component weights were similar between the control and test groups. Carcass yield was not affected by the diet treatment. Similar organosomatic indices and serum parameters did not indicate the characteristics of organ dysfunction. All observed values of the BT-799 and CC-2 groups were within the calculated tolerance intervals. This research indicates that the performance, egg quality, organ health and carcass yield of laying hens fed diets containing the BT-799 or CC-2 corn line were similar

  6. Nutrition, aging and cancer: lessons from dietary intervention studies.

    PubMed

    Carruba, Giuseppe; Cocciadiferro, Letizia; Di Cristina, Antonietta; Granata, Orazia M; Dolcemascolo, Cecilia; Campisi, Ildegarda; Zarcone, Maurizio; Cinquegrani, Maria; Traina, Adele

    2016-01-01

    There is convincing epidemiological and clinical evidence that, independent of aging, lifestyle and, notably, nutrition are associated with development or progression of major human cancers, including breast, prostate, colorectal tumors, and an increasingly large collection of diet-related cancers. Mechanisms underlying this association are mostly related to the distinct epigenetic effects of different dietary patterns. In this context, Mediterranean diet has been reported to significantly reduce mortality rates for various chronic illnesses, including cardiovascular diseases, neurodegenerative diseases and cancer. Although many observational studies have supported this evidence, dietary intervention studies using a Mediterranean dietary pattern or its selected food components are still limited and affected by a rather large variability in characteristics of study subjects, type and length of intervention, selected end-points and statistical analysis. Here we review data of two of our intervention studies, the MeDiet study and the DiMeSa project, aimed at assessing the effects of traditional Mediterranean diet and/or its component(s) on a large panel of both plasma and urine biomarkers. Both published and unpublished results are presented and discussed. PMID:27057203

  7. Adding Qualitative and Mixed Methods Research to Health Intervention Studies: Interacting With Differences.

    PubMed

    Johnson, R Burke; Schoonenboom, Judith

    2016-04-01

    The purpose of this article is to explain how to improve intervention designs, such as randomized controlled trials (RCTs), in health science research using a process philosophy and theory known as dialectical pluralism (DP). DP views reality as plural and uses dialectical, dialogical, and hermeneutical approaches to knowledge construction. Using DP and its "both/and" logic, and its attempt to produce new creative syntheses, researchers on heterogeneous teams can better dialogue with qualitative and mixed methods approaches, concepts, paradigms, methodologies, and methods to improve their intervention research studies. The concept of reflexivity is utilized but is expanded when it is a component of DP. Examples of strategies for identifying, inviting, and creating divergence and integrative strategies for producing strong mixed methods intervention studies are provided and illustrated using real-life examples.

  8. Recruitment to a physical activity intervention study in women at increased risk of breast cancer

    PubMed Central

    2009-01-01

    Background Physical activity is being studied as a breast cancer prevention strategy. Women at risk of breast cancer report interest in lifestyle modification, but recruitment to randomized physical activity intervention studies is challenging. Methods We conducted an analysis of recruitment techniques used for a prospective, randomized pilot study of physical activity in women at risk of breast cancer. We evaluated differences in proportion of eligible patients, enrolled patients, and successful patients identified by each individual recruitment method. The Fisher-Freeman-Halton test (an extension of Fisher's exact test from 2 × 2 tables to general row by column tables) was used to compare the success of different recruitment strategies. Results We received 352 inquiries from women interested in participating, of whom 171 (54%) were eligible. Ninety-nine women completed a baseline activity evaluation, and 58 (34% of eligible; 16% of total inquiries) were randomized. Recruitment methods fell into three broad categories: media techniques, direct contact with potential participants, and contacts with health care providers. Recruitment strategies differed significantly in their ability to identify eligible women (p = 0.01), and women who subsequently enrolled in the study (p = 0.02). Conclusion Recruitment techniques had varying success. Our data illustrate the challenges in recruiting to behavior modification studies, and provide useful information for tailoring future recruitment efforts for lifestyle intervention trials. Trial Registration No(s) CDR0000393790, NCI-04-C-0276, NCI-NAVY-B05-001 PMID:19397816

  9. Impact of Individualized Diet Intervention on Body Composition and Respiratory Variables in Children with Respiratory Insufficiency- a Pilot Intervention Study

    PubMed Central

    Martinez, Enid E; Bechard, Lori J; Smallwood, Craig D; Duggan, Christopher P; Graham, Robert J; Mehta, Nilesh M

    2015-01-01

    Objective Diet modification may improve body composition and respiratory parameters in children with respiratory insufficiency. Our objective was to examine the effect of an individualized diet intervention on changes in weight, lean body mass (LBM), minute ventilation (MV) and carbon dioxide production (VCO2) in children on home mechanical ventilator support. Design Prospective, open-labeled interventional study. Setting Study subjects' homes Patients Children, ages 1 month to 17 years, dependent on at least 12 hours per day of transtracheal mechanical ventilator support. Intervention Twelve weeks of an individualized diet modified to deliver energy at 90-110% of measured energy expenditure (MEE) and protein intake per age-based guidelines. Measurements & Main Results During a multidisciplinary home visit we obtained baseline values of height and weight, LBM% by bioelectrical impedance analysis, actual energy and protein intake by food record, and MEE by indirect calorimetry. An individualized diet was then prescribed to optimize energy and protein intake. After 12 weeks on this interventional diet we evaluated changes in weight, height, LBM%, MV and VCO2. Sixteen subjects, mean age 9.3y (SD 4.9), 8 male, completed the study. For the diet intervention, a majority of subjects required a change in energy and protein prescription. The mean percentage of energy delivered as carbohydrate was significantly decreased, 51.7% at baseline vs. 48.2% at follow-up, p=0.009. Mean height and weight increased on the modified diet. Mean LBM% increased from 58.3% to 61.8%. MV was significantly lower (0.18 L/min/kg vs. 0.15 L/min/kg, p=0.04) and we observed a trend towards lower VCO2 (5.4 ml/min*kg vs. 5.3 ml/min*kg, p=0.06) after 12 weeks on the interventional diet. Conclusions Individualized diet modification is feasible and associated with a significant decrease in minute ventilation, a trend towards significant reduction in carbon dioxide production, and improved body

  10. Efficacy of Yoga for Vasomotor Symptoms: A Randomized Controlled Trial

    PubMed Central

    Newton, Katherine M.; Reed, Susan D.; Guthrie, Katherine A.; Sherman, Karen J.; Booth-LaForce, Cathryn; Caan, Bette; Sternfeld, Barbara; Carpenter, Janet S.; Learman, Lee A.; Freeman, Ellen W.; Cohen, Lee S.; Joffe, Hadine; Anderson, Garnet L.; Larson, Joseph C.; Hunt, Julie R.; Ensrud, Kristine E.; LaCroix, Andrea Z.

    2013-01-01

    Objective To determine the efficacy of yoga in alleviating VMS frequency and bother. Methods Three by two factorial design, randomized, controlled. Eligible women were randomized to yoga (n=107), exercise (n=106), or usual activity (n=142), and were simultaneously randomized to double-blind comparison of omega-3 fatty acid (n=177) or placebo (n=178) capsules. Yoga intervention was twelve, weekly, 90-minute yoga classes with daily home practice. Primary outcomes were VMS frequency and bother assessed by daily diaries at baseline, 6, and 12 weeks. Secondary outcomes included insomnia symptoms (Insomnia Severity Index) at baseline and 12 weeks. Results Among 249 randomized women, 237 (95%) completed 12-week assessments. Mean baseline VMS frequency was 7.4/day (95% CI 6.6, 8.1) in the yoga group and 8.0/day (95% CI 7.3, 8.7) in the usual activity group. Intent-to-treat analyses included all participants with response data (n=237). There was no difference between intervention groups in change in VMS frequency from baseline to 6 and 12 weeks (mean difference (yoga – usual activity) from baseline −0.3 (95% CI −1.1, 0.5) at 6 weeks and −0.3 (95% CI −1.2, 0.6) at 12 weeks (p=0.119 across both time points). Results were similar for VMS bother. At week 12, yoga was associated with an improvement in insomnia symptoms (mean difference [yoga-usual activity] in change –Insomnia Severity Index, 1.3 [95% CI −2.5, −0.1][p=0.007]). Conclusion Among healthy women, 12 weeks of yoga class plus home practice compared with usual activity did not improve VMS frequency or bother, but reduced insomnia symptoms. PMID:24045673

  11. Omega-3 Fatty Acid Supplementation for 12 Weeks Increases Resting and Exercise Metabolic Rate in Healthy Community-Dwelling Older Females.

    PubMed

    Logan, Samantha L; Spriet, Lawrence L

    2015-01-01

    Critical among the changes that occur with aging are decreases in muscle mass and metabolic rate and an increase in fat mass. These changes may predispose older adults to chronic disease and functional impairment; ultimately resulting in a decrease in the quality of life. Research has suggested that long chain omega-3 fatty acids, found predominantly in fatty fish, may assist in reducing these changes. The objective of this study was to evaluate the effect of fish oil (FO) supplementation in a cohort of healthy, community-dwelling older females on 1) metabolic rate and substrate oxidation at rest and during exercise; 2) resting blood pressure and resting and exercise heart rates; 3) body composition; 4) strength and physical function, and; 5) blood measures of insulin, glucose, c-reactive protein, and triglycerides. Twenty-four females (66 ± 1 yr) were recruited and randomly assigned to receive either 3g/d of EPA and DHA or a placebo (PL, olive oil) for 12 wk. Exercise measurements were taken before and after 12 wk of supplementation and resting metabolic measures were made before and at 6 and 12 wk of supplementation. The results demonstrated that FO supplementation significantly increased resting metabolic rate by 14%, energy expenditure during exercise by 10%, and the rate of fat oxidation during rest by 19% and during exercise by 27%. In addition, FO consumption lowered triglyceride levels by 29% and increased lean mass by 4% and functional capacity by 7%, while no changes occurred in the PL group. In conclusion, FO may be a strategy to improve age-related physical and metabolic changes in healthy older females. Trial registration: ClinicalTrials.gov NCT01734538.

  12. The application of near infrared spectroscopy in nutritional intervention studies

    PubMed Central

    Jackson, Philippa A.; Kennedy, David O.

    2013-01-01

    Functional near infrared spectroscopy (NIRS) is a non-invasive optical imaging technique used to monitor cerebral blood flow (CBF) and by proxy neuronal activation. The use of NIRS in nutritional intervention studies is a relatively novel application of this technique, with only a small, but growing, number of trials published to date. These trials—in which the effects on CBF following administration of dietary components such as caffeine, polyphenols and omega-3 polyunsaturated fatty acids are assessed—have successfully demonstrated NIRS as a sensitive measure of change in hemodynamic response during cognitive tasks in both acute and chronic treatment intervention paradigms. The existent research in this area has been limited by the constraints of the technique itself however advancements in the measurement technology, paired with studies endeavoring increased sophistication in number and locations of channels over the head should render the use of NIRS in nutritional interventions particularly valuable in advancing our understanding of the effects of nutrients and dietary components on the brain. PMID:23964231

  13. Pilot walnut intervention study of urolithin bioavailability in human volunteers.

    PubMed

    Pfundstein, Beate; Haubner, Roswitha; Würtele, Gerd; Gehres, Nicole; Ulrich, Cornelia M; Owen, Robert W

    2014-10-22

    A pilot intervention study was conducted in human volunteers (n = 4) to establish the bioavailability of urolithins, which are the terminal end-products of ellagitannin metabolism by the gastrointestinal microflora. Biospecimens (blood, feces, and urine) along with urolithins purified therefrom were analyzed for their antioxidant capacity in a range of in vitro assays. Urolithin metabolites were identified and quantitated in the biospecimens by negative ion mode HPLC-ESI-MS analysis. The data in this pilot study show that the metabolism of ellagitannins in the four volunteers gave rise to a diverse profile and a highly variable concentration of urolithins in urine. The concentration of glucuronidated urolithins in blood and urine did not correlate with antioxidant capacity. However, the antioxidant capacity of urine, but not plasma biospecimens, was highly correlated with uric acid concentration. The antioxidant capacity of fecal extracts correlated positively with the concentration of urolithin D in both the DPPH and FRAP assays, but not in the ORAC assay, which was entirely consistent with the in vitro assays for pure urolithin D.

  14. Recruitment of pregnant women to an exercise-intervention study.

    PubMed

    Carpenter, R E; Emery, S J; Rassi, D; Uzun, O; Lewis, M J

    2016-01-01

    We share here our experience of recruiting pregnant women into an exercise intervention study. Recruitment challenges were anticipated owing to the study design, which required four hospital visits for cardiovascular assessment, a long-term (nine-month) commitment, and adherence to a 20-week exercise programme. Fifty-three women were assigned to one of three groups (no-exercise, land exercise or water exercise) using a 2 × 2 × 2 flexible randomisation design. Seven hundred forty-four women were screened at an antenatal clinic, of whom 501 were eligible to participate in the study. One hundred forty-five women were subsequently approached: 46 (32%) of whom agreed to participate, 42 (29%) were interested but then declined and 57 (39%) declined outright. Our study design helped recruit pregnant women as it allowed them some choice of group membership. We also noted that the participant-researcher relationship is important in reducing attrition. Our experience provides indications of likely recruitment and attrition rates for future randomised controlled trials of this type.

  15. Morphological adaptation of muscle collagen and receptor of advanced glycation end product (RAGE) in osteoarthritis patients with 12 weeks of resistance training: influence of anti-inflammatory or glucosamine treatment.

    PubMed

    Mattiello-Sverzut, Ana Claudia; Petersen, Susanne G; Kjaer, Michael; Mackey, Abigail L

    2013-09-01

    The aim of this study was to investigate the effect of 12-week resistance training on morphological presence of collagen and RAGE (receptor for advanced glycation end products) in skeletal muscle of patients with knee osteoarthritis (OA). Little is known about the influence of exercise on the skeletal muscle matrix that supports joints affected by OA mainly when it is associated with medication taken by OA patients (non-steroid anti-inflammatory drugs (NSAID) and glucosamine). A biopsy was collected from the vastus lateralis muscle in all patients before and after 12-week period of training. The patients (age 55-69 years) were divided into three groups, treated with NSAID, glucosamine or placebo. In addition, the muscle samples were analysed by immunohistochemistry for collagen types, RAGE and capillaries ratio. An increment in immunoreactivity for type IV collagen after the training period was observed in 72 % of all biopsies when compared with their respective baseline samples. Reduced immunoreactivity of collagen type I was observed in all patients treated with glucosamine. A significant increase with training in the amount of RAGE was detected in the placebo group only (p < 0.05). Comparison of post-treatment states indicated significant differences between the placebo and glucosamine group data, demonstrating increased levels in the placebo group (p < 0.05). These findings suggest a basement membrane remodelling in favour of a strengthened extracellular matrix surrounding individual muscle fibres after 12 weeks of resistance training. Glucosamine with training appeared to attenuate RAGE accumulation more than was seen with NSAID or placebo in skeletal muscle of OA patients.

  16. Heart rate recovery and heart rate variability are unchanged in patients with coronary artery disease following 12 weeks of high-intensity interval and moderate-intensity endurance exercise training.

    PubMed

    Currie, Katharine D; Rosen, Lee M; Millar, Philip J; McKelvie, Robert S; MacDonald, Maureen J

    2013-06-01

    Decreased heart rate variability and attenuated heart rate recovery following exercise are associated with an increased risk of mortality in cardiac patients. This study investigated the effects of 12 weeks of moderate-intensity endurance exercise (END) and a novel low-volume high-intensity interval exercise protocol (HIT) on measures of heart rate recovery and heart rate variability in patients with coronary artery disease (CAD). Fourteen males with CAD participated in 12 weeks of END or HIT training, each consisting of 2 supervised exercise sessions per week. END consisted of 30-50 min of continuous cycling at 60% peak power output (PPO). HIT involved ten 1-min intervals at 88% PPO separated by 1-min intervals at 10% PPO. Heart rate recovery at 1 min and 2 min was measured before and after training (pre- and post-training, respectively) using a submaximal exercise bout. Resting time and spectral and nonlinear domain measures of heart rate variability were calculated. Following 12 weeks of END and HIT, there was no change in heart rate recovery at 1 min (END, 40 ± 12 beats·min(-1) vs. 37 ± 19 beats·min(-1); HIT, 31 ± 8 beats·min(-1) vs. 35 ± 8 beats·min(-1); p ≥ 0.05 for pre- vs. post-training) or 2 min (END, 44 ± 18 beats·min(-1) vs. 43 ± 19 beats·min(-1); HIT, 42 ± 10 beats·min(-1) vs. 50 ± 6 beats·min(-1); p ≥ 0.05 for pre- vs. post-training). All heart rate variability indices were unchanged following END and HIT training. In conclusion, neither END nor HIT exercise programs elicited training-induced improvements in cardiac autonomic function in patients with CAD. The absence of improvements with training may be attributed to the optimal medical management and normative pretraining state of our sample.

  17. Liquid versus gel handrub formulation: a prospective intervention study

    PubMed Central

    Traore, Ousmane; Hugonnet, Stéphane; Lübbe, Jann; Griffiths, William; Pittet, Didier

    2007-01-01

    Introduction Hand hygiene is one of the cornerstones of the prevention of health care-associated infection, but health care worker (HCW) compliance with good practices remains low. Alcohol-based handrub is the new standard for hand hygiene action worldwide and usually requires a system change for its successful introduction in routine care. Product acceptability by HCWs is a crucial step in this process. Methods We conducted a prospective intervention study to compare the impact on HCW compliance of a liquid (study phase I) versus a gel (phase II) handrub formulation of the same product during daily patient care. All staff (102 HCWs) of the medical intensive care unit participated. Compliance with hand hygiene was monitored by a single observer. Skin tolerance and product acceptability were assessed using subjective and objective scoring systems, self-report questionnaires, and biometric measurements. Logistic regression was used to estimate the association between predictors and compliance with the handrub formulation as the main explanatory variable and to adjust for potential risk factors. Results Overall compliance (phases I and II) with hand hygiene practices among nurses, physicians, nursing assistants, and other HCWs was 39.1%, 27.1%, 31.1%, and 13.9%, respectively (p = 0.027). Easy access to handrub improved compliance (35.3% versus 50.6%, p = 0.035). Nurse status, working on morning shifts, use of the gel formulation, and availability of the alcohol-based handrub in the HCW's pocket were independently associated with higher compliance. Immediate accessibility was the strongest predictor. Based on self-assessment, observer assessment, and the measurement of epidermal water content, the gel performed significantly better than the liquid formulation. Conclusion Facilitated access to an alcohol-based gel formulation leads to improved compliance with hand hygiene and better skin condition in HCWs. PMID:17477858

  18. No effect of 12 weeks' supplementation with 1 g DHA-rich or EPA-rich fish oil on cognitive function or mood in healthy young adults aged 18-35 years.

    PubMed

    Jackson, Philippa A; Deary, Michael E; Reay, Jonathon L; Scholey, Andrew B; Kennedy, David O

    2012-04-01

    The n-3 PUFA are a unique class of fatty acids that cannot be manufactured by the body, and must be acquired via dietary sources. In the UK, as well as in other Western nations, these 'essential' fatty acids are consumed in quantities that fall below government guidelines. The present study explored the effects of 12 weeks' dietary supplementation with 1 g/d of two types of fish oil (FO; DHA-rich and EPA-rich) in 159 healthy young adults aged 18-35 years. An assessment of performance on a battery of computerised cognitive tasks and mood measures took place before and following the 12-week treatment regimen. Venous blood samples were also supplied by participants at both time points which were later analysed for serum fatty acid concentrations. Despite good adherence to the study protocol - as reflected in increased concentrations of n-3 serum fatty acids - compared with placebo, the observed effects of both active treatments were minimal. The only finding of note revealed that supplementation with EPA-rich FO may reduce subjective mental fatigue at times of high cognitive demand, although further investigation is required. These findings, taken together with other recent reports of null effects, suggest that dietary supplementation with n-3 PUFA in healthy, normally developing and impairment-free populations is unlikely to result in cognitive enhancement.

  19. Validity of repeated dietary measurements in a dietary intervention study.

    PubMed

    Johansson, G; Callmer, E; Gustafsson, J A

    1992-10-01

    The aim of the study was to evaluate the compliance in a dietary intervention study. When drawing conclusions about the relationship between dietary intake and disease occurrence/disease-related variables it is important to obtain valid dietary data. 20 healthy, non-smoking normal-weight omnivores changed from a mixed to a lactovegetarian diet. Dietary surveys (four 24 h recalls per person and time-period), urinary and faecal sample collections were performed before and 3, 6 and 12 months after the dietary shift. The validation of energy, protein, sodium and potassium yielded approximately the same ratio of dietary intake to biological marker at 0 and 3 months. This ratio decreased towards 6 months and continued to decrease towards 12 months. The fibre intake was compared to the total faecal weight directly and indirectly by calculating the fibre intake from the stool weight, the water content in faeces and the excretion of short-chain fatty acids (SCFAs). These four methods of fibre validation showed that the ratio of dietary intake to biological marker was always highest at 12 months, indicating an overestimation of the fibre intake at the end of the study. This is the first time these methods of validating fibre intake have been used in an epidemiological study. The ratio of dietary calcium intake to urinary and faecal calcium excretion did not show any statistical difference between the period before and 3 months after the dietary shift. To conclude, almost all investigated dietary data show approximately the same validity before and 3 months after the dietary shift, and show the least validity 12 months after the dietary shift. Thus, this study demonstrates that it is difficult to obtain valid dietary data 1 year after a drastic dietary change, indicating a decreased compliance to the new dietary regimen at the end of the 1 year study period. This represents important information when attempting to relate biological effects to dietary intake, and illustrates

  20. Prevention and Intervention Studies with Telmisartan, Ramipril and Their Combination in Different Rat Stroke Models

    PubMed Central

    Schmerbach, Kristin; Krikov, Maxim; Wengenmayer, Christina; Godes, Michael; Mueller, Susanne; Villringer, Arno; Steckelings, Ulrike

    2011-01-01

    Objectives The effects of AT1 receptor blocker, telmisartan, and the ACE inhibitor, ramipril, were tested head-to head and in combination on stroke prevention in hypertensive rats and on potential neuroprotection in acute cerebral ischemia in normotensive rats. Methods Prevention study: Stroke-prone spontaneously hypertensive rats (SHR-SP) were subjected to high salt and randomly assigned to 4 groups: (1) untreated (NaCl, n = 24), (2) telmisartan (T; n = 27), (3) ramipril (R; n = 27) and (4) telmisartan +ramipril (T+R; n = 26). Drug doses were selected to keep blood pressure (BP) at 150 mmHg in all groups. Neurological signs and stroke incidence at 50% mortality of untreated SHR-SP were investigated. Intervention study: Normotensive Wistar rats were treated s.c. 5 days prior to middle cerebral artery occlusion (MCAO) for 90 min with reperfusion. Groups (n = 10 each): (1) sham, (2) vehicle (V; 0,9% NaCl), (3) T (0,5 mg/kg once daily), (4) R (0,01 mg/kg twice daily), (5) R (0,1 mg/kg twice daily) or (6) T (0,5 mg/kg once daily) plus R (0,01 mg/kg twice daily). Twenty-four and 48 h after MCAO, neurological outcome (NO) was determined. Forty-eight h after MCAO, infarct volume by MRI, neuronal survival, inflammation factors and neurotrophin receptor (TrkB) were analysed. Results Stroke incidence was reduced, survival was prolonged and neurological outcome was improved in all treated SHR-SP with no differences between treated groups. In the acute intervention study, T and T+R, but not R alone, improved NO, reduced infarct volume, inflammation (TNFα), and induced TrkB receptor and neuronal survival in comparison to V. Conclusions T, R or T+R had similar beneficial effects on stroke incidence and NO in hypertensive rats, confirming BP reduction as determinant factor in stroke prevention. In contrast, T and T+R provided superior neuroprotection in comparison to R alone in normotensive rats with induced cerebral ischemia. PMID:21901125

  1. Challenges of long-term nutrition intervention studies on cognition: discordance between observational and intervention studies of vitamin B12 and cognition.

    PubMed

    McCracken, Cherie

    2010-11-01

    Conducting long-term nutrition intervention studies on cognition can be challenging. The gaps in current methodology are addressed via a case study of the relationship between vitamin B(12) and cognition in people aged 60 and older. There is robust evidence from many observational studies, both cross-sectional and longitudinal, showing that a deficit of the vitamin is associated with poor or declining cognition in this age group, but supplementation of the vitamin in trials does not bring about improved cognition. The evidence from observational studies as well as clinical trials is reviewed here, and the potential difficulties in conducting long-term nutritional intervention studies in this area are highlighted.

  2. Prevention of hamstring strains in elite soccer: an intervention study.

    PubMed

    Arnason, A; Andersen, T E; Holme, I; Engebretsen, L; Bahr, R

    2008-02-01

    The purpose was to test the effect of eccentric strength training and flexibility training on the incidence of hamstring strains in soccer. Hamstring strains and player exposure were registered prospectively during four consecutive soccer seasons (1999-2002) for 17-30 elite soccer teams from Iceland and Norway. The first two seasons were used as baseline, while intervention programs consisting of warm-up stretching, flexibility and/or eccentric strength training were introduced during the 2001 and 2002 seasons. During the intervention seasons, 48% of the teams selected to use the intervention programs. There was no difference in the incidence of hamstring strains between teams that used the flexibility training program and those who did not [relative risk (RR)=1.53, P=0.22], nor was there a difference compared with the baseline data (RR=0.89, P=0.75). The incidence of hamstring strains was lower in teams who used the eccentric training program compared with teams that did not use the program (RR=0.43, P=0.01), as well as compared with baseline data for the same intervention teams (RR=0.42, P=0.009). Eccentric strength training with Nordic hamstring lowers combined with warm-up stretching appears to reduce the risk of hamstring strains, while no effect was detected from flexibility training alone. These results should be verified in randomized clinical trials.

  3. Dietary Antioxidants and Melanoma: Evidence from Cohort and Intervention Studies.

    PubMed

    Miura, Kyoko; Green, Adèle C

    2015-01-01

    Melanoma is the most serious form of skin cancer affecting mostly people of Caucasian origin and is associated with high exposure to solar ultraviolet (UV) radiation. Antioxidants in the diet are thought to prevent UV-induced DNA damage and oxidative stress and laboratory-based studies have shown that high antioxidant intakes inhibit melanoma development. Corresponding epidemiological evidence is inconsistent, however. We therefore reviewed results from prospective observational studies and randomized controlled trials (RCTs) to clarify whether consumption of antioxidant vitamin C, E (tocopherol), and A (retinol), carotenoids and selenium, as food, supplements, or both, or high fruit and vegetable intake, reduce the incidence of cutaneous melanoma. A total of 9 studies (2 cohort, 1 nested case-control, 6 RCTs) were included. Neither antioxidant nutrients, individually or combined, nor fruit and vegetable intake showed any strong and significant associations with melanoma, though the number of relevant studies was limited and several had methodological shortcomings. In particular, melanoma was not a primary disease outcome in any of the RCTs and therefore, none adequately accounted for potential confounding by sun exposure. In conclusion, available evidence is currently inadequate to assess possible beneficial effects of antioxidant intake on melanoma risk. PMID:26147450

  4. An Intervention Study Targeting Nutritional Intake in Worksite Cafeterias

    PubMed Central

    Lowe, Michael R.; Tappe, Karyn A.; Butryn, Meghan L.; Annunziato, Rachel A.; Coletta, Maria C.; Ochner, Christopher N.; Rolls, Barbara J.

    2010-01-01

    Modifying the food environment is a promising strategy for promoting healthier eating behavior. This study aimed to evaluate nutritional and weight changes in a program that used worksite cafeterias to reduce employees’ calorie content of purchased foods and improve their macronutrient intake. Participants were randomly assigned to one of two conditions: 1) only environmental change (i.e., the introduction of 10 new low-energy-density (ED) foods and provision of labels for all foods sold at lunch, which listed ED, calories, and macronutrient content) or 2) the environmental change plus pricing incentives for purchasing low-ED foods and education about low-ED eating delivered in four, 1-hour group sessions. Participant lunch choices were monitored electronically at the point of purchase for 3 months before the intervention was instituted (i.e., the baseline period) and for 3 months afterward (i.e., intervention period). Participants were adults (n = 96, BMI = 29.7 ± 6.0 kg/m2) who regularly ate lunch at their workplace cafeteria. There was no difference between groups in total energy intake over the study period. Across groups, energy and percent of energy from fat decreased and percent of energy from carbohydrate increased from baseline to the intervention period (all p <. 01). Follow-up analyses, conducted by averaging Baseline Months 1 and 2 and comparing them to Intervention Month 3 as a conservative estimate of overall impact of the intervention, indicated that change in energy, carbohydrate, and fat intake remained significant (p < .001). Providing nutrition labels and reducing the ED of selected foods was associated with improved dietary intake. PMID:20434060

  5. Taking a low glycemic index multi-nutrient supplement as breakfast improves glycemic control in patients with type 2 diabetes mellitus: a randomized controlled trial.

    PubMed

    Li, Di; Zhang, Peiwen; Guo, Honghui; Ling, Wenhua

    2014-12-01

    Dietary therapy is the mainstay of treatment for diabetes. This study examined the effect of a low glycemic index (GI) multi-nutrient supplement, consumed in place of breakfast, on glycemic control in patients with type 2 diabetes mellitus (T2DM). A total of 71 participants were randomized at a 2:1 ratio into either a breakfast replacement group or a normal breakfast group for a 12-week interventional study. The primary outcome measure was change in hemoglobin A1c (HbA1c). Nutrition status and somatometry were studied as secondary outcomes. The breakfast replacement group displayed a -0.2% absolute reduction in HbA1c (95% CI (confidence interval), -0.38% to -0.07%, p = 0.004), while the HbA1c of the control group increased 0.3% (95% CI, 0.1% to 0.5%, p = 0.005). The baseline Mini Nutritional Assessment score for both groups was 26.0 and no significant changes occurred following intervention. However, there was a statistically significant difference in body mass index between the treatment and control groups (p = 0.032) due to the weight gain in the control group (increased 0.5 kg, 95% CI was 0.2 to 0.9, p = 0.007). These data suggest that breakfast replacement with a low GI multi-nutrient supplement can improve glycemic and weight control in T2DM. PMID:25514391

  6. Taking a low glycemic index multi-nutrient supplement as breakfast improves glycemic control in patients with type 2 diabetes mellitus: a randomized controlled trial.

    PubMed

    Li, Di; Zhang, Peiwen; Guo, Honghui; Ling, Wenhua

    2014-12-10

    Dietary therapy is the mainstay of treatment for diabetes. This study examined the effect of a low glycemic index (GI) multi-nutrient supplement, consumed in place of breakfast, on glycemic control in patients with type 2 diabetes mellitus (T2DM). A total of 71 participants were randomized at a 2:1 ratio into either a breakfast replacement group or a normal breakfast group for a 12-week interventional study. The primary outcome measure was change in hemoglobin A1c (HbA1c). Nutrition status and somatometry were studied as secondary outcomes. The breakfast replacement group displayed a -0.2% absolute reduction in HbA1c (95% CI (confidence interval), -0.38% to -0.07%, p = 0.004), while the HbA1c of the control group increased 0.3% (95% CI, 0.1% to 0.5%, p = 0.005). The baseline Mini Nutritional Assessment score for both groups was 26.0 and no significant changes occurred following intervention. However, there was a statistically significant difference in body mass index between the treatment and control groups (p = 0.032) due to the weight gain in the control group (increased 0.5 kg, 95% CI was 0.2 to 0.9, p = 0.007). These data suggest that breakfast replacement with a low GI multi-nutrient supplement can improve glycemic and weight control in T2DM.

  7. The influence of sample freezing at – 80 °C for 2–12 weeks on glycated haemoglobin (HbA1c) concentration assayed by HPLC method on Bio-Rad D-10® auto analyzer

    PubMed Central

    Bergmann, Katarzyna; Sypniewska, Grazyna

    2016-01-01

    Introduction The aim of the study was to evaluate the effect of a single freeze/thaw cycle on HbA1c concentrations measured by commercially available HPLC method. Materials and methods Study included 128 whole blood samples collected from diabetic patients (N = 60) and healthy volunteers (N = 68). HbA1c concentrations were measured in fresh blood samples. Then samples were frozen at - 80 °C for up to 12 weeks. HbA1c was assayed by ion-exchange HPLC method on Bio-Rad D-10® analyzer. Variables were compared using Wilcoxon and ANOVA Kruskal-Wallis tests. Bias between HbA1c measured in fresh and frozen samples was calculated. The comparability of HbA1c concentrations was assessed by Bland-Altman plot. Results Median (IQR) HbA1c concentration was 45.3 (36.6–61.2) mmol/mol for fresh and 45.3 (36.6–60.6) mmol/mol for frozen/thawed samples. No significant difference in HbA1c concentrations was found comparing fresh and frozen/thawed samples (P = 0.070) in the whole group, as well as in healthy and diabetic subjects. The median calculated bias between fresh and frozen/thawed samples was 0% in whole group and healthy subjects, and 1.19% in diabetic patients. No significant difference was found between the biases according to baseline HbA1c values (P = 0.150). The Bland-Altman plot analysis showed a positive bias of 0.4% (95% CI: - 2.8 - 3.7%), which indicates high compliance between HbA1c values and no relevant influence of sample freezing on clinical significance of HbA1c measurement. Conclusions Storage for up to 12 weeks at – 80 °C with a single freeze/thaw cycle does not affect HbA1c concentrations measured with HPLC method on Bio-Rad D-10® analyzer. PMID:27812303

  8. Lower extremity power training in elderly subjects with moderate mobility limitations: A randomized controlled trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Fifty-seven community-dwelling older adults were randomized to either high-velocity high-power training (POW), slow-velocity progressive resistance training (STR) or a control group of lower extremity stretching (CON). Training was performed three times per week for 12 weeks and subjects completed t...

  9. Cognitive-Behavioral Therapy for Intermittent Explosive Disorder: A Pilot Randomized Clinical Trial

    ERIC Educational Resources Information Center

    McCloskey, Michael S.; Noblett, Kurtis L.; Deffenbacher, Jerry L.; Gollan, Jackie K.; Coccaro, Emil F.

    2008-01-01

    No randomized clinical trials have evaluated the efficacy of psychotherapy for intermittent explosive disorder (IED). In the present study, the authors tested the efficacy of 12-week group and individual cognitive-behavioral therapies (adapted from J. L. Deffenbacher & M. McKay, 2000) by comparing them with a wait-list control in a randomized…

  10. Vestibular Stimulation for ADHD: Randomized Controlled Trial of Comprehensive Motion Apparatus

    ERIC Educational Resources Information Center

    Clark, David L.; Arnold, L. Eugene; Crowl, Lindsay; Bozzolo, Hernan; Peruggia, Mario; Ramadan, Yaser; Bornstein, Robert; Hollway, Jill A.; Thompson, Susan; Malone, Krista; Hall, Kristy L.; Shelton, Sara B.; Bozzolo, Dawn R.; Cook, Amy

    2008-01-01

    Objective: This research evaluates effects of vestibular stimulation by Comprehensive Motion Apparatus (CMA) in ADHD. Method: Children ages 6 to 12 (48 boys, 5 girls) with ADHD were randomized to thrice-weekly 30-min treatments for 12 weeks with CMA, stimulating otoliths and semicircular canals, or a single-blind control of equal duration and…

  11. A Pilot Randomized Controlled Trial of Omega-3 Fatty Acids for Autism Spectrum Disorder

    ERIC Educational Resources Information Center

    Bent, Stephen; Bertoglio, Kiah; Ashwood, Paul; Bostrom, Alan; Hendren, Robert L.

    2011-01-01

    We conducted a pilot randomized controlled trial to determine the feasibility and initial safety and efficacy of omega-3 fatty acids (1.3 g/day) for the treatment of hyperactivity in 27 children ages 3-8 with autism spectrum disorder (ASD). After 12 weeks, hyperactivity, as measured by the Aberrant Behavior Checklist, improved 2.7 (plus or minus…

  12. Supervised Home Training of Dialogue Skills in Chronic Aphasia: A Randomized Parallel Group Study

    ERIC Educational Resources Information Center

    Nobis-Bosch, Ruth; Springer, Luise; Radermacher, Irmgard; Huber, Walter

    2011-01-01

    Purpose: The aim of this study was to prove the efficacy of supervised self-training for individuals with aphasia. Linguistic and communicative performance in structured dialogues represented the main study parameters. Method: In a cross-over design for randomized matched pairs, 18 individuals with chronic aphasia were examined during 12 weeks of…

  13. Outcome of Youth with Early-Phase Schizophrenia-Spectrum Disorders and Psychosis Not Otherwise Specified Treated with Second-Generation Antipsychotics: 12 Week Results from a Prospective, Naturalistic Cohort Study

    PubMed Central

    Vernal, Ditte L.; Kapoor, Sandeep; Al-Jadiri, Aseel; Sheridan, Eva M.; Borenstein, Yehonathan; Mormando, Charles; David, Lisa; Singh, Sukhbir; Seidman, Andrew J.; Carbon, Maren; Gerstenberg, Miriam; Saito, Ema; Kane, John M.; Steinhausen, Hans-Christoph

    2015-01-01

    Abstract Objectives: The purpose of this study was to assess differences in the outcomes of youth with schizophrenia-spectrum disorders (SCZ-S) and psychotic disorder not otherwise specified (PsyNOS) during early antipsychotic treatment. Methods: The study was a prospective, naturalistic, inception cohort study of youth ≤19 years old with SCZ-S (schizophrenia, schizoaffective disorder, schizophreniform disorder) or PsyNOS (PsyNOS, brief psychotic disorder) and ≤24 months of lifetime antipsychotic treatment receiving clinician's choice antipsychotic treatment. Baseline demographic, illness and treatment variables, and effectiveness outcomes were compared at 12 weeks last-observation-carried-forward across SCZ-S and PsyNOS patients, adjusting for significantly different baseline variables. Results: Altogether, 130 youth with SCZ-S (n=42) or PsyNOS (n=88), mostly antipsychotic naïve (76.9%), were prescribed risperidone (47.7%), olanzapine (19.2%), aripiprazole (14.6%), quetiapine (11.5%), or ziprasidone (6.9%). Compared with those with PsyNOS, SCZ-S youth were older (16.4±2.1 vs. 14.8±3.2, p=0.0040), and less likely to be Caucasian (19.1% vs. 42.5%, p=0.009). At baseline, SCZ-S patients had significantly higher Clinical Global Impressions-Severity (CGI-S) scores (6.0±0.9 vs. 5.5±0.8, p=0.0018) and lower Children's Global Assessment Scale (CGAS) scores (29.6±9.2 vs. 36.1±8.9, p=0.0002) and were more likely to be in the severely ill CGAS group (i.e., CGAS≤40). SCZ-S and PsyNOS patients did not differ regarding all-cause discontinuation (40.5 vs. 40.3%. p=0.49), discontinuation because of adverse effects (12.2% vs. 12.4%, p=0.97), or nonadherence (29.3% vs. 30.9%, p=0.88), but somewhat more SCZ-S patients discontinued treatment for inefficacy (19.5% vs. 7.4%, p=0.063). CGI-S and CGAS scores improved significantly in both diagnostic groups (p=0.0001, each). Adjusting for baseline differences, PsyNOS patients experienced significantly better CGI-I improvement

  14. FAST CP: protocol of a randomised controlled trial of the efficacy of a 12-week combined Functional Anaerobic and Strength Training programme on muscle properties and mechanical gait deficiencies in adolescents and young adults with spastic-type cerebral palsy

    PubMed Central

    Gillett, Jarred G; Lichtwark, Glen A; Boyd, Roslyn N; Barber, Lee A

    2015-01-01

    Introduction Individuals with cerebral palsy (CP) have muscles that are smaller, weaker and more resistant to stretch compared to typically developing people. Progressive resistance training leads to increases in muscle size and strength. In CP, the benefits of resistance training alone may not transfer to improve other activities such as walking; however, the transfer of strength improvements to improved mobility may be enhanced by performing training that involves specific functional tasks or motor skills. This study aims to determine the efficacy of combined functional anaerobic and strength training in (1) influencing muscle strength, structure and function and (2) to determine if any changes in muscle strength and structure following training impact on walking ability and gross motor functional capacity and performance in the short (following 3 months of training) and medium terms (a further 3 months post-training). Methods and analysis 40 adolescents and young adults with CP will be recruited to undertake a 12-week training programme. The training programme will consist of 3×75 min sessions per week, made up of 5 lower limb resistance exercises and 2–3 functional anaerobic exercises per session. The calf muscles will be specifically targeted, as they are the most commonly impacted muscles in CP and are a key muscle group involved in walking. If, as we believe, muscle properties change following combined strength and functional training, there may be long-term benefits of this type of training in slowing the deterioration of muscle function in people with spastic-type CP. Ethics and dissemination Ethical approval has been obtained from the ethics committees at The University of Queensland (2014000066) and Children's Health Queensland (HREC/15/QRCH/30). The findings will be disseminated by publications in peer-reviewed journals, conferences and local research organisations’ media. Trial registration number Australian and New Zealand Clinical Trials

  15. Efficacy and safety of the oral Janus kinase inhibitor peficitinib (ASP015K) monotherapy in patients with moderate to severe rheumatoid arthritis in Japan: a 12-week, randomised, double-blind, placebo-controlled phase IIb study

    PubMed Central

    Takeuchi, Tsutomu; Tanaka, Yoshiya; Iwasaki, Manabu; Ishikura, Hiroaki; Saeki, Satoshi; Kaneko, Yuichiro

    2016-01-01

    Objective To evaluate the efficacy, safety and dose response of a novel oral Janus kinase inhibitor, peficitinib (ASP015K), as monotherapy in Japanese patients with moderate to severe rheumatoid arthritis (RA). Methods In a 12-week, double-blind study, 281 adult patients with RA with active disease not on concomitant disease-modifying antirheumatic drug therapy were randomised equally to once-daily placebo or peficitinib 25, 50, 100 and 150 mg. The primary endpoint was American College of Rheumatology (ACR) 20 response in the peficitinib treatment groups versus placebo at week 12. Results Mean age was 53.0 years, 81.1% were female and 25.3% had previously used antitumour necrosis factor therapy. Peficitinib 50, 100 and 150 mg each showed statistically significantly higher ACR20 response rates compared with placebo, and response rates increased up to 150 mg with a statistically significant dose response. The total incidence of treatment-emergent adverse events (TEAEs) was similar between the placebo (64.3%) and peficitinib 25, 50, 100 and 150 mg groups (70.9%, 64.9%, 52.7% and 67.2%, respectively). TEAEs occurring more frequently in the peficitinib group compared with the placebo group included nasopharyngitis, increased blood creatine phosphokinase and diarrhoea. No cases of serious infections were reported. Herpes zoster occurred in four patients (two each in peficitinib 25 and 100 mg). Conclusions Treatment with peficitinib as monotherapy for 12 weeks in Japanese patients with moderate to severe RA is efficacious and showed acceptable safety profile. These findings support further developments of peficitinib for RA treatment. Trial registration number NCT01649999; Results. PMID:26672064

  16. Depressor and Anti-Inflammatory Effects of Angiotensin II Receptor Blockers in Metabolic and/or Hypertensive Patients With Coronary Artery Disease: A Randomized, Prospective Study (DIAMOND Study)

    PubMed Central

    Adachi, Sen; Miura, Shin-ichiro; Shiga, Yuhei; Arimura, Tadaaki; Kuwano, Takashi; Kitajima, Ken; Ike, Amane; Sugihara, Makoto; Iwata, Atsushi; Nishikawa, Hiroaki; Morito, Natsumi; Saku, Keijiro

    2016-01-01

    Background We compared the efficacy and safety of azilsartan to those of olmesartan in a prospective, randomized clinical trial. Methods Forty-four hypertensive patients who had coronary artery disease (CAD) were enrolled. We randomly assigned patients to changeover from their prior angiotensin II receptor blockers (ARBs) to either azilsartan or olmesartan, and followed the patients for 12 weeks. Results Office systolic blood pressure (SBP) in the azilsartan group was significantly decreased after 12 weeks. SBP and diastolic blood pressure (DBP) after 12 weeks in the azilsartan group were significantly lower than those in the olmesartan group. The percentage of patients who reached the target BP at 12 weeks (78%) in the azilsartan group was significantly higher than that at 12 weeks (45%) in the olmesartan group. There were no significant changes in pentraxin-3, high-sensitively C-reactive protein or adiponectin in blood after 12 weeks in either group. Although serum levels of creatinine (Cr) in the azilsartan group significantly increased, these changes were within the respective normal range. Conclusion In conclusion, the ability of azilsartan to reduce BP may be superior to that of prior ARBs with equivalent safety in hypertensive patients with CAD.

  17. Depressor and Anti-Inflammatory Effects of Angiotensin II Receptor Blockers in Metabolic and/or Hypertensive Patients With Coronary Artery Disease: A Randomized, Prospective Study (DIAMOND Study)

    PubMed Central

    Adachi, Sen; Miura, Shin-ichiro; Shiga, Yuhei; Arimura, Tadaaki; Kuwano, Takashi; Kitajima, Ken; Ike, Amane; Sugihara, Makoto; Iwata, Atsushi; Nishikawa, Hiroaki; Morito, Natsumi; Saku, Keijiro

    2016-01-01

    Background We compared the efficacy and safety of azilsartan to those of olmesartan in a prospective, randomized clinical trial. Methods Forty-four hypertensive patients who had coronary artery disease (CAD) were enrolled. We randomly assigned patients to changeover from their prior angiotensin II receptor blockers (ARBs) to either azilsartan or olmesartan, and followed the patients for 12 weeks. Results Office systolic blood pressure (SBP) in the azilsartan group was significantly decreased after 12 weeks. SBP and diastolic blood pressure (DBP) after 12 weeks in the azilsartan group were significantly lower than those in the olmesartan group. The percentage of patients who reached the target BP at 12 weeks (78%) in the azilsartan group was significantly higher than that at 12 weeks (45%) in the olmesartan group. There were no significant changes in pentraxin-3, high-sensitively C-reactive protein or adiponectin in blood after 12 weeks in either group. Although serum levels of creatinine (Cr) in the azilsartan group significantly increased, these changes were within the respective normal range. Conclusion In conclusion, the ability of azilsartan to reduce BP may be superior to that of prior ARBs with equivalent safety in hypertensive patients with CAD. PMID:27635180

  18. Invited review: Recommendations for reporting intervention studies on reproductive performance in dairy cattle: Improving design, analysis, and interpretation of research on reproduction.

    PubMed

    Lean, Ian J; Lucy, Matthew C; McNamara, John P; Bradford, Barry J; Block, Elliot; Thomson, Jennifer M; Morton, John M; Celi, Pietro; Rabiee, Ahmad R; Santos, José E P; Thatcher, William W; LeBlanc, Stephen J

    2016-01-01

    Abundant evidence from the medical, veterinary, and animal science literature demonstrates that there is substantial room for improvement of the clarity, completeness, and accuracy of reporting of intervention studies. More rigorous reporting guidelines are needed to improve the quality of data available for use in comparisons of outcomes (or meta-analyses) of multiple studies. Because of the diversity of factors that affect reproduction and the complexity of interactions between these, a systematic approach is required to design, conduct, and analyze basic and applied studies of dairy cattle reproduction. Greater consistency, clarity, completeness, and correctness of design and reporting will improve the value of each report and allow for greater depth of evaluation in meta-analyses. Each of these benefits will improve understanding and application of current knowledge and better identify questions that require additional modeling or primary research. The proposed guidelines and checklist will aid in the design, conduct, analysis, and reporting of intervention studies. We propose an adaptation of the REFLECT (Reporting Guidelines for Randomized Controlled Trials for Livestock and Food Safety) statement to provide guidelines and a checklist specific to reporting intervention studies in dairy cattle reproduction. Furthermore, we provide recommendations that will assist investigators to produce studies with greater internal and external validity that can more often be included in systematic reviews and global meta-analyses. Such studies will also assist the development of models to describe the physiology of reproduction.

  19. Effect of 12-week vanadate and magnesium co-administration on chosen haematological parameters as well as on some indices of iron and copper metabolism and biomarkers of oxidative stress in rats.

    PubMed

    Scibior, Agnieszka; Adamczyk, Agnieszka; Gołębiowska, Dorota; Niedźwiecka, Irmina

    2012-09-01

    Changes in some blood parameters after 12-week administration of sodium metavanadate (SMV; 0.125mgV/ml) or/and magnesium sulphate (MS; 0.06mgMg/ml) in drinking water were studied in outbred male Wistar rats (16 rats/each group) to explore the probable mechanism(s) underlying SMV toxicity and check whether Mg at the level selected during SMV co-administration can protect, at least in part, from a possible deleterious action of SMV. Exposure to SMV alone and in combination with MS (a) led to a decrease in fluid and food intake and body weight gain; (b) predisposed the animals to the development of microcytic-hypochromic anaemia (with excessive liver and spleen Fe deposition, unaltered plasma Fe level and enhanced Zn concentration in the erythrocytes (RBCs) characterized by a reduced haematocrit (Ht) index and haemoglobin (Hb) level, unchanged erythrocyte and reticulocyte count, anisocytosis, lowered total iron binding capacity (TIBC) and elevated transferrin saturation (TS); (c) disturbed Cu homeostasis, but (d) did not influence the leukocyte count and the plasma total antioxidant status (TAS). We suggest that abnormal metabolism and accumulation of Fe as well as an altered Cu status and the RBC Zn level might lead to defective Fe utilization and be a factor promoting the development of Fe-utilization anaemia. The disturbances in the antioxidative capacity reported previously in rats' RBCs after SMV intoxication (Ścibior, Zaporowska, Environ. Toxicol. Pharmacol. 30 (2010) 153-161) may suggest that oxidative stress (OS) could also be, in part, involved in the mechanism responsible for the development of anaemia. The Mg dose ingested in combination with V under SMV-MS co-administration (a) was able to decrease, to some extent, the V concentration in the blood, (b) normalized the RBC Mg and Fe levels and (c) restored the values of some parameters of the Fe status near the control values. These results allow a supposition that a higher Mg dose consumed during SMV

  20. Phonological and Articulation Treatment Approaches in Portuguese Children with Speech and Language Impairments: A Randomized Controlled Intervention Study

    ERIC Educational Resources Information Center

    Lousada, M.; Jesus, Luis M. T.; Capelas, S.; Margaca, C.; Simoes, D.; Valente, A.; Hall, A.; Joffe, V. L.

    2013-01-01

    Background: In Portugal, the routine clinical practice of speech and language therapists (SLTs) in treating children with all types of speech sound disorder (SSD) continues to be articulation therapy (AT). There is limited use of phonological therapy (PT) or phonological awareness training in Portugal. Additionally, at an international level there…

  1. Using Tablet Computers to Increase Patient Engagement With Electronic Personal Health Records: Protocol For a Prospective, Randomized Interventional Study

    PubMed Central

    Magan Mendoza, Yimdriuska; Rosenthal, Jaime; Jacolbia, Ronald; Rajkomar, Alvin; Lee, Herman; Auerbach, Andrew

    2016-01-01

    Background Inadequate patient engagement in care is a major barrier to successful transitions from the inpatient setting and can lead to preventable adverse events after discharge, particularly for older adults. While older adults may be less familiar with mobile devices and applications, they may benefit from focused bedside training to engage them in using their Personal Health Record (PHR). Mobile technologies such as tablet computers can be used in the hospital to help bridge this gap in experience by teaching older, hospitalized patients to actively manage their medication list through their PHR during hospitalization and continue to use their PHR for other post-discharge tasks such as scheduling follow-up appointments, viewing test results, and communicating with providers. Bridging this gap is especially important for older, hospitalized adults as they are at higher risk than younger populations for low engagement in transitions of care and poor outcomes such as readmission. Greater understanding of the advantages and limitations of mobile devices for older adults may be important for improving transitions of care. Objective To better understand the effective use of mobile technologies to improve transitions in care for hospitalized, older adults and leverage these technologies to improve inpatient and postdischarge care for older adults. Methods We will compare an intervention group with tablet-based training to engage effectively with their PHR to a control group also receiving tablets and basic access to their PHR but no additional training on how to engage with their PHR. Results Patient enrollment is ongoing. Conclusions Through this grant, we will further develop our preliminary dataset and practical experience with these mobile technologies to catalyze patient engagement during hospitalization. ClinicalTrial ClinicalTrials.gov NCT02109601; https://clinicaltrials.gov/ct2/show/NCT02109601 (Archived by WebCite at http://www.webcitation.org/6jpXjkwM8) PMID:27599452

  2. Powerful and Cost-Efficient Designs for Longitudinal Intervention Studies with Two Treatment Groups

    ERIC Educational Resources Information Center

    Moerbeek, Mirjam

    2008-01-01

    Three issues need to be decided in the design stage of a longitudinal intervention study: the number of persons, the number of repeated measurements per person, and the duration of the study. The degree to which polynomial effects vary across persons and the drop-out pattern also influence the statistical power to detect intervention effects. This…

  3. Experimental Intervention Studies on Word Problem Solving and Math Disabilities: A Selective Analysis of the Literature

    ERIC Educational Resources Information Center

    Zheng, Xinhua; Flynn, Lindsay J.; Swanson, H. Lee

    2013-01-01

    This article provides a quantitative synthesis of the published literature on word problem solving intervention studies for children with math disabilities (MD). Seven group and eight single-subject design studies met inclusion criteria. Mean effect sizes ("ES"s) for solution accuracy for group design studies were 0.95 (SE = 0.19) for children…

  4. A Replication by Any Other Name: A Systematic Review of Replicative Intervention Studies

    ERIC Educational Resources Information Center

    Cook, Bryan G.; Collins, Lauren W.; Cook, Sara C.; Cook, Lysandra

    2016-01-01

    Replication research is essential to scientific knowledge. Reviews of replication studies often electronically search for "replicat*" as a textword, which does not identify studies that replicate previous research but do not self-identify as such. We examined whether the 83 intervention studies published in six non-categorical research…

  5. A Content and Methodological Review of Self-Advocacy Intervention Studies

    ERIC Educational Resources Information Center

    Test, David W.; Fowler, Catherine H.; Brewer, Denise M.; Wood, Wendy M.

    2005-01-01

    A content and methodological review of the literature of 25 self-advocacy intervention studies was conducted. First, each article was analyzed in terms of purpose, participants, design, dependent variable(s), independent variable(s), and results. Second, each manuscript was reviewed in terms of the quality indicators for single subject (n = 11),…

  6. Bullying and Students with Disabilities: A Systematic Literature Review of Intervention Studies

    ERIC Educational Resources Information Center

    Houchins, David E.; Oakes, Wendy Peia; Johnson, Zachary G.

    2016-01-01

    Bullying is a serious issue affecting the psychological, social, and physical well-being of students. Although a substantial amount of bullying research has been conducted with general education students, there is a paucity of experimental prevention or intervention studies specifically focused on students with disabilities. The aim of this…

  7. The Effect of Teacher Beliefs on Student Competence in Mathematical Modeling--An Intervention Study

    ERIC Educational Resources Information Center

    Mischo, Christoph; Maaß, Katja

    2013-01-01

    This paper presents an intervention study whose aim was to promote teacher beliefs about mathematics and learning mathematics and student competences in mathematical modeling. In the intervention, teachers received written curriculum materials about mathematical modeling. The concept underlying the materials was based on constructivist ideas and…

  8. An Assessment of Treatment Integrity in Behavioral Intervention Studies Conducted with Persons with Mental Retardation

    ERIC Educational Resources Information Center

    Wheeler, John J.; Mayton, Michael R.; Carter, Stacy L.; Chitiyo, Morgan; Menendez, Anthony L.; Huang, Ann

    2009-01-01

    The purpose of this study was to assess the degree to which behavioral intervention studies conducted with persons with mental retardation operationally defined the independent variables and evaluated and reported measures of treatment integrity. The study expands the previous work in this area reported by Gresham, Gansle, and Noell (1993) and…

  9. Treatment Integrity: A Review of Intervention Studies Conducted with Children with Autism

    ERIC Educational Resources Information Center

    Wheeler, John J.; Baggett, Bob A.; Fox, James; Blevins, Leia

    2006-01-01

    The purpose of this study was to assess the degree to which behavioral intervention studies conducted with children diagnosed with autism operationally defined the independent variables (IVs) and evaluated treatment integrity (TI). The study replicated the criteria from Gresham, Gansle, and Noell (1993) and focused exclusively on research studies…

  10. Randomized Trial Comparing Two Treatment Strategies Using Prize-Based Reinforcement of Abstinence in Cocaine and Opiate Users

    ERIC Educational Resources Information Center

    Preston, Kenzie L.; Ghitza, Udi E.; Schmittner, John P.; Schroeder, Jennifer R.; Epstein, David H.

    2008-01-01

    We compared two strategies of prize-based contingency management (CM) in methadone-maintained outpatients. Urine was tested thrice weekly for 5 weeks pre-CM, 12 weeks CM, and 8 weeks post-CM. Participants were randomly assigned to a cocaine contingency (four prize draws for each cocaine-negative urine, N = 29) or an opiate-cocaine contingency (one…

  11. Anti-diabetic and antioxidant effect of cinnamon in poorly controlled type-2 diabetic Iraqi patients: A randomized, placebo-controlled clinical trial

    PubMed Central

    Sahib, Ahmed Salih

    2016-01-01

    Aim: To determine the effect of cinnamon on fasting blood glucose, hemoglobin (Hb) A1c, and oxidative stress markers in poorly controlled type 2 diabetes. Patients and Methods: A total of 25 type 2 diabetic patients of both sexes, aged 49.1 ± 6.0, treated only with hypoglycemic agent sulfonylurea (glibenclamide) were randomly assigned to receive either 1 g of cinnamon or placebo daily for 12 weeks. Results: A highly significant (P ≤ 0.001) reduction (10.12%) of fasting blood glucose level after 6 and 12 weeks of treatment 10.12% and 17.4%, respectively, compared to baseline value and to placebo group at corresponding duration. Meanwhile, the value of glycosylated Hb reduced in cinnamon treated group by (2.625%) and (8.25%) after 6 and 12 weeks, respectively, although this reduction was non-significant compared to baseline value. Concerning the oxidative stress markers, the level of serum glutathione showed highly significant (P ≤ 0.001) elevation after 12 weeks as compared to baseline value and placebo group at corresponding duration, malondialdehyde serum level decreased after treatment of diabetic patients with cinnamon resulted in highly significant (P ≤ 0.001) reduction after 6 and 12 weeks compared to placebo group, but when compared to baseline value, there is a (15%) reduction only after 12 weeks of treatment which was considered highly significant (P ≤ 0.001) change, Finally, administration of cinnamon to diabetic patients for 12 weeks resulted in significant (P ≤ 0.05) elevation of superoxide dismutase level. Conclusion: Intake of 1 g of cinnamon for 12 weeks reduces fasting blood glucose and glycosylated Hb among poorly controlled type 2 diabetes patients, as well as, there is improvement in the oxidative stress markers, indicating the beneficial effect of adjuvant cinnamon as anti-diabetic and antioxidant along with conventional medications to treat poorly controlled type 2 diabetes mellitus. PMID:27104030

  12. Effective weight loss for overweight children: a meta-analysis of intervention studies.

    PubMed

    Snethen, Julia A; Broome, Marion E; Cashin, Susan E

    2006-02-01

    Childhood overweight has increased in the United States. Success of weight-loss programs has been limited (Barlow, S.E., & Dietz, W.H. (1998). Obesity evaluation and treatment: Expert committee recomendations. Pediatrics, 102, e29.). The purpose of this investigation was to systematically examine the effectiveness of weight-loss interventions for children. For this meta-analysis, seven weight-loss intervention studies were coded and quality index scores calculated. The interventions had a significant positive effect on weight-loss average d = 0.95, with a 95% confidence interval of 0.79 to 1.11. Limited interventional studies with effective long-term maintenance of weight loss in children are available in the literature. However, there are effective methods for weight loss in children.

  13. Change over time in alcohol consumption in control groups in brief intervention studies: systematic review and meta-regression study.

    PubMed

    Jenkins, Richard J; McAlaney, John; McCambridge, Jim

    2009-02-01

    Reactivity to assessment has attracted recent attention in the brief alcohol intervention literature. This systematic review sought to examine the nature of change in alcohol consumption over time in control groups in brief intervention studies. Primary studies were identified from existing reviews published in English language, peer-reviewed journals between 1995 and 2005. Change in alcohol consumption and selected study-level characteristics for each primary study were extracted. Consumption change data were pooled in random effects models and meta-regression was used to explore predictors of change. Eleven review papers reported the results of 44 individual studies. Twenty-six of these studies provided data suitable for quantitative study. Extreme heterogeneity was identified and the extent of observed reduction in consumption over time was greater in studies undertaken in Anglophone countries, with single gender study participants, and without special targeting by age. Heterogeneity was reduced but was still substantial in a sub-set of 15 general population studies undertaken in English language countries. The actual content of the control group procedure itself was not predictive of reduction in drinking, nor were a range of other candidate variables including setting, the exclusion of dependent drinkers, the collection of a biological sample at follow-up, and duration of study. Further investigations may yield novel insights into the nature of behaviour change with potential to inform brief interventions design.

  14. Evaluation of the effectiveness of testicular cancer and testicular self-examination training for patient care personnel: intervention study.

    PubMed

    Akar, Serife Zehra; Bebiş, Hatice

    2014-12-01

    Testicular cancer (TC) is the most common malignancy among men aged 15-35 years. Testicular self-examination (TSE) is an important tool for preventing late-stage TC diagnoses. This study aimed to assess health beliefs and knowledge related to TC and TSE and the effectiveness of TC and TSE training for patient care staff in a hospital. This was a prospective, randomized, controlled intervention study. The study included 96 patient care staff divided into two groups of 48 participants each: Group I, the interactive education group, and Group II, the pamphlet education group. The results demonstrated that TSE practice and TC knowledge significantly increased in both Group I and Group II. Significant differences were observed between the groups pre and post education. TSE and TC knowledge levels were higher for participants in Group I than those in Group II. There was a significant difference in the performance of TSEs between groups: the rates were 83.3% in Group I and 54.2% in Group II. Perceived confidence and perceived barriers increased significantly for both groups. Interactive education sessions should be used to train men at risk for TC to perform TSEs. PMID:25248831

  15. Who to target in sudden unexpected death in epilepsy prevention and how? Risk factors, biomarkers, and intervention study designs.

    PubMed

    Tomson, Torbjörn; Surges, Rainer; Delamont, Robert; Haywood, Serena; Hesdorffer, Dale C

    2016-01-01

    The risk of dying suddenly and unexpectedly is increased 24- to 28-fold among young people with epilepsy compared to the general population, but the incidence of sudden unexpected death in epilepsy (SUDEP) varies markedly depending on the epilepsy population. This article first reviews risk factors and biomarkers for SUDEP with the overall aim of enabling identification of epilepsy populations with different risk levels as a background for a discussion of possible intervention strategies. The by far most important clinical risk factor is frequency of generalized tonic-clonic seizures (GTCS), but nocturnal seizures, early age at onset, and long duration of epilepsy have been identified as additional risk factors. Lack of antiepileptic drug (AED) treatment or, in the context of clinical trials, adjunctive placebo versus active treatment is associated with increased risks. Despite considerable research, reliable electrophysiologic (electrocardiography [ECG] or electroencephalography [EEG]) biomarkers of SUDEP risk remain to be established. This is an important limitation for prevention strategies and intervention studies. There is a lack of biomarkers for SUDEP, and until validated biomarkers are found, the endpoint of interventions to prevent SUDEP must be SUDEP itself. These interventions, be they pharmacologic, seizure-detection devices, or nocturnal supervision, require large numbers. Possible methods for assessing prevention measures include public health community interventions, self-management, and more traditional (and much more expensive) randomized clinical trials.

  16. Transcutaneous pulsed radiofrequency treatment for patients with shoulder pain booked for surgery: a double-blind, randomized controlled trial.

    PubMed

    Taverner, Murray; Loughnan, Terence

    2014-02-01

    Shoulder pain is the third most common musculoskeletal problem and accounts for 5% of general practitioner consultations. Although many treatments are described, there is no consensus on optimal treatment and up to 40% of patients still have pain 12 months after initially seeking help for pain. Previously, the effect of transcutaneous pulsed radiofrequency treatment (TCPRFT) was evaluated in a retrospective audit that showed good pain relief for a mean 395 days and justified this randomized sham controlled trial. In this study, 51 patients entered into a randomized double-blinded, placebo controlled study of TCPRFT. Patients were assessed at 4 and 12 weeks by a blinded observer and compared with baseline. We observed sustained reductions in pain at night, pain with activity, and functional improvement at 4 and 12 weeks with active but not sham TCPRFT. The 25 subjects who received active treatment showed statistically significant reductions of 24/100 in pain at night and 20/100 of pain with activity at 4 weeks and 18/100 and 19/100, respectively, at 12 weeks from baseline. Statistically significant lower Brief Pain Inventory pain and function scores (4 and 12 weeks), improved pain self-efficacy (4 weeks), Oxford Shoulder scores (12 weeks), and internal rotation (12 weeks) were seen. Pain at both rest and shoulder elevation were not improved by active treatment. No complications were seen. This study of a simple, low risk, outpatient treatment confirms the findings of our earlier study of TCPRFT for knee pain and shoulder pain audit that transcutaneous pulsed radiofrequency treatment may help some people with painful shoulders.

  17. Pain management in the neonatal piglet during routine management procedures. Part 1: a systematic review of randomized and non-randomized intervention studies.

    PubMed

    Dzikamunhenga, R S; Anthony, R; Coetzee, J; Gould, S; Johnson, A; Karriker, L; McKean, J; Millman, S T; Niekamp, S R; O'Connor, A M

    2014-06-01

    Routine procedures carried out on piglets (i.e. castration, tail docking, teeth clipping, and ear notching) are considered painful. Unfortunately the efficacy of current pain mitigation modalities is poorly understood. The aim of this systematic review was to synthesize the existing primary scientific literature regarding the effectiveness of pain management interventions used for routine procedures on piglets. The review question was, 'In piglets under twenty-eight days old, undergoing castration, tail docking, teeth clipping, and/or methods of identification that involve cutting of the ear tissue, what is the effect of pain mitigation compared with no pain mitigation on behavioral and non-behavioral outcomes that indicate procedural pain and post-procedural pain?' A review protocol was designed a priori. Data sources used were Agricola (EBSCO), CAB Abstracts (Thomson Reuters), PubMed, Web of Science (Thomson Reuters), BIOSIS Previews (Thomson Reuters), and ProQuest Dissertations & Theses Full Text. No restrictions on year of publication or language were placed on the search. Eligible studies assessed an intervention designed to mitigate the pain of the procedures of interest and included a comparison group that did not receive an intervention. Eligible non-English studies were translated using a translation service. Two reviewers independently screened titles and abstracts for relevance using pre-defined questions. Data were extracted from relevant articles onto pre-defined forms. From the 2203 retrieved citations forty publications, containing 52 studies met the eligibility criteria. In 40 studies, piglets underwent castration only. In seven studies, piglets underwent tail docking only. In one study, piglets underwent teeth clipping only, and in one study piglets underwent ear notching only. Three studies used multiple procedures. Thirty-two trial arms assessed general anesthesia protocols, 30 trial arms assessed local anesthetic protocols, and 28 trial arms assessed non-steroidal anti-inflammatory drugs (NSAIDs) protocols. Forty-one trial arms were controls where piglets received either placebo or no treatment. Forty-five outcomes were extracted from the studies, however only the results from studies that assessed cortisol (six studies), β-endorphins (one study), vocalisations (nine studies), and pain-related behaviors (nine studies) are reported. Other outcomes were reported in only one or two studies. Confident decision making will likely be difficult based on this body of work because lack of comprehensive reporting precludes calculation of the magnitude of pain mitigation for most outcomes. PMID:25605277

  18. Ethical complexities of screening for depression and intimate partner violence (IPV) in intervention studies

    PubMed Central

    2011-01-01

    Background Intervention studies for depression and intimate partner violence (IPV) commonly incorporate screening to identify eligible participants. The challenge is that current ethical evaluation is largely informed by the four principle approach applying principles of beneficence, non-maleficence, and respect for justice and autonomy. We examine three intervention studies for IPV, postnatal depression (PND) and depression that used screening from the perspective of principlism, followed by the perspective of a narrative and relational approach. We suggest that a narrative and relational approach to ethics brings to light concerns that principlism can overlook. Discussion The justification most commonly used to incorporate screening is that the potential benefits of identifying intervention efficacy balance the risk of individual harm. However, considerable risks do exist. The discovery of new information may result in further depression or worries, people might feel burdened, open to further risk, unsure of whether to disclose information to family members and disappointed if they are allocated to a control group. This raises questions about study design and whether the principle of equipoise remains an adequate justification in studies with vulnerable groups. In addition, autonomy is said to be respected because participants give informed consent to participate. However, the context of where recruitment is undertaken has been shown to influence how people make decisions. Summary The four principles have been subjected to criticisms in recent years but they remain prominent in public health and medical research. We provide a set of simple, interrogative questions that are narrative and relationally driven which may assist to further evaluate the potential impacts of using screening to identify eligible research participants in intervention studies. A narrative and relational based approach requires seeing people as situated within their social and cultural

  19. Ensuring Treatment Fidelity in a Multi-site Behavioral Intervention Study: Implementing NIH Behavior Change Consortium Recommendations in the SMART Trial

    PubMed Central

    Robb, Sheri L.; Burns, Debra S.; Docherty, Sharron L.; Haase, Joan E.

    2010-01-01

    The Stories and Music for Adolescent/Young Adult Resilience during Transplant (SMART) study (R01NR008583; U10CA098543; U10CA095861) is an ongoing multi-site Children’s Oncology Group randomized clinical trial testing the efficacy of a therapeutic music video intervention for adolescents/young adults (11–24 years of age) with cancer undergoing stem cell transplant. Treatment fidelity strategies from our trial are consistent with the NIH Behavior Change Consortium Treatment Fidelity Workgroup (BCC) recommendations and provide a successful working model for treatment fidelity implementation in a large, multi-site behavioral intervention study. In this paper we summarize 20 specific treatment fidelity strategies used in the SMART trial and how these strategies correspond with NIH BCC recommendations in 5 specific areas: 1) study design, 2) training providers, 3) delivery of treatment, 4) receipt of treatment, and 5) enactment of treatment skills. Increased use and reporting of treatment fidelity procedures is essential in advancing the reliability and validity of behavioral intervention research. The SMART trial provides a strong model for the application of fidelity strategies to improve scientific findings and addresses the absence of published literature illustrating the application of BCC recommendations in behavioral intervention studies. PMID:22012943

  20. The perceived quality of interprofessional teamwork in an intensive care unit: A single centre intervention study.

    PubMed

    Van den Bulcke, Bo; Vyt, Andre; Vanheule, Stijn; Hoste, Eric; Decruyenaere, Johan; Benoit, Dominique

    2016-05-01

    This article describes a study that evaluated the quality of teamwork in a surgical intensive care unit and assessed whether teamwork could be improved significantly through a tailor-made intervention. The quality of teamwork prior to and after the intervention was assessed using the Interprofessional Practice and Education Quality Scales (IPEQS) using the PROSE online diagnostics and documenting system, which assesses three domains of teamwork: organisational factors, care processes, and team members' attitudes and beliefs. Furthermore, team members evaluated strengths and weaknesses of the teamwork through open-ended questions. Information gathered by means of the open questions was used to design a tailor-made 12-week intervention consisting of (1) optimising the existing weekly interdisciplinary meetings with collaborative decision-making and clear communication of goal-oriented actions, including the psychosocial aspects of care; and (2) organising and supporting the effective exchange of information over time between all professions involved. It was found that the intervention had a significant impact on organisational factors and care processes related to interprofessional teamwork for the total group and within all subgroups, despite baseline differences between the subgroups in interprofessional teamwork. In conclusion, teamwork, and more particularly the organisational aspects of interprofessional collaboration and processes of care, can be improved by a tailor-made intervention that takes into account the professional needs of healthcare workers. PMID:27152533

  1. The perceived quality of interprofessional teamwork in an intensive care unit: A single centre intervention study.

    PubMed

    Van den Bulcke, Bo; Vyt, Andre; Vanheule, Stijn; Hoste, Eric; Decruyenaere, Johan; Benoit, Dominique

    2016-05-01

    This article describes a study that evaluated the quality of teamwork in a surgical intensive care unit and assessed whether teamwork could be improved significantly through a tailor-made intervention. The quality of teamwork prior to and after the intervention was assessed using the Interprofessional Practice and Education Quality Scales (IPEQS) using the PROSE online diagnostics and documenting system, which assesses three domains of teamwork: organisational factors, care processes, and team members' attitudes and beliefs. Furthermore, team members evaluated strengths and weaknesses of the teamwork through open-ended questions. Information gathered by means of the open questions was used to design a tailor-made 12-week intervention consisting of (1) optimising the existing weekly interdisciplinary meetings with collaborative decision-making and clear communication of goal-oriented actions, including the psychosocial aspects of care; and (2) organising and supporting the effective exchange of information over time between all professions involved. It was found that the intervention had a significant impact on organisational factors and care processes related to interprofessional teamwork for the total group and within all subgroups, despite baseline differences between the subgroups in interprofessional teamwork. In conclusion, teamwork, and more particularly the organisational aspects of interprofessional collaboration and processes of care, can be improved by a tailor-made intervention that takes into account the professional needs of healthcare workers.

  2. Physical fitness improvements and occupational low-back loading - an exercise intervention study with firefighters.

    PubMed

    Beach, Tyson A C; Frost, David M; McGill, Stuart M; Callaghan, Jack P

    2014-01-01

    The impact of exercise on firefighter job performance and cardiorespiratory fitness has been studied extensively, but its effect on musculoskeletal loading remains unknown. The aim of this study was to contrast the physical fitness and low-back loading outcomes of two groups of firefighters who completed different exercise programmes. Before and after 12 weeks of exercise, subjects performed a physical fitness test battery, the Functional Movement Screen™ (FMS) and simulated job tasks during which peak L4/L5 joint compression and reaction shear forces were quantified using a dynamic biomechanical model. Subjects who exercised exhibited statistically significant improvements (p < 0.05) in body composition, cardiorespiratory fitness, muscular strength, power, endurance and flexibility, but FMS scores and occupational low-back loading measures were not consistently affected. Firefighters who are physically fit are better able to perform essential job duties and avoid cardiac events, but short-term improvements in physical fitness may not necessarily translate into reduced low-back injury risk. PMID:24689834

  3. Improvement in Patient Performance of Skin Self-examinations After Intervention With Interactive Education and Telecommunication Reminders: A Randomized Controlled Study.

    PubMed

    Aneja, Savina; Brimhall, Angela K; Kast, Douglas R; Aneja, Sanjay; Carlson, Diana; Cooper, Kevin D; Bordeaux, Jeremy S

    2012-11-01

    OBJECTIVE To determine if interactive computerized patient education, skin self-examination (SSE) tutorials, and telecommunication reminders could be combined to increase patient performance of SSEs, increase confidence in ability to identify melanoma, and influence individual melanoma risk perception. DESIGN A total of 132 adult participants from our dermatology clinics were enrolled in an interventional study and randomized to a control group or an intervention group. Survey data were collected from all participants on the day of enrollment and 3 months after enrollment. SETTING University Hospitals Case Medical Center outpatient dermatology clinics. PARTICIPANTS English speakers older than 18 years. INTERVENTIONS The intervention group (1) participated in a computer-assisted learning tutorial, (2) took part in a hands-on SSE tutorial, (3) received monthly telecommunication reminders to perform SSEs for 12 weeks, and (4) received a brochure on melanoma detection. The control group received only the brochure on melanoma detection. MAIN OUTCOME MEASURES Self-report of performance of SSEs. Melanoma risk perception and confidence in ability to identify melanoma were secondary considerations. Logistic regressions, controlling for race, age, sex, education, and family history of melanoma, were used to assess the effectiveness of the intervention. RESULTS At the 3-month follow-up, those in the intervention group were more likely to perform SSEs (odds ratio [OR], 2.36; P ≤ .05). In addition, those who participated in the intervention were more likely to report being confident in their ability to identify melanoma during an SSE (OR, 2.72; P ≤ .05). CONCLUSION Computer-assisted patient education used in conjunction with a hands-on SSE tutorial and telecommunication reminders can increase patient performance of SSEs and confidence in the ability to identify melanoma.

  4. Motivation for physical activity and exercise in severe mental illness: A systematic review of intervention studies.

    PubMed

    Farholm, Anders; Sørensen, Marit

    2016-06-01

    There has been increasing interest for research on motivation for physical activity (PA) and exercise among individuals with severe mental illness (SMI). The aim of this systematic review is to summarize findings from all intervention studies on PA or exercise that either include empirical data on motivational constructs or apply motivational techniques/theories in their intervention. Systematic searches of seven databases were conducted from database inception to February 2015. Studies were eligible if they: (i) included participants with SMI, (ii) had PA as part of the intervention, and (iii) reported empirical data on motivational constructs related to PA or incorporated motivational techniques/theory in their intervention. Of the 79 studies that met the inclusion criteria only one had motivation for PA as its main outcome. Nine additional interventions reported empirical data on motivational constructs. Altogether these studies yielded mixed results with respect to change in motivational constructs. Only one of those examined the association between motivation and PA, but found none. Sixty-four studies reported using motivational techniques/theory in their intervention. Motivational interviewing and goal-setting were the most popular techniques. Due to the exploratory nature of most of these studies, findings from intervention studies do not so far give very clear directions for motivational work with the patients. There is an urgent need for a more systematic theory based approach when developing strategies that target to increase engagement in PA among people with SMI.

  5. Coffee Consumption and Oxidative Stress: A Review of Human Intervention Studies.

    PubMed

    Martini, Daniela; Del Bo', Cristian; Tassotti, Michele; Riso, Patrizia; Del Rio, Daniele; Brighenti, Furio; Porrini, Marisa

    2016-01-01

    Research on the potential protective effects of coffee and its bioactives (caffeine, chlorogenic acids and diterpenes) against oxidative stress and related chronic disease risk has been increasing in the last years. The present review summarizes the main findings on the effect of coffee consumption on protection against lipid, protein and DNA damage, as well as on the modulation of antioxidant capacity and antioxidant enzymes in human studies. Twenty-six dietary intervention studies (involving acute and chronic coffee intake) have been considered. Overall, the results suggest that coffee consumption can increase glutathione levels and improve protection against DNA damage, especially following regular/repeated intake. On the contrary, the effects of coffee on plasma antioxidant capacity and antioxidant enzymes, as well as on protein and lipid damage, are unclear following both acute and chronic exposure. The high heterogeneity in terms of type of coffee, doses and duration of the studies, the lack of information on coffee and/or brew bioactive composition, as well as the choice of biomarkers and the methods used for their evaluation, may partially explain the variability observed among findings. More robust and well-controlled intervention studies are necessary for a thorough understanding of the effect of coffee on oxidative stress markers in humans. PMID:27483219

  6. Reporting of results of interventional studies by the information service of the National Institutes of Health

    PubMed Central

    Shamliyan, Tatyana

    2010-01-01

    The Food and Drug Administration Amendments Act of 2007 mandated that sponsors of applicable studies must provide results within one year of study completion. We aimed to analyze the factors associated with reporting of results from interventional studies registered on ClinicalTrials.gov. On May 20, 2010, we retrieved 20 available fields from 57,233 closed studies on the website and identified 31,161 interventional studies that were required to post results. We compared the proportion of studies with results versus studies without results by age, gender, and disease status of participants, by interventions, sponsors, phase of clinical trials, and completion dates. The results of studies were reported for 4.7% of applicable studies, 8% of industry-sponsored studies, 7.5% of Phase II and 6.5% of Phase IV clinical trials, 4.9% of drug studies, and 0% of genetic studies. Withdrawn (n = 486) and suspended (n = 414) interventions did not provide results. The percentage of studies with results varied from 0% to 21% among different sponsors. The first studies with results were completed in 1992. The proportion of studies with results increased over time. Completion dates were not available for 7446 studies. The database does not have fields available to facilitate routine analysis of the rate of compliance with federal law for posting results. The analysis of accuracy of the protocols in relation to the results and publications is not possible without time-consuming evaluation of individual postings and individual publications. PMID:22291502

  7. Vitamin D and muscle strength throughout the life course: a review of epidemiological and intervention studies.

    PubMed

    McCarthy, E K; Kiely, M

    2015-12-01

    The putative role of vitamin D in muscle function and strength throughout the life course is of interest because muscle strength is required for engagement in physical activity at all ages. As vitamin D deficiency is widely reported in the population, especially in countries at high latitude, the potential importance of vitamin D in muscle function throughout life, and the potential impacts on growth and development, participation in physical activity, and effects on skeletal and cardio-metabolic health, comprise an important topic for discussion. This review provides an overview of muscle function and summarises the role of the vitamin D receptor and the proposed molecular mechanisms of action of vitamin D in muscle cells. In addition, the review provides a comprehensive assessment of the clinical evidence surrounding the association between vitamin D and muscle strength. Among adults, particularly older adults, cross-sectional and cohort studies reported a positive association between vitamin D status and muscle strength. These associations have been largely confirmed by intervention studies. Limited research has been carried out in adolescents and children; two cross-sectional studies in adolescents have suggested an association between serum 25-hydroxyvitamin D concentrations and muscle strength. However, the two intervention studies in adolescents have yielded conflicting results. Other than a single observational study, data in young children are very limited and further investigation in under 12-year-olds is warranted.

  8. Reduction of use of latex gloves in food handlers: an intervention study.

    PubMed

    Lee, A; Nixon, R; Frowen, K

    2001-02-01

    Frequent latex glove use is a risk factor for the development of latex allergy. With the increase in latex glove use, latex allergy has become more prevalent. There are a number of occupational groups in which the use of latex gloves is both inappropriate and even hazardous, including food handlers, where the hazard relates particularly to their latex-sensitive customers. The aim of this study was to assess both the use of latex gloves by food handlers and the impact of an intervention study on reducing latex glove use. This was done at the Queen Victoria Market in Melbourne, Australia. We found that 10 out of 30 stalls (33%) used latex gloves, and that following a short education program, this was reduced to 1 stall (3%, p=0.006). The potential to reduce latex glove use by using this intervention study was 93% (95% confidence interval of 54%-100%). We recommend that food handlers be educated during their training, not only about hygiene issues, but also about the appropriate type of glove to wear, in order to prevent both the development of a new occupational group at risk of becoming allergic to latex, but more importantly to protect their latex-sensitive customers. PMID:11205407

  9. Motivation for physical activity and exercise in severe mental illness: A systematic review of intervention studies.

    PubMed

    Farholm, Anders; Sørensen, Marit

    2016-06-01

    There has been increasing interest for research on motivation for physical activity (PA) and exercise among individuals with severe mental illness (SMI). The aim of this systematic review is to summarize findings from all intervention studies on PA or exercise that either include empirical data on motivational constructs or apply motivational techniques/theories in their intervention. Systematic searches of seven databases were conducted from database inception to February 2015. Studies were eligible if they: (i) included participants with SMI, (ii) had PA as part of the intervention, and (iii) reported empirical data on motivational constructs related to PA or incorporated motivational techniques/theory in their intervention. Of the 79 studies that met the inclusion criteria only one had motivation for PA as its main outcome. Nine additional interventions reported empirical data on motivational constructs. Altogether these studies yielded mixed results with respect to change in motivational constructs. Only one of those examined the association between motivation and PA, but found none. Sixty-four studies reported using motivational techniques/theory in their intervention. Motivational interviewing and goal-setting were the most popular techniques. Due to the exploratory nature of most of these studies, findings from intervention studies do not so far give very clear directions for motivational work with the patients. There is an urgent need for a more systematic theory based approach when developing strategies that target to increase engagement in PA among people with SMI. PMID:26916699

  10. Effects of a Brief Early Start Denver Model (ESDM)-Based Parent Intervention on Toddlers at Risk for Autism Spectrum Disorders: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Rogers, Sally J.; Estes, Annette; Lord, Catherine; Vismara, Laurie; Winter, Jamie; Fitzpatrick, Annette; Guo, Mengye; Dawson, Geraldine

    2012-01-01

    Objective: This study was carried out to examine the efficacy of a 12-week, low-intensity (1-hour/wk of therapist contact), parent-delivered intervention for toddlers at risk for autism spectrum disorders (ASD) aged 14 to 24 months and their families. Method: A randomized controlled trial involving 98 children and families was carried out in three…

  11. N-Acetylcysteine in the Treatment of Pediatric Trichotillomania: A Randomized, Double-Blind, Placebo-Controlled Add-On Trial

    ERIC Educational Resources Information Center

    Bloch, Michael H.; Panza, Kaitlyn E.; Grant, Jon E.; Pittenger, Christopher; Leckman, James F.

    2013-01-01

    Objective: To examine the efficacy of N-acetylcysteine (NAC) for the treatment of pediatric trichotillomania (TTM) in a double-blind, placebo-controlled, add-on study. Method: A total of 39 children and adolescents aged 8 to 17 years with pediatric trichotillomania were randomly assigned to receive NAC or matching placebo for 12 weeks. Our primary…

  12. The Impacts of Traffic-Related and Woodsmoke Particulate Matter on Measures of Cardiovascular Health: A HEPA Filter Intervention Study

    PubMed Central

    Kajbafzadeh, Majid; Brauer, Michael; Karlen, Barbara; Carlsten, Chris; van Eeden, Stephan; Allen, Ryan W.

    2016-01-01

    Background Combustion-generated fine particulate matter (PM2.5) is associated with cardiovascular morbidity. Both traffic-related air pollution and residential wood combustion may be important, but few studies have compared their impacts. Objectives To assess and compare effects of traffic-related and woodsmoke PM2.5 on endothelial function and systemic inflammation (C-reactive protein, interleukin-6, and band cells) among healthy adults in Vancouver, British Columbia, Canada using high efficiency particulate air (HEPA) filtration to introduce indoor PM2.5 exposure gradients. Methods We recruited 83 healthy adults from 44 homes in traffic- or woodsmoke-impacted areas to participate in this randomized, single-blind crossover intervention study. PM2.5 concentrations were measured during two consecutive 7-day periods, one with filtration and the other with “placebo filtration”. Endothelial function and biomarkers of systematic inflammation were measured at the end of each 7-day period. Results HEPA filtration was associated with a 40% decrease in indoor PM2.5 concentrations. There was no relationship between PM2.5 exposure and endothelial function. There was evidence of an association between indoor PM2.5 and C-reactive protein among those in traffic-impacted locations [42.1% increase in C-reactive protein per interquartile range increase in indoor PM2.5, 95% CI, 1.2 to 99.5] but not among those in woodsmoke-impacted locations. There were no associations with interleukin-6 or band cells. Conclusions Evidence of an association between C-reactive protein and indoor PM2.5 among healthy adults in traffic-impacted areas is consistent with the hypothesis that traffic-related particles, even at relatively low concentrations, play an important role in the cardiovascular effects of the urban PM mixture. Trial registered at www.clinicaltrials.gov (NCT01570062) PMID:25896330

  13. Community mobilization and household level waste management for dengue vector control in Gampaha district of Sri Lanka; an intervention study

    PubMed Central

    Abeyewickreme, W; Wickremasinghe, A R; Karunatilake, K; Sommerfeld, Johannes; Kroeger, Axel

    2012-01-01

    Introduction Waste management through community mobilization to reduce breeding places at household level could be an effective and sustainable dengue vector control strategy in areas where vector breeding takes place in small discarded water containers. The objective of this study was to assess the validity of this assumption. Methods An intervention study was conducted from February 2009 to February 2010 in the populous Gampaha District of Sri Lanka. Eight neighborhoods (clusters) with roughly 200 houses each were selected randomly from high and low dengue endemic areas; 4 of them were allocated to the intervention arm (2 in the high and 2 in the low endemicity areas) and in the same way 4 clusters to the control arm. A baseline household survey was conducted and entomological and sociological surveys were carried out simultaneously at baseline, at 3 months, at 9 months and at 15 months after the start of the intervention. The intervention programme in the treatment clusters consisted of building partnerships of local stakeholders, waste management at household level, the promotion of composting biodegradable household waste, raising awareness on the importance of solid waste management in dengue control and improving garbage collection with the assistance of local government authorities. Results The intervention and control clusters were very similar and there were no significant differences in pupal and larval indices of Aedes mosquitoes. The establishment of partnerships among local authorities was well accepted and sustainable; the involvement of communities and households was successful. Waste management with the elimination of the most productive water container types (bowls, tins, bottles) led to a significant reduction of pupal indices as a proxy for adult vector densities. Conclusion The coordination of local authorities along with increased household responsibility for targeted vector interventions (in our case solid waste management due to the type of

  14. An intervention study examining the effects of condom wrapper graphics and scent on condom use in the Botswana Defence Force.

    PubMed

    Tran, Bonnie Robin; Thomas, Anne Goldzier; Vaida, Florin; Ditsela, Mooketsi; Phetogo, Robert; Kelapile, David; Haubrich, Richard; Chambers, Christina; Shaffer, Richard

    2014-01-01

    Free condoms provided by the government are often not used by Botswana Defence Force (BDF) personnel due to a perceived unpleasant scent and unattractive wrapper. Formative work with the BDF found that scented condoms and military-inspired (camouflage) wrapper graphics were appealing to personnel. A non-randomized intervention study was implemented to determine whether condom wrapper graphics and scent improved condom use in the BDF. Four military sites were selected for participation. Two sites in the south received the intervention condom wrapped in a generic wrapper and two sites in the north received the intervention condom wrapped in a military-inspired wrapper; intervention condoms were either scented or unscented. Two hundred and eleven male soldiers who ever had sex, aged 18-30 years, and stationed at one of the selected sites consented to participate. Sexual activity and condom use were measured pre- and post-intervention using sexual behavior diaries. A condom use rate (CUR; frequency of protected sex divided by the total frequency of sex) was computed for each participant. Mean CURs significantly increased over time (85.7% baseline vs. 94.5% post-intervention). Adjusted odds of condom use over time were higher among participants who received the intervention condom packaged in the military wrapper compared with the generic wrapper. Adjusted odds of condom use were also higher for participants who reported using scented vs. unscented condoms. Providing scented condoms and condoms packaged in a military-inspired wrapper may help increase condom use and reduce HIV infection among military personnel.

  15. Community-centred eco-bio-social approach to control dengue vectors: an intervention study from Myanmar

    PubMed Central

    Wai, Khin Thet; Htun, Pe Than; Oo, Tin; Myint, Hla; Lin, Zaw; Kroeger, Axel; Sommerfeld, Johannes; Petzold, Max

    2012-01-01

    Objectives To build up and analyse the feasibility, process, and effectiveness of a partnership-driven ecosystem management intervention in reducing dengue vector breeding and constructing sustainable partnerships among multiple stakeholders. Methods A community-based intervention study was conducted from May 2009 to January 2010 in Yangon city. Six high-risk and six low-risk clusters were randomized and allocated as intervention and routine service areas, respectively. For each cluster, 100 households were covered. Bi-monthly entomological evaluations (i.e. larval and pupal surveys) and household acceptability surveys at the end of 6-month intervention period were conducted, supplemented by qualitative evaluations. Intervention description The strategies included eco-friendly multi-stakeholder partner groups (Thingaha) and ward-based volunteers, informed decision-making of householders, followed by integrated vector management approach. Findings Pupae per person index (PPI) decreased at the last evaluation by 5.7% (0.35–0.33) in high-risk clusters. But in low-risk clusters, PPI remarkably decreased by 63.6% (0.33–0.12). In routine service area, PPI also decreased due to availability of Temephos after Cyclone Nargis. As for total number of pupae in all containers, when compared to evaluation 1, there was a reduction of 18.6% in evaluation 2 and 44.1% in evaluation 3 in intervention area. However, in routine service area, more reduction was observed. All intervention tools were found as acceptable, being feasible to implement by multi-stakeholder partner groups. Conclusions The efficacy of community-controlled partnership-driven interventions was found to be superior to the vertical approach in terms of sustainability and community empowerment. PMID:23318238

  16. Trend analysis of nursing intervention studies published by Taiwan nurses association between 1954 and 2006.

    PubMed

    Yang, Hsiao-Ling; Lou, Meei-Fang; Liu, Pei-Ching; Ni, Lee-Fen; Chang, Hao-Yuan; Chen, Yueh-Chih

    2009-06-01

    This study reviewed historical nursing intervention studies in Taiwan and analyzed results based on sample characteristics, methodology characteristics, and content characteristics. Historical studies were split into four groups, G1970, G1980, G1990, and G2000, based on the decade in which they were published. A comparison was then made to identify significant differences between G2000 and other groups. A total of 103 nursing intervention studies were analyzed in this study. Results included sample characteristics of studies conducted primarily by single-disciplinary research teams, although multidisciplinary studies showed a growth trend across decades, with the number of multidisciplinary studies significantly greater in G2000 than in other decades. Nursing practice was the main area of research, clients were the major participants studied, and hospitals provided the principal research setting. No statistical difference was noted in the above mentioned variables. In terms of methodology characteristics, questionnaires were used most frequently to collect data. A quasi-experimental design was the primary research design employed. Although the number of experimental designs has increased significantly in recent years, most studies specified their inclusion criteria. Reliability and validity of instruments were more clearly specified in recent decade groups than in earlier decade groups. Methodology rigor has improved in recent years, achieving a statistically significant difference between G2000 and other groups in all categories, with the exception of instrument validity. In terms of content characteristics, health education was the leading intervention type. Most interventions were categorized as tertiary prevention, with perceptual outcome used most often as the outcome indicator. However, no statistical differences in content dimension variables were identified between G2000 and other groups. In summary, the number of nursing intervention research cases has

  17. Understanding Price Elasticities to Inform Public Health Research and Intervention Studies: Key Issues

    PubMed Central

    Nghiem, Nhung; Genç, Murat; Blakely, Tony

    2013-01-01

    Pricing policies such as taxes and subsidies are important tools in preventing and controlling a range of threats to public health. This is particularly so in tobacco and alcohol control efforts and efforts to change dietary patterns and physical activity levels as a means of addressing increases in noncommunicable diseases. To understand the potential impact of pricing policies, it is critical to understand the nature of price elasticities for consumer products. For example, price elasticities are key parameters in models of any food tax or subsidy that aims to quantify health impacts and cost-effectiveness. We detail relevant terms and discuss key issues surrounding price elasticities to inform public health research and intervention studies. PMID:24028228

  18. Understanding price elasticities to inform public health research and intervention studies: key issues.

    PubMed

    Nghiem, Nhung; Wilson, Nick; Genç, Murat; Blakely, Tony

    2013-11-01

    Pricing policies such as taxes and subsidies are important tools in preventing and controlling a range of threats to public health. This is particularly so in tobacco and alcohol control efforts and efforts to change dietary patterns and physical activity levels as a means of addressing increases in noncommunicable diseases. To understand the potential impact of pricing policies, it is critical to understand the nature of price elasticities for consumer products. For example, price elasticities are key parameters in models of any food tax or subsidy that aims to quantify health impacts and cost-effectiveness. We detail relevant terms and discuss key issues surrounding price elasticities to inform public health research and intervention studies. PMID:24028228

  19. Public Health Under Attack: The American Stop Smoking Intervention Study (ASSIST) and the Tobacco Industry

    PubMed Central

    White, Jenny; Bero, Lisa A.

    2004-01-01

    We describe the tobacco industry’s response to the American Stop Smoking Intervention Study (ASSIST). Tobacco industry documents from the University of California, San Francisco/Legacy Tobacco Documents Library and industry Web sites were analyzed. LexisNexis and the Library of Congress’s Thomas Web site were searched for legislative history. We found that the tobacco industry considered ASSIST a major threat because of its emphasis on policy and creation of local tobacco control infrastructures. The industry mobilized resources for a well-coordinated attack on ASSIST. Although industry executives were sometimes frustrated in their efforts, they ultimately had a chilling effect on ASSIST. This evidence suggest that tobacco control advocates should expect a vigorous response from the tobacco industry to policy advocacy efforts, particularly at the local level. PMID:14759933

  20. Use of miRNAs in biofluids as biomarkers in dietary and lifestyle intervention studies.

    PubMed

    Rome, Sophie

    2015-09-01

    The selection of biomarkers in nutrigenomics needs to reflect subtle changes in homoeostasis representing the relation between nutrition and health, or nutrition and disease. It is believed that noncoding RNAs, such as circulating microRNAs (miRNAs), may represent such a new class of integrative biomarkers. Until now, the most relevant body fluids for miRNA quantification in response to nutrition have not been clearly defined, but recent studies listed in this review indicate that miRNAs from plasma or serum, PBMC and faeces might be relevant biomarkers to quantify the physiological impacts of dietary or lifestyle intervention studies. In addition, a number of recent studies also indicate that miRNAs could permit to monitor the impact of diet on gut microbiota. We also discuss the main preanalytical considerations that are important to take into account before miRNA screening which can affect the reproducibility of the data.

  1. Development of immune organs and functioning in humans and test animals: Implications for immune intervention studies.

    PubMed

    Kuper, C Frieke; van Bilsen, Jolanda; Cnossen, Hilde; Houben, Geert; Garthoff, Jossie; Wolterbeek, Andre

    2016-09-01

    A healthy immune status is mostly determined during early life stages and many immune-related diseases may find their origin in utero and the first years of life. Therefore, immune health optimization may be most effective during early life. This review is an inventory of immune organ maturation events in relation to developmental timeframes in minipig, rat, mouse and human. It is concluded that time windows of immune organ development in rodents can be translated to human, but minipig reflects the human timeframes better; however the lack of prenatal maternal-fetal immune interaction in minipig may cause less responsiveness to prenatal intervention. It is too early to conclude which immune parameters are most appropriate, because there are not enough comparative immune parameters. Filling these gaps will increase the predictability of results observed in experimental animals, and guide future intervention studies by assessing relevant parameters in the right corresponding developmental time frames.

  2. A water-based training program that includes perturbation exercises improves speed of voluntary stepping in older adults: a randomized controlled cross-over trial.

    PubMed

    Elbar, Ori; Tzedek, Irit; Vered, Elisha; Shvarth, Gali; Friger, Michael; Melzer, Itshak

    2013-01-01

    This study evaluated the effects of a water exercise training program that includes perturbation exercises (WEP) to improve the speed of voluntary stepping reaction in older adults. Speed of voluntary stepping considered as an important skill to prevent a fall when balance is lost. In a single-blinded randomized controlled trial with a crossover design thirty-six independent old adults (64-88 years old) were divided into two groups. Group A received WEP for the first 12 weeks, followed by no intervention for the second 12 weeks. Group B did not receive intervention for the first 12 weeks and received WEP for the second 12 weeks. Voluntary Step Execution Test and postural stability in upright standing (eyes open and closed conditions) were measured at baseline, 12 weeks, and 24 weeks. A significant interaction effect between group and time was found for the step execution, due to improvement in initiation phase and swing phase durations in the WEP group. Also significant improvement in postural stability parameters in eyes open and closed conditions is noted. The present results indicate that the primary benefit of WEP that include perturbations to induce stepping, was a reduction in voluntary stepping times. The WEP generalized to a better control of balance in up-right standing. PMID:22951028

  3. A water-based training program that includes perturbation exercises improves speed of voluntary stepping in older adults: a randomized controlled cross-over trial.

    PubMed

    Elbar, Ori; Tzedek, Irit; Vered, Elisha; Shvarth, Gali; Friger, Michael; Melzer, Itshak

    2013-01-01

    This study evaluated the effects of a water exercise training program that includes perturbation exercises (WEP) to improve the speed of voluntary stepping reaction in older adults. Speed of voluntary stepping considered as an important skill to prevent a fall when balance is lost. In a single-blinded randomized controlled trial with a crossover design thirty-six independent old adults (64-88 years old) were divided into two groups. Group A received WEP for the first 12 weeks, followed by no intervention for the second 12 weeks. Group B did not receive intervention for the first 12 weeks and received WEP for the second 12 weeks. Voluntary Step Execution Test and postural stability in upright standing (eyes open and closed conditions) were measured at baseline, 12 weeks, and 24 weeks. A significant interaction effect between group and time was found for the step execution, due to improvement in initiation phase and swing phase durations in the WEP group. Also significant improvement in postural stability parameters in eyes open and closed conditions is noted. The present results indicate that the primary benefit of WEP that include perturbations to induce stepping, was a reduction in voluntary stepping times. The WEP generalized to a better control of balance in up-right standing.

  4. Randomized Polypill Crossover Trial in People Aged 50 and Over

    PubMed Central

    Wald, David S.; Morris, Joan K.; Wald, Nicholas J.

    2012-01-01

    Background A Polypill is proposed for the primary prevention of cardiovascular disease in people judged to be at risk on account of their age alone. Its efficacy in reducing cholesterol and blood pressure is uncertain. Methods We conducted a randomized double-blind placebo-controlled crossover trial of a Polypill among individuals aged 50+ without a history of cardiovascular disease and compared the reductions with those predicted from published estimates of the effects of the individual drugs. Participants took the Polypill (amlodipine 2.5 mg, losartan 25 mg, hydrochlorothiazide 12.5 mg and simvastatin 40 mg) each evening for 12 weeks and a placebo each evening for 12 weeks in random sequence. The mean within-person differences in blood pressure and low density lipoprotein (LDL) cholesterol at the end of each 12 week period were determined. Results 84 out of 86 participants completed both treatment periods. The mean systolic blood pressure was reduced by 17.9 mmHg (95% CI, 15.7–20.1) on the Polypill, diastolic blood pressure by 9.8 mmHg (8.1–11.5), and LDL cholesterol by 1.4 mmol/L (1.2–1.6), reductions of 12%, 11%, and 39% respectively. The results were almost identical to those predicted; 18.4 mmHg, 9.7 mmHg, and 1.4 mmol/L respectively. Conclusion The Polypill resulted in the predicted reductions in blood pressure and LDL cholesterol. Long term reductions of this magnitude would have a substantial effect in preventing heart attacks and strokes. Trial Registration Controlled-Trials.com ISRCTN36672232 PMID:22815989

  5. Do patients adhere to over-the-counter artemisinin combination therapy for malaria? evidence from an intervention study in Uganda

    PubMed Central

    2012-01-01

    Background Increasing affordability of artemisinin combination therapy (ACT) in the African retail sector could be critical to expanding access to effective malaria treatment, but must be balanced by efforts to protect the efficacy of these drugs. Previous research estimates ACT adherence rates among public sector patients, but adherence among retail sector purchasers could differ substantially. This study aimed to estimate adherence rates to subsidized, over-the-counter ACT in rural Uganda. Methods An intervention study was conducted with four licensed drug shops in Eastern Uganda in December 2009. Artemether-lumefantrine (AL) was made available for sale at a 95% subsidy over-the counter. Customers completed a brief survey at the time of purchase and then were randomly assigned to one of three study arms: no follow-up, follow-up after two days or follow-up after three days. Surveyors recorded the number of pills remaining through blister pack observation or through self-report if the pack was unavailable. The purpose of the three-day follow-up arm was to capture non-adherence in the sense of an incomplete treatment course ("under-dosing"). The purpose of the two-day follow-up arm was to capture whether participants completed the full course too soon ("over-dosing"). Results Of the 106 patients in the two-day follow-up sample, 14 (13.2%) had finished the entire treatment course by the second day. Of the 152 patients in the three-day follow-up sample, 49 (32.2%) were definitely non-adherent, three (2%) were probably non-adherent and 100 (65.8%) were probably adherent. Among the 52 who were non-adherent, 31 (59.6%) had more than a full day of treatment remaining. Conclusions Overall, adherence to subsidized ACT purchased over-the-counter was found to be moderate. Further, a non-trivial fraction of those who complete treatment are taking the full course too quickly. Strategies to increase adherence in the retail sector are needed in the context of increasing

  6. The effect of a school-based educational intervention on menstrual health: an intervention study among adolescent girls in Bangladesh

    PubMed Central

    Haque, Syed Emdadul; Rahman, Mosiur; Itsuko, Kawashima; Mutahara, Mahmuda; Sakisaka, Kayako

    2014-01-01

    Objectives To assess the impact of a school-based menstrual education programme on: (1) menstrual knowledge, beliefs and practices, (2) menstrual disorders experienced, and (3) restrictions on menstruating adolescents. Design Intervention study. Setting Araihazar area, Bangladesh. Participants 416 adolescent female students aged 11–16 years, in grade 6–8, and living with their parents. Interventions A school-based health education study conducted from April 2012 to April 2013. Primary and secondary outcome measures We randomly selected 3 of 26 high schools in the study area. We delivered 6 months of educational intervention by trained (by an obstetrician and gynaecologist) research assistants (RAs) on menstrual hygiene among school girls. RAs read the questionnaire and participants answered. The changes in knowledge, beliefs and practices regarding menstruation, menstrual disorders experienced, and the restrictions and behaviours practiced by menstruating adolescents were compared between the baseline and the follow-up assessments. Results After health education, participants reported a significant improvement (p<0.001) in ‘high knowledge and beliefs’ scores compared to baseline (51% vs 82.4%). Significant improvement was also observed in overall good menstrual practices (28.8% vs 88.9%), including improvements in using sanitary pads (22.4% change after the intervention), frequency of changing pads/cloths per day (68.8%), drying the used absorbent (77.6%), methods of disposing of the used absorbent (25.5%), and cleaning of genitalia (19.2%). During the follow-up, the participants reported significant improvements in the regularity of their menstrual cycle (94.5% vs 99.5%) and fewer complications during menstruation (78.6% vs 59.6%). Conclusions The programme produced significant changes in the knowledge, beliefs and practices of menstrual hygiene, complications from lack of hygiene, and the behaviour and restrictions of the menstruating adolescents

  7. Impact of pedometer-based walking on menopausal women's sleep quality: a randomized controlled trial.

    PubMed

    Tadayon, M; Abedi, P; Farshadbakht, F

    2016-08-01

    Objective Sleep disturbances are one of the most common psycho-physiological issues among postmenopausal women. This study was designed to evaluate the impact of walking with a pedometer on the sleep quality of postmenopausal Iranian women. Methods This randomized, controlled trial was conducted on 112 women who were randomly assigned to two groups. The women in the intervention group (n = 56) were asked to walk with a pedometer each day for 12 weeks and to increase their walking distance by 500 steps per week. A sociodemographic instrument and the Pittsburgh Sleep Quality Index were used to collect data. Sleep quality was measured at baseline, 4, 8, and 12 weeks after intervention. The control group (n = 56) did not receive any intervention. Results After 12 weeks, subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction improved to a significantly greater extent in the intervention group than in the control group (p < 0.05). The total sleep quality score was significantly higher in the intervention group than in the control group (0.64 vs. 0.98, p = 0.001). Conclusion This study showed that walking with a pedometer is an easy and cost-effective way to improve the quality of sleep among postmenopausal women. Use of this method in public health centers is recommended.

  8. Impact of pedometer-based walking on menopausal women's sleep quality: a randomized controlled trial.

    PubMed

    Tadayon, M; Abedi, P; Farshadbakht, F

    2016-08-01

    Objective Sleep disturbances are one of the most common psycho-physiological issues among postmenopausal women. This study was designed to evaluate the impact of walking with a pedometer on the sleep quality of postmenopausal Iranian women. Methods This randomized, controlled trial was conducted on 112 women who were randomly assigned to two groups. The women in the intervention group (n = 56) were asked to walk with a pedometer each day for 12 weeks and to increase their walking distance by 500 steps per week. A sociodemographic instrument and the Pittsburgh Sleep Quality Index were used to collect data. Sleep quality was measured at baseline, 4, 8, and 12 weeks after intervention. The control group (n = 56) did not receive any intervention. Results After 12 weeks, subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction improved to a significantly greater extent in the intervention group than in the control group (p < 0.05). The total sleep quality score was significantly higher in the intervention group than in the control group (0.64 vs. 0.98, p = 0.001). Conclusion This study showed that walking with a pedometer is an easy and cost-effective way to improve the quality of sleep among postmenopausal women. Use of this method in public health centers is recommended. PMID:26757356

  9. Effects of Light Intensity Activity on CVD Risk Factors: A Systematic Review of Intervention Studies

    PubMed Central

    Batacan, Romeo B.; Duncan, Mitch J.; Dalbo, Vincent J.; Tucker, Patrick S.; Fenning, Andrew S.

    2015-01-01

    The effects of light intensity physical activity (LIPA) on cardiovascular disease (CVD) risk factors remain to be established. This review summarizes the effects of LIPA on CVD risk factors and CVD-related markers in adults. A systematic search of four electronic databases (PubMed, Academic Search Complete, SPORTDiscus, and CINAHL) examining LIPA and CVD risk factors (body composition, blood pressure, glucose, insulin, glycosylated hemoglobin, and lipid profile) and CVD-related markers (maximal oxygen uptake, heart rate, C-reactive protein, interleukin-6, tumor necrosis factor-alpha, and tumor necrosis factor receptors 1 and 2) published between 1970 and 2015 was performed on 15 March 2015. A total of 33 intervention studies examining the effect of LIPA on CVD risk factors and markers were included in this review. Results indicated that LIPA did not improve CVD risk factors and CVD-related markers in healthy individuals. LIPA was found to improve systolic and diastolic blood pressure in physically inactive populations with a medical condition. Reviewed studies show little support for the role of LIPA to reduce CVD risk factors. Many of the included studies were of low to fair study quality and used low doses of LIPA. Further studies are needed to establish the value of LIPA in reducing CVD risk. PMID:26543862

  10. Effects of Light Intensity Activity on CVD Risk Factors: A Systematic Review of Intervention Studies.

    PubMed

    Batacan, Romeo B; Duncan, Mitch J; Dalbo, Vincent J; Tucker, Patrick S; Fenning, Andrew S

    2015-01-01

    The effects of light intensity physical activity (LIPA) on cardiovascular disease (CVD) risk factors remain to be established. This review summarizes the effects of LIPA on CVD risk factors and CVD-related markers in adults. A systematic search of four electronic databases (PubMed, Academic Search Complete, SPORTDiscus, and CINAHL) examining LIPA and CVD risk factors (body composition, blood pressure, glucose, insulin, glycosylated hemoglobin, and lipid profile) and CVD-related markers (maximal oxygen uptake, heart rate, C-reactive protein, interleukin-6, tumor necrosis factor-alpha, and tumor necrosis factor receptors 1 and 2) published between 1970 and 2015 was performed on 15 March 2015. A total of 33 intervention studies examining the effect of LIPA on CVD risk factors and markers were included in this review. Results indicated that LIPA did not improve CVD risk factors and CVD-related markers in healthy individuals. LIPA was found to improve systolic and diastolic blood pressure in physically inactive populations with a medical condition. Reviewed studies show little support for the role of LIPA to reduce CVD risk factors. Many of the included studies were of low to fair study quality and used low doses of LIPA. Further studies are needed to establish the value of LIPA in reducing CVD risk. PMID:26543862

  11. A carnosine intervention study in overweight human volunteers: bioavailability and reactive carbonyl species sequestering effect

    NASA Astrophysics Data System (ADS)

    Regazzoni, Luca; de Courten, Barbora; Garzon, Davide; Altomare, Alessandra; Marinello, Cristina; Jakubova, Michaela; Vallova, Silvia; Krumpolec, Patrik; Carini, Marina; Ukropec, Jozef; Ukropcova, Barbara; Aldini, Giancarlo

    2016-06-01

    Carnosine is a natural dipeptide able to react with reactive carbonyl species, which have been recently associated with the onset and progression of several human diseases. Herein, we report an intervention study in overweight individuals. Carnosine (2 g/day) was orally administered for twelve weeks in order to evaluate its bioavailability and metabolic fate. Two carnosine adducts were detected in the urine samples of all subjects. Such adducts are generated from a reaction with acrolein, which is one of the most toxic and reactive compounds among reactive carbonyl species. However, neither carnosine nor adducts have been detected in plasma. Urinary excretion of adducts and carnosine showed a positive correlation although a high variability of individual response to carnosine supplementation was observed. Interestingly, treated subjects showed a significant decrease in the percentage of excreted adducts in reduced form, accompanied by a significant increase of the urinary excretion of both carnosine and carnosine-acrolein adducts. Altogether, data suggest that acrolein is entrapped in vivo by carnosine although the response to its supplementation is possibly influenced by individual diversities in terms of carnosine dietary intake, metabolism and basal production of reactive carbonyl species.

  12. Intervention study on cardiac autonomic nervous effects of methylmercury from seafood.

    PubMed

    Yaginuma-Sakurai, Kozue; Murata, Katsuyuki; Shimada, Miyuki; Nakai, Kunihiko; Kurokawa, Naoyuki; Kameo, Satomi; Satoh, Hiroshi

    2010-01-01

    To scrutinize whether the provisional tolerable weekly intake (PTWI, 3.4 microg/kg body weight/week) of methylmercury in Japan is safe for adults, we conducted an intervention study using heart rate variability (HRV) that has been considered to reflect cardiac events. Fifty-four healthy volunteers were recruited and divided into experimental and control groups. The experimental group was exposed to methylmercury at the PTWI level through consumption of bigeye tuna and swordfish for 14 weeks, and HRV parameters were compared between the two groups. In the experimental group, mean hair mercury levels, determined before and after the dietary methylmercury exposure and after 15-week wash-out period following the cessation of exposure, were 2.30, 8.76 and 4.90 microg/g, respectively. The sympathovagal balance index of HRV was significantly elevated after the exposure, and decreased to the baseline level at the end of this study. Still, such changes in HRV parameters were not found in the control group with a mean hair mercury level of around 2.1 microg/g. In conclusion, the PTWI does not appear to be safe for adult health, because methylmercury exposure from fish consumption induced a temporary sympathodominant state. Rather, long-term exposure to methylmercury may pose a potential risk for cardiac events involving sympathovagal imbalance among fish-consuming populations. PMID:19732823

  13. Workplace restructurings in intervention studies – a challenge for design, analysis and interpretation

    PubMed Central

    Olsen, Ole; Albertsen, Karen; Nielsen, Martin Lindhardt; Poulsen, Kjeld Børge; Gron, Sisse Malene Frydendal; Brunnberg, Hans Lennart

    2008-01-01

    Background Interventions in occupational health often target worksites rather than individuals. The objective of this paper is to describe the (lack of) stability in units of analysis in occupational health and safety intervention projects directed toward worksites. Methods A case study approach is used to describe naturally occurring organizational changes in four, large, Nordic intervention projects that ran 3–5 years, covered 3–52 worksites, cost 0.25 mill–2.2 mill €, and involved 3–7 researchers. Results In all four cases, high rates of closing, merging, moving, downsizing or restructuring was observed, and in all four cases at least one company/worksite experienced two or more re-organizations during the project period. If individual worksites remained, ownership or (for publicly owned) administrative or legal base often shifted. Forthcoming closure led employees and managers to seek employment at other worksites participating in the studies. Key employees involved in the intervention process often changed. Conclusion Major changes were the rule rather than the exception. Frequent fundamental changes at worksites need to be taken into account when planning intervention studies and raises serious questions concerning design, analyses and interpretation of results. The frequent changes may also have deleterious implications for the potential effectiveness of many real life interventions directed toward worksites. We urge researchers and editors to prioritize this subject in order to improve the quality of future intervention research and preventive action. PMID:18554380

  14. Use of Free-standing Filters in an Asthma Intervention Study

    PubMed Central

    Batterman, Stuart; Du, Liuliu; Parker, Edith; Robins, Thomas; Lewis, Toby; Mukherjee, Bhramar; Ramirez, Erminia; Rowe, Zachary; Brakefield-Caldwell, Wilma

    2014-01-01

    This study characterizes the use of HEPA air filters provided to 89 households participating in an intervention study investigating the respiratory health of children with asthma. Freestanding filters were placed in the child's bedroom and monitored continuously for nearly a year in each household. Filter use was significantly affected by study phase, season and monitoring week. During the “intensive” weeks when a community education worker and a field technician visited the household, the use rate averaged 70±33%. During season-long “non-intensive” periods between seasonal visits, use dropped to 34±30%. Filter use rapidly decreased during the 3 to 4 weeks following each intensive, was slightly higher in spring, summer, and in the evening and at night when the child was likely to be home, although households did not follow consistent diurnal patterns. While participants expressed an understanding of the benefits of filter use and reported good experiences with them, use rates were low, particularly during unobserved non-intensive periods. The provision of freestanding air filters to individuals or households must be considered an active intervention that requires monitoring and evaluation, otherwise unknown and unexpected patterns of filter use may alter and possibly bias results due to exposure misclassification. PMID:24436726

  15. A multicenter, non-interventional study to evaluate patient-reported experiences of living with psoriasis

    PubMed Central

    Pariser, David; Schenkel, Brad; Carter, Chureen; Farahi, Kamyar; Brown, T. Michelle; Ellis, Charles N.

    2016-01-01

    Abstract Background: Moderate to severe plaque psoriasis (with or without psoriatic arthritis) places significant burden on patients’ lives. Objective: Explore and document patients’ experiences of living with psoriasis, including symptoms, treatments, impact on daily lives and patient-reported functioning. Methods: In a US-based, non-interventional study, narrative interviews were conducted at baseline and again within 16 weeks. In interviews, patients with moderate to severe psoriasis indicated symptoms, ranked symptoms according to level of bother and indicated areas of their lives affected by psoriasis. Transcripts of interviews were coded for themes. Measurements of psoriasis severity including BSA, PGA and PASI were recorded. Results: Symptoms reported most frequently included flaking/scaling (non-scalp areas), itching/scratching and rash, while the most bothersome symptoms were itching/scratching, flaking/scaling (non-scalp areas) and skin pain. Frequently reported impact areas were social and emotional. Conclusion: Broad-reaching interviews with patients with psoriasis show that these patients suffer in many aspects of their lives and in ways not indicated by typical psoriasis severity measures. Patients with psoriatic arthritis reported symptoms and disease-related complications at higher rates than those without arthritis. Physicians’ explorations of the effect of psoriasis on patients’ life events could aid in managing these patients. PMID:26138406

  16. Religious communities and HIV prevention: an intervention-study using a human rights-based approach

    PubMed Central

    Paiva, V.; Garcia, J.; Rios, L.F.; Santos, A.O.; Terto, V.; Munõz-Laboy, M.

    2011-01-01

    Religious communities have been a challenge to HIV prevention globally. Focusing on the acceptability component of the right to health, this intervention study examined how local Catholic, Evangelical and Afro-Brazilian religious communities can collaborate to foster young people’s sexual health and ensure their access to comprehensive HIV prevention in their communities in Brazil. This article describes the process of a three-stage sexual health promotion and HIV prevention initiative that used a multicultural human rights approach to intervention. Methods included 27 in-depth interviews with religious authorities on sexuality, AIDS prevention and human rights, and training 18 young people as research-agents, who surveyed 177 youth on the same issues using self-administered questionnaires. The results, analysed using a rights-based perspective on health and the vulnerability framework, were discussed in daylong interfaith workshops. Emblematic of the collaborative process, workshops are the focus of the analysis. Our findings suggest that this human rights framework is effective in increasing inter-religious tolerance and in providing a collective understanding of the sexuality and prevention needs of youth from different religious communities, and also serves as a platform for the expansion of state AIDS programmes based on laical principles. PMID:20373192

  17. Sampling, Recruitment, and Retention in a Bereavement Intervention Study: Experiences from the Living After Loss Project

    PubMed Central

    Caserta, Michael; Utz, Rebecca; Lund, Dale; de Vries, Brian

    2010-01-01

    This paper reports on the sampling and recruitment challenges, as well as the strategies used to address them in the Living After Loss (LAL) project, a bereavement intervention study conducted in Salt Lake City and San Francisco comparing two 14-week group conditions with follow-up. We encountered three major challenges: 1) difficulty determining eligibility for some potential participants who were contacted, 2) locating and recruiting nonwhites, and 3) unavailable phone numbers for approximately one-third of those we attempted to contact. Despite these challenges, we achieved a 42% response rate with a sample size of 328 participants comprising 15% nonwhite. Eighty-five percent of the participants completed all of the follow-up data points. Leading factors in participants’ decisions to join and remain in the study were 1) opportunities to obtain help and support, 2) to potentially help other bereaved individuals, 3) to contribute to research, and 4) their on-going interactions with a professional, empathetic, and culturally sensitive project staff. Effectively focusing recruitment efforts and carefully and systematically training research staff were among the most effective strategies we employed and therefore suggest for those planning similar investigations. PMID:20873532

  18. A carnosine intervention study in overweight human volunteers: bioavailability and reactive carbonyl species sequestering effect

    PubMed Central

    Regazzoni, Luca; de Courten, Barbora; Garzon, Davide; Altomare, Alessandra; Marinello, Cristina; Jakubova, Michaela; Vallova, Silvia; Krumpolec, Patrik; Carini, Marina; Ukropec, Jozef; Ukropcova, Barbara; Aldini, Giancarlo

    2016-01-01

    Carnosine is a natural dipeptide able to react with reactive carbonyl species, which have been recently associated with the onset and progression of several human diseases. Herein, we report an intervention study in overweight individuals. Carnosine (2 g/day) was orally administered for twelve weeks in order to evaluate its bioavailability and metabolic fate. Two carnosine adducts were detected in the urine samples of all subjects. Such adducts are generated from a reaction with acrolein, which is one of the most toxic and reactive compounds among reactive carbonyl species. However, neither carnosine nor adducts have been detected in plasma. Urinary excretion of adducts and carnosine showed a positive correlation although a high variability of individual response to carnosine supplementation was observed. Interestingly, treated subjects showed a significant decrease in the percentage of excreted adducts in reduced form, accompanied by a significant increase of the urinary excretion of both carnosine and carnosine-acrolein adducts. Altogether, data suggest that acrolein is entrapped in vivo by carnosine although the response to its supplementation is possibly influenced by individual diversities in terms of carnosine dietary intake, metabolism and basal production of reactive carbonyl species. PMID:27265207

  19. A Narrative Review of Diabetes Intervention Studies to Explore Diabetes Care Opportunities for Pharmacists.

    PubMed

    Ayadurai, Shamala; Hattingh, H Laetitia; Tee, Lisa B G; Md Said, Siti Norlina

    2016-01-01

    Background. We conducted a review of current diabetes intervention studies in type 2 diabetes and identified opportunities for pharmacists to deliver quality diabetes care. Methods. A search on randomised controlled trials (RCT) on diabetes management by healthcare professionals including pharmacists published between 2010 and 2015 was conducted. Results and Discussion. Diabetes management includes multifactorial intervention which includes seven factors as outlined in diabetes guidelines, namely, glycaemic, cholesterol and blood pressure control, medication, lifestyle, education, and cardiovascular risk factors. Most studies do not provide evidence that the intervention methods used included all seven factors with exception of three RCT which indicated HbA1c (glycated hemoglobin) reduction range of 0.5% to 1.8%. The varied HbA1C reduction suggests a lack of standardised and consistent approach to diabetes care. Furthermore, the duration of most studies was from one month to two years; therefore long term outcomes could not be established. Conclusion. Although pharmacists' contribution towards improving clinical outcomes of diabetes patients was well documented, the methods used to deliver structured, consistent evidence-based care were not clearly stipulated. Therefore, approaches to achieving long term continuity of care are uncertain. An intervention strategy that encompass all seven evidence-based factors will be useful. PMID:27247949

  20. Child development surveillance: intervention study with nurses of the Family Health Strategy1

    PubMed Central

    Reichert, Altamira Pereira da Silva; Collet, Neusa; Eickmann, Sophie Helena; Lima, Marília de Carvalho

    2015-01-01

    Objective: to evaluate the effectiveness of an educational action in child development surveillance performed by nurses working in primary health care. Methods: interventional study with a before-and-after type of design, carried out with 45 nurses and 450 mothers of children under 2 years of age. Initially, it was evaluated the practices and knowledge of nurses on child development surveillance and the mothers were interviewed about these practices. Subsequently, workshops were carried out with nurses and four months later, the knowledge of nurses and the maternal information were reevaluated. Results: after intervention there was significant increase in the frequency of the following aspects: from 73% to 100%, in relation to the practice of nurses of asking the opinion of mothers about their children's development; from 42% to 91%, regarding the use of the systematized instrument of evaluation; from 91% to 100% with respect to guidance to mothers on how to stimulate child development. Conclusions: the intervention contributed to the increase of knowledge of nurses and implementation of child development surveillance, showing the importance of this initiative to improve the quality of child health care. PMID:26487147

  1. Use of Free-standing Filters in an Asthma Intervention Study.

    PubMed

    Batterman, Stuart; Du, Liuliu; Parker, Edith; Robins, Thomas; Lewis, Toby; Mukherjee, Bhramar; Ramirez, Erminia; Rowe, Zachary; Brakefield-Caldwell, Wilma

    2013-12-01

    This study characterizes the use of HEPA air filters provided to 89 households participating in an intervention study investigating the respiratory health of children with asthma. Freestanding filters were placed in the child's bedroom and monitored continuously for nearly a year in each household. Filter use was significantly affected by study phase, season and monitoring week. During the "intensive" weeks when a community education worker and a field technician visited the household, the use rate averaged 70±33%. During season-long "non-intensive" periods between seasonal visits, use dropped to 34±30%. Filter use rapidly decreased during the 3 to 4 weeks following each intensive, was slightly higher in spring, summer, and in the evening and at night when the child was likely to be home, although households did not follow consistent diurnal patterns. While participants expressed an understanding of the benefits of filter use and reported good experiences with them, use rates were low, particularly during unobserved non-intensive periods. The provision of freestanding air filters to individuals or households must be considered an active intervention that requires monitoring and evaluation, otherwise unknown and unexpected patterns of filter use may alter and possibly bias results due to exposure misclassification. PMID:24436726

  2. Development of luciferase tagged brain tumour models in mice for chemotherapy intervention studies.

    PubMed

    Kemper, E M; Leenders, W; Küsters, B; Lyons, S; Buckle, T; Heerschap, A; Boogerd, W; Beijnen, J H; van Tellingen, O

    2006-12-01

    The blood-brain barrier (BBB) is considered one of the major causes for the low efficacy of cytotoxic compounds against primary brain tumours. The aim of this study was to develop intracranial tumour models in mice featuring intact or locally disrupted BBB properties, which can be used in testing chemotherapy against brain tumours. These tumours were established by intracranial injection of suspensions of different tumour cell lines. All cell lines had been transfected with luciferase to allow non-invasive imaging of tumour development using a super-cooled CCD-camera. Following their implantation, tumours developed which displayed the infiltrative, invasive or expansive growth patterns that are also found in primary brain cancer or brain metastases. Contrast-enhanced magnetic resonance imaging showed that the Mel57, K1735Br2 and RG-2 lesions grow without disruption of the BBB, whereas the BBB was leaky in the U87MG and VEGF-A-transfected Mel57 lesions. This was confirmed by immunohistochemistry. Bioluminescence measurements allowed the visualisation of tumour burden already within 4 days after injection of the tumour cells. The applicability of our models for performing efficacy studies was demonstrated in an experiment using temozolomide as study drug. In conclusion, we have developed experimental brain tumour models with partly disrupted, or completely intact BBB properties. In vivo imaging by luciferase allows convenient follow-up of tumour growth and these models will be useful for chemotherapeutic intervention studies.

  3. The healthy building intervention study: Objectives, methods and results of selected environmental measurements

    SciTech Connect

    Fisk, W.J.; Faulkner, D.; Sullivan, D.

    1998-02-17

    To test proposed methods for reducing SBS symptoms and to learn about the causes of these symptoms, a double-blind controlled intervention study was designed and implemented. This study utilized two different interventions designed to reduce occupants` exposures to airborne particles: (1) high efficiency filters in the building`s HVAC systems; and (2) thorough cleaning of carpeted floors and fabric-covered chairs with an unusually powerful vacuum cleaner. The study population was the workers on the second and fourth floors of a large office building with mechanical ventilation, air conditioning, and sealed windows. Interventions were implemented on one floor while the occupants on the other floor served as a control group. For the enhanced-filtration intervention, a multiple crossover design was used (a crossover is a repeat of the experiment with the former experimental group as the control group and vice versa). Demographic and health symptom data were collected via an initial questionnaire on the first study week and health symptom data were obtained each week, for eight additional weeks, via weekly questionnaires. A large number of indoor environmental parameters were measured during the study including air temperatures and humidities, carbon dioxide concentrations, particle concentrations, concentrations of several airborne bioaerosols, and concentrations of several microbiologic compounds within the dust sampled from floors and chairs. This report describes the study methods and summarizes the results of selected environmental measurements.

  4. A Narrative Review of Diabetes Intervention Studies to Explore Diabetes Care Opportunities for Pharmacists

    PubMed Central

    Ayadurai, Shamala; Hattingh, H. Laetitia; Tee, Lisa B. G.; Md Said, Siti Norlina

    2016-01-01

    Background. We conducted a review of current diabetes intervention studies in type 2 diabetes and identified opportunities for pharmacists to deliver quality diabetes care. Methods. A search on randomised controlled trials (RCT) on diabetes management by healthcare professionals including pharmacists published between 2010 and 2015 was conducted. Results and Discussion. Diabetes management includes multifactorial intervention which includes seven factors as outlined in diabetes guidelines, namely, glycaemic, cholesterol and blood pressure control, medication, lifestyle, education, and cardiovascular risk factors. Most studies do not provide evidence that the intervention methods used included all seven factors with exception of three RCT which indicated HbA1c (glycated hemoglobin) reduction range of 0.5% to 1.8%. The varied HbA1C reduction suggests a lack of standardised and consistent approach to diabetes care. Furthermore, the duration of most studies was from one month to two years; therefore long term outcomes could not be established. Conclusion. Although pharmacists' contribution towards improving clinical outcomes of diabetes patients was well documented, the methods used to deliver structured, consistent evidence-based care were not clearly stipulated. Therefore, approaches to achieving long term continuity of care are uncertain. An intervention strategy that encompass all seven evidence-based factors will be useful. PMID:27247949

  5. Benefits of swimming pools in two remote Aboriginal communities in Western Australia: intervention study

    PubMed Central

    Lehmann, Deborah; Tennant, Mary T; Silva, Desiree T; McAullay, Daniel; Lannigan, Francis; Coates, Harvey; Stanley, Fiona J

    2003-01-01

    Objective To determine the health impact of swimming pools built with the aim of improving quality of life and reducing high rates of pyoderma and otitis media. Design Intervention study assessing prevalence of ear disease and skin infections before and at six monthly intervals after opening of swimming pools. Setting Two remote Aboriginal communities in Western Australia. Participants 84 boys and 78 girls aged < 17 years. Main outcome measures Changes in prevalence and severity of pyoderma and perforation of tympanic membranes with or without otorrhoea over 18 months after opening of pools. Results In community A, 61 children were seen before the pool was opened, and 41, 46, and 33 children were seen at the second, third, and fourth surveys. Equivalent figures for community B were 60, 35, 39, and 45. Prevalence of pyoderma declined significantly from 62% to 18% in community A and from 70% to 20% in community B during the 18 months after the pools opened. Over the same period, prevalence of severe pyoderma fell from 30% to 15% in community A and from 48% to 0% in community B. Prevalence of perforations of the tympanic membrane fell from 32% in both communities to 13% in community A and 18% in community B. School attendance improved in community A. Conclusion Swimming pools in remote communities were associated with reduction in prevalence of pyoderma and tympanic membrane perforations, which could result in long term benefits through reduction in chronic disease burden and improved educational and social outcomes. PMID:12933727

  6. Involvement of informal caregivers in supporting patients with COPD: a review of intervention studies

    PubMed Central

    Bryant, Jamie; Mansfield, Elise; Boyes, Allison W; Waller, Amy; Sanson-Fisher, Rob; Regan, Timothy

    2016-01-01

    Caregivers of individuals with COPD have a key role in maintaining patient adherence and optimizing patient function. However, no systematic review has examined how the caregiver role has been operationalized in interventions to improve outcomes of individuals with COPD or the quality or effectiveness of these interventions. The aims of this review were to 1) determine whether caregivers have been involved as part of interventions to improve outcomes of individuals with COPD; 2) determine the risk of bias within included intervention studies; and 3) examine the effectiveness of interventions that have involved caregivers in improving outcomes of individuals with COPD. The electronic databases of Medline, Embase, PsycINFO, and Cochrane Library were searched from January 2000 to November 2015. Experimental studies testing interventions that involved a caregiver to improve COPD patient outcomes were eligible. Nine studies involving caregivers met inclusion criteria. No studies reported any intervention components targeted solely at caregivers, with most instead including caregivers in dyadic or group education sessions about COPD delivered by health care professionals. The risk of bias identified in included studies was mixed. Seven of the nine studies were effective in improving a broad range of outcomes. These findings highlight that there is an urgent need for methodologically rigorous interventions to examine the effectiveness of strategies to assist caregivers to provide direct care, encourage adherence to health care provider recommendations, act as a health care advocate, and provide emotional and psychosocial support to individuals with COPD. PMID:27478372

  7. A Randomized Clinical Trial of Transdiagnostic CBT for Anxiety Disorder by Comparison to Relaxation Training

    PubMed Central

    Norton, Peter J.

    2012-01-01

    Transdiagnostic cognitive-behavioral treatments for anxiety disorders have been gaining increased attention and empirical study in recent years. Despite this, all of the research on transdiagnostic anxiety treatments to date have either not used a control condition, or have relied on no-treatment or delayed-treatment controls, thus limiting inferences about comparative efficacy. The current study was a randomized clinical trial examining the efficacy of a 12-week transdiagnostic cognitive-behavioral group treatment in comparison to a 12-week comprehensive relaxation training program. Results from 87 treatment initiators suggested significant and statistically equivalent/non-inferior outcomes across conditions, although relaxation was associated with a greater rate of dropout despite no differences in treatment credibility. No evidence was found for any differential effects of transdiagnostic CBT for any primary or comorbid diagnoses. PMID:22697440

  8. School-based humanistic counseling for psychological distress in young people: pilot randomized controlled trial.

    PubMed

    McArthur, Katherine; Cooper, Mick; Berdondini, Lucia

    2013-01-01

    School-based humanistic counseling (SBHC) is a widely delivered intervention for psychological distress in young people, particularly in the UK. This study piloted a set of procedures for evaluating SBHC and obtaining indications of effect. Psychologically distressed young people (aged 13-16) were randomized to either 12 weeks of SBHC or a waiting list control. The primary outcome was psychological distress at the 12-week endpoint, as measured by the Young Person's CORE. Those allocated to counseling (n=16) showed significantly greater reductions in psychological distress than participants in the control group (n=17), with an effect size (ES) (g) of 1.14 on the primary outcome and a mean ES across all four outcome measures of 0.73 at endpoint. The findings indicate that SBHC may be an effective means of reducing psychological distress in young people.

  9. Random Vibrations

    NASA Technical Reports Server (NTRS)

    Messaro. Semma; Harrison, Phillip

    2010-01-01

    Ares I Zonal Random vibration environments due to acoustic impingement and combustion processes are develop for liftoff, ascent and reentry. Random Vibration test criteria for Ares I Upper Stage pyrotechnic components are developed by enveloping the applicable zonal environments where each component is located. Random vibration tests will be conducted to assure that these components will survive and function appropriately after exposure to the expected vibration environments. Methodology: Random Vibration test criteria for Ares I Upper Stage pyrotechnic components were desired that would envelope all the applicable environments where each component was located. Applicable Ares I Vehicle drawings and design information needed to be assessed to determine the location(s) for each component on the Ares I Upper Stage. Design and test criteria needed to be developed by plotting and enveloping the applicable environments using Microsoft Excel Spreadsheet Software and documenting them in a report Using Microsoft Word Processing Software. Conclusion: Random vibration liftoff, ascent, and green run design & test criteria for the Upper Stage Pyrotechnic Components were developed by using Microsoft Excel to envelope zonal environments applicable to each component. Results were transferred from Excel into a report using Microsoft Word. After the report is reviewed and edited by my mentor it will be submitted for publication as an attachment to a memorandum. Pyrotechnic component designers will extract criteria from my report for incorporation into the design and test specifications for components. Eventually the hardware will be tested to the environments I developed to assure that the components will survive and function appropriately after exposure to the expected vibration environments.

  10. Effect of Combining Therapy with Traditional Chinese Medicine-Based Psychotherapy and Herbal Medicines in Women with Menopausal Syndrome: A Randomized Controlled Clinical Trial

    PubMed Central

    Yang, Hongyan; Yang, Jing; Wen, Zehuai; Zha, Qinglin; Nie, Guangning; Huang, Xuchun; Zhang, Chunlin; Lu, Aiping; Jiang, Miao; Wang, Xiaoyun

    2012-01-01

    This multicenter, randomized, controlled clinical study was designed to address the effectiveness of combined traditional-Chinese-medicine- (TCM-) based psychotherapy and Chinese herbal medicine (CHM) in the treatment of menopausal syndrome. Altogether 424 eligible women diagnosed as menopausal syndrome and categorized as Kidney-Yin/Kidney-Yang deficiency pattern in TCM were randomly assigned into 4 groups and accepted TCM-based psychotherapy (PSY), CHM, PSY + CHM, or placebo therapies, respectively, for 12 weeks, and another 12 weeks were taken as the followup. Kupperman Index (KI) and the Menopause-Specific Quality of Life (MENQOL) with its four subscales (vasomotor, physical, psychosocial, and sexual) were employed for efficacy assessment. Results showed that 400 participants completed 12-week treatment, of which 380 finished the record of KI and MENQOF at week 24. The average adjusted number of KI score decreased between baseline and 12 weeks in all groups. Statistically significant differences were detected in the average adjusted change between the PSY + CHM group and placebo at overall time points (P < 0.05). No severe adverse events occurred in each group and no significant differences were indicated between any of the three groups and placebo in adverse event proportion. We concluded that TCM psychotherapy combined with CHM has a favorable outcome in treating menopausal syndrome. PMID:23304198

  11. Effects of free leucine supplementation and resistance training on muscle strength and functional status in older adults: a randomized controlled trial

    PubMed Central

    Trabal, Joan; Forga, Maria; Leyes, Pere; Torres, Ferran; Rubio, Jordi; Prieto, Esther; Farran-Codina, Andreu

    2015-01-01

    Objective To assess the effect of free leucine supplementation combined with resistance training versus resistance training only on muscle strength and functional status in older adults. Methods This was a randomized, double-blind, placebo-controlled, parallel study with two intervention groups. Thirty older adults were randomly assigned to receive either 10 g leucine/day (leucine group [LG], n=15) or a placebo (control group [CG], n=15), plus resistance training over a 12-week period. Maximal overcoming isometric leg strength, functional status, nutritional status, body composition, health-related quality of life, depression, and dietary intake were assessed at 4 and 12 weeks. Missing data at 12 weeks were handled using mixed models for repeated measurements for data imputation. Results Twenty-four subjects completed the 4-week assessment and eleven completed the 12-week intervention. Clinically significant gains were found in isometric leg strength at both assessment time points. Analysis of the effect size also showed how participants in LG outperformed those in CG for chair stands and the timed up and go test. No significant changes were observed for the rest of the outcomes. Conclusion Our combined analysis showed moderate changes in isometric leg muscle strength and certain components of functional status. The magnitude of changes found on these outcomes should be qualified as a positive effect of the concomitant intervention. PMID:25926725

  12. A Systematic Investigation of Program Differentiation within a Kindergarten Reading Intervention Study: The Importance of Accounting for Implementation across Conditions

    ERIC Educational Resources Information Center

    Civetelli, Christina

    2012-01-01

    This study examined dimensions of treatment integrity, specifically program differentiation, within the context of a kindergarten reading intervention study. The study explored the relationship between program differentiation and student outcomes. The study was conducted within the context of Project Early Reading Intervention (ERI), a four-year…

  13. The Role of Teacher Behavior Management in the Development of Disruptive Behaviors: An Intervention Study with the Good Behavior Game

    ERIC Educational Resources Information Center

    Leflot, Geertje; van Lier, Pol A. C.; Onghena, Patrick; Colpin, Hilde

    2010-01-01

    The role of teacher behavior management for children's disruptive behavior development (hyperactive and oppositional behavior) was investigated using a universal classroom preventive intervention study. Five-hundred seventy children were followed from second to third grade of elementary school. Observations of teacher behavior management and…

  14. The Effectiveness of Disaster Risk Communication: A Systematic Review of Intervention Studies

    PubMed Central

    Bradley, Declan T; McFarland, Marie; Clarke, Mike

    2014-01-01

    Introduction: A disaster is a serious disruption to the functioning of a community that exceeds its capacity to cope within its own resources. Risk communication in disasters aims to prevent and mitigate harm from disasters, prepare the population before a disaster, disseminate information during disasters and aid subsequent recovery. The aim of this systematic review is to identify, appraise and synthesise the findings of studies of the effects of risk communication interventions during four stages of the disaster cycle. Methods: We searched the Cochrane Central Register of Controlled Trials, Embase, MEDLINE, PsycInfo, Sociological Abstracts, Web of Science and grey literature sources for randomised trials, cluster randomised trials, controlled and uncontrolled before and after studies, interrupted time series studies and qualitative studies of any method of disaster risk communication to at-risk populations. Outcome criteria were disaster-related knowledge and behaviour, and health outcomes. Results: Searches yielded 5,224 unique articles, of which 100 were judged to be potentially relevant. Twenty-five studies met the inclusion criteria, and two additional studies were identified from other searching. The studies evaluated interventions in all four stages of the disaster cycle, included a variety of man-made, natural and infectious disease disasters, and were conducted in many disparate settings. Only one randomised trial and one cluster randomised trial were identified, with less robust designs used in the other studies. Several studies reported improvements in disaster-related knowledge and behaviour. Discussion: We identified and appraised intervention studies of disaster risk communication and present an overview of the contemporary literature. Most studies used non-randomised designs that make interpretation challenging. We do not make specific recommendations for practice but highlight the need for high-quality randomised trials and appropriately

  15. Recommendations for reporting whole-grain intake in observational and intervention studies.

    PubMed

    Ross, Alastair B; Kristensen, Mette; Seal, Chris J; Jacques, Paul; McKeown, Nicola M

    2015-05-01

    The finding that people who eat the most whole grains have a lower risk of cardiovascular disease and diabetes, compared with those who eat the least, is one of the most consistent findings in nutritional epidemiology. However, criteria for reporting whole-grain intake have varied widely, making it difficult to precisely explore the relation of whole grains and grain components with health outcomes. To enable better understanding of the health benefits of whole grain-rich diets, we propose that both observational and intervention studies should as far as possible be required to report as follows when describing whole grains: 1) quantify the amount of whole grain in the food or product in grams on a dry-weight basis, 2) describe the whole-grain definition used, 3) report and separate the different types of grains used, 4) if possible, report the structure of the grains (intact, crushed, partially milled) in foods, and 5) describe the main types of products used and processes used to make them. Added bran and germ should be reported distinctly from whole grains. In addition, we strongly recommend the incorporation of biomarkers of whole-grain intake to check compliance to intervention diets and help attenuate for errors in dietary recall of whole-grain intake. Of these measures, reporting whole-grain intake in grams is essential for future research work in the area. Improving reporting and estimation of whole-grain intake will enable easier comparison between different studies and lead to stronger meta-analyses in the future.

  16. Brain imaging and human nutrition: which measures to use in intervention studies?

    PubMed

    Sizonenko, Stéphane V; Babiloni, Claudio; de Bruin, Eveline A; Isaacs, Elizabeth B; Jönsson, Lena S; Kennedy, David O; Latulippe, Marie E; Mohajeri, M Hasan; Moreines, Judith; Pietrini, Pietro; Walhovd, Kristine B; Winwood, Robert J; Sijben, John W

    2013-08-01

    The present review describes brain imaging technologies that can be used to assess the effects of nutritional interventions in human subjects. Specifically, we summarise the biological relevance of their outcome measures, practical use and feasibility, and recommended use in short- and long-term nutritional studies. The brain imaging technologies described consist of MRI, including diffusion tensor imaging, magnetic resonance spectroscopy and functional MRI, as well as electroencephalography/magnetoencephalography, near-IR spectroscopy, positron emission tomography and single-photon emission computerised tomography. In nutritional interventions and across the lifespan, brain imaging can detect macro- and microstructural, functional, electrophysiological and metabolic changes linked to broader functional outcomes, such as cognition. Imaging markers can be considered as specific for one or several brain processes and as surrogate instrumental endpoints that may provide sensitive measures of short- and long-term effects. For the majority of imaging measures, little information is available regarding their correlation with functional endpoints in healthy subjects; therefore, imaging markers generally cannot replace clinical endpoints that reflect the overall capacity of the brain to behaviourally respond to specific situations and stimuli. The principal added value of brain imaging measures for human nutritional intervention studies is their ability to provide unique in vivo information on the working mechanism of an intervention in hypothesis-driven research. Selection of brain imaging techniques and target markers within a given technique should mainly depend on the hypothesis regarding the mechanism of action of the intervention, level (structural, metabolic or functional) and anticipated timescale of the intervention's effects, target population, availability and costs of the techniques.

  17. Effects of a Randomised Reading Intervention Study: An Application of Structural Equation Modelling

    ERIC Educational Resources Information Center

    Wolff, Ulrika

    2011-01-01

    An intensive phonics-based intervention program for nine-year-old Swedish pupils with reading difficulties was performed. Pupils (N = 112) were randomly assigned to either an intervention or a control group. The training was tailored to the Swedish transparent orthography and designed for one-to-one-tutoring during twelve weeks. Previously,…

  18. Preservice Teachers' Beliefs and Attitude about Teaching and Learning Mathematics through Music: An Intervention Study

    ERIC Educational Resources Information Center

    An, Song A.; Ma, Tingting; Capraro, Mary Margaret

    2011-01-01

    This article presents exploratory research investigating the integration of music and a mathematics lesson as an intervention to promote preservice teachers' attitude and confidence and to extend their beliefs toward teaching mathematics integrated with music. Thirty students were randomly selected from 64 preservice teachers in a southern…

  19. Peer Acceptance and the Development of Emotional and Behavioural Problems: Results from a Preventive Intervention Study

    ERIC Educational Resources Information Center

    Menting, Barbara; Koot, Hans; van Lier, Pol

    2015-01-01

    Difficulties in peer acceptance during elementary school have been associated with emotional and behavioural problems. This study used a randomized controlled intervention design to test whether improvements in peer acceptance mediated reduced rates of emotional and behavioural problems in intervention compared to control-group children. A total…

  20. Self-Regulation, Motivation and Teaching Styles in Physical Education Classes: An Intervention Study

    ERIC Educational Resources Information Center

    Chatzipanteli, Athanasia; Digelidis, Nikolaos; Papaioannou, Athanasios G.

    2015-01-01

    The aim of the study was to investigate the influence of student-activated teaching styles through a specific intervention program on students' self-regulation, lesson satisfaction, and motivation. Six hundred and one 7th grade students (318 boys and 283 girls), aged 13 years were randomly assigned to an experimental group and a comparison group.…

  1. Cabozantinib in Patients With Advanced Prostate Cancer: Results of a Phase II Randomized Discontinuation Trial

    PubMed Central

    Smith, David C.; Smith, Matthew R.; Sweeney, Christopher; Elfiky, Aymen A.; Logothetis, Christopher; Corn, Paul G.; Vogelzang, Nicholas J.; Small, Eric J.; Harzstark, Andrea L.; Gordon, Michael S.; Vaishampayan, Ulka N.; Haas, Naomi B.; Spira, Alexander I.; Lara, Primo N.; Lin, Chia-Chi; Srinivas, Sandy; Sella, Avishay; Schöffski, Patrick; Scheffold, Christian; Weitzman, Aaron L.; Hussain, Maha

    2013-01-01

    Purpose Cabozantinib (XL184) is an orally bioavailable tyrosine kinase inhibitor with activity against MET and vascular endothelial growth factor receptor 2. We evaluated the activity of cabozantinib in patients with castration-resistant prostate cancer (CRPC) in a phase II randomized discontinuation trial with an expansion cohort. Patients and Methods Patients received 100 mg of cabozantinib daily. Those with stable disease per RECIST at 12 weeks were randomly assigned to cabozantinib or placebo. Primary end points were objective response rate at 12 weeks and progression-free survival (PFS) after random assignment. Results One hundred seventy-one men with CRPC were enrolled. Random assignment was halted early based on the observed activity of cabozantinib. Seventy-two percent of patients had regression in soft tissue lesions, whereas 68% of evaluable patients had improvement on bone scan, including complete resolution in 12%. The objective response rate at 12 weeks was 5%, with stable disease in 75% of patients. Thirty-one patients with stable disease at week 12 were randomly assigned. Median PFS was 23.9 weeks (95% CI, 10.7 to 62.4 weeks) with cabozantinib and 5.9 weeks (95% CI, 5.4 to 6.6 weeks) with placebo (hazard ratio, 0.12; P < .001). Serum total alkaline phosphatase and plasma cross-linked C-terminal telopeptide of type I collagen were reduced by ≥ 50% in 57% of evaluable patients. On retrospective review, bone pain improved in 67% of evaluable patients, with a decrease in narcotic use in 56%. The most common grade 3 adverse events were fatigue (16%), hypertension (12%), and hand-foot syndrome (8%). Conclusion Cabozantinib has clinical activity in men with CRPC, including reduction of soft tissue lesions, improvement in PFS, resolution of bone scans, and reductions in bone turnover markers, pain, and narcotic use. PMID:23169517

  2. Fractional randomness

    NASA Astrophysics Data System (ADS)

    Tapiero, Charles S.; Vallois, Pierre

    2016-11-01

    The premise of this paper is that a fractional probability distribution is based on fractional operators and the fractional (Hurst) index used that alters the classical setting of random variables. For example, a random variable defined by its density function might not have a fractional density function defined in its conventional sense. Practically, it implies that a distribution's granularity defined by a fractional kernel may have properties that differ due to the fractional index used and the fractional calculus applied to define it. The purpose of this paper is to consider an application of fractional calculus to define the fractional density function of a random variable. In addition, we provide and prove a number of results, defining the functional forms of these distributions as well as their existence. In particular, we define fractional probability distributions for increasing and decreasing functions that are right continuous. Examples are used to motivate the usefulness of a statistical approach to fractional calculus and its application to economic and financial problems. In conclusion, this paper is a preliminary attempt to construct statistical fractional models. Due to the breadth and the extent of such problems, this paper may be considered as an initial attempt to do so.

  3. The Steps to Health Randomized Trial for Arthritis

    PubMed Central

    Wilcox, Sara; McClenaghan, Bruce; Sharpe, Patricia A.; Baruth, Meghan; Hootman, Jennifer M.; Leith, Katherine; Dowda, Marsha

    2015-01-01

    Background Despite the established benefits of exercise for adults with arthritis, participation is low. Safe, evidence-based, self-directed programs, which have the potential for high reach at a low cost, are needed. Purpose To test a 12-week, self-directed, multicomponent exercise program for adults with arthritis. Design Randomized controlled trial. Data were collected from 2010 to 2012. Data were analyzed in 2013 and 2014. Setting/participants Adults with arthritis (N=401, aged 56.3 [10.7] years, 85.8% women, 63.8% white, 35.2% African American, BMI of 33.0 [8.2]) completed measures at a university research center and participated in a self-directed exercise intervention (First Step to Active Health®) or nutrition control program (Steps to Healthy Eating). Intervention Intervention participants received a self-directed multicomponent exercise program and returned self-monitoring logs for 12 weeks. Main outcome measures Self-reported physical activity, functional performance measures, and disease-specific outcomes (arthritis symptoms and self-efficacy) assessed at baseline, 12 weeks, and 9 months. Results Participants in the exercise condition showed greater increases in physical activity than those in the nutrition control group (p=0.01). Significant improvements, irrespective of condition, were seen in lower body strength, functional exercise capacity, lower body flexibility, pain, fatigue, stiffness, and arthritis management self-efficacy (p values <0.0001). More adverse events occurred in the exercise than nutrition control condition, but only one was severe and most were expected with increased physical activity. Conclusions The exercise program improves physical activity, and both programs improve functional and psychosocial outcomes. Potential reasons for improvements in the nutrition control condition are discussed. These interventions have the potential for large-scale dissemination. This study is registered at Clinicaltrials.gov NCT01172327. PMID

  4. Impact of Simulation and Clinical Experience on Self-efficacy in Nursing Students: Intervention Study.

    PubMed

    Kimhi, Einat; Reishtein, Judith L; Cohen, Miri; Friger, Michael; Hurvitz, Nancy; Avraham, Rinat

    2016-01-01

    This study compared the effect of simulation and clinical experience timing on self-confidence/self-efficacy for the nursing process. Using a randomized, double-crossover design, self-efficacy was measured 3 times. Although self-efficacy was significantly higher at time 1 for students who had clinical experience, there was no difference between the groups at the end of the course (time 2). Thus, simulation increased self-confidence/self-efficacy equivalently if placed either before or after clinical experience.

  5. Valacyclovir Decreases Plasma HIV-1 RNA in HSV-2 Seronegative Individuals: A Randomized Placebo-Controlled Crossover Trial

    PubMed Central

    Vanpouille, Christophe; Lisco, Andrea; Grivel, Jean-Charles; Bassit, Leda C.; Kauffman, Robert C.; Sanchez, Jorge; Schinazi, Raymond F.; Lederman, Michael M.; Rodriguez, Benigno; Margolis, Leonid

    2015-01-01

    Background. Acyclovir (ACV), a highly specific anti-herpetic drug, acts as a DNA chain terminator for several human herpesviruses (HHVs), including HHV-2 (HSV-2), a common human immunodeficiency virus (HIV)-1 co-pathogen. Several trials demonstrated that HSV-2 suppressive therapy using ACV or its prodrug valacyclovir (valACV) reduced plasma HIV-1 viral load (VL) in HIV-1/HSV-2 coinfected persons, and this was proposed to be due to a decrease in generalized immune activation. Recently, however, we found that ACV directly suppresses HIV-1 ex vivo in tissues free of HSV-2 but endogenously coinfected with other HHVs. Here, we asked whether valACV suppresses VL in HIV-1 infected HSV-2-seronegative persons. Methods. Eighteen HIV-1 infected HSV-2-seronegative individuals were randomly assigned in a double blind placebo-controlled, crossover trial. Eligible participants had CD4 cell counts of ≥500 cells/µL and were not taking antiretroviral therapy. Subjects in group A received 12 weeks of valACV 500 mg given twice daily by mouth followed by 2 weeks of a no treatment washout and then 12 weeks of placebo; subjects in group B received 12 weeks of placebo followed by 2 weeks of no treatment washout and then 12 weeks of valACV 500 mg twice daily. Results. HIV-1 VL in plasma of patients treated with valACV 500 mg twice daily for 12 weeks was reduced on average by 0.37 log10 copies/mL. Conclusions. These data indicate that the effects of valACV on HIV-1 replication are not related to the suppression of HSV-2-mediated inflammation and are consistent with a direct effect of ACV on HIV-1 replication. PMID:25740794

  6. Effects of sulfur bath on hip osteoarthritis: a randomized, controlled, single-blind, follow-up trial: a pilot study

    NASA Astrophysics Data System (ADS)

    Kovács, Csaba; Bozsik, Ágnes; Pecze, Mariann; Borbély, Ildikó; Fogarasi, Andrea; Kovács, Lajos; Tefner, Ildikó Katalin; Bender, Tamás

    2016-06-01

    The effects of balneotherapy were evaluated in patients with osteoarthritis of the hip. This randomized, controlled, investigator-blinded study enrolled outpatients with hip osteoarthritis according to ACR criteria. In addition to home exercise therapy, one patient group received balneotherapy for 3 weeks on 15 occasions. The mineral water used in this study is one of the mineral waters with the highest sulfide ion content (13.2 mg/L) in Hungary. The control group received exercise therapy alone. The WOMAC Likert 3.1 index and the EQ-5D quality of life self-administered questionnaire were completed three times during the study: prior to first treatment, at the end of the 3-week treatment course, and 12 weeks later. The main endpoint was achievement of Minimal Clinically Important Improvement (MCII) at 12 weeks, defined as ≥7.9 points in a normalized WOMAC function score. The intention to treat analysis included 20 controls and 21 balneotherapy patients. At 12 weeks, 17 (81 %) balneotherapy group patients had Minimal Clinically Important Improvement and 6 (30 %) of controls (p = 0.001). Comparing the results of the two groups at the end of treatment, there was a significant difference in the WOMAC stiffness score only, whereas after 12 weeks, the WOMAC pain, stiffness, function, and total scores also showed a significant difference in favor of the balneotherapy group. The difference between the two groups was significant after 12 weeks in point of EQVAS score, too. The results of our study suggest that the combination of balneotherapy and exercise therapy achieves more sustained improvement of joint function and decreases in pain than exercise therapy alone.

  7. Financial incentives for smoking cessation in pregnancy: protocol for a single arm intervention study

    PubMed Central

    2013-01-01

    Background Smoking during pregnancy and in the postnatal period is a major cause of low birth weight and a range of adverse infant health outcomes. Stop smoking services can double quit rates, but only 17% of pregnant women smoking at the time they book for antenatal care use these services. In a recent Cochrane review on the effectiveness of smoking cessation interventions in pregnancy, financial incentives were found to be the single most effective intervention. We describe a single arm intervention study offering participation in a financial incentive scheme for smoking cessation to all pregnant smokers receiving antenatal care in one area in England. The aim of the study is to assess the potential effectiveness of using financial incentives to achieve smoking cessation in pregnant women who smoke, to inform the use of financial incentive schemes in routine clinical practice as well as the interpretation of existing trials and the design of future studies. Method/design 500 consecutive pregnant smokers are offered participation in the scheme, which involves attending for up to 32 assessments until six months post-partum, to verify smoking cessation by self report and a negative exhaled carbon monoxide measurement. At each visit when cessation is verified, participants receive a shopping voucher starting at a value of £8 and increasing by £1 at each consecutive successful visit. Assessments decline in frequency, occurring most frequently during the first two weeks after quitting and the first two weeks after delivery. The maximum cumulative total that can be earned through the scheme is £752. Discussion The results of this study will inform the use of financial incentive schemes in routine clinical practice as well as the interpretation of existing trials and the design of future studies. The main results are (a) an estimate of the proportion of pregnant smokers who enrol in the scheme; (b) estimates of the proportion of pregnant smokers who participate in the

  8. Effectiveness of a one-year multi-component day-camp intervention for overweight children: study protocol of the Odense overweight intervention study (OOIS)

    PubMed Central

    2014-01-01

    Background Childhood overweight has noticeable psychological and social consequences for the child and leads to an increased risk of mortality and morbidity later in life. With the high prevalence of overweight in children and adolescents, it is important to identify effective approaches for the prevention and treatment of overweight in children and young individuals. The primary aim of the study is to assess the effect of an intensive day-camp intervention on body mass index (BMI) in overweight children. Methods The Odense Overweight Intervention Study is a semi-blinded randomized controlled trial. Overweight children from the Municipality of Odense, Denmark, were invited to participate in the trial. Based on power calculations 98 participants were found to be sufficient to randomize in order to find an effect of minimum 1.5 BMI points. Gender-stratified concealed block randomization with a ratio of 1:1 and random block sizes of two, four, and six ensured balance between study arms. The intervention consisted of a six-week multi-component day camp including increased physical activity, healthy diet and health education followed by 46 weeks of family-based habitual intervention. The standard care arm was offered two weekly hours of physical activity training for six weeks. The outcomes were measured at baseline and at six-week and 52-week follow-ups. Furthermore, BMI will be assessed again at 48-month follow-up. Test personnel were kept blinded. The intervention effect will be evaluated using mixed model analyses. During 2012 and 2013, 115 children were enrolled in the study. Fifty-nine children were randomized to the day-camp intervention arm and 56 to the standard intervention arm. Discussion This study will provide novel information about the long-term health effects of an intense day-camp intervention program on overweight children, due to the design and the follow-up period. Moreover, it will add to the knowledge on designing and implementing feasible camp

  9. A Facility Specialist Model for Improving Retention of Nursing Home Staff: Results from a Randomized, Controlled Study

    ERIC Educational Resources Information Center

    Pillemer, Karl; Meador, Rhoda; Henderson, Charles, Jr.; Robison, Julie; Hegeman, Carol; Graham, Edwin; Schultz, Leslie

    2008-01-01

    Purpose: This article reports on a randomized, controlled intervention study designed to reduce employee turnover by creating a retention specialist position in nursing homes. Design and Methods: We collected data three times over a 1-year period in 30 nursing homes, sampled in stratified random manner from facilities in New York State and…

  10. High Beta-palmitate formula and bone strength in term infants: a randomized, double-blind, controlled trial.

    PubMed

    Litmanovitz, Ita; Davidson, Keren; Eliakim, Alon; Regev, Rivka H; Dolfin, Tzipora; Arnon, Shmuel; Bar-Yoseph, Fabiana; Goren, Amit; Lifshitz, Yael; Nemet, Dan

    2013-01-01

    We aimed to compare the effect of 12-week feeding of commercially available infant formulas with different percentages of palmitic acid at sn-2 (beta-palmitate) on anthropometric measures and bone strength of term infants. It was hypothesized that feeding infants with high beta-palmitate (HBP) formula will enhance their bone speed of sound (SOS). Eighty-three infants appropriate for gestational age participated in the study; of these, 58 were formula-fed and 25 breast-fed infants, serving as a reference group. The formula-fed infants were randomly assigned to receive HBP formula (43 % of the palmitic acid is esterified to the middle position of the glycerol backbone, study group; n = 30) or regular formula with low-beta palmitate (LBP, 14 % of the palmitic acid is esterified to the middle position of the glycerol backbone, n = 28). Sixty-six infants completed the 12-week study. Anthropometric and quantitative ultrasound measurements of bone SOS for assessment of bone strength were performed at randomization and at 6 and 12 weeks postnatal age. At randomization, gestational age, birth weight, and bone SOS were comparable between the three groups. At 12 weeks postnatal age, the mean bone SOS of the HBP group was significantly higher than that of the LBP group (2,896 ± 133 vs. 2,825 ± 79 m/s respectively, P = 0.049) and comparable with that of the breast-fed group (2,875 ± 85 m/s). We concluded that infants consuming HBP formula had changes in bone SOS that were comparable to those of infants consuming breast milk and favorable compared to infants consuming LBP formula.

  11. Remuneration for non-interventional studies--results of a survey in the pharmaceutical industry in Germany.

    PubMed

    Ruppert, Thorsten; Hahn, Michael; Hundt, Ferdinand

    2012-01-01

    In 2007 the Association of Research-Based Pharmaceutical Companies (vfa) published recommendations to improve the quality and transparency of non-interventional studies. These recommendations include quality assurance measures, in particular with respect to transparency as well as for the verification of the data collected in these studies. This publication presents the results of a survey on fees in non-interventional studies which was conducted within the member companies of the vfa in June 2011. These results demonstrate a consistent adherence to the statutory requirements and the implementation of the recommendations concerning the remuneration of the study centers. Depending on the indication, the number of routine doctor/patient contacts is different and associated with that number the documentation efforts vary. Accordingly, the fee varies based on the fee schedule for physicians (German: Gebührenordnung für Ärzte) by taking into account the actual efforts at the study center.

  12. Hypericum perforatum extract in burning mouth syndrome: a randomized placebo-controlled study.

    PubMed

    Sardella, Andrea; Lodi, Giovanni; Demarosi, Federica; Tarozzi, Marco; Canegallo, Lorenza; Carrassi, Antonio

    2008-08-01

    Burning mouth syndrome (BMS) or stomatodynia is characterized by a spontaneous burning pain in the oral mucosa without known cause or recognized treatment. This double-blind, randomized, placebo-controlled, single-center study evaluated the effects of systemic Hypericum perforatum extract in patients with BMS. Forty-three patients participated, of whom 39 (35 women, four men, aged 64.9 +/- 4.7 years) completed the study. The patients took indistinguishable 300-mg capsules containing either H. perforatum extract (hypericin 0.31% and hyperforin 3.0%) or placebo three times a day for 12 weeks. The intensity of burning pain was evaluated using a 10-cm visual analog scale (VAS) before the first dose and at visits after 4, 8, and 12 weeks. Furthermore, we also recorded the number of oral mucosa sites with reported burning symptoms and the self-reported descriptions of the patient's condition before and after the treatment. Pain, measured using the VAS, was similar at the beginning of the study and even though a slightly better performance in the test group, the difference was not statistically significant (P = 0.2216). The results failed to demonstrate that 300 mg of H. perforatum extract taken three times a day for 12 weeks improved the pain of BMS patients, although the general reduction in the number of sites with reported burning sensation, a less accurate and objective score, was significant.

  13. Challenges and implications for biomedical research and intervention studies in older populations: insights from the ELDERMET study.

    PubMed

    Cusack, Siobhán; O'Toole, Paul W

    2013-01-01

    Older people constitute a growing proportion of the worldwide population. Despite this, older people are often excluded from clinical research and are generally underrepresented in intervention studies. This severely restricts the ability to generalise outcomes from research involving younger populations, which may impact on the progression of knowledge and the development of best practice guidelines for the care of older people. This opinion piece outlines the challenges and practical difficulties experienced and overcome by the ELDERMET project. The ELDERMET project has recruited almost 500 subjects, aged 65 years and older, across a range of health states from the very frail to the very fit, half of whom have been studied at multiple time points. All ELDERMET subjects have participated in an extensive protocol and supplied multiple biological sample types. The challenges and obstacles faced by both researchers in recruiting older subjects and older people engaging with research and intervention studies are set out. Strategies are discussed for: the recruitment and retention of older subjects; recruiting subjects with physical or cognitive impairment; recruitment from specific locations; collecting accurate and robust data, particularly from subjects with mild to severe cognitive impairment; intervention product design, delivery and compliance. Practical and realistic solutions for maximising the engagement of older people with research and intervention studies are offered. The increased benefit brought by the generalisation and application of research and intervention outcomes to older populations is discussed.

  14. Obesity and pregnancy, an epidemiological and intervention study from a psychosocial perspective

    PubMed Central

    Bogaerts, A.

    2014-01-01

    Background: Maternal obesity is a growing public health concern in Belgium as well as in other European countries and is now becoming the most common risk factor associated with pregnancy complications with impact on the health of the women and her offspring. At this moment, there is no specific management strategy for obese pregnant women and mothers, focusing on physical health and psychological well-being. Objectives: We aimed (1) to study the influence of socio-demographic and obstetrical correlates on pre-pregnancy body mass index (BMI) and gestational weight gain (GWG) in different regions of Flanders, Belgium, (2) to review the literature on the onset and progression of labour in normal weight and obese pregnant women, (3) to compare levels and evolution of anxiety and depressed mood during pregnancy between obese women and normal-weight women, (4) to examine whether a prenatal lifestyle intervention programme, based on principles of motivational interviewing, in obese pregnant women reduces GWG and lowers levels of anxiety and depressed mood during pregnancy, (5) to examine associations between inter-pregnancy weight change from the first to the second pregnancy and the risk for adverse perinatal outcomes during the second pregnancy and finally (6) to study predictors of postpartum weight retention (PPWR) in obese mothers at six months after delivery in order to provide clues for the design of interventions aimed at preventing weight retention related to childbearing. Methods: We performed an epidemiological study, an intervention study during pregnancy with postpartum follow up and a literature review. Results: One in three Flemish women start pregnancy being overweight or obese and this prevalence has slowly been rising since 2009 in the Flanders. We identified women at risk for a high pre-pregnancy BMI and excessive GWG, both being important predictors for increased pregnancy and birth related complications. In a literature review, we showed that the

  15. Is random access memory random?

    NASA Technical Reports Server (NTRS)

    Denning, P. J.

    1986-01-01

    Most software is contructed on the assumption that the programs and data are stored in random access memory (RAM). Physical limitations on the relative speeds of processor and memory elements lead to a variety of memory organizations that match processor addressing rate with memory service rate. These include interleaved and cached memory. A very high fraction of a processor's address requests can be satified from the cache without reference to the main memory. The cache requests information from main memory in blocks that can be transferred at the full memory speed. Programmers who organize algorithms for locality can realize the highest performance from these computers.

  16. Carnosine Treatment for Gulf War Illness: A Randomized Controlled Trial

    PubMed Central

    Baraniuk, James N.; El-Amin, Suliman; Corey, Rebecca; Rayhan, Rakib U.; Timbol, Christian R.

    2013-01-01

    About 25% of 1990-1991 Persian Gulf War veterans experience disabling fatigue, widespread pain, and cognitive dysfunction termed Gulf War illness (GWI) or Chronic Multisymptom Illness (CMI). A leading theory proposes that wartime exposures initiated prolonged production of reactive oxygen species (ROS) and central nervous system injury. The endogenous antioxidant L-carnosine (β-alanyl-L-histidine) is a potential treatment since it is a free radical scavenger in nervous tissue. To determine if nutritional supplementation with L-carnosine would significantly improve pain, cognition and fatigue in GWI, a randomized double blind placebo controlled 12 week dose escalation study involving 25 GWI subjects was employed. L-carnosine was given as 500, 1000, and 1500 mg increasing at 4 week intervals. Outcomes included subjective fatigue, pain and psychosocial questionnaires, and instantaneous fatigue and activity levels recorded by ActiWatch Score devices. Cognitive function was evaluated by WAIS-R digit symbol substitution test. Carnosine had 2 potentially beneficial effects: WAIS-R scores increased significantly, and there was a decrease in diarrhea associated with irritable bowel syndrome. No other significant incremental changes were found. Therefore, 12 weeks of carnosine (1500 mg) may have beneficial cognitive effects in GWI. Fatigue, pain, hyperalgesia, activity and other outcomes were resistant to treatment. PMID:23618477

  17. Particulate matter concentrations in residences: an intervention study evaluating stand-alone filters and air conditioners

    PubMed Central

    Batterman, S.; Du, L.; Mentz, G.; Mukherjee, B.; Parker, E.; Godwin, C.; Chin, J.-Y.; O'Toole, A.; Robins, T.; Rowe, Z.; Lewis, T.

    2014-01-01

    This study, a randomized controlled trial, evaluated the effectiveness of free-standing air filters and window air conditioners (ACs) in 126 low-income households of children with asthma. Households were randomized into a control group, a group receiving a free-standing HEPA filter placed in the child's sleeping area, and a group receiving the filter and a window-mounted AC. Indoor air quality (IAQ) was monitored for week-long periods over three to four seasons. High concentrations of particulate matter (PM) and carbon dioxide were frequently seen. When IAQ was monitored, filters reduced PM levels in the child's bedroom by an average of 50%. Filter use varied greatly among households and declined over time, for example, during weeks when pollutants were monitored, filter use was initially high, averaging 84 ± 27%, but dropped to 63 ± 33% in subsequent seasons. In months when households were not visited, use averaged only 34 ± 30%. Filter effectiveness did not vary in homes with central or room ACs. The study shows that measurements over multiple seasons are needed to characterize air quality and filter performance. The effectiveness of interventions using free-standing air filters depends on occupant behavior, and strategies to ensure filter use should be an integral part of interventions. PMID:22145709

  18. The effects of fantastical pretend-play on the development of executive functions: An intervention study.

    PubMed

    Thibodeau, Rachel B; Gilpin, Ansley T; Brown, Melissa M; Meyer, Brooke A

    2016-05-01

    Although recent correlational studies have found a relationship between fantasy orientation (FO; i.e., a child's propensity to play in a fantastical realm) and higher order cognitive skills called executive functions (EFs), no work has addressed the causality and directionality of this relationship. The current study experimentally examined the directionality of the observed relationship between FO and EF development in preschool-aged children through an innovative play intervention employing a randomized controlled design. A sample of 110 children between the ages of 3 and 5years were randomly assigned to one of three conditions: fantastical pretend-play intervention, non-imaginative play intervention, or business-as-usual control. Results revealed that children who participated in a 5-week fantastical pretend-play intervention showed improvements in EFs, whereas children in the other two conditions did not. Within the fantastical pretend-play condition, children who were highly engaged in the play and those who were highly fantastical demonstrated the greatest gains in EFs. These data provide evidence for the equifinal relationship between fantasy-oriented play and EF development, such that engaging in fantasy-oriented play may be one of many ways to directly enhance EF development. PMID:26835841

  19. A randomized clinical trial of negative pressure ventilation in severe chronic obstructive pulmonary disease: design and methods.

    PubMed

    Shapiro, S H; Macklem, P T; Gray-Donald, K; Martin, J G; Ernst, P P; Wood-Dauphinee, S; Hutchinson, T A; Spitzer, W O

    1991-01-01

    This report documents the design and methods of a randomized clinical trial designed to test the effectiveness of home negative pressure ventilation in patients with severe chronic obstructive pulmonary disease. Active negative pressure ventilation was compared with a sham version of the treatment after a pre-trial assessment had indicated the feasibility of the latter. Over 1200 patients in the metropolitan Montreal area were screened. Of these, 348 patients were recruited to enter a 4-week stabilization period, and 184 were subsequently randomized to receive either active or sham negative pressure ventilation. A 5-day in-hospital period was used to train patients in ventilator use and obtain baseline measures of exercise capacity, lung function, respiratory symptoms, and quality of life. Home ventilation treatment took place during a following 12-week period. Respirator use was recorded both from patient logs and from concealed meters installed in the units. Patients received four home visits by physiotherapists during the 12-week period and returned for follow-up to the hospital 4 and 12 weeks post-discharge for reassessment.

  20. Weight management for overweight and obese men delivered through professional football clubs: a pilot randomized trial

    PubMed Central

    2013-01-01

    Background The prevalence of male obesity is increasing, but men are less likely than women to attend existing weight management programmes. We have taken a novel approach to reducing perceived barriers to weight loss for men by using professional football (soccer) clubs to encourage participation in a weight management group programme, gender-sensitised in content and style of delivery. Football Fans in Training (FFIT) provides 12 weeks of weight loss, physical activity and healthy eating advice at top professional football clubs in Scotland. This pilot randomized trial explored the feasibility of using these clubs as a setting for a randomized controlled trial of 12 month weight loss following men’s participation in FFIT. Methods A two-arm pilot trial at two Scottish Premier League football clubs (one large, one smaller), with 103 men (aged 35–65, body mass index (BMI) ≥27 kg/m2) individually randomized to the intervention (n=51, received the pilot programme (p-FFIT) immediately) and waitlist comparison (n=52, received p-FFIT after four months) groups. Feasibility of recruitment, randomization, data collection and retention were assessed. Objective physical measurements (weight, waist circumference, blood pressure, body composition) and questionnaires (self-reported physical activity, diet, alcohol consumption, psychological outcomes) were obtained from both groups by fieldworkers trained to standard protocols at baseline and 12 weeks, and from the intervention group at 6 and 12 months. Qualitative methods elicited men’s experiences of participation in the pilot trial. Results Following a short recruitment period, the recruitment target was achieved at the large, but not smaller, club. Participants’ mean age was 47.1±8.4 years; mean BMI 34.5±5.0 kg/m2. Retention through the trial was good (>80% at 12 weeks and 6 months; >75% at 12 months), and 76% attended at least 80% of available programme delivery sessions. At 12 weeks, the intervention group lost

  1. Effect of Lepidium meyenii Walp. on Semen Parameters and Serum Hormone Levels in Healthy Adult Men: A Double-Blind, Randomized, Placebo-Controlled Pilot Study

    PubMed Central

    Melnikovova, Ingrid; Fait, Tomas; Kolarova, Michaela; Fernandez, Eloy C.; Milella, Luigi

    2015-01-01

    Background/Aims. Products of Lepidium meyenii Walp. (maca) are touted worldwide as an alimentary supplement to enhance fertility and restore hormonal balance. Enhancing properties of maca on semen parameters in animals were previously reported by various authors, but we present to the best of our knowledge the first double-blind, randomized, placebo-controlled pilot trial in men. The aim of this study was to evaluate the effects of maca on semen parameters and serum hormone levels in healthy adult men. Methods. A group of 20 volunteers aged 20–40 years was supplied by milled hypocotyl of maca or placebo (1.75 g/day) for 12 weeks. Negative controls of semen were compared to the samples after 6 and 12 weeks of maca administration; negative blood controls were compared to the samples after 12 weeks of treatment. Results. Sperm concentration and motility showed rising trends compared to placebo even though levels of hormones did not change significantly after 12 weeks of trial. Conclusion. Our results indicate that maca possesses fertility enhancing properties in men. As long as men prefer to use alimentary supplement to enhance fertility rather than prescribed medication or any medical intervention, it is worth continuing to assess its possible benefits. PMID:26421049

  2. Effect of Lepidium meyenii Walp. on Semen Parameters and Serum Hormone Levels in Healthy Adult Men: A Double-Blind, Randomized, Placebo-Controlled Pilot Study.

    PubMed

    Melnikovova, Ingrid; Fait, Tomas; Kolarova, Michaela; Fernandez, Eloy C; Milella, Luigi

    2015-01-01

    Background/Aims. Products of Lepidium meyenii Walp. (maca) are touted worldwide as an alimentary supplement to enhance fertility and restore hormonal balance. Enhancing properties of maca on semen parameters in animals were previously reported by various authors, but we present to the best of our knowledge the first double-blind, randomized, placebo-controlled pilot trial in men. The aim of this study was to evaluate the effects of maca on semen parameters and serum hormone levels in healthy adult men. Methods. A group of 20 volunteers aged 20-40 years was supplied by milled hypocotyl of maca or placebo (1.75 g/day) for 12 weeks. Negative controls of semen were compared to the samples after 6 and 12 weeks of maca administration; negative blood controls were compared to the samples after 12 weeks of treatment. Results. Sperm concentration and motility showed rising trends compared to placebo even though levels of hormones did not change significantly after 12 weeks of trial. Conclusion. Our results indicate that maca possesses fertility enhancing properties in men. As long as men prefer to use alimentary supplement to enhance fertility rather than prescribed medication or any medical intervention, it is worth continuing to assess its possible benefits. PMID:26421049

  3. Effects of zinc supplementation on subscales of anorexia in children: A randomized controlled trial

    PubMed Central

    Khademian, Majid; Farhangpajouh, Neda; Shahsanaee, Armindokht; Bahreynian, Maryam; Mirshamsi, Mehran; Kelishadi, Roya

    2014-01-01

    Objectives: This study aims to assess the effects of zinc supplementation on improving the appetite and its subscales in children. Methods: This study was conducted in 2013 in Isfahan, Iran. It had two phases. At the first step, after validation of the Child Eating Behaviour Questionaire (CEBQ), it was completed for 300 preschool children, who were randomly selected. The second phase was conducted as a randomized controlled trial. Eighty of these children were randomly selected, and were randomly assigned to two groups of equal number receiving zinc (10 mg/day) or placebo for 12 weeks. Results: Overall 77 children completed the trial (39 in the case and 3 in the control group).The results showed that zinc supplement can improve calorie intake in children by affecting some CEBQ subscales like Emotional over Eating and Food Responsible. Conclusion: Zinc supplementation had positive impact in promoting the calorie intake and some subscales of anorexia. PMID:25674110

  4. Community-based recruitment strategies for a longitudinal interventional study: the VECAT experience.

    PubMed

    Garrett, S K; Thomas, A P; Cicuttini, F; Silagy, C; Taylor, H R; McNeil, J J

    2000-05-01

    This article examines different recruitment strategies for the VECAT Study, a 4-year, double-masked, placebo-controlled, randomized clinical trial of vitamin E in the prevention of cataract and age-related maculopathy. Five recruitment methods were employed: newspaper advertising, radio advertising, approaches to community groups, approaches via general practices, and an electoral roll mail-out. Participants (1204) from the community in Melbourne, Australia were recruited and enrolled within 15 months (age range: 55-80 years, mean 66 years; gender ratio: 57% female, 43% male). The electoral roll mail-out and newspaper advertising were the most efficient methods of recruitment in terms of absolute numbers of participants recruited and cost per participant. Recruitment for the VECAT study was successfully completed within the planned period. Although the electoral roll mail-out and newspaper advertising were the most efficient for this study, other methods may be of value for studies with different subject selection criteria. PMID:10812328

  5. Improving nutrition and physical activity in the workplace: a meta-analysis of intervention studies.

    PubMed

    Hutchinson, Amanda D; Wilson, Carlene

    2012-06-01

    A comprehensive search of the literature for studies examining physical activity or nutrition interventions in the workplace, published between 1999 and March 2009, was conducted. This search identified 29 relevant studies. Interventions were grouped according to the theoretical framework on which the interventions were based (e.g. education, cognitive-behavioural, motivation enhancement, social influence, exercise). Weighted Cohen's d effect sizes, percentage overlap statistics, confidence intervals and fail safe Ns were calculated. Most theoretical approaches were associated with small effects. However, large effects were found for some measures of interventions using motivation enhancement. Effect sizes were larger for studies focusing on one health behaviour and for randomized controlled trials. The workplace is a suitable environment for making modest changes in the physical activity, nutrition and health of employees. Further research is necessary to determine whether these changes can be maintained in the long term.

  6. The nurse clinician as research participant recruiter: experience from a longitudinal intervention study.

    PubMed

    Morrison-Beedy, D; Aronowitz, T; Dyne, J; Mkandawire, L; Murphy, C; Martin, J

    2001-01-01

    One of the most critical phases involved in carrying out a research project is participant recruitment. Recruitment into clinical trials and health programs is a primary public health challenge, particularly among adolescents. Special skills and abilities are needed to successfully recruit participants from this developmental age group. This paper describes the similarities found between the recruitment process developed for a randomized controlled trial with adolescents and the steps of the nursing process, and demonstrates that knowledge of the nursing process can assist in successfully recruiting individuals for a research study. Even without research training, clinical nurses can play a significant role in research studies because of their skills and experiences with the nursing process. Thus, nurse scientists and clinicians can work together successfully to conduct research studies and health projects that involve challenging recruitment efforts. PMID:16052902

  7. Effects of a three-month therapeutic lifestyle modification program to improve bone health in postmenopausal Korean women in a rural community: a randomized controlled trial.

    PubMed

    Oh, Eui Geum; Yoo, Jae Yong; Lee, Jung Eun; Hyun, Sa Saeng; Ko, Il Sun; Chu, Sang Hui

    2014-08-01

    In this randomized controlled trial, we examined the effects of a 3-month therapeutic lifestyle modification (TLM) intervention on knowledge, self-efficacy, and health behaviors related to bone health in postmenopausal women in rural Korea. Forty-one women ages 45 or older were randomly assigned to either the intervention (n = 21) or control (n = 20) group. The intervention group completed a 12-week, 24-session TLM program of individualized health monitoring, group health education, exercise, and calcium-vitamin D supplementation. Compared with the control group, the intervention group showed significant increases in knowledge and self-efficacy and improvement in diet and exercise after 12 weeks, providing evidence that a comprehensive TLM program can be effective in improving health behaviors to maintain bone health in women at high risk of osteoporosis.

  8. Single versus repetitive injection of lignocaine in the management of carpal tunnel syndrome--a randomized controlled trial.

    PubMed

    Akarsu, S; Karadaş, Ö; Tok, F; Levent Gül, H; Eroğlu, E

    2015-02-01

    The aim of this study was to determine the efficacy of single versus repetitive injection of lignocaine into the carpal tunnel for the management of carpal tunnel syndrome. The 42 patients included were randomly assigned to two Groups: group 1 was injected with 4 mL of 1% lignocaine once and Group 2 was injected with 4 mL of 1% lignocaine twice a week for 2 weeks. Clinical and electrophysiological evaluations were performed at the study onset, and at 6 and 12 weeks following the final injection. Initially, the groups were similar with respect to clinical and electrophysiological findings. All parameters in Group 2 improved 6 weeks post treatment (p < 0.05), and these improvements persisted at 12 weeks post treatment (p < 0.05). Repetitive local lignocaine injection was effective in reducing the symptoms of carpal tunnel syndrome and improving electrophysiological findings.

  9. Single versus repetitive injection of lignocaine in the management of carpal tunnel syndrome--a randomized controlled trial.

    PubMed

    Akarsu, S; Karadaş, Ö; Tok, F; Levent Gül, H; Eroğlu, E

    2015-02-01

    The aim of this study was to determine the efficacy of single versus repetitive injection of lignocaine into the carpal tunnel for the management of carpal tunnel syndrome. The 42 patients included were randomly assigned to two Groups: group 1 was injected with 4 mL of 1% lignocaine once and Group 2 was injected with 4 mL of 1% lignocaine twice a week for 2 weeks. Clinical and electrophysiological evaluations were performed at the study onset, and at 6 and 12 weeks following the final injection. Initially, the groups were similar with respect to clinical and electrophysiological findings. All parameters in Group 2 improved 6 weeks post treatment (p < 0.05), and these improvements persisted at 12 weeks post treatment (p < 0.05). Repetitive local lignocaine injection was effective in reducing the symptoms of carpal tunnel syndrome and improving electrophysiological findings. PMID:25061062

  10. Preventing Acute Malnutrition among Young Children in Crises: A Prospective Intervention Study in Niger

    PubMed Central

    Langendorf, Céline; Roederer, Thomas; de Pee, Saskia; Brown, Denise; Doyon, Stéphane; Mamaty, Abdoul-Aziz; Touré, Lynda W.-M.; Manzo, Mahamane L.; Grais, Rebecca F.

    2014-01-01

    Background Finding the most appropriate strategy for the prevention of moderate acute malnutrition (MAM) and severe acute malnutrition (SAM) in young children is essential in countries like Niger with annual “hunger gaps.” Options for large-scale prevention include distribution of supplementary foods, such as fortified-blended foods or lipid-based nutrient supplements (LNSs) with or without household support (cash or food transfer). To date, there has been no direct controlled comparison between these strategies leading to debate concerning their effectiveness. We compared the effectiveness of seven preventive strategies—including distribution of nutritious supplementary foods, with or without additional household support (family food ration or cash transfer), and cash transfer only—on the incidence of SAM and MAM among children aged 6–23 months over a 5-month period, partly overlapping the hunger gap, in Maradi region, Niger. We hypothesized that distributions of supplementary foods would more effectively reduce the incidence of acute malnutrition than distributions of household support by cash transfer. Methods and Findings We conducted a prospective intervention study in 48 rural villages located within 15 km of a health center supported by Forum Santé Niger (FORSANI)/Médecins Sans Frontières in Madarounfa. Seven groups of villages (five to 11 villages) were allocated to different strategies of monthly distributions targeting households including at least one child measuring 60 cm–80 cm (at any time during the study period whatever their nutritional status): three groups received high-quantity LNS (HQ-LNS) or medium-quantity LNS (MQ-LNS) or Super Cereal Plus (SC+) with cash (€38/month [US$52/month]); one group received SC+ and family food ration; two groups received HQ-LNS or SC+ only; one group received cash only (€43/month [US$59/month]). Children 60 cm–80 cm of participating households were assessed at each monthly distribution from

  11. Evaluation of the PPAR-γ Agonist Pioglitazone in Mild Asthma: A Double-Blind Randomized Controlled Trial

    PubMed Central

    Anderson, J. R.; Pang, L.; Smith, K. M; Bailey, H.; Hodgson, D. B.; Shaw, D. E.; Knox, A. J.; Harrison, T. W.

    2016-01-01

    Background Peroxisome proliferator-activated receptor gamma (PPAR-γ) is a nuclear receptor that modulates inflammation in models of asthma. To determine whether pioglitazone improves measures of asthma control and airway inflammation, we performed a single-center randomized, double-blind, placebo-controlled, parallel-group trial. Methods Sixty-eight participants with mild asthma were randomized to 12 weeks pioglitazone (30 mg for 4 weeks, then 45 mg for 8 weeks) or placebo. The primary outcome was the adjusted mean forced expiratory volume in one second (FEV1) at 12 weeks. The secondary outcomes were mean peak expiratory flow (PEF), scores on the Juniper Asthma Control Questionnaire (ACQ) and Asthma Quality of Life Questionnaire (AQLQ), fractional exhaled nitric oxide (FeNO), bronchial hyperresponsiveness (PD20), induced sputum counts, and sputum supernatant interferon gamma-inducible protein-10 (IP-10), vascular endothelial growth factor (VEGF), monocyte chemotactic protein-1 (MCP-1), and eosinophil cationic protein (ECP) levels. Study recruitment was closed early after considering the European Medicines Agency’s reports of a potential increased risk of bladder cancer with pioglitazone treatment. Fifty-five cases were included in the full analysis (FA) and 52 in the per-protocol (PP) analysis. Results There was no difference in the adjusted FEV1 at 12 weeks (-0.014 L, 95% confidence interval [CI] -0.15 to 0.12, p = 0.84) or in any of the secondary outcomes in the FA. The PP analysis replicated the FA, with the exception of a lower evening PEF in the pioglitazone group (-21 L/min, 95% CI -39 to -4, p = 0.02). Conclusions We found no evidence that treatment with 12 weeks of pioglitazone improved asthma control or airway inflammation in mild asthma. Trial Registration ClinicalTrials.gov NCT01134835 PMID:27560168

  12. Chronic resistance training does not affect post-exercise blood pressure in normotensive older women: a randomized controlled trial.

    PubMed

    Gerage, Aline Mendes; Ritti-Dias, Raphael Mendes; do Nascimento, Matheus Amarante; Pina, Fábio Luiz Cheche; Gonçalves, Cássio Gustavo Santana; Sardinha, Luís B; Cyrino, Edilson Serpeloni

    2015-06-01

    Resistance training has been recommended for maintenance or improvement of the functional health of older adults, but its effect on acute cardiovascular responses remains unclear. Thus, the purpose of this study was to analyze the effect of 12 weeks of resistance training on post-exercise blood pressure (BP) in normotensive older women. Twenty-eight normotensive and physically inactive women (≥ 60 years) were randomly assigned to a training group (TG) or a control group (CG). The TG underwent a resistance training program (12 weeks, 8 exercises, 2 sets, 10-15 repetitions, 3 days/week), while the CG performed stretching exercises (12 weeks, 2 sets, 20 s each, 2 days/week). At baseline and after the intervention, participants were randomly submitted to two experimental sessions: a resistance exercise session (7 exercises, 2 sets, 10-15 repetitions) and a control session. BP was obtained pre- and post-sessions (90 min), through auscultation. Post-exercise hypotension was observed for systolic, diastolic, and mean BP in the TG (-6.1, -3.4, and -4.3 mmHg, respectively; P < 0.05) and in the CG (-4.1, -0.7, and -1.8 mmHg, respectively; P < 0.05). After the intervention period, the magnitude and pattern of this phenomenon for systolic, diastolic, and mean BP were similar between groups (TG -8.8, -4.1, and -5.7 mmHg, respectively; P < 0.05 vs CG -11.1, -5.8, and -7.6 mmHg, respectively; P < 0.05). These results indicate that a single session of resistance exercise promotes reduction in post-exercise BP and 12 weeks of resistance training program do not change the occurrence or magnitude of this hypotension. (ClinicalTrial.gov: NCT02346981).

  13. Outcomes from a Randomized Controlled Trial of a Group Intervention for HIV Positive Men and Women Coping with AIDS-Related Loss and Bereavement

    ERIC Educational Resources Information Center

    Sikkema, Kathleen J.; Hansen, Nathan B.; Kochman, Arlene; Tate, David C.; DiFranceisco, Wayne

    2004-01-01

    The purpose of this study was to examine the impact of a group coping intervention for HIV-positive men and women who have lost a loved one(s) to AIDS in the past 2 years. Two hundred thirty-five participants, diverse with respect to race/ethnicity and sexual orientation, were randomly assigned to a 12-week cognitive-behavioral group intervention…

  14. [Promoting non-smoking behavior in 13-year-old students in primary schools and high schools. A prospective, randomized intervention study with 1,956 students].

    PubMed

    Scholz, M; Kaltenbach, M

    2000-02-01

    1956 7th grade students of high schools and secondary modern schools in three cities with 110,000 to 180,000 inhabitants were asked about cigarette, alcohol and drug consumption using questionnaires. Subsequently 1080 of the students took part in a newly invented non-smoking curriculum which was held during 8 lessons within 4 weeks (intervention group (I)). The lessons were performed by non-smoking physicians who had passed a training programme before. 876 students served as control (C) group. 2 years later the questioning was repeated. The number of students who started smoking within the two years was significantly lower in the intervention group. In the high schools a significant effect was seen in boys (I: 13.0%, K: 22.4%; p < 0.01) and girls (I: 21.4%, K: 28.4%; p < 0.05) whereas in secondary modern schools a significant effect was seen only in boys (I: 17.4%, K: 25.2%; p < 0.05) not in girls (I: 18.0%, K: 22.0%; n.s.). First-time consumers of drugs like cannabis, marihuana and organic solvents were found less often in the intervention group among boys in high schools than in the control group (I: 14.9%; K: 23.6%; p < 0.05). No effects of the intervention were seen in girls of high schools and in students of secondary modern schools. No effects of the intervention were seen on alcohol consumption. Students who drank beer, wine or liquor several times a week were found at the same rate in the intervention and control groups. We conclude that a non-smoking intervention of 8 lessons in the 7th grade of high schools and secondary modern schools may lower the rate of first-time consumers of cigarettes but not of alcohol and drugs.

  15. Consumption of açai (Euterpe oleracea Mart.) functional beverage reduces muscle stress and improves effort tolerance in elite athletes: a randomized controlled intervention study.

    PubMed

    Carvalho-Peixoto, Jacqueline; Moura, Mirian Ribeiro Leite; Cunha, Felipe Amorim; Lollo, Pablo Christiano B; Monteiro, Walace David; Carvalho, Lucia Maria Jaeger de; Farinatti, Paulo de Tarso Veras

    2015-07-01

    The study analyzed the effect of an açai (Euterpe oleracea Mart.) functional beverage (AB) on muscle and oxidative stress markers, cardiorespiratory responses, perceived exertion, and time-to-exhaustion during maximal treadmill running. The beverage was developed as an ergogenic aid for athletes and contained 27.6 mg of anthocyanins per dose. Fourteen athletes performed 3 exercise tests: a ramp-incremental maximal exercise test and 2 maximal exercise bouts performed in 2 conditions (AB and without AB (control)) at 90% maximal oxygen uptake. Blood was collected at baseline and after maximal exercise in both conditions to determine biomarkers. AB increased time to exhaustion during short-term high-intensity exercise (mean difference: 69 s, 95% confidence interval = -296 s to 159 s, t = 2.2, p = 0.045), attenuating the metabolic stress induced by exercise (p < 0.05). AB also reduced perceived exertion and enhanced cardiorespiratory responses (p < 0.05). The AB may be a useful and practical ergogenic aid to enhance performance during high-intensity training. PMID:26140415

  16. Consumption of açai (Euterpe oleracea Mart.) functional beverage reduces muscle stress and improves effort tolerance in elite athletes: a randomized controlled intervention study.

    PubMed

    Carvalho-Peixoto, Jacqueline; Moura, Mirian Ribeiro Leite; Cunha, Felipe Amorim; Lollo, Pablo Christiano B; Monteiro, Walace David; Carvalho, Lucia Maria Jaeger de; Farinatti, Paulo de Tarso Veras

    2015-07-01

    The study analyzed the effect of an açai (Euterpe oleracea Mart.) functional beverage (AB) on muscle and oxidative stress markers, cardiorespiratory responses, perceived exertion, and time-to-exhaustion during maximal treadmill running. The beverage was developed as an ergogenic aid for athletes and contained 27.6 mg of anthocyanins per dose. Fourteen athletes performed 3 exercise tests: a ramp-incremental maximal exercise test and 2 maximal exercise bouts performed in 2 conditions (AB and without AB (control)) at 90% maximal oxygen uptake. Blood was collected at baseline and after maximal exercise in both conditions to determine biomarkers. AB increased time to exhaustion during short-term high-intensity exercise (mean difference: 69 s, 95% confidence interval = -296 s to 159 s, t = 2.2, p = 0.045), attenuating the metabolic stress induced by exercise (p < 0.05). AB also reduced perceived exertion and enhanced cardiorespiratory responses (p < 0.05). The AB may be a useful and practical ergogenic aid to enhance performance during high-intensity training.

  17. Reducing smoking reduces suicidality among individuals with psychosis: Complementary outcomes from a Healthy Lifestyles intervention study.

    PubMed

    Sankaranarayanan, Anoop; Clark, Vanessa; Baker, Amanda; Palazzi, Kerrin; Lewin, Terry J; Richmond, Robyn; Kay-Lambkin, Frances J; Filia, Sacha; Castle, David; Williams, Jill M

    2016-09-30

    This study sought to explore the impact of smoking reduction on suicidality (suicide ideation and behaviour) among people with a psychotic disorder (n=235) who participated in a randomized trial of a healthy lifestyle intervention trial. Suicidality, measured by item -4 of the Brief Psychiatric Rating Scale (BPRS) was the main variable of interest. Measures were collected by research assistants blind to treatment allocation at baseline, at 15 weeks (mid-intervention) and 12 months after baseline. Mediation analysis, adjusted for confounders, was used to determine the relationship between smoking reduction and suicidality and to explore whether this was mediated through depression. At 12 months, smoking reduction was found to be significantly associated with suicidality change; an association was also seen between smoking reduction and depression and depression and suicidality. After adjusting for depression, the association between smoking reduction and suicidality was attenuated but remained statistically significant; the proportion of the total effect that was mediated through depression was 30%. There was no significant association between suicidality and treatment group (vs. controls) over time. Our study suggests that smoking interventions may have benefits over and above those for improved physical health, by reducing suicidal ideation in people with psychosis. PMID:27450743

  18. A cross-national trial of brief interventions with heavy drinkers. WHO Brief Intervention Study Group.

    PubMed Central

    1996-01-01

    OBJECTIVES. The relative effects of simple advice and brief counseling were evaluated with heavy drinkers identified in primary care and other health settings in eight countries. METHODS. Subjects (1260 men, 299 women) with no prior history of alcohol dependence were selected if they consumed alcohol with sufficient frequency or intensity to be considered at risk of alcohol-related problems. Subjects were randomly assigned to a control group, a simple advice group, or a group receiving brief counseling. Seventy-five percent of subjects were evaluated 9 months later. RESULTS. Male patients exposed to the interventions reported approximately 17% lower average daily alcohol consumption than those in the control group. Reductions in the intensity of drinking were approximately 10%. For women, significant reductions were observed in both the control and the intervention groups. Five minutes of simple advice were as effective as 20 minutes of brief counseling. CONCLUSIONS. Brief interventions are consistently robust across health care settings and sociocultural groups and can make a significant contribution to the secondary prevention of alcohol-related problems if they are widely used in primary care. PMID:8669518

  19. The Keys to Healthy Family Child Care Homes intervention: Study design and rationale

    PubMed Central

    Østbye, Truls; Mann, Courtney M.; Vaughn, Amber E.; Namenek Brouwer, Rebecca J.; Benjamin Neelon, Sara E.; Hales, Derek; Bangdiwala, Shrikant I.; Ward, Dianne S.

    2014-01-01

    Background Obesity is a major public health problem for which early preventive interventions are needed. Large numbers of young children are enrolled in some form of child care program, making these facilities influential environments in children’s development. Family child care homes (FCCH) are a specific type of child care in which children are cared for within the provider’s own residence. FCCHs serve approximately 1.5 million children in the U.S.; however, research to date has overlooked FCCH providers and their potential to positively influence children’s health-related behaviors. Methods Keys to Healthy Family Child Care Homes (Keys) is a cluster-randomized controlled trial testing the efficacy of an intervention designed to help providers become healthy role models, provide quality food- and physical activity-supportive FCCH environments, and implement effective business practices. The intervention is delivered through workshops, home visits, tailored coaching calls, and educational toolkits. Primary outcomes are child physical activity measured via accelerometry data and dietary intake data collected using direct observation at the FCCH. Secondary outcomes include child body mass index, provider weight-related behaviors, and observed obesogenic environmental characteristics. Conclusion Keys is an innovative approach to promoting healthy eating and physical activity in young children. The intervention operates in a novel setting, targets children during a key developmental period, and addresses both provider and child behaviors to synergistically promote health. PMID:25460337

  20. Tai chi chuan: mind-body practice or exercise intervention? Studying the benefit for cancer survivors.

    PubMed

    Mansky, Patrick; Sannes, Tim; Wallerstedt, Dawn; Ge, Adeline; Ryan, Mary; Johnson, Laura Lee; Chesney, Margaret; Gerber, Lynn

    2006-09-01

    Tai chi chuan (TCC) has been used as a mind-body practice in Asian culture for centuries to improve wellness and reduce stress and has recently received attention by researchers as an exercise intervention. A review of the English literature on research in TCC published from 1989 to 2006 identified 20 prospective, randomized, controlled clinical trials in a number of populations, including elderly participants (7 studies), patients with cardiovascular complications (3 studies), patients with chronic disease (6 studies), and patients who might gain psychological benefit from TCC practice (2 studies). However, only the studies of TCC in the elderly and 2 studies of TCC for cardiovascular disease had adequate designs and size to allow conclusions about the efficacy of TCC. Most (11 studies) were small and provided limited information on the benefit of TCC in the settings tested. There is growing awareness that cancer survivors represent a population with multiple needs related to physical deconditioning, cardiovascular disease risk, and psychological stress. TCC as an intervention may provide benefit to cancer survivors in these multiple areas of need based on its characteristics of combining aspects of meditation and aerobic exercise. However, little research has been conducted to date to determine the benefit of TCC in this population. We propose a model to study the unique characteristics of TCC compared to physical exercise that may highlight characteristic features of this mind-body intervention in cancer survivors.

  1. Brief Online Training Enhances Competitive Performance: Findings of the BBC Lab UK Psychological Skills Intervention Study

    PubMed Central

    Lane, Andrew M.; Totterdell, Peter; MacDonald, Ian; Devonport, Tracey J.; Friesen, Andrew P.; Beedie, Christopher J.; Stanley, Damian; Nevill, Alan

    2016-01-01

    In conjunction with BBC Lab UK, the present study developed 12 brief psychological skill interventions for online delivery. A protocol was designed that captured data via self-report measures, used video recordings to deliver interventions, involved a competitive concentration task against an individually matched computer opponent, and provided feedback on the effects of the interventions. Three psychological skills were used; imagery, self-talk, and if-then planning, with each skill directed to one of four different foci: outcome goal, process goal, instruction, or arousal-control. This resulted in 12 different intervention participant groups (randomly assigned) with a 13th group acting as a control. Participants (n = 44,742) completed a competitive task four times—practice, baseline, following an intervention, and again after repeating the intervention. Results revealed performance improved following practice with incremental effects for imagery-outcome, imagery-process, and self-talk-outcome and self-talk-process over the control group, with the same interventions increasing the intensity of effort invested, arousal and pleasant emotion. Arousal-control interventions associated with pleasant emotions, low arousal, and low effort invested in performance. Instructional interventions were not effective. Results offer support for the utility of online interventions in teaching psychological skills and suggest brief interventions that focus on increasing motivation, increased arousal, effort invested, and pleasant emotions were the most effective. PMID:27065904

  2. Predictors of Sexual Risk Reduction Among Mexican Female Sex Workers Enrolled in a Behavioral Intervention Study

    PubMed Central

    Strathdee, Steffanie A.; Mausbach, Brent; Lozada, Remedios; Staines-Orozco, Hugo; Semple, Shirley J.; Abramovitz, Daniela; Fraga-Vallejo, Miguel; de la Torre, Adela; Amaro, Hortensia; Martínez-Mendizábal, Gustavo; Magis-Rodríguez, Carlos; Patterson, Thomas L.

    2009-01-01

    Objective We recently showed efficacy of an intervention to increase condom use among female sex workers (FSWs) in Tijuana and Ciudad Juarez, situated on the Mexico–United States border. We determined whether increases in condom use were predicted by social cognitive theory and injection drug user status among women randomized to this intervention. Methods Four hundred nine HIV-negative FSWs aged ≥18 years having unprotected sex with clients within the prior 2 months received a brief individual counseling session integrating motivational interviewing and principles of behavior change (ie, HIV knowledge, self-efficacy for using condoms, and outcome expectancies). Results Increases in self-efficacy scores were associated with increases in percent condom use (P = 0.008), whereas outcome expectancies were not. Female sex workers who inject drugs (FSW-IDUs) increased condom use with clients but not to the same extent as other FSWs (P = 0.09). Change in HIV knowledge was positively associated with change in percent condom use among FSW-IDUs (P = 0.03) but not noninjection drug users. Conclusions Increases in self-efficacy significantly predicted increased condom use among FSWs, consistent with social cognitive theory. Increased HIV knowledge was also important among FSW-IDUs, but their changes in condom use were modest. Enhanced interventions for FSW-IDUs are needed, taking into account realities of substance use during sexual transactions that can compromise safer sex negotiation. PMID:19384101

  3. Brief Online Training Enhances Competitive Performance: Findings of the BBC Lab UK Psychological Skills Intervention Study.

    PubMed

    Lane, Andrew M; Totterdell, Peter; MacDonald, Ian; Devonport, Tracey J; Friesen, Andrew P; Beedie, Christopher J; Stanley, Damian; Nevill, Alan

    2016-01-01

    In conjunction with BBC Lab UK, the present study developed 12 brief psychological skill interventions for online delivery. A protocol was designed that captured data via self-report measures, used video recordings to deliver interventions, involved a competitive concentration task against an individually matched computer opponent, and provided feedback on the effects of the interventions. Three psychological skills were used; imagery, self-talk, and if-then planning, with each skill directed to one of four different foci: outcome goal, process goal, instruction, or arousal-control. This resulted in 12 different intervention participant groups (randomly assigned) with a 13th group acting as a control. Participants (n = 44,742) completed a competitive task four times-practice, baseline, following an intervention, and again after repeating the intervention. Results revealed performance improved following practice with incremental effects for imagery-outcome, imagery-process, and self-talk-outcome and self-talk-process over the control group, with the same interventions increasing the intensity of effort invested, arousal and pleasant emotion. Arousal-control interventions associated with pleasant emotions, low arousal, and low effort invested in performance. Instructional interventions were not effective. Results offer support for the utility of online interventions in teaching psychological skills and suggest brief interventions that focus on increasing motivation, increased arousal, effort invested, and pleasant emotions were the most effective. PMID:27065904

  4. Effect of topical honey on limitation of radiation-induced oral mucositis: an intervention study.

    PubMed

    Khanal, B; Baliga, M; Uppal, N

    2010-12-01

    Radiation therapy for oral carcinoma is therapeutically useful in dose of at least 6000 cGy but causes mucositis that severely interferes with oral function. The literature indicates that honey appears to promote wound healing, so the authors investigated whether its anti-inflammatory properties might limit the severity of radiation-induced oral mucositis. A single-blinded, randomized, controlled clinical trial was carried out to compare the mucositis-limiting qualities of honey with lignocaine. A visual assessment scale permitted scoring of degrees of mucositis and statistical evaluation of the results was performed using the χ(2) test. Only 1 of 20 patients in the honey group developed intolerable oral mucositis compared with the lignocaine group, indicating that honey is strongly protective (RR=0.067) against the development of mucositis. The proportion of patients with intolerable oral mucositis was lower in the honey group and this was statistically significant (p=0.000). Honey applied topically to the oral mucosa of patients undergoing radiation therapy appears to provide a distinct benefit by limiting the severity of mucositis. Honey is readily available, affordable and well accepted by patients making it useful for improving the quality of life in irradiated patients.

  5. Impact of a pharmacist-prepared interim residential care medication administration chart on gaps in continuity of medication management after discharge from hospital to residential care: a prospective pre- and post-intervention study (MedGap Study)

    PubMed Central

    Tran, Tim; Taylor, Simone E; Harvey, Penelope A; Belfrage, Mary K; Jennings, Rhonda J; Marriott, Jennifer L

    2012-01-01

    Objectives To test the impact of a hospital pharmacist-prepared interim residential care medication administration chart (IRCMAC) on medication administration errors and use of locum medical services after discharge from hospital to residential care. Design Prospective pre-intervention and post-intervention study. Setting One major acute care hospital and one subacute aged-care hospital; 128 residential care facilities (RCF) in Victoria, Australia. Participants 428 patients (median age 84 years, IQR 79–88) discharged to a RCF from an inpatient ward over two 12-week periods. Intervention Seven-day IRCMAC auto-populated with patient and medication data from the hospitals' pharmacy dispensing software, completed and signed by a hospital pharmacist and sent with the patient to the RCF. Primary and secondary outcome measures Primary end points were the proportion of patients with one or more missed or significantly delayed (>50% of prescribed dose interval) medication doses, and the proportion of patients whose RCF medication chart was written by a locum doctor, in the 24 h after discharge. Secondary end points included RCF staff and general practitioners' opinions about the IRCMAC. Results The number of patients who experienced one or more missed or delayed doses fell from 37/202 (18.3%) to 6/226 (2.7%) (difference in percentages 15.6%, 95% CI 9.5% to 21.9%, p<0.001). The number of patients whose RCF medication chart was written by a locum doctor fell from 66/202 (32.7%) to 25/226 (11.1%) (difference in percentages 21.6%, 95% CI 13.5% to 29.7%, p<0.001). For 189/226 (83.6%) discharges, RCF staff reported that the IRCMAC improved continuity of care; 31/35 (88.6%) general practitioners said that the IRCMAC reduced the urgency for them to attend the RCF and 35/35 (100%) said that IRCMACs should be provided for all patients discharged to a RCF. Conclusions A hospital pharmacist-prepared IRCMAC significantly reduced medication errors and use of locum medical services

  6. Nasal cytology in southwest metropolitan Mexico City inhabitants: a pilot intervention study.

    PubMed

    Calderon-Garcidueñas, L; Roy-Ocotla, G

    1993-06-01

    Southwest metropolitan Mexico City (SWMMC) inhabitants have been exposed several hours per day for the last 6 years to photochemical smog, ozone being the most important oxidant pollutant. Subjects exposed to the SWMMC atmosphere develop several histopathological changes in their nasal mucosa: dysplasia is the most significant, affecting 78.72% of adult individuals within 60 or more days of residence in SWMMC. This study was originally designed to explore whether chemical intervention could modify nasal dysplasia, as determined by nasal cytology, in a defined adult population. In a placebo-controlled, randomized, double-blind trial, 177 healthy male subjects were divided into 5 groups to whom 5000 IU of vitamin A, 100 IU of vitamin E, a combination of vitamins A and E (5000 IU + 100 IU), 16 mg of beta-carotene, or placebo were administered daily for 4 months. Sixteen clinical and cytological variables were monitored. No effect on dysplasia was seen at the end of the 4-month trial; however, an apparent reversibility as well as progression of the dysplastic nasal lesions and high correlation coefficients between dysplasia and nasal cytology of polymorphonuclear leukocytes (PMNs; 0.85), squamous metaplasia (SM; 0.50), and nasal mucosa atrophy (NMA; 0.41) were found. A mathematical theoretical nasal dysplasia (tD) predictor equation for SWMMC adult male inhabitants is proposed (tD = 0.85 delta PMNs + 0.50 delta SM + 0.41 delta NMA + 0.98), in which PMNs are the best single dysplasia predictor, and all variables are independent.(ABSTRACT TRUNCATED AT 250 WORDS)

  7. Nasal cytology in southwest metropolitan Mexico City inhabitants: A pilot intervention study

    SciTech Connect

    Calderon-Garciduenas, L.; Roy-Ocotla, G. )

    1993-06-01

    Southwest metropolitan Mexico City (SWMMC) inhabitants have been exposed several hours per day for the last 6 years to photochemical smog, ozone being the most important oxidant pollutant. Subjects exposed to the SWMMC atmosphere develop several histopathological changes in their nasal mucosa: dysplasia is the most significant, affecting 78.72% of adult individuals within 60 or more days of residence in SWMMC. This study was originally designed to explore whether chemical intervention could modify nasal dysplasia, as determined by nasal cytology, in a defined adult population. In a placebo-controlled, randomized, double-blind trial, 177 healthy male subjects were divided into 5 groups to whom 5000 IU of vitamin A, 100 IU of vitamin E, a combination of vitamins A and E (5000 IU + 100 IU), 16 mg of beta-carotene, or placebo were administered daily for 4 months. Sixteen clinical and cytological variables were monitored. No effect on dysplasia was seen at the end of the 4-month trial; however, an apparent reversibility as well as progression of the dysplastic nasal lesions and high correlation coefficients between dysplasia and nasal cytology of polymorphonuclear leukocytes (PMNs; 0.85), squamous metaplasia (SM; 0.50), and nasal mucosa atrophy (NMA; 0.41) were found. A mathematical theoretical nasal dysplasia (tD) predictor equation for SWMMC adult male inhabitants is proposed (tD = 0.85 delta PMNs + 0.50 delta SM + 0.41 delta NMA + 0.98), in which PMNs are the best single dysplasia predictor, and all variables are independent.

  8. Supporting Well-Being in Retirement through Meaningful Social Roles: Systematic Review of Intervention Studies

    PubMed Central

    Heaven, Ben; Brown, Laura Je; White, Martin; Errington, Linda; Mathers, John C; Moffatt, Suzanne

    2013-01-01

    Context The marked demographic change toward greater proportions of older people in developed nations poses significant challenges for health and social care. Several studies have demonstrated an association between social roles in later life and positive health and well-being outcomes. After retiring from work, people may lose roles that provide purpose and social contacts. The outcomes of interventions to promote social roles in retirement have not been systematically reviewed. Methods We examined three research questions: (1) What kinds of intervention have been developed to promote social roles in retirement? (2) How much have they improved perceived roles? (3) Have these roles improved health or well-being? We included those studies that evaluated the provision of social roles; used a control or comparison group; targeted healthy retirement-transition adults who were living in the community; provided an abstract written in English; took place in a highly developed nation; and reported social role, health, or well-being outcomes. We searched eight electronic databases and combined the results with hand searches. Findings Through our searches, we identified 9,062 unique publications and eleven evaluative studies of acceptable quality, which reported seven interventions that met our inclusion criteria. These interventions varied in year of inception and scope, but only two were based outside North America. The studies rarely reported the quality or meaning of roles. Only three studies used random allocation, thus limiting inferences of causality from these studies. Interventions providing explicit roles and using supportive group structures were somewhat effective in improving one or more of the following: life satisfaction, social support and activity, physical health and activity, functional health, and cognition. Conclusions Social role interventions may improve health and well-being for people in retirement transition. Future research should improve the

  9. Strategies to recruit and retain older adults in intervention studies: a quantitative comparative study.

    PubMed

    Michelet, Mona; Lund, Anne; Sveen, Unni

    2014-01-01

    Recruitment and retention of participants in randomized controlled trials (RCTs) drawn from the older population is challenging, and studies have shown that poor recruitment and retention may lead to biased samples and results. Several strategies to improve the participation of older adults in research are outlined in the literature. The objective was to identify factors associated with participation in an RCT aiming at preventing depressive symptoms and social isolation in a later phase following a stroke, in an older population living in their homes. Strategies to improve participation were applied in the RCT "Lifestyle intervention for older adults in rehabilitation after stroke: development, implementation and evaluation". Quantitative data collected on participants (n=99) and non-participants (n=56) in the trial were compared using statistical analyses. The findings are in line with earlier studies in that the participants were younger (p=0.01) and received less help in the home (p=0.01) than did non-participants. The results differ from earlier studies in that participants had a higher rate of depressive symptoms (participation rate was 57% with HAD depression scale score 0-2, 61% with score 3-4, 62% with score 5-6 and 79% with a score 7 or above). The findings also illustrate a poorer health-related quality of life among the participants in the role physical domain on Short Form-36 (p=0.01). The results indicate that the use of targeted strategies to enhance participation may lead to a less biased sample as well as the inclusion of more subjects who seem to meet the aims of the intervention.

  10. Effects of sodium and potassium supplementation on endothelial function: a fully controlled dietary intervention study.

    PubMed

    Gijsbers, Lieke; Dower, James I; Schalkwijk, Casper G; Kusters, Yvo H A M; Bakker, Stephan J L; Hollman, Peter C H; Geleijnse, Johanna M

    2015-11-14

    High Na and low K intakes have adverse effects on blood pressure, which increases the risk for CVD. The role of endothelial dysfunction and inflammation in this pathophysiological process is not yet clear. In a randomised placebo-controlled cross-over study in untreated (pre)hypertensives, we examined the effects of Na and K supplementation on endothelial function and inflammation. During the study period, subjects were provided with a diet that contained 2·4 g/d of Na and 2·3 g/d of K for a 10 460 kJ (2500 kcal) intake. After 1-week run-in, subjects received capsules with supplemental Na (3·0 g/d), supplemental K (2·8 g/d) or placebo, for 4 weeks each, in random order. After each intervention, circulating biomarkers of endothelial function and inflammation were measured. Brachial artery flow-mediated dilation (FMD) and skin microvascular vasomotion were assessed in sub-groups of twenty-two to twenty-four subjects. Of thirty-seven randomised subjects, thirty-six completed the study. Following Na supplementation, serum endothelin-1 was increased by 0·24 pg/ml (95 % CI 0·03, 0·45), but no change was seen in other endothelial or inflammatory biomarkers. FMD and microvascular vasomotion were unaffected by Na supplementation. K supplementation reduced IL-8 levels by 0·28 pg/ml (95 % CI 0·03, 0·53), without affecting other circulating biomarkers. FMD was 1·16 % (95% CI 0·37, 1·96) higher after K supplementation than after placebo. Microvascular vasomotion was unaffected. In conclusion, a 4-week increase in Na intake increased endothelin-1, but had no effect on other endothelial or inflammatory markers. Increased K intake had a beneficial effect on FMD and possibly IL-8, without affecting other circulating endothelial or inflammatory biomarkers.

  11. A preliminary, randomized trial of aerobic exercise for alcohol dependence.

    PubMed

    Brown, Richard A; Abrantes, Ana M; Minami, Haruka; Read, Jennifer P; Marcus, Bess H; Jakicic, John M; Strong, David R; Dubreuil, Mary Ella; Gordon, Alan A; Ramsey, Susan E; Kahler, Christopher W; Stuart, Gregory L

    2014-07-01

    Interventions targeting physical activity may be valuable as an adjunct to alcohol treatment, but have been relatively untested. In the current study, alcohol dependent, physically sedentary patients were randomized to: a 12-week moderate-intensity, group aerobic exercise intervention (AE; n=25) or a brief advice to exercise intervention (BA-E; n=23). Results showed that individuals in AE reported significantly fewer drinking and heavy drinking days, relative to BA-E during treatment. Furthermore adherence to AE strengthened the beneficial effect of intervention on alcohol use outcomes. While high levels of moderate-intensity exercise appeared to facilitate alcohol recovery regardless of intervention arm, attending the group-based AE intervention seemed to further enhance the positive effects of exercise on alcohol use. Study findings indicate that a moderate intensity, group aerobic exercise intervention is an efficacious adjunct to alcohol treatment. Improving adherence to the intervention may enhance its beneficial effects on alcohol use.

  12. A Randomized, Open-Label, Comparative Study of Efficacy and Safety of Tolterodine Combined with Tamsulosin or Doxazosin in Patients with Benign Prostatic Hyperplasia

    PubMed Central

    Cao, Yanwei; Wang, Yonghua; Guo, Lei; Yang, Xuecheng; Chen, Tao; Niu, Haitao

    2016-01-01

    Background Benign prostatic hyperplasia (BPH), a common disease in men over age 50 years, often causes bladder outlet obstruction and lower urinary tract symptoms (LUTS). Alpha blockers in combination with muscarinic receptor antagonists may have the potential to improve symptoms. This study aimed to assess the efficacy and safety of doxazosin or tamsulosin combined with tolterodine extend release (ER) in patients with BPH and LUTS. Material/Methods In a prospective, randomized, open-label study (ChiCTR-IPR-15005763), 220 consecutive men with BPH and LUTS were allocated to receive doxazosin 4 mg and tolterodine ER 4 mg per day (doxazosin group) or tamsulosin 0.2 mg and tolterodine ER 4 mg per day (tamsulosin group). Treatment lasted 12 weeks. The primary endpoint was the international prostatic symptom score (IPSS). Secondary endpoints were quality of life (QoL) and maximum flow rate (Qmax), which were evaluated at 0, 6, and 12 weeks, and urodynamic parameters assessed at 0 and 12 weeks. Results A total of 192 patients completed the trial. Baseline measurements showed no differences between the groups. After 6 weeks, IPSS improved in both groups and QoL was significantly better in the doxazosin group (P=0.01). After 12 weeks, Qmax, IPSS, QoL, intravesical pressure (Pves), and bladder compliance (BC) in the doxazosin group were significantly better than in the tamsulosin group (P=0.03, P<0.001, P<0.001, P=0.027, and P=0.044, respectively). Conclusions Administration of alpha blockers combined with muscarinic receptor blocker for 12 weeks improved LUTS in men with BPH. PMID:27260129

  13. A Randomized, Open-Label, Comparative Study of Efficacy and Safety of Tolterodine Combined with Tamsulosin or Doxazosin in Patients with Benign Prostatic Hyperplasia.

    PubMed

    Cao, Yanwei; Wang, Yonghua; Guo, Lei; Yang, Xuecheng; Chen, Tao; Niu, Haitao

    2016-01-01

    BACKGROUND Benign prostatic hyperplasia (BPH), a common disease in men over age 50 years, often causes bladder outlet obstruction and lower urinary tract symptoms (LUTS). Alpha blockers in combination with muscarinic receptor antagonists may have the potential to improve symptoms. This study aimed to assess the efficacy and safety of doxazosin or tamsulosin combined with tolterodine extend release (ER) in patients with BPH and LUTS. MATERIAL AND METHODS In a prospective, randomized, open-label study (ChiCTR-IPR-15005763), 220 consecutive men with BPH and LUTS were allocated to receive doxazosin 4 mg and tolterodine ER 4 mg per day (doxazosin group) or tamsulosin 0.2 mg and tolterodine ER 4 mg per day (tamsulosin group). Treatment lasted 12 weeks. The primary endpoint was the international prostatic symptom score (IPSS). Secondary endpoints were quality of life (QoL) and maximum flow rate (Qmax), which were evaluated at 0, 6, and 12 weeks, and urodynamic parameters assessed at 0 and 12 weeks. RESULTS A total of 192 patients completed the trial. Baseline measurements showed no differences between the groups. After 6 weeks, IPSS improved in both groups and QoL was significantly better in the doxazosin group (P=0.01). After 12 weeks, Qmax, IPSS, QoL, intravesical pressure (Pves), and bladder compliance (BC) in the doxazosin group were significantly better than in the tamsulosin group (P=0.03, P<0.001, P<0.001, P=0.027, and P=0.044, respectively). CONCLUSIONS Administration of alpha blockers combined with muscarinic receptor blocker for 12 weeks improved LUTS in men with BPH.

  14. Trials and tribulations of conducting interventional studies in urban slums of a developing country: Experiences from Kolkata, India.

    PubMed

    Mahapatra, Tanmay; Mahapatra, Sanchita; Pal, Debottam; Saha, Jayanta; Lopez, AnnaLena; Ali, Mohammad; Bannerjee, Barnali; Manna, Byomkesh; Sur, Dipika; Bhattacharya, Sujit; Kanungo, Suman

    2016-01-01

    Experimental studies involving human subjects provide most internally valid evidences in epidemiological research due to their robust methodology. While conducting population-based interventional studies, to achieve external validity, inclusion of information from vulnerable groups like urban slum-dwellers of the developing world, in the epidemiological estimates is of paramount importance. The challenges faced while conducting 2 consecutive large-scale, community-based vaccine trials in urban slums of Kolkata, India are presented in this article. Interventions in these communities often get constrained by issues pertaining to human rights and benefits, socio-cultural factors, political environment, methodological shortcomings in addition to the challenges in ensuring community participation. While conducting these trials although we intermittently faced obstacles, by virtue of having a long term and robust surveillance system and developing a trusted relationship between the researchers, community leaders and residents we were able to come up with a commendable community participation which culminated into the success of the interventions. Bridging the gap between research and field operations by incorporating knowledge gathered from interventional studies and making strategies to improve health conditions of these informal settlers is a major unfulfilled agenda. We believe the lessons learnt during our research will help researchers while developing efficient interventions in similar setting.

  15. Trials and tribulations of conducting interventional studies in urban slums of a developing country: Experiences from Kolkata, India

    PubMed Central

    Mahapatra, Tanmay; Mahapatra, Sanchita; Pal, Debottam; Saha, Jayanta; Lopez, AnnaLena; Ali, Mohammad; Bannerjee, Barnali; Manna, Byomkesh; Sur, Dipika; Bhattacharya, Sujit; Kanungo, Suman

    2016-01-01

    Experimental studies involving human subjects provide most internally valid evidences in epidemiological research due to their robust methodology. While conducting population-based interventional studies, to achieve external validity, inclusion of information from vulnerable groups like urban slum-dwellers of the developing world, in the epidemiological estimates is of paramount importance. The challenges faced while conducting 2 consecutive large-scale, community-based vaccine trials in urban slums of Kolkata, India are presented in this article. Interventions in these communities often get constrained by issues pertaining to human rights and benefits, socio-cultural factors, political environment, methodological shortcomings in addition to the challenges in ensuring community participation. While conducting these trials although we intermittently faced obstacles, by virtue of having a long term and robust surveillance system and developing a trusted relationship between the researchers, community leaders and residents we were able to come up with a commendable community participation which culminated into the success of the interventions. Bridging the gap between research and field operations by incorporating knowledge gathered from interventional studies and making strategies to improve health conditions of these informal settlers is a major unfulfilled agenda. We believe the lessons learnt during our research will help researchers while developing efficient interventions in similar setting. PMID:26224251

  16. Utility of a thematic network in primary health care: a controlled interventional study in a rural area

    PubMed Central

    Coma del Corral, Maria Jesús; Abaigar Luquín, Pedro; Cordero Guevara, José; Olea Movilla, Angel; Torres Torres, Gerardo; Lozano Garcia, Javier

    2005-01-01

    Background UniNet is an Internet-based thematic network for a virtual community of users (VCU). It supports a virtual multidisciplinary community for physicians, focused on the improvement of clinical practice. This is a study of the effects of a thematic network such as UniNet on primary care medicine in a rural area, specifically as a platform of communication between specialists at the hospital and doctors in the rural area. Methods In order to study the effects of a thematic network such as UniNet on primary care medicine in a rural area, we designed an interventional study that included a control group. The measurements included the number of patient displacements due to disease, number of patient hospital stays and the number of prescriptions of drugs of low therapeutic utility and generic drug prescriptions by doctors. These data were analysed and compared with those of the control center. Results Our study showed positive changes in medical practice, reflected in the improvement of the evaluated parameters in the rural health area where the interventional study was carried out, compared with the control area. We discuss the strengths and weaknesses of UniNet as a potential medium to improve the quality of medical care in rural areas. Conclusion The rural doctors had an effective, useful, user-friendly and cheap source of medical information that may have contributed to the improvement observed in the medical quality indices. PMID:16042778

  17. Effects of low-fat dairy consumption on markers of low-grade systemic inflammation and endothelial function in overweight and obese subjects: an intervention study.

    PubMed

    van Meijl, Leonie E C; Mensink, Ronald P

    2010-11-01

    Although increased concentrations of plasma inflammatory markers are not one of the criteria to diagnose the metabolic syndrome, low-grade systemic inflammation is receiving large attention as a metabolic syndrome component and cardiovascular risk factor. As several epidemiological studies have suggested a negative relationship between low-fat dairy consumption and the metabolic syndrome, we decided to investigate the effects of low-fat dairy consumption on inflammatory markers and adhesion molecules in overweight and obese subjects in an intervention study. Thirty-five healthy subjects (BMI>27 kg/m²) consumed, in a random order, low-fat dairy products (500 ml low-fat milk and 150 g low-fat yogurt) or carbohydrate-rich control products (600 ml fruit juice and three fruit biscuits) daily for 8 weeks. Plasma concentrations of TNF-α were decreased by 0.16 (SD 0.50) pg/ml (P = 0.070), and soluble TNF-α receptor-1 (s-TNFR-1) was increased by 110.0 (SD 338.4) pg/ml (P = 0.062) after the low-fat dairy period than after the control period. s-TNFR-2 was increased by 227.0 (SD 449.0) pg/ml (P = 0.020) by the dairy intervention. As a result, the TNF-α index, defined as the TNF-α:s-TNFR-2 ratio, was decreased by 0.000053 (SD 0.00012) (P = 0.015) after the dairy diet consumption. Low-fat dairy consumption had no effect on IL-6, monocyte chemoattractant protein-1, intracellular adhesion molecule-1 and vascular cell adhesion molecule-1 concentrations. The present results indicate that in overweight and obese subjects, low-fat dairy consumption for 8 weeks may increase concentrations of s-TNFR compared with carbohydrate-rich product consumption, but that it has no effects on other markers of chronic inflammation and endothelial function.

  18. Impact of palm date consumption on microbiota growth and large intestinal health: a randomised, controlled, cross-over, human intervention study.

    PubMed

    Eid, Noura; Osmanova, Hristina; Natchez, Cecile; Walton, Gemma; Costabile, Adele; Gibson, Glenn; Rowland, Ian; Spencer, Jeremy P E

    2015-10-28

    The reported inverse association between the intake of plant-based foods and a reduction in the prevalence of colorectal cancer may be partly mediated by interactions between insoluble fibre and (poly)phenols and the intestinal microbiota. In the present study, we assessed the impact of palm date consumption, rich in both polyphenols and fibre, on the growth of colonic microbiota and markers of colon cancer risk in a randomised, controlled, cross-over human intervention study. A total of twenty-two healthy human volunteers were randomly assigned to either a control group (maltodextrin-dextrose, 37·1 g) or an intervention group (seven dates, approximately 50 g). Each arm was of 21 d duration and was separated by a 14-d washout period in a cross-over manner. Changes in the growth of microbiota were assessed by fluorescence in situ hybridisation analysis, whereas SCFA levels were assessed using HPLC. Further, ammonia concentrations, faecal water genotoxicity and anti-proliferation ability were also assessed using different assays, which included cell work and the Comet assay. Accordingly, dietary intakes, anthropometric measurements and bowel movement assessment were also carried out. Although the consumption of dates did not induce significant changes in the growth of select bacterial groups or SCFA, there were significant increases in bowel movements and stool frequency (P<0·01; n 21) and significant reductions in stool ammonia concentration (P<0·05; n 21) after consumption of dates, relative to baseline. Furthermore, date fruit intake significantly reduced genotoxicity in human faecal water relative to control (P<0·01; n 21). Our data indicate that consumption of date fruit may reduce colon cancer risk without inducing changes in the microbiota.

  19. Adolescent Diet and Subsequent Serum Hormones, Breast Density and Bone Mineral Density in Young Women: Results of the Dietary Intervention Study in Children (DISC) Follow-Up Study

    PubMed Central

    Dorgan, Joanne F.; Liu, Lea; Klifa, Catherine; Hylton, Nola; Shepherd, John A.; Stanczyk, Frank Z.; Snetselaar, Linda G.; Van Horn, Linda; Stevens, Victor J.; Robson, Alan; Kwiterovich, Peter O.; Lasser, Norman L.; Himes, John H.; Gabriel, Kelley Pettee; Kriska, Andrea; Ruder, Elizabeth H.; Fang, Carolyn Y.; Barton, Bruce A.

    2010-01-01

    Background Adolescent diet is hypothesized to influence breast cancer risk. We evaluated the long-term effects of an intervention to lower fat intake among adolescent girls on biomarkers that are related to breast cancer risk in adults. Methods A follow-up study was conducted of 230 girls who participated in the Dietary Intervention Study in Children (DISC), in which healthy, prepubertal 8-10 year olds were randomly assigned to usual care or to a behavioral intervention that promoted a reduced fat diet. Participants were 25-29 years old at follow-up visits. All tests of statistical significance are two-sided. Results In analyses that did not take account of diet at the time of the follow-up visit, the only statistically significant treatment group difference was higher bone mineral content (BMC) in intervention group participants compared to usual care group participants; their mean BMCs were 2,444g and 2,377g, respectively. After adjustment for current diet, the intervention group also had statistically significantly higher bone mineral density and luteal phase serum estradiol concentrations. Serum progesterone concentrations and breast density did not differ by treatment group in unadjusted or adjusted analyses. Conclusion Results do not support the hypothesis that consumption of a lower fat diet during adolescence reduces breast cancer risk via effects on subsequent serum estradiol and progesterone levels, breast density or BMD. Impact Additional research is needed to clarify the association of adolescent diet with breast cancer risk and to determine if the results reported here are specific to the DISC intervention or more broadly applicable. PMID:20501774

  20. An exploratory intervention study suggests clinical benefits of training in chronic stroke to be paralleled by changes in brain activity using repeated fMRI

    PubMed Central

    Landsmann, Barbara; Pinter, Daniela; Pirker, Eva; Pichler, Gerald; Schippinger, Walter; Weiss, Elisabeth M; Mathie, Gabriel; Gattringer, Thomas; Fazekas, Franz; Enzinger, Christian

    2016-01-01

    Purpose Previous studies demonstrated changes in sensorimotor network activation over time after stroke that have been interpreted as partly compensatory. Locomotor and balance trainings may improve both mobility and cognition even in chronic stroke and thereby impact on cerebral activation patterns. We here aimed at testing these assumptions in an exploratory study to inform subsequent larger intervention studies. Patients and methods Eight patients (73.3±4.4 years) with a chronic lacunar stroke (mean interval 3.7 years after the acute event with a range from 2 to 4 years) and residual leg paresis leading to gait disturbance received a guided 5-week training focusing on mobility, endurance, and coordination. Before and afterward, they underwent clinical, neuropsychological, and gait assessments and brain MRI at 3 T including a functional ankle movement paradigm. Sixteen healthy controls (HCs; 68.8±5.4 years) followed the same protocol without intervention. Results After training, patients had improved in mobility, memory, and delayed recall of memory. While cerebral activations in HC remained completely unaltered, patients showed increased activations in the right precentral gyrus, the right and left superior frontal gyri, and the right frontal lobe, with bipedal ankle movements after training. Conclusion In this exploratory study of chronic stroke, we found not only significant effects of physical training on mobility but also distinct aspects of cognition already with a small number of highly selected patients. These improvements were paralleled by alterations in cerebral activity possibly reflecting neuronal plasticity. Larger studies including randomization are needed. PMID:26869779

  1. Impact of palm date consumption on microbiota growth and large intestinal health: a randomised, controlled, cross-over, human intervention study.

    PubMed

    Eid, Noura; Osmanova, Hristina; Natchez, Cecile; Walton, Gemma; Costabile, Adele; Gibson, Glenn; Rowland, Ian; Spencer, Jeremy P E

    2015-10-28

    The reported inverse association between the intake of plant-based foods and a reduction in the prevalence of colorectal cancer may be partly mediated by interactions between insoluble fibre and (poly)phenols and the intestinal microbiota. In the present study, we assessed the impact of palm date consumption, rich in both polyphenols and fibre, on the growth of colonic microbiota and markers of colon cancer risk in a randomised, controlled, cross-over human intervention study. A total of twenty-two healthy human volunteers were randomly assigned to either a control group (maltodextrin-dextrose, 37·1 g) or an intervention group (seven dates, approximately 50 g). Each arm was of 21 d duration and was separated by a 14-d washout period in a cross-over manner. Changes in the growth of microbiota were assessed by fluorescence in situ hybridisation analysis, whereas SCFA levels were assessed using HPLC. Further, ammonia concentrations, faecal water genotoxicity and anti-proliferation ability were also assessed using different assays, which included cell work and the Comet assay. Accordingly, dietary intakes, anthropometric measurements and bowel movement assessment were also carried out. Although the consumption of dates did not induce significant changes in the growth of select bacterial groups or SCFA, there were significant increases in bowel movements and stool frequency (P<0·01; n 21) and significant reductions in stool ammonia concentration (P<0·05; n 21) after consumption of dates, relative to baseline. Furthermore, date fruit intake significantly reduced genotoxicity in human faecal water relative to control (P<0·01; n 21). Our data indicate that consumption of date fruit may reduce colon cancer risk without inducing changes in the microbiota. PMID:26428278

  2. How to Do Random Allocation (Randomization)

    PubMed Central

    Shin, Wonshik

    2014-01-01

    Purpose To explain the concept and procedure of random allocation as used in a randomized controlled study. Methods We explain the general concept of random allocation and demonstrate how to perform the procedure easily and how to report it in a paper. PMID:24605197

  3. Effects of combined exercise on physical fitness and neurotransmitters in children with ADHD: a pilot randomized controlled study.

    PubMed

    Lee, Sun-Kyoung; Lee, Chung-Moo; Park, Jong-Hwan

    2015-09-01

    [Purpose] The purpose of the present study was to determine the effect of a jump rope and ball combined exercise program on the physical fitness the neurotransmitter (epinephrine, serotonin) levels of children with attention-deficit hyperactivity disorder. [Subjects and Methods] The subjects were 12 boys attending elementary school, whose grade levels ranged from 1-4. The block randomization method was used to distribute the participants between the combined exercise group (n = 6) and control group (n = 6). The program consisted of a 60-min exercise (10-min warm-up, 40-min main exercise, and 10-min cool down) performed three times a week, for a total of 12 weeks. [Results] The exercise group showed a significant improvement in cardiorespiratory endurance, muscle strength, muscle endurance and flexibility after 12 weeks. A significant increase in the epinephrine level was observed in the exercise group. [Conclusion] The 12-week combined exercise program in the current study (jump rope and ball exercises) had a positive effect on overall fitness level, and neurotransmission in children with attention-deficit hyperactivity disorder. PMID:26504324

  4. Effects of combined exercise on physical fitness and neurotransmitters in children with ADHD: a pilot randomized controlled study.

    PubMed

    Lee, Sun-Kyoung; Lee, Chung-Moo; Park, Jong-Hwan

    2015-09-01

    [Purpose] The purpose of the present study was to determine the effect of a jump rope and ball combined exercise program on the physical fitness the neurotransmitter (epinephrine, serotonin) levels of children with attention-deficit hyperactivity disorder. [Subjects and Methods] The subjects were 12 boys attending elementary school, whose grade levels ranged from 1-4. The block randomization method was used to distribute the participants between the combined exercise group (n = 6) and control group (n = 6). The program consisted of a 60-min exercise (10-min warm-up, 40-min main exercise, and 10-min cool down) performed three times a week, for a total of 12 weeks. [Results] The exercise group showed a significant improvement in cardiorespiratory endurance, muscle strength, muscle endurance and flexibility after 12 weeks. A significant increase in the epinephrine level was observed in the exercise group. [Conclusion] The 12-week combined exercise program in the current study (jump rope and ball exercises) had a positive effect on overall fitness level, and neurotransmission in children with attention-deficit hyperactivity disorder.

  5. Evaluation of Rhubarb Supplementation in Stages 3 and 4 of Chronic Kidney Disease: A Randomized Clinical Trial

    PubMed Central

    Khan, Irfan A.; Nasiruddin, Mohammad; Haque, Shahzad F.; Khan, Rahat A.

    2014-01-01

    Objective. To evaluate the efficacy and safety of Rhubarb supplementation in patients of chronic kidney disease. Material and Methods. This study was a prospective comparative study conducted in patients of chronic kidney disease (stages 3 & 4) attending Renal Clinic of Department of Medicine, JN Medical College & Hospital, AMU, Aligarh. Patients were randomly divided into two interventional groups. Group I (Control) was given conservative management while Group II (Rhubarb) received conservative management along with Rhubarb capsule (350 mg, thrice daily) for 12 weeks. Haemogram and renal function tests were measured at 0, 4, 8, and 12 weeks of treatment. Results. There was progressive improvement in clinical features in both the groups after 12 weeks of treatment but Rhubarb group showed more marked improvement as compared to control group. Both groups showed gradual improvement in the biochemical parameters as compared to their pretreated values which was more marked in Rhubarb supplemented group. There was reduction in blood glucose, blood urea, serum creatinine, and 24 hour total urine protein (TUP). There was increase in haemoglobin, 24 hour total urine volume (TUV), and glomerular filtration rate (GFR). There was no statistical difference in two groups with respect to side effects (P > 0.05). Conclusion. Rhubarb supplementation improved the therapeutic effect of conservative management in stage 3 and stage 4 patients of chronic kidney disease. PMID:26464863

  6. Dry-needling and exercise for chronic whiplash-associated disorders: a randomized single-blind placebo-controlled trial.

    PubMed

    Sterling, Michele; Vicenzino, Bill; Souvlis, Tina; Connelly, Luke B

    2015-04-01

    This randomized controlled trial investigated the effectiveness and cost-effectiveness of dry-needling and exercise compared with sham dry-needling and exercise for chronic whiplash-associated disorders (WAD). The setting was a single university centre and 4 physiotherapy practices in Queensland, Australia. Eighty patients with chronic WAD (>3 months) were enrolled between June 2009 and August 2012 with 1-year follow-up completed in August 2013. The interventions were 6 weeks of dry-needling to posterior neck muscles (n = 40) and exercise or sham dry-needling and exercise (n = 40). The primary outcomes of the Neck Disability Index (NDI) and self-rated recovery were measured at baseline, 6 and 12 weeks, 6 and 12 months by a blinded assessor. Analysis was intention to treat. An economic evaluation was planned but missing data deemed further analysis unwarranted. Seventy-nine patients (99%) were followed up at 6 weeks, 78 (98%) at 12 weeks, 74 (93%) at 6 months, and 73 (91%) at 12 months. The dry-needling and exercise intervention was more effective than sham dry-needling and exercise in reducing disability at 6 and 12 months but not at 6 and 12 weeks. The treatment effects were small and not clinically worthwhile. At 6 weeks, the treatment effect on the 0-100 NDI was -0.3 (95% confidence interval -5.4 to 4.7), 12 weeks -0.3 (-5.2 to 4.9), 6 months -4.4 (-9.6 to -0.74), and 12 months -3.8 (-9.1 to -0.5). There was no effect for self-rated recovery. In patients with chronic WAD, dry-needling and exercise has no clinically worthwhile effects over sham dry-needling and exercise. PMID:25790454

  7. The Effect of Green Tea Ingestion and Interval Sprinting Exercise on the Body Composition of Overweight Males: A Randomized Trial

    PubMed Central

    Gahreman, Daniel; Heydari, Mehrdad; Boutcher, Yati; Freund, Judith; Boutcher, Stephen

    2016-01-01

    The combined effect of green tea ingestion and interval sprinting exercise on body and abdominal fat of overweight males was investigated. Participants were randomly assigned into control (C), green tea (GT), interval sprinting exercise (ISE), and green tea and ISE (GT + ISE) groups. The GT, GT + ISE, and C groups consumed three GT capsules daily. The ISE and GT + ISE groups completed 36 ISE sessions over 12 weeks. Forty eight overweight males with a mean BMI of 28.5 ± 0.92 kg/m2 and age of 26 ± 0.7 years acted as participants. There was a significant reduction in total and abdominal fat mass for the ISE and GT + ISE groups, p < 0.05, however, total and abdominal fat mass did not significantly change in the GT and C groups. There was a significant increase in total lean mass, p < 0.05, after the intervention for the ISE and GT + ISE groups only. There was a significant increase in fat oxidation during submaximal aerobic exercise, p < 0.05, after the intervention for the ISE, GT + ISE, and GT groups with no change for the C group. Following the 12-week intervention the ISE and GT + ISE groups, compared to C, recorded a significantly greater decrease in body and abdominal fat, and a significant increase in total lean mass. Ingestion of green tea by itself, however, did not result in a significant decrease in body or abdominal fat, but increased fat utilization during submaximal exercise. The combination of 12 weeks of GT ingestion and ISE did not result in greater total and abdominal fat reduction compared to 12 weeks of ISE alone. PMID:27548216

  8. The Effect of Green Tea Ingestion and Interval Sprinting Exercise on the Body Composition of Overweight Males: A Randomized Trial.

    PubMed

    Gahreman, Daniel; Heydari, Mehrdad; Boutcher, Yati; Freund, Judith; Boutcher, Stephen

    2016-01-01

    The combined effect of green tea ingestion and interval sprinting exercise on body and abdominal fat of overweight males was investigated. Participants were randomly assigned into control (C), green tea (GT), interval sprinting exercise (ISE), and green tea and ISE (GT + ISE) groups. The GT, GT + ISE, and C groups consumed three GT capsules daily. The ISE and GT + ISE groups completed 36 ISE sessions over 12 weeks. Forty eight overweight males with a mean BMI of 28.5 ± 0.92 kg/m² and age of 26 ± 0.7 years acted as participants. There was a significant reduction in total and abdominal fat mass for the ISE and GT + ISE groups, p < 0.05, however, total and abdominal fat mass did not significantly change in the GT and C groups. There was a significant increase in total lean mass, p < 0.05, after the intervention for the ISE and GT + ISE groups only. There was a significant increase in fat oxidation during submaximal aerobic exercise, p < 0.05, after the intervention for the ISE, GT + ISE, and GT groups with no change for the C group. Following the 12-week intervention the ISE and GT + ISE groups, compared to C, recorded a significantly greater decrease in body and abdominal fat, and a significant increase in total lean mass. Ingestion of green tea by itself, however, did not result in a significant decrease in body or abdominal fat, but increased fat utilization during submaximal exercise. The combination of 12 weeks of GT ingestion and ISE did not result in greater total and abdominal fat reduction compared to 12 weeks of ISE alone. PMID:27548216

  9. Dry-needling and exercise for chronic whiplash-associated disorders: a randomized single-blind placebo-controlled trial.

    PubMed

    Sterling, Michele; Vicenzino, Bill; Souvlis, Tina; Connelly, Luke B

    2015-04-01

    This randomized controlled trial investigated the effectiveness and cost-effectiveness of dry-needling and exercise compared with sham dry-needling and exercise for chronic whiplash-associated disorders (WAD). The setting was a single university centre and 4 physiotherapy practices in Queensland, Australia. Eighty patients with chronic WAD (>3 months) were enrolled between June 2009 and August 2012 with 1-year follow-up completed in August 2013. The interventions were 6 weeks of dry-needling to posterior neck muscles (n = 40) and exercise or sham dry-needling and exercise (n = 40). The primary outcomes of the Neck Disability Index (NDI) and self-rated recovery were measured at baseline, 6 and 12 weeks, 6 and 12 months by a blinded assessor. Analysis was intention to treat. An economic evaluation was planned but missing data deemed further analysis unwarranted. Seventy-nine patients (99%) were followed up at 6 weeks, 78 (98%) at 12 weeks, 74 (93%) at 6 months, and 73 (91%) at 12 months. The dry-needling and exercise intervention was more effective than sham dry-needling and exercise in reducing disability at 6 and 12 months but not at 6 and 12 weeks. The treatment effects were small and not clinically worthwhile. At 6 weeks, the treatment effect on the 0-100 NDI was -0.3 (95% confidence interval -5.4 to 4.7), 12 weeks -0.3 (-5.2 to 4.9), 6 months -4.4 (-9.6 to -0.74), and 12 months -3.8 (-9.1 to -0.5). There was no effect for self-rated recovery. In patients with chronic WAD, dry-needling and exercise has no clinically worthwhile effects over sham dry-needling and exercise.

  10. The Effect of Green Tea Ingestion and Interval Sprinting Exercise on the Body Composition of Overweight Males: A Randomized Trial.

    PubMed

    Gahreman, Daniel; Heydari, Mehrdad; Boutcher, Yati; Freund, Judith; Boutcher, Stephen

    2016-08-19

    The combined effect of green tea ingestion and interval sprinting exercise on body and abdominal fat of overweight males was investigated. Participants were randomly assigned into control (C), green tea (GT), interval sprinting exercise (ISE), and green tea and ISE (GT + ISE) groups. The GT, GT + ISE, and C groups consumed three GT capsules daily. The ISE and GT + ISE groups completed 36 ISE sessions over 12 weeks. Forty eight overweight males with a mean BMI of 28.5 ± 0.92 kg/m² and age of 26 ± 0.7 years acted as participants. There was a significant reduction in total and abdominal fat mass for the ISE and GT + ISE groups, p < 0.05, however, total and abdominal fat mass did not significantly change in the GT and C groups. There was a significant increase in total lean mass, p < 0.05, after the intervention for the ISE and GT + ISE groups only. There was a significant increase in fat oxidation during submaximal aerobic exercise, p < 0.05, after the intervention for the ISE, GT + ISE, and GT groups with no change for the C group. Following the 12-week intervention the ISE and GT + ISE groups, compared to C, recorded a significantly greater decrease in body and abdominal fat, and a significant increase in total lean mass. Ingestion of green tea by itself, however, did not result in a significant decrease in body or abdominal fat, but increased fat utilization during submaximal exercise. The combination of 12 weeks of GT ingestion and ISE did not result in greater total and abdominal fat reduction compared to 12 weeks of ISE alone.

  11. Health benefits of different sport disciplines for adults: systematic review of observational and intervention studies with meta-analysis.

    PubMed

    Oja, Pekka; Titze, Sylvia; Kokko, Sami; Kujala, Urho M; Heinonen, Ari; Kelly, Paul; Koski, Pasi; Foster, Charlie

    2015-04-01

    The aim was to assess the quality and strength of evidence for the health benefits of specific sport disciplines. Electronic search yielded 2194 records and the selection resulted in 69 eligible studies (47 cross-sectional, 9 cohort, 13 intervention studies). 105 comparisons between participation and non-participation groups in 26 different sport disciplines were reported. Moderately strong evidence showed that both running and football improve aerobic fitness and cardiovascular function at rest, and football reduces adiposity. Conditional evidence showed that running benefits metabolic fitness, adiposity and postural balance, and football improves metabolic fitness, muscular performance, postural balance, and cardiac function. Evidence for health benefits of other sport disciplines was either inconclusive or tenuous. The evidence base for the health benefits of specific sports disciplines is generally compromised by weak study design and quality. Future research should address the health effects of different sport disciplines using rigorous research designs.

  12. Ancillary Benefits for Caregivers of Children with Asthma Participating in an Environmental Intervention Study to Alleviate Asthma Symptoms

    PubMed Central

    Kubzansky, Laura D.; Spengler, John D.; Levy, Jonathan I.

    2009-01-01

    Providing care for children with asthma can be demanding and time-intensive with far-reaching effects on caregivers’ lives. Studies have documented childhood asthma symptom reductions and improved asthma-related quality of life (AQOL) with indoor allergen-reducing environmental interventions. Few such studies, however, have considered ancillary benefits to caregivers or other family members. Ancillary benefits could be derived from child health improvements and reduced caregiving burden or from factors such as improved living environments or social support that often accompanies intensive residential intervention efforts. As part of the Boston Healthy Public Housing Initiative (HPHI), a longitudinal single-cohort intervention study of asthmatic children, we examined trends in caregivers’ quality of life related to their child’s asthma (caregiver AQOL) using monthly Juniper Caregiver Asthma Quality of Life Questionnaires (AQLQ) for 32 primary caregivers to 42 asthmatic children aged 4 to 17 years. Longitudinal analyses were used to examine caregiver AQOL trends and their relationship to the child’s AQOL, then to consider additional predictors of caregiver AQOL. Caregiver AQLQ improved significantly over the course of the study with overall improvements significantly correlated with child AQOL (p = 0.005). However, caregiver AQOL improved most in the months before environmental interventions, while children’s AQOL improved most in the months following. Time trends in caregiver AQOL, controlling for child AQOL, were not explained by available social support or caregiver stress measures. Our findings suggest potential participation effects not adequately captured by standard measures. Future environmental intervention studies should more formally consider social support and participation effects for both children and caregivers PMID:19184446

  13. Ancillary benefits for caregivers of children with asthma participating in an environmental intervention study to alleviate asthma symptoms.

    PubMed

    Clougherty, Jane E; Kubzansky, Laura D; Spengler, John D; Levy, Jonathan I

    2009-03-01

    Providing care for children with asthma can be demanding and time-intensive with far-reaching effects on caregivers' lives. Studies have documented childhood asthma symptom reductions and improved asthma-related quality of life (AQOL) with indoor allergen-reducing environmental interventions. Few such studies, however, have considered ancillary benefits to caregivers or other family members. Ancillary benefits could be derived from child health improvements and reduced caregiving burden or from factors such as improved living environments or social support that often accompanies intensive residential intervention efforts. As part of the Boston Healthy Public Housing Initiative (HPHI), a longitudinal single-cohort intervention study of asthmatic children, we examined trends in caregivers' quality of life related to their child's asthma (caregiver AQOL) using monthly Juniper Caregiver Asthma Quality of Life Questionnaires (AQLQ) for 32 primary caregivers to 42 asthmatic children aged 4 to 17 years. Longitudinal analyses were used to examine caregiver AQOL trends and their relationship to the child's AQOL, then to consider additional predictors of caregiver AQOL. Caregiver AQLQ improved significantly over the course of the study with overall improvements significantly correlated with child AQOL (p = 0.005). However, caregiver AQOL improved most in the months before environmental interventions, while children's AQOL improved most in the months following. Time trends in caregiver AQOL, controlling for child AQOL, were not explained by available social support or caregiver stress measures. Our findings suggest potential participation effects not adequately captured by standard measures. Future environmental intervention studies should more formally consider social support and participation effects for both children and caregivers. PMID:19184446

  14. Efficacy and Safety of a Chinese Herbal Medicine Formula (RCM-104) in the Management of Simple Obesity: A Randomized, Placebo-Controlled Clinical Trial

    PubMed Central

    Lenon, George Binh; Li, Kang Xiao; Chang, Yung-Hsien; Yang, Angela Weihong; Da Costa, Clifford; Li, Chun Guang; Cohen, Marc; Mann, Neil; Xue, Charlie C. L.

    2012-01-01

    Objective. This study was to evaluate the efficacy and safety of a Chinese herbal medicine formula (RCM-104) for the management of simple obesity. Method. Obese subjects aged between 18 and 60 years were selected for 12-week, double-blind, randomized, placebo-controlled trial. Subjects were randomly assigned to take 4 capsules of either the RCM-104 formula (n = 59) or placebo (n = 58), 3 times daily for 12 weeks. Measures of BW, BMI and WC, HC, WHR and BF composition were assessed at baseline and once every four weeks during the 12 week treatment period. Results. Of the 117 subjects randomised, 92 were included in the ITT analysis. The weight, BMI and BF in RCM-104 group were reduced by 1.5 kg, 0.6 kg/m2 and 0.9% and those in the placebo group were increased by 0.5 kg, 0.2 kg/m2 and 0.1% respectively. There were significant differences in BW and BMI (P < 0.05) between the two groups. Eleven items of the WLQOQ were significantly improved in the RCM-104 group while only 2 items were significantly improved in the placebo group. Adverse events were minor in both groups. Conclusion. RCM-104 treatment appears to be well tolerated and beneficial in reducing BW and BMI in obese subjects. PMID:22550541

  15. Efficacy of Synbiotics in Patients with Slow Transit Constipation: A Prospective Randomized Trial

    PubMed Central

    Ding, Chao; Ge, Xiaolong; Zhang, Xueying; Tian, Hongliang; Wang, Hongkan; Gu, Lili; Gong, Jianfeng; Zhu, Weiming; Li, Ning

    2016-01-01

    Synbiotic intake may efficiently restore the balance of gut microbiota and improve gastrointestinal functions. The aim of the study was to evaluate the efficacy of a synbiotic in patients with slow transit constipation. A total of 100 patients with slow transit constipation were randomized to receive either a synbiotic or placebo twice daily for 12 weeks. The primary efficacy endpoints were the clinical remission and improvement rates at weeks 4 and 12. Stool frequency and consistency, colonic transit time (CTT), evacuation and abdominal symptoms, patient assessment of constipation symptoms, gastrointestinal quality-of-life index scores, satisfaction scores, and adverse events were also monitored. The clinical remission rates reached 37.5% at week 4 and 45.8% at week 12 in the treatment group, compared to 13.3% at week 4 and 16.7% at week 12 in the placebo group (p < 0.01 for both comparisons). Over 12 weeks, 64.6% of the patients who received the synbiotic experienced clinical improvement, compared to 29.2% of the patients in the placebo group (p < 0.01). During the intervention period, patients who were treated with the synbiotic exhibited increased stool frequency, improved stool consistency, decreased CTT, and improved constipation-related symptoms. This randomized, placebo-controlled trial suggested that dietary supplementation with a synbiotic improved evacuation-parameters-associated symptoms and colonic motility in patients with slow transit constipation (STC). PMID:27690093

  16. Random broadcast on random geometric graphs

    SciTech Connect

    Bradonjic, Milan; Elsasser, Robert; Friedrich, Tobias

    2009-01-01

    In this work, we consider the random broadcast time on random geometric graphs (RGGs). The classic random broadcast model, also known as push algorithm, is defined as: starting with one informed node, in each succeeding round every informed node chooses one of its neighbors uniformly at random and informs it. We consider the random broadcast time on RGGs, when with high probability: (i) RGG is connected, (ii) when there exists the giant component in RGG. We show that the random broadcast time is bounded by {Omicron}({radical} n + diam(component)), where diam(component) is a diameter of the entire graph, or the giant component, for the regimes (i), or (ii), respectively. In other words, for both regimes, we derive the broadcast time to be {Theta}(diam(G)), which is asymptotically optimal.

  17. A (Pan-Canadian) Cluster Randomized Control Effectiveness Trial of the ABRACADABRA Web-Based Literacy Program

    ERIC Educational Resources Information Center

    Savage, Robert; Abrami, Philip C.; Piquette, Noella; Wood, Eileen; Deleveaux, Gia; Sanghera-Sidhu, Sukhbinder; Burgos, Giovani

    2013-01-01

    This report describes a cluster randomized control trial (RCT) intervention study of the effectiveness of the ABRACADABRA (ABRA) Web-based literacy system using a classroom-level RCT intervention with 1,067 children in 74 kindergarten and Grade 1 or Grade 1/2 classrooms across Canada. The authors closely followed the CONSORT criteria for executing…

  18. Quantumness, Randomness and Computability

    NASA Astrophysics Data System (ADS)

    Solis, Aldo; Hirsch, Jorge G.

    2015-06-01

    Randomness plays a central role in the quantum mechanical description of our interactions. We review the relationship between the violation of Bell inequalities, non signaling and randomness. We discuss the challenge in defining a random string, and show that algorithmic information theory provides a necessary condition for randomness using Borel normality. We close with a view on incomputablity and its implications in physics.

  19. Reducing Phthalate, Paraben, and Phenol Exposure from Personal Care Products in Adolescent Girls: Findings from the HERMOSA Intervention Study

    PubMed Central

    Harley, Kim G.; Kogut, Katherine; Madrigal, Daniel S.; Cardenas, Maritza; Vera, Irene A.; Meza-Alfaro, Gonzalo; She, Jianwen; Gavin, Qi; Zahedi, Rana; Bradman, Asa; Eskenazi, Brenda; Parra, Kimberly L.

    2016-01-01

    Background: Personal care products are a source of exposure to potentially endocrine-disrupting chemicals such as phthalates, parabens, triclosan, and benzophenone-3 (BP-3) for adolescent girls. Methods: We enrolled 100 Latina girls in a youth-led, community-based participatory research intervention study to determine whether using personal care products whose labels stated they did not contain these chemicals for 3 days could lower urinary concentrations. Pre- and postintervention urine samples were analyzed for phthalate metabolites, parabens, triclosan, and BP-3 using high-performance liquid chromatography/tandem mass spectrometry. Results: Urinary concentrations of mono-ethyl phthalate (MEP) decreased by 27.4% (95% CI: –39.3, –13.2) on average over the 3-day intervention; no significant changes were seen in urinary concentrations of mono-n-butyl phthalate (MnBP) and mono-isobutyl phthalate (MiBP). Methyl and propyl paraben concentrations decreased by 43.9% (95% CI: –61.3, –18.8) and 45.4% (95% CI: –63.7, –17.9), respectively. Unexpectedly, concentrations of ethyl and butyl paraben concentrations increased, although concentrations were low overall and not detected in almost half the samples. Triclosan concentrations decreased by 35.7% (95% CI: –53.3, –11.6), and BP-3 concentrations decreased by 36.0% (95% CI: –51.0, –16.4). Discussion: This study demonstrates that techniques available to consumers, such as choosing personal care products that are labeled to be free of phthalates, parabens, triclosan, and BP-3, can reduce personal exposure to possible endocrine-disrupting chemicals. Involving youth in the design and implementation of the study was key to recruitment, retention, compliance, and acceptability of the intervention. Citation: Harley KG, Kogut K, Madrigal DS, Cardenas M, Vera IA, Meza-Alfaro G, She J, Gavin Q, Zahedi R, Bradman A, Eskenazi B, Parra KL. 2016. Reducing phthalate, paraben, and phenol exposure from personal care

  20. Directed random walk with random restarts: The Sisyphus random walk

    NASA Astrophysics Data System (ADS)

    Montero, Miquel; Villarroel, Javier

    2016-09-01

    In this paper we consider a particular version of the random walk with restarts: random reset events which suddenly bring the system to the starting value. We analyze its relevant statistical properties, like the transition probability, and show how an equilibrium state appears. Formulas for the first-passage time, high-water marks, and other extreme statistics are also derived; we consider counting problems naturally associated with the system. Finally we indicate feasible generalizations useful for interpreting different physical effects.

  1. LA Sprouts Randomized Controlled Nutrition, Cooking and Gardening Program Reduces Obesity and Metabolic Risk in Latino Youth

    PubMed Central

    Gatto, Nicole M.; Martinez, Lauren C.; Spruijt-Metz, Donna; Davis, Jaimie N.

    2015-01-01

    Objective To assess the effects of a 12-week gardening, nutrition, and cooking intervention (“LA Sprouts”) on dietary intake, obesity parameters and metabolic disease risk among low-income, primarily Hispanic/Latino youth in Los Angeles. Methods Randomized control trial involving four elementary schools [2 schools randomized to intervention (172, 3rd–5th grade students); 2 schools randomized to control (147, 3rd–5th grade students)]. Classes were taught in 90-minute sessions once a week to each grade level for 12 weeks. Data collected at pre- and post-intervention included dietary intake via food frequency questionnaire (FFQ), anthropometric measures [BMI, waist circumference (WC)], body fat, and fasting blood samples. Results LA Sprouts participants had significantly greater reductions in BMI z-scores (0.1 versus 0.04 point decrease, respectively; p=0.01) and WC (−1.2 cm vs. no change; p<0.001). Fewer LA Sprouts participants had the metabolic syndrome (MetSyn) after the intervention than before, while the number of controls with MetSyn increased. LA Sprouts participants had improvements in dietary fiber intake (+3.5% vs. −15.5%; p=0.04) and less decreases in vegetable intake (−3.6% vs. −26.4%; p=0.04). Change in fruit intake before and after the intervention did not significantly differ between LAS and control subjects. Conclusions LA Sprouts was effective in reducing obesity and metabolic risk. PMID:25960146

  2. The Management of Diabetic Foot Ulcers with Porcine Small Intestine Submucosa Tri-Layer Matrix: A Randomized Controlled Trial

    PubMed Central

    Cazzell, Shawn M.; Lange, Darrell L.; Dickerson, Jaime E.; Slade, Herbert B.

    2015-01-01

    Objective: This study demonstrates that superior outcomes are possible when diabetic foot ulcers (DFU) are managed with tri-layer porcine small intestine submucosa (SIS). Approach: Patients with DFU from 11 centers participated in this prospective randomized controlled trial. Qualified subjects were randomized (1:1) to either SIS or standard care (SC) selected at the discretion of the Investigator and followed for 12 weeks or complete ulcer closure. Results: Eighty-two subjects (41 in each group) were evaluable in the intent-to-treat analysis. Ulcers managed with SIS had a significantly greater proportion closed by 12 weeks than for the Control group (54% vs. 32%, p=0.021) and this proportion was numerically higher at all visits. Time to closure for ulcers achieving closure was 2 weeks earlier for the SIS group than for SC. Median reduction in ulcer area was significantly greater for SIS at each weekly visit (all p values<0.05). Review of reported adverse events found no safety concerns. Innovation: These data support the use of tri-layer SIS for the effective management of DFU. Conclusion: In this randomized controlled trial, SIS was found to be associated with more rapid improvement, and a higher likelihood of achieving complete ulcer closure than those ulcers treated with SC. PMID:26634183

  3. Augmenting Psychoeducation with a Mobile Intervention for Bipolar Disorder: A Randomized Controlled Trial

    PubMed Central

    Depp, Colin A; Ceglowski, Jenni; Wang, Vicki C; Yaghouti, Faraz; Mausbach, Brent T; Thompson, Wesley K; Granholm, Eric L

    2014-01-01

    Background Psychosocial interventions for bipolar disorder are frequently unavailable and resource intensive. Mobile technology may improve access to evidence-based interventions and may increase their efficacy. We evaluated the feasibility, acceptability and efficacy of an augmentative mobile ecological momentary intervention targeting self-management of mood symptoms. Methods This was a randomized single-blind controlled trial with 82 consumers diagnosed with bipolar disorder who completed a four-session psychoeducational intervention and were assigned to 10 weeks of either: 1) mobile device delivered interactive intervention linking patient-reported mood states with personalized self-management strategies, or 2) paper-and-pencil mood monitoring. Participants were assessed at baseline, 6 weeks (mid-point), 12 weeks (post-treatment), and 24 weeks (follow up) with clinician-rated depression and mania scales and self-reported functioning. Results Retention at 12 weeks was 93% and both conditions were associated with high satisfaction. Compared to the paper-and-pencil condition, participants in the augmented mobile intervention condition showed significantly greater reductions in depressive symptoms at 6 and 12 weeks (Cohen's d for both were d=0.48). However, these effects were not maintained at 24-week follow up. Conditions did not differ significantly in the impact on manic symptoms or functional impairment. Limitations This was not a definitive trial and was not powered to detect moderators and mediators. Conclusions Automated mobile-phone intervention is feasible, acceptable, and may enhance the impact of brief psychoeducation on depressive symptoms in bipolar disorder. However, sustainment of gains from symptom self-management mobile interventions, once stopped, may be limited. PMID:25479050

  4. Quercetin supplementation and upper respiratory tract infection: A randomized community clinical trial.

    PubMed

    Heinz, Serena A; Henson, Dru A; Austin, Melanie D; Jin, Fuxia; Nieman, David C

    2010-09-01

    Quercetin in culture with target cells and pathogens exerts anti-pathogenic activities against a wide variety of viruses and bacteria. A few small-scale human quercetin supplementation studies have produced conflicting results regarding quercetin's effects on upper respiratory tract infection rates, and little is known regarding the appropriate human dose. The purpose of this randomized, double-blinded, placebo-controlled trial was to measure the influence of two quercetin doses (500 and 1000 mg/day) compared to placebo on upper respiratory tract infection (URTI) rates in a large community group (N=1002) of subjects varying widely in age (18-85 years). Subjects ingested supplements for 12 weeks and logged URTI symptoms on a daily basis using the Wisconsin Upper Respiratory Symptom Survey (WURSS). No significant group differences were measured for URTI outcomes for all subjects combined, or when analyzing separately by gender, body mass index, and age categories. Regression analysis revealed that the strongest interaction effect with group status was self-reported fitness level. A separate analysis of subjects 40 years of age and older rating themselves in the top half of the entire group for fitness level (N=325) showed lower URTI severity (36% reduction, P=0.020) and URTI total sick days (31% reduction, P=0.048) for the Q-1000 group compared to placebo. In summary, for all subjects combined, quercetin supplementation over 12 weeks had no significant influence on URTI rates or symptomatology compared to placebo. A reduction in URTI total sick days and severity was noted in middle aged and older subjects ingesting 1000 mg quercetin/day for 12 weeks who rated themselves as physically fit.

  5. Randomized Trial of a Smartphone Mobile Application Compared to Text Messaging to Support Smoking Cessation

    PubMed Central

    Borland, Ron; Bettinghaus, Erwin P.; Shane, James H.; Zimmerman, Donald E.

    2014-01-01

    Abstract Background: Text messaging has successfully supported smoking cessation. This study compares a mobile application with text messaging to support smoking cessation. Materials and Methods: Young adult smokers 18–30 years old (n=102) participated in a randomized pretest–posttest trial. Smokers received a smartphone application (REQ-Mobile) with short messages and interactive tools or a text messaging system (onQ), managed by an expert system. Self-reported usability of REQ-Mobile and quitting behavior (quit attempts, point-prevalence, 30-day point-prevalence, and continued abstinence) were assessed in posttests. Results: Overall, 60% of smokers used mobile services (REQ-Mobile, 61%, mean of 128.5 messages received; onQ, 59%, mean of 107.8 messages), and 75% evaluated REQ-Mobile as user-friendly. A majority of smokers reported being abstinent at posttest (6 weeks, 53% of completers; 12 weeks, 66% of completers [44% of all cases]). Also, 37% (25%of all cases) reported 30-day point-prevalence abstinence, and 32% (22% of all cases) reported continuous abstinence at 12 weeks. OnQ produced more abstinence (p<0.05) than REQ-Mobile. Use of both services predicted increased 30-day abstinence at 12 weeks (used, 47%; not used, 20%; p=0.03). Conclusions: REQ-Mobile was feasible for delivering cessation support but appeared to not move smokers to quit as quickly as text messaging. Text messaging may work better because it is simple, well known, and delivered to a primary inbox. These advantages may disappear as smokers become more experienced with new handsets. Mobile phones may be promising delivery platforms for cessation services using either smartphone applications or text messaging. PMID:24350804

  6. Open versus percutaneous release of the A1-pulley for stenosing tendovaginitis: a prospective randomized trial.

    PubMed

    Dierks, Ulf; Hoffmann, Reimer; Meek, Marcel F

    2008-09-01

    A prospective randomized trial for release of the first annular pulley (A-1 pulley) in trigger fingers with a percutaneous technique versus the open surgical technique is presented. Thirty-six patients were randomized to either open (n = 16) or percutaneous (#15 blade; n = 20) release of the A-1 pulley. All patients were evaluated for grip strength, active range of motion of the proximal interphalangeal joint, and residual pain at 1 and 12 weeks after release. Furthermore, the operation time was assessed, and the costs were calculated. Overall, 100% success in terms of grip strength, active range of motion of the proximal interphalangeal joint, and residual pain was obtained in both groups. Mean operation time was significantly longer with the open technique. Because of lower costs and quicker procedure with equal functional outcome when compared with open surgery, we recommend the percutaneous technique using a #15 blade for trigger finger release. PMID:18776782

  7. Laboratory, epidemiological, and human intervention studies show that tea (Camellia sinensis) may be useful in the prevention of obesity.

    PubMed

    Grove, Kimberly A; Lambert, Joshua D

    2010-03-01

    Tea (Camellia sinensis, Theaceae) and tea polyphenols have been studied for the prevention of chronic diseases, including obesity. Obesity currently affects >20% of adults in the United States and is a risk factor for chronic diseases such as type II diabetes, cardiovascular disease, and cancer. Given this increasing public health concern, the use of dietary agents for the prevention of obesity would be of tremendous benefit. Whereas many laboratory studies have demonstrated the potential efficacy of green or black tea for the prevention of obesity, the underlying mechanisms remain unclear. The results of human intervention studies are mixed and the role of caffeine has not been clearly established. Finally, there is emerging evidence that high doses of tea polyphenols may have adverse side effects. Given that the results of scientific studies on dietary components, including tea polyphenols, are often translated into dietary supplements, understanding the potential toxicities of the tea polyphenols is critical to understanding their potential usefulness in preventing obesity. In this review, we will critically evaluate the evidence for the prevention of obesity by tea, discuss the relevance of proposed mechanisms in light of tea polyphenol bioavailability, and review the reports concerning the toxic effects of high doses of tea polyphenols and the implication that this has for the potential use of tea for the prevention of obesity. We hope that this review will expose areas for further study and encourage research on this important public health issue.

  8. Guidelines for the design, conduct and reporting of human intervention studies to evaluate the health benefits of foods.

    PubMed

    Welch, Robert W; Antoine, Jean-Michel; Berta, Jean-Louis; Bub, Achim; de Vries, Jan; Guarner, Francisco; Hasselwander, Oliver; Hendriks, Henk; Jäkel, Martin; Koletzko, Berthold V; Patterson, Chris C; Richelle, Myriam; Skarp, Maria; Theis, Stephan; Vidry, Stéphane; Woodside, Jayne V

    2011-11-01

    There is substantial evidence to link what we eat to the reduction of the risk of major chronic diseases and/or the improvement of functions. Thus, it is important for public health agencies and the food industry to facilitate the consumption of foods with particular health benefits by providing consumer products and messages based on scientific evidence. Although fragmentary advice is available from a range of sources, there is a lack of comprehensive scientific guidelines for the design, conduct and reporting of human intervention studies to evaluate the health benefits of foods. Such guidelines are needed both to support nutrition science in general, and to facilitate the substantiation of health claims. In the present study, which presents the consensus view of an International Life Sciences Institute Europe Expert Group that included senior scientists from academia and industry, the term 'foods' refers to foods, dietary supplements and food constituents, but not to whole diets. The present study is based on an initial survey of published papers, which identified the range and strengths and weaknesses of current methodologies, and was finalised following exchanges between representatives from industry, academia and regulatory bodies. The major factors involved in the design, conduct and reporting of studies are identified, summarised in a checklist table that is based on the Consolidated Standards of Reporting Trials guidelines, and elaborated and discussed in the text.

  9. Anthocyanin/polyphenolic-rich fruit juice reduces oxidative cell damage in an intervention study with patients on hemodialysis.

    PubMed

    Spormann, Thomas M; Albert, Franz W; Rath, Thomas; Dietrich, Helmut; Will, Frank; Stockis, Jean-Pierre; Eisenbrand, Gerhard; Janzowski, Christine

    2008-12-01

    Hemodialysis patients face an elevated risk of cancer, arteriosclerosis, and other diseases, ascribed in part to increased oxidative stress. Red fruit juice with high anthocyanin/polyphenol content had been shown to reduce oxidative damage in healthy probands. To test its preventive potential in hemodialysis patients, 21 subjects in a pilot intervention study consumed 200 mL/day of red fruit juice (3-week run-in; 4-week juice uptake; 3-week wash-out). Weekly blood sampling was done to monitor DNA damage (comet assay +/- formamidopyrimidine-DNA glycosylase enzyme), glutathione, malondialdehyde, protein carbonyls, trolox equivalent antioxidant capacity, triglycerides, and DNA binding capacity of the transcription factor nuclear factor-kappaB. Results show a significant decrease of DNA oxidation damage (P < 0.0001), protein and lipid peroxidation (P < 0.0001 and P < 0.001, respectively), and nuclear factor-kappaB binding activity (P < 0.01), and an increase of glutathione level and status (both P < 0.0001) during juice uptake. We attribute this reduction in oxidative (cell) damage in hemodialysis patients to the especially high anthocyanin/polyphenol content of the juice. This provides promising perspectives into the prevention of chronic diseases such as cancer and cardiovascular disease in population subgroups exposed to enhanced oxidative stress like hemodialysis patients.

  10. Challenges in designing, conducting, and reporting oral health behavioral intervention studies in primary school age children: methodological issues

    PubMed Central

    Cooper, Anna Mary; Coffey, Margaret; Dugdill, Lindsey

    2014-01-01

    Often within oral health, clinical outcome measures dominate trial design rather than behavioral outcome measures, and often there is a reliance on proxy self-reporting of children’s behavior with no corroboration through triangulation of measures. The complexity of the interventions involved in oral health intervention is often overlooked in trial design, and more flexible pragmatic designs that take account of the research context may be more appropriate. Some of the limitations in oral health behavioral intervention studies (trials) in primary school age children were reported in a recently published Cochrane review. This paper aims to critically discuss the findings of a recent Cochrane review in terms of the methodological implications that arise for future design, development, measurement, and reporting of oral health trials in primary school age children. Key components of the UK Medical Research Council’s framework for the design and evaluation of complex interventions are discussed in relation to using taxonomies of behavior change. This paper is not designed to be a definitive guide but aims to bring learning from other areas of public health and health promotion into dental public health. Ultimately, the aim is to aid the design of more successful interventions that produce long-term behavioral changes in children in relation to toothbrushing and nighttime sugar snacking. PMID:27774028

  11. Antioxidant-rich coffee reduces DNA damage, elevates glutathione status and contributes to weight control: results from an intervention study.

    PubMed

    Bakuradze, Tamara; Boehm, Nadine; Janzowski, Christine; Lang, Roman; Hofmann, Thomas; Stockis, Jean-Pierre; Albert, Franz W; Stiebitz, Herbert; Bytof, Gerhard; Lantz, Ingo; Baum, Matthias; Eisenbrand, Gerhard

    2011-05-01

    Epidemiological and experimental evidence increasingly suggests coffee consumption to be correlated to prevention or delay of degenerative diseases connected with oxidative cellular stress. In an intervention study comprising 33 healthy volunteers, we examined DNA-protective and antioxidative effects exerted in vivo by daily ingestion of 750 mL of freshly brewed coffee rich in both green coffee bean constituents as well as roast products. The study design encompassed an initial 4 wk of wash-out, followed by 4 wk of coffee intake and 4 wk of second wash-out. At the start and after each study phase blood samples were taken to monitor biomarkers of oxidative stress response. In addition, body weight/composition and intake of energy/nutrients were recorded. In the coffee ingestion period, the primary endpoint, oxidative DNA damage as measured by the Comet assay (± FPG), was markedly reduced (p<0.001). Glutathione level (p<0.05) and GSR-activity (p<0.01) were elevated. Body weight (p<0.01)/body fat (p<0.05) and energy (p<0.001)/nutrient (p<0.001-0.05) intake were reduced. Our results allow to conclude that daily consumption of 3-4 cups of brew from a special Arabica coffee exerts health beneficial effects, as evidenced by reduced oxidative damage, body fat mass and energy/nutrient uptake.

  12. An evaluation of the effect of gonadotropin-releasing hormone analogs and medroxyprogesterone acetate on uterine leiomyomata volume by magnetic resonance imaging: a prospective, randomized, double blind, placebo-controlled, crossover trial.

    PubMed

    Carr, B R; Marshburn, P B; Weatherall, P T; Bradshaw, K D; Breslau, N A; Byrd, W; Roark, M; Steinkampf, M P

    1993-05-01

    The purpose of this study was to prospectively compare the effectiveness of administering medroxyprogesterone acetate (MPA; 20 mg/day) in either the first (protocol A) or last (protocol B) 12-week period along with a 6-month course of the GnRH analog (GnRH-a; leuprolide acetate; 1 mg/day, sc) on uterine and leiomyomata volumes and hormone (estradiol, LH, and FSH) and serum lipid (total cholesterol, triglycerides, and high and low density lipoprotein) levels. Sixteen women were randomized into protocol A or B, received either MPA or placebo along with GnRH-a, respectively, and were then crossed over at 12 weeks to placebo or MPA, respectively, for the final 12-week interval of GnRH-a therapy. Total, myoma, and nonmyoma uterine volumes were determined by magnetic resonance imaging, and serum studies were performed at the beginning of the study and at 12 and 24 weeks. In both protocols, LH and estradiol levels declined by 80-90% (P < 0.03) and 55-72% (P < 0.02) of the baseline, respectively, at 12 weeks and remained at this level at 24 weeks. There were no significant changes in the other laboratory tests between protocols or longitudinally over time. Total uterine volume decreased to 73% of the baseline at 12 weeks in protocol B (P < 0.04), but did not change in protocol A. After crossover at 12 weeks, the total uterine volume of women in protocol A decreased to 74% of the baseline (P < 0.02) at 24 weeks. Between-protocol comparisons demonstrated a greater decline in total uterine volume in protocol B than A at 12 weeks, but after cross-over, MPA addition was associated with a significant increase in total uterine volume (protocol B) compared to a decrease in protocol A at 24 weeks (P < 0.005). In contrast, although myoma volume declined in both protocols, no significant changes in myoma volume were detected within or between groups over the treatment period. Nonmyoma volume changes in protocols A and B roughly paralleled total uterine volume changes, with MPA

  13. Comparison of the treatment of hydrocolloid and saline gauze for pressure ulcer: a meta-analysis of randomized controlled trials

    PubMed Central

    Zheng, Xuemei; Li, Jieqiong

    2015-01-01

    Purpose: To determine the hydrocolloid dressing versus saline gauze for the treatment of pressure ulcer. Methods: Pubmed and Web of Knowledge were searched for randomized controlled trials for the treatment of hydrocolloid and saline gauze for pressure ulcer. The random effect model was used. Sensitivity analysis and publication bias were conducted. Results: Seven randomized controlled trials involving a total of 329 participants were included in this meta-analysis. The combined results suggested that significant association in complete healing were detected among hydrocolloid dressings and saline gauze [Summary RR=2.20, 95% CI=1.21-4.02, I2=48.5%]. The associations were also significant when we only combine the results for ulcers healed and the treatment duration of 8-12 weeks. No publication bias was found. Conclusions: Our meta-analysis suggested that the use of hydrocolloid dressing increased the likelihood of complete healing by more than two-fold compared with saline gauze dressing. PMID:26885012

  14. Randomization in robot tasks

    NASA Technical Reports Server (NTRS)

    Erdmann, Michael

    1992-01-01

    This paper investigates the role of randomization in the solution of robot manipulation tasks. One example of randomization is shown by the strategy of shaking a bin holding a part in order to orient the part in a desired stable state with some high probability. Randomization can be useful for mobile robot navigation and as a means of guiding the design process.

  15. Random Item IRT Models

    ERIC Educational Resources Information Center

    De Boeck, Paul

    2008-01-01

    It is common practice in IRT to consider items as fixed and persons as random. Both, continuous and categorical person parameters are most often random variables, whereas for items only continuous parameters are used and they are commonly of the fixed type, although exceptions occur. It is shown in the present article that random item parameters…

  16. Exogenous nitric oxide inhibits Rho-associated kinase activity in patients with angina pectoris: a randomized controlled trial.

    PubMed

    Maruhashi, Tatsuya; Noma, Kensuke; Fujimura, Noritaka; Kajikawa, Masato; Matsumoto, Takeshi; Hidaka, Takayuki; Nakashima, Ayumu; Kihara, Yasuki; Liao, James K; Higashi, Yukihito

    2015-07-01

    The RhoA/Rho-associated kinase (ROCK) pathway has a key physiological role in the pathogenesis of atherosclerosis. Increased ROCK activity is associated with cardiovascular diseases. Endogenous nitric oxide (NO) has an anti-atherosclerotic effect, whereas the exogenous NO-mediated cardiovascular effect still remains controversial. The purpose of this study was to evaluate the effect of exogenous NO on ROCK activity in patients with angina pectoris. This is a prospective, open-label, randomized, controlled study. A total of 30 patients with angina pectoris were randomly assigned to receive 40 mg day(-1) of isosorbide mononitrate (n=15, 12 men and 3 women, mean age of 63±12 years, isosorbide mononitrate group) or conventional treatment (n=15, 13 men and 2 women, mean age of 64±13 years, control group) for 12 weeks. ROCK activity in peripheral leukocytes was measured by western blot analysis. ROCK activities at 4 and 12 weeks after treatment were decreased in the isosorbide mononitrate group (0.82±0.33 at 0 week, 0.62±0.20 at 4 weeks, 0.61±0.19 at 12 weeks, n=15 in each group, P<0.05, respectively) but not altered in the control group. ROCK1 and ROCK2 expression levels were similar in all treatment periods in the two groups. These findings suggest that the administration of exogenous NO can inhibit ROCK activity, indicating that the usage of exogenous NO could have a protective effect in patients with angina pectoris.

  17. Treatment of Iron Deficiency with or without Anaemia with Intravenous Ferric Carboxymaltose in Gynaecological Practices - A Non-Interventional Study.

    PubMed

    Herfs, R; Fleitmann, L; Kocsis, I

    2014-01-01

    In this multi-centre, prospective, non-interventional study, the effectiveness and tolerance of ferric carboxymaltose (ferinject®; FCM) was tested through use in standard gynaecological practice. In total, data from 273 patients was evaluated. 193 of these patients displayed iron deficiency anaemia (IDA), and 68 had iron deficiency without anaemia (ID). The reasons for the ID/IDA were hypermenorrhoea (HyM) (n = 170), post-partum condition (PP) (n = 53) or another indication (n = 53). The average age of the patients was 40 years old, with 8 % of them being vegetarians. Half of the patients had already been treated for anaemia, primarily with oral iron products (94 %). The primary, serious accompanying symptoms of anaemia were fatigue (72 %), lack of concentration (42 %), pale mucous membranes (42 %), headache (26 %) and sleep disorders (21 %). Only one patient did not show serious symptoms at the start of the study. The most frequent indications for parenteral therapy were the need for rapid iron substitution to reduce symptoms (> 70 %), followed by the lower effectiveness or intolerance of oral products (42 % each) as well as patients not completing the course of treatment with oral products (12 %). Patient information was collected at both the beginning and the end of the observation period, which lasted 15 weeks on average. FCM was most frequently administered via infusion (92 %; average infusion duration 21 minutes). Seven percent of patients received bolus injections. The average total iron dosage per patient was 788.7 mg (median 550 mg; range: 50-3000 mg); the median individual dosage was 500 mg (range: 50-1000 mg). The total dosage was, in most cases, administered through a single application (range: 1-10). Symptoms, blood values (Hb), iron stores (serum-ferritin [S-ferritin]) and transport iron (transferrin saturation [TSAT]) normalised to a large extent. In all subgroups, 92 % of women displayed a marked

  18. Impact of aesthetic restorative treatment on anterior teeth with fluorosis among residents of an endemic area in Brazil: intervention study

    PubMed Central

    2014-01-01

    Background Endemic dental fluorosis has already been described in some regions of the world. The aim of this study was to evaluate the functional and psychosocial impact of direct aesthetic restorative treatments in endemic fluorosis patients in the northern state of Minas Gerais, Brazil. Was a quasi-experimental intervention study. Methods The reference population consisted of individuals between 9 and 27 years of age that were served by a project intended to recover the smiles of patients with severe fluorosis. The questionnaires were administered on two occasions, 24 months apart (before and after dental treatment). Initially, descriptive analyses were conducted. Prevalence and severity, as well as the extent of the functional and psychosocial impact of oral disorders were estimated based on the Oral Health Impact Profile instrument (OHIP-14). Comparisons between baseline and follow-up and between treatment techniques were carried out using the McNemar, Wilcoxon, and Mann–Whitney tests. Results The study involved 53 individuals, with a mean age of 15.9 years, treated with microabrasion, dental composite, or a combination of both techniques. The treatments performed proved to be competent for reducing the functional and psychosocial impact of oral disorders as measured by the OHIP-14, pointing to the possibility of establishing protocols to be used in programs aimed at restoring the aesthetics and functionality of the anterior teeth in large populations. Conclusions After performing the direct aesthetic restorative treatments in patients with endemic fluorosis, a significant improvement was observed in the prevalence and severity, as well as the extent of the functional and psychosocial impact of oral disorders. PMID:24886223

  19. Prediction of fruit and vegetable intake from biomarkers using individual participant data of diet-controlled intervention studies.

    PubMed

    Souverein, Olga W; de Vries, Jeanne H M; Freese, Riitta; Watzl, Bernhard; Bub, Achim; Miller, Edgar R; Castenmiller, Jacqueline J M; Pasman, Wilrike J; van Het Hof, Karin; Chopra, Mridula; Karlsen, Anette; Dragsted, Lars O; Winkels, Renate; Itsiopoulos, Catherine; Brazionis, Laima; O'Dea, Kerin; van Loo-Bouwman, Carolien A; Naber, Ton H J; van der Voet, Hilko; Boshuizen, Hendriek C

    2015-05-14

    Fruit and vegetable consumption produces changes in several biomarkers in blood. The present study aimed to examine the dose-response curve between fruit and vegetable consumption and carotenoid (α-carotene, β-carotene, β-cryptoxanthin, lycopene, lutein and zeaxanthin), folate and vitamin C concentrations. Furthermore, a prediction model of fruit and vegetable intake based on these biomarkers and subject characteristics (i.e. age, sex, BMI and smoking status) was established. Data from twelve diet-controlled intervention studies were obtained to develop a prediction model for fruit and vegetable intake (including and excluding fruit and vegetable juices). The study population in the present individual participant data meta-analysis consisted of 526 men and women. Carotenoid, folate and vitamin C concentrations showed a positive relationship with fruit and vegetable intake. Measures of performance for the prediction model were calculated using cross-validation. For the prediction model of fruit, vegetable and juice intake, the root mean squared error (RMSE) was 258.0 g, the correlation between observed and predicted intake was 0.78 and the mean difference between observed and predicted intake was - 1.7 g (limits of agreement: - 466.3, 462.8 g). For the prediction of fruit and vegetable intake (excluding juices), the RMSE was 201.1 g, the correlation was 0.65 and the mean bias was 2.4 g (limits of agreement: -368.2, 373.0 g). The prediction models which include the biomarkers and subject characteristics may be used to estimate average intake at the group level and to investigate the ranking of individuals with regard to their intake of fruit and vegetables when validating questionnaires that measure intake.

  20. The Impact of E-Learning on Adherence to Guidelines for Acute Gastroenteritis: A Single-Arm Intervention Study

    PubMed Central

    Nicastro, Emanuele; Lo Vecchio, Andrea; Liguoro, Ilaria; Chmielewska, Anna; De Bruyn, Caroline; Dolinsek, Jernej; Doroshina, Elena; Fessatou, Smaragdi; Pop, Tudor Lucian; Prell, Christine; Tabbers, Merit Monique; Tavares, Marta; Urenden-Elicin, Pinar; Bruzzese, Dario; Zakharova, Irina; Sandhu, Bhupinder; Guarino, Alfredo

    2015-01-01

    Objective E-learning is a candidate tool for clinical practice guidelines (CPG) implementation due to its versatility, universal access and low costs. We aimed to assess the impact of a five-module e-learning course about CPG for acute gastroenteritis (AGE) on physicians’ knowledge and clinical practice. Study design This work was conceived as a pre/post single-arm intervention study. Physicians from 11 European countries registered for the online course. Personal data, pre- and post-course questionnaires and clinical data about 3 to 5 children with AGE managed by each physician before and after the course were collected. Primary outcome measures included the proportion of participants fully adherent to CPG and number of patients managed with full adherence. Results Among the 149 physicians who signed up for the e-learning course, 59 took the course and reported on their case management of 519 children <5 years of age who were referred to their practice because of AGE (281 and 264 children seen before and after the course, respectively). The course improved knowledge scores (pre-course 8.6 ± 2.7 versus post-course 12.8 ± 2.1, P < 0.001), average adherence (from 87.0 ± 7.7% to 90.6 ± 7.1%, P = 0.001) and the number of patients managed in full adherence with the guidelines (from 33.6 ± 31.7% to 43.9 ± 36.1%, P = 0.037). Conclusions E-learning is effective in increasing knowledge and improving clinical practice in paediatric AGE and is an effective tool for implementing clinical practice guidelines. PMID:26148301

  1. Prediction of fruit and vegetable intake from biomarkers using individual participant data of diet-controlled intervention studies.

    PubMed

    Souverein, Olga W; de Vries, Jeanne H M; Freese, Riitta; Watzl, Bernhard; Bub, Achim; Miller, Edgar R; Castenmiller, Jacqueline J M; Pasman, Wilrike J; van Het Hof, Karin; Chopra, Mridula; Karlsen, Anette; Dragsted, Lars O; Winkels, Renate; Itsiopoulos, Catherine; Brazionis, Laima; O'Dea, Kerin; van Loo-Bouwman, Carolien A; Naber, Ton H J; van der Voet, Hilko; Boshuizen, Hendriek C

    2015-05-14

    Fruit and vegetable consumption produces changes in several biomarkers in blood. The present study aimed to examine the dose-response curve between fruit and vegetable consumption and carotenoid (α-carotene, β-carotene, β-cryptoxanthin, lycopene, lutein and zeaxanthin), folate and vitamin C concentrations. Furthermore, a prediction model of fruit and vegetable intake based on these biomarkers and subject characteristics (i.e. age, sex, BMI and smoking status) was established. Data from twelve diet-controlled intervention studies were obtained to develop a prediction model for fruit and vegetable intake (including and excluding fruit and vegetable juices). The study population in the present individual participant data meta-analysis consisted of 526 men and women. Carotenoid, folate and vitamin C concentrations showed a positive relationship with fruit and vegetable intake. Measures of performance for the prediction model were calculated using cross-validation. For the prediction model of fruit, vegetable and juice intake, the root mean squared error (RMSE) was 258.0 g, the correlation between observed and predicted intake was 0.78 and the mean difference between observed and predicted intake was - 1.7 g (limits of agreement: - 466.3, 462.8 g). For the prediction of fruit and vegetable intake (excluding juices), the RMSE was 201.1 g, the correlation was 0.65 and the mean bias was 2.4 g (limits of agreement: -368.2, 373.0 g). The prediction models which include the biomarkers and subject characteristics may be used to estimate average intake at the group level and to investigate the ranking of individuals with regard to their intake of fruit and vegetables when validating questionnaires that measure intake. PMID:25850683

  2. Ma-Pi 2 macrobiotic diet and type 2 diabetes mellitus: pooled analysis of short-term intervention studies.

    PubMed

    Porrata-Maury, C; Hernández-Triana, M; Ruiz-Álvarez, V; Díaz-Sánchez, M E; Fallucca, F; Bin, W; Baba-Abubakari, B; Pianesi, M

    2014-03-01

    The macrobiotic, Ma-Pi 2 diet (12% protein, 18% fat and 70% carbohydrate), has shown benefit in adults with type 2 diabetes mellitus (T2DM). This pooled analysis aims to confirm results from four, 21-day intervention studies with the Ma-Pi 2 diet, carried out in Cuba, China, Ghana and Italy. Baseline and end of study biochemical, body composition and blood pressure data, were compared using multivariate statistical methods and assessment of the Cohen effect size (d). Results showed that all measured indicators demonstrated significant changes (p < 0.001); most of them with a very high (d ≥ 1.30), or high (d = 0.80-1.29) effect size. The global effect size of the diet was Italy (1.96), China (1.79), Cuba (1.38) and Ghana (0.98). The magnitude of the individual effect on each variable by country, and the global effect by country, was independent of the sample size (p > 0.05). Similarly, glycemia and glycemic profiles in all four studies were independent of the sample size (p = 0.237). The Ma-Pi diet 2 significantly reduced glycemia, serum lipids, uremia and cardiovascular risk in adults with T2DM. These results suggest that the Ma-Pi 2 diet could be a valid alternative treatment for patients with T2DM and point to the need for further clinical studies. Mechanisms related to its benefits as a functional diet are discussed.

  3. Effects of an Automated Telephone Support System on Caregiver Burden and Anxiety: Findings from the REACH for TLC Intervention Study

    ERIC Educational Resources Information Center

    Mahoney, Diane Feeney; Tarlow, Barbara J.; Jones, Richard N.

    2003-01-01

    Purpose: We determine the main outcome effects of a 12-month computer-mediated automated interactive voice response (IVR) intervention designed to assist family caregivers managing persons with disruptive behaviors related to Alzheimer's disease (AD). Design and Methods: We conducted a randomized controlled study of 100 caregivers, 51 in the usual…

  4. The Role of Friends' Disruptive Behavior in the Development of Children's Tobacco Experimentation: Results from a Preventive Intervention Study

    ERIC Educational Resources Information Center

    van Lier, Pol A. C.; Huizink, Anja; Vuijk, Patricia

    2011-01-01

    Having friends who engage in disruptive behavior in childhood may be a risk factor for childhood tobacco experimentation. This study tested the role of friends' disruptive behavior as a mediator of the effects of a classroom based intervention on children's tobacco experimentation. 433 Children (52% males) were randomly assigned to the Good…

  5. Patients’ Depression Treatment Preferences and Initiation, Adherence, and Outcome: A Randomized Primary Care Study

    PubMed Central

    Raue, Patrick J.; Schulberg, Herbert C.; Heo, Moonseong; Klimstra, Sibel; Bruce, Martha L.

    2009-01-01

    Objective We examined the association of treatment preferences with treatment initiation, adherence, and clinical outcome among depressed mid-life and elderly primary care patients. Methods 60 primary care participants meeting DSM-IV criteria for major depression were randomized to receive treatment congruent or incongruent with their primary stated preference. Participants received either 20 weeks of escitalopram as monitored by a care manager, or 12 weekly sessions of interpersonal psychotherapy followed by 2 monthly booster sessions. Adherence to treatment and depression severity were reassessed at weeks 4, 8, 12, and 24. Results Participants expressed stronger preferences for psychotherapy than antidepressant medication. Preference strength was a more sensitive measure of outcomes than congruence versus incongruence of preference with the assigned treatment. Across age groups, preference strength was significantly associated with treatment initiation and 12-week adherence rate, but not with depression severity or remission. Conclusions A continuous measure of preference strength may be a more useful measure in clinical practice than preferences per se. Future research should focus on whether and how greater facilitation of the patient-clinician treatment decision-making process influences clinical outcome. PMID:19252046

  6. Effect of different types of exercise on postural balance in elderly women: a randomized controlled trial.

    PubMed

    de Oliveira, Marcio R; da Silva, Rubens A; Dascal, Juliana B; Teixeira, Denilson C

    2014-01-01

    Different types of exercise are indicated for the elderly to prevent functional capacity limitations due to aging and reduce the risk of falls. This study aimed to evaluate the effect of three different exercises (mini-trampoline, MT; aquatic gymnastics, AG and general floor gymnastics, GG) on postural balance in elderly women. Seventy-four physically independent elderly women, mean age 69±4 years, were randomly assigned to three intervention groups: (1) MT (n=23), (2) AG (n=28), and (3) GG (n=23). Each group performed physical training, including cardiorespiratory, muscular strength and endurance, flexibility and sensory-motor exercises for 12 weeks. To determine the effects on each intervention group, five postural balance tasks were performed on a force platform (BIOMEC 400): the two-legged stand with eyes open (TLEO) and two-legged stand with eyes closed (TLEC); the semi-tandem stand with eyes open (STEO) and semi-tandem stand with eyes closed (STEC) and the one-legged stand. Three trials were performed for each task (with 30s of rest between them) and the mean was used to compute balance parameters such as center of pressure (COP) sway movements. All modalities investigated such as the MT, AG and GG were significantly (P<0.05) efficient in improving the postural balance of elderly women after 12 weeks of training. These results provide further evidence concerning exercise and balance for promoting health in elderly women.

  7. A Randomized Controlled Study of a Web Based Performance Improvement System for Substance Abuse Treatment Providers

    PubMed Central

    Crits-Christoph, Paul; Ring-Kurtz, Sarah; McClure, Bridget; Temes, Christina; Kulaga, Agatha; Gallop, Robert; Forman, Robert; Rotrosen, John

    2010-01-01

    We report here on the results of a randomized, controlled trial evaluating the efficacy of a semi-automated performance improvement system (“Patient Feedback”) that enables real-time monitoring of patient outcomes in outpatient substance abuse treatment clinics. The study involved 118 clinicians working at 20 community-based outpatient substance abuse treatment clinics in the northeast United States. Ten clinics received 12 weeks of the Patient Feedback performance improvement intervention and ten clinics received no intervention during the 12 weeks. Over 1500 patients provided anonymous ratings of therapeutic alliance, treatment satisfaction, and drug/alcohol use. There was no evidence of an intervention effect on the primary drug and alcohol use scales. There was also no evidence of an intervention effect on secondary measures of therapeutic alliance. Clinician-rated measures of organizational functioning and job satisfaction also showed no intervention effect. Possible insights from these findings, and alternative methods of utilizing feedback reports to enhance clinical outcomes are proposed. PMID:20116964

  8. A Randomized Clinical Trial of Treatments for Symptomatic Convergence Insufficiency in Children

    PubMed Central

    2009-01-01

    Objective To compare home-based pencil push-ups (HBPP), home-based computer vergence/accommodative therapy and pencil push-ups (HBCVAT+), office-based vergence/accommodative therapy with home reinforcement (OBVAT), and office-based placebo therapy with home reinforcement (OBPT) as treatments for symptomatic convergence insufficiency (CI). Methods In a randomized clinical trial, 221 children 9 to 17 years with symptomatic CI were assigned to one of four treatments. Main Outcome Measures Convergence Insufficiency Symptom Survey (CISS) score after 12 weeks of treatment. Secondary outcomes were near point of convergence (NPC) and positive fusional vergence at near (PFV). Results After 12 weeks of treatment the OBVAT group’s CISS score (15.1) was statistically significantly lower than the HBCVAT+, HBPP, and OBPT groups’ scores of 21.3, 24.7, and 21.9, respectively (P < 0.001). The OBVAT group also demonstrated a significantly improved NPC and PFV compared with the other groups (P <= 0.005). A successful or improved outcome for the OBVAT, HBPP, HBCVAT+, and OBPT groups was found in 73%, 43%, 33%, and 35%, respectively. Conclusion Twelve weeks of OBVAT results in a significantly greater improvement in symptoms and clinical measures of NPC and PFV and a greater percentage of patients reaching pre-determined criteria of success when compared with HBPP, HBCVAT+, or OBPT. PMID:18852411

  9. The Use of Text Messaging to Promote Physical Activity in Working Women: A Randomized Controlled Trial

    PubMed Central

    Gell, Nancy M.; Wadsworth, Danielle D.

    2014-01-01

    Background The study evaluated the effects of a text message intervention on physical activity in adult working women. Methods Eighty-seven participants were randomized to an intervention (n=41) or control group (n=46). Pedometer step counts and measures of self-efficacy were collected at baseline, 12 and 24 weeks. Intervention participants received approximately three text messages per week that were motivational, informational, and specific to performing physical activity. Results ANCOVA results showed a significant difference between groups for mean steps/day at 12 weeks (6540.0 vs. 5685.0, p=.01) and no significant difference at 24 weeks (6867.7 vs. 6189.0, p= .06). There was no change in mean step counts during or after the intervention compared to baseline. There was a significant difference between groups for mean self-efficacy scores at 12 weeks (68.5, vs. 60.3, p=.02) and at 24 weeks (67.3 vs. 59.0, p=.03). Conclusions Intervention participants had higher step counts after 12 and 24 weeks compared to a control group; however, the difference was significant only at the midpoint of the intervention and was attributable to a decrease in steps for the control group. Text messaging did not increase step counts but may be a cost effective tool for maintenance of physical activity behavior. PMID:25110303

  10. Fractional Carbon Dioxide Laser for Keratosis Pilaris: A Single-Blind, Randomized, Comparative Study

    PubMed Central

    Vachiramon, Vasanop; Anusaksathien, Pattarin; Kanokrungsee, Silada; Chanprapaph, Kumutnart

    2016-01-01

    Objective. Keratosis pilaris (KP) is a common condition which can frequently be cosmetically disturbing. Topical treatments can be used with limited efficacy. The objective of this study is to evaluate the effectiveness and safety of fractional carbon dioxide (CO2) laser for the treatment of KP. Patients and Methods. A prospective, randomized, single-blinded, intraindividual comparative study was conducted on adult patients with KP. A single session of fractional CO2 laser was performed to one side of arm whereas the contralateral side served as control. Patients were scheduled for follow-up at 4 and 12 weeks after treatment. Clinical improvement was graded subjectively by blinded dermatologists. Patients rated treatment satisfaction at the end of the study. Results. Twenty patients completed the study. All patients stated that the laser treatment improved KP lesions. At 12-week follow-up, 30% of lesions on the laser-treated side had moderate to good improvement according to physicians' global assessment (p = 0.02). Keratotic papules and hyperpigmentation appeared to respond better than the erythematous component. Four patients with Fitzpatrick skin type V developed transient pigmentary alteration. Conclusions. Fractional CO2 laser treatment may be offered to patients with KP. Dark-skinned patients should be treated with special caution. PMID:27247936

  11. Quantum random number generation

    DOE PAGES

    Ma, Xiongfeng; Yuan, Xiao; Cao, Zhu; Zhang, Zhen; Qi, Bing

    2016-06-28

    Here, quantum physics can be exploited to generate true random numbers, which play important roles in many applications, especially in cryptography. Genuine randomness from the measurement of a quantum system reveals the inherent nature of quantumness -- coherence, an important feature that differentiates quantum mechanics from classical physics. The generation of genuine randomness is generally considered impossible with only classical means. Based on the degree of trustworthiness on devices, quantum random number generators (QRNGs) can be grouped into three categories. The first category, practical QRNG, is built on fully trusted and calibrated devices and typically can generate randomness at amore » high speed by properly modeling the devices. The second category is self-testing QRNG, where verifiable randomness can be generated without trusting the actual implementation. The third category, semi-self-testing QRNG, is an intermediate category which provides a tradeoff between the trustworthiness on the device and the random number generation speed.« less

  12. Fixed combination of cinnarizine and dimenhydrinate versus betahistine dimesylate in the treatment of Ménière's disease: a randomized, double-blind, parallel group clinical study.

    PubMed

    Novotný, Miroslav; Kostrica, Rom

    2002-01-01

    In a randomized, double-blind clinical study, we evaluated the efficacy and tolerability of the fixed combination of cinnarizine, 20 mg, and dimenhydrinate, 40 mg (Arlevert [ARL]) in comparison to betahistine dimesylate (12 mg) in 82 patients suffering from Ménière's disease for at least 3 months and showing the characteristic triad of symptoms (paroxysmal vertigo attacks, cochlear hearing loss, and tinnitus). The treatment (one tablet three times daily) extended to 12 weeks, with control visits at 1, 3, 6, and 12 weeks after drug intake. The study demonstrated for both the fixed-combination ARL and for betahistine a highly efficient reduction of vertigo symptoms in the course of the 12 weeks of treatment; however, no statistically significant difference between the two treatment groups could be established. Similar results were found for tinnitus (approximately 60% reduction) and for the associated vegetative symptoms (almost complete disappearance). Vestibulospinal reactions, recorded by means of craniocorpography, also improved distinctly, with a statistically significant superiority of ARL versus betahistine (p < .042) for the parameter of lateral sway (Unterberger's test). The caloric tests (electronystagmography) showed only minor changes for both treatment groups in the course of the study. A statistically significant improvement of hearing function of the affected ear (p = .042) was found for the combination preparation after 12 weeks of treatment. The tolerability was judged by the vast majority of patients (97.5%) in both groups to be very good. Only one patient (betahistine group) reported a nonserious adverse event, and two betahistine patients did not complete the study. In conclusion, the combination preparation proved to be a highly efficient and safe treatment option for Ménière's disease and may be used both in the management of acute episodes and in long-term treatment. Efficacy and safety were found to be similar to the widely used standard

  13. Effect of Hydroxychloroquine Treatment on Dry Eyes in Subjects with Primary Sjögren’s Syndrome: a Double-Blind Randomized Control Study

    PubMed Central

    2016-01-01

    The effect of hydroxychloroquine (HCQ) on dry eye has not been fully determined. This study aimed to compare the 12-week efficacy of HCQ medication with that of a placebo in the management of dry eye in primary Sjögren's syndrome (pSS). A double-blind, randomized control study was conducted in 39 pSS subjects from May 2011 through August 2013. pSS was diagnosed based on the classification criteria of the American-European Consensus Group. Subjects received 300 mg of HCQ or placebo once daily for 12 weeks and were evaluated at baseline, 6, and 12 weeks, with a re-visit at 16 weeks after drug discontinuance. The fluorescein staining score, Schirmer test score, tear film break-up time (TBUT), and ocular surface disease index (OSDI) were measured, and tears and blood were collected for ESR, IL-6, IL-17, B-cell activating factor (BAFF), and Th17 cell analysis. Color testing was performed and the fundus was examined to monitor HCQ complications. Twenty-six subjects completed the follow-up. The fluorescein staining score and Schirmer test score did not differ significantly. The OSDI improved with medication in the HCQ group but was not significantly different between the groups. TBUT, serum IL-6, ESR, serum and tear BAFF, and the proportion of Th17 cells did not change in either group. HCQ at 300 mg daily for 12 weeks has no apparent clinical benefit for dry eye and systemic inflammation in pSS (ClinicalTrials.gov. NCT01601028). PMID:27366013

  14. Effect of Hydroxychloroquine Treatment on Dry Eyes in Subjects with Primary Sjögren's Syndrome: a Double-Blind Randomized Control Study.

    PubMed

    Yoon, Chang Ho; Lee, Hyun Ju; Lee, Eun Young; Lee, Eun Bong; Lee, Won-Woo; Kim, Mee Kum; Wee, Won Ryang

    2016-07-01

    The effect of hydroxychloroquine (HCQ) on dry eye has not been fully determined. This study aimed to compare the 12-week efficacy of HCQ medication with that of a placebo in the management of dry eye in primary Sjögren's syndrome (pSS). A double-blind, randomized control study was conducted in 39 pSS subjects from May 2011 through August 2013. pSS was diagnosed based on the classification criteria of the American-European Consensus Group. Subjects received 300 mg of HCQ or placebo once daily for 12 weeks and were evaluated at baseline, 6, and 12 weeks, with a re-visit at 16 weeks after drug discontinuance. The fluorescein staining score, Schirmer test score, tear film break-up time (TBUT), and ocular surface disease index (OSDI) were measured, and tears and blood were collected for ESR, IL-6, IL-17, B-cell activating factor (BAFF), and Th17 cell analysis. Color testing was performed and the fundus was examined to monitor HCQ complications. Twenty-six subjects completed the follow-up. The fluorescein staining score and Schirmer test score did not differ significantly. The OSDI improved with medication in the HCQ group but was not significantly different between the groups. TBUT, serum IL-6, ESR, serum and tear BAFF, and the proportion of Th17 cells did not change in either group. HCQ at 300 mg daily for 12 weeks has no apparent clinical benefit for dry eye and systemic inflammation in pSS (ClinicalTrials.gov. NCT01601028). PMID:27366013

  15. Continuous Positive Airway Pressure Increases Pulsatile Growth Hormone Secretion and Circulating Insulin-like Growth Factor-1 in a Time-Dependent Manner in Men With Obstructive Sleep Apnea: A Randomized Sham-Controlled Study

    PubMed Central

    Hoyos, Camilla M.; Killick, Roo; Keenan, Daniel M.; Baxter, Robert C.; Veldhuis, Johannes D.; Liu, Peter Y.

    2014-01-01

    Study Objectives: To assess the time-dependent effect of continuous positive airway pressure (CPAP), on insulin-like growth factor-1 (IGF-1), IGF binding proteins (IGFBPs) and pulsatile growth hormone (GH) secretion. Design: A randomized, double-blind, sham-controlled, parallel group study. Participants: Sixty-five middle-aged men with moderate to severe obstructive sleep apnea. Intervention: Active (n = 34) or sham (n = 31) CPAP for 12 weeks, followed by 12 weeks of active CPAP (n = 65). Measurements and Results: Fasting morning IGF-1, IGFBP-3, and IGFBP-1 blood levels at 0, 6, 12, and 24 weeks. Overnight GH secretion was calculated by mathematical deconvolution of serial GH measurements from serum samples collected every 10 min (22:00-06:00) during simultaneous polysomnography in a subset of 18 men (active n = 11, sham n = 7) at week 12. Active, compared with sham, CPAP increased IGF-1 at 12 weeks (P = 0.006), but not at 6 weeks (P = 0.44). Changes in IGFBP-3 and IGFBP-1 were not different between groups at 6 or 12 weeks (all P ≥ 0.15). At week 24, there was a further increase in IGF-1 and a decrease in IGFBP-1 in the pooled group (P = 0.0001 and 0.046, respectively). In the subset, total (P = 0.001) and pulsatile (P = 0.002) GH secretion, mean GH concentration (P = 0.002), mass of GH secreted per pulse (P = 0.01) and pulse frequency (P = 0.04) were all higher after 12 weeks of CPAP compared with sham. Basal secretion, interpulse regularity, and GH regularity were not different between groups (all P > 0.11). Conclusions: Twelve weeks, but not 6 weeks, of CPAP increases IGF-1, with a further increase after 24 weeks. Total and pulsatile GH secretion, secretory burst mass and pulse frequency are also increased by 12 weeks. CPAP improves specific elements of the GH/IGF-1 axis in a time-dependent manner. Clinical Trials Registration: Australia New Zealand Clinical Trials Network, www.anzctr.org.au, number ACTRN12608000301369. Citation: Hoyos CM; Killick R; Keenan DM

  16. Mavoglurant in fragile X syndrome: Results of two randomized, double-blind, placebo-controlled trials.

    PubMed

    Berry-Kravis, Elizabeth; Des Portes, Vincent; Hagerman, Randi; Jacquemont, Sébastien; Charles, Perrine; Visootsak, Jeannie; Brinkman, Marc; Rerat, Karin; Koumaras, Barbara; Zhu, Liansheng; Barth, Gottfried Maria; Jaecklin, Thomas; Apostol, George; von Raison, Florian

    2016-01-13

    Fragile X syndrome (FXS), the most common cause of inherited intellectual disability and autistic spectrum disorder, is typically caused by transcriptional silencing of the X-linked FMR1 gene. Work in animal models has described altered synaptic plasticity, a result of the up-regulation of metabotropic glutamate receptor 5 (mGluR5)-mediated signaling, as a putative downstream effect. Post hoc analysis of a randomized, placebo-controlled, crossover phase 2 trial suggested that the selective mGluR5 antagonist mavoglurant improved behavioral symptoms in FXS patients with completely methylated FMR1 genes. We present the results of two phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies of mavoglurant in FXS, designed to confirm this result in adults (n = 175, aged 18 to 45 years) and adolescents (n = 139, aged 12 to 17 years). In both trials, participants were stratified by methylation status and randomized to receive mavoglurant (25, 50, or 100 mg twice daily) or placebo over 12 weeks. Neither of the studies achieved the primary efficacy end point of improvement on behavioral symptoms measured by the Aberrant Behavior Checklist-Community Edition using the FXS-specific algorithm (ABC-C(FX)) after 12 weeks of treatment with mavoglurant. The safety and tolerability profile of mavoglurant was as previously described, with few adverse events. Therefore, under the conditions of our study, we could not confirm the mGluR theory of FXS nor the ability of the methylation state of the FMR1 promoter to predict mavoglurant efficacy. Preclinical results suggest that future clinical trials might profitably explore initiating treatment in a younger population with longer treatment duration and longer placebo run-ins and identifying new markers to better assess behavioral and cognitive benefits.

  17. Does Cataract Surgery Alleviate Poverty? Evidence from a Multi-Centre Intervention Study Conducted in Kenya, the Philippines and Bangladesh

    PubMed Central

    Kuper, Hannah; Polack, Sarah; Mathenge, Wanjiku; Eusebio, Cristina; Wadud, Zakia; Rashid, Mamunur; Foster, Allen

    2010-01-01

    Background Poverty and blindness are believed to be intimately linked, but empirical data supporting this purported relationship are sparse. The objective of this study is to assess whether there is a reduction in poverty after cataract surgery among visually impaired cases. Methodology/Principal Findings A multi-centre intervention study was conducted in three countries (Kenya, Philippines, Bangladesh). Poverty data (household per capita expenditure – PCE, asset ownership and self-rated wealth) were collected from cases aged ≥50 years who were visually impaired due to cataract (visual acuity<6/24 in the better eye) and age-sex matched controls with normal vision. Cases were offered free/subsidised cataract surgery. Approximately one year later participants were re-interviewed about poverty. 466 cases and 436 controls were examined at both baseline and follow-up (Follow up rate: 78% for cases, 81% for controls), of which 263 cases had undergone cataract surgery (“operated cases”). At baseline, operated cases were poorer compared to controls in terms of PCE (Kenya: $22 versus £35 p = 0.02, Bangladesh: $16 vs $24 p = 0.004, Philippines: $24 vs 32 p = 0.0007), assets and self-rated wealth. By follow-up PCE had increased significantly among operated cases in each of the three settings to the level of controls (Kenya: $30 versus £36 p = 0.49, Bangladesh: $23 vs $23 p = 0.20, Philippines: $45 vs $36 p = 0.68). There were smaller increases in self-rated wealth and no changes in assets. Changes in PCE were apparent in different socio-demographic and ocular groups. The largest PCE increases were apparent among the cases that were poorest at baseline. Conclusions/Significance This study showed that cataract surgery can contribute to poverty alleviation, particularly among the most vulnerable members of society. This study highlights the need for increased provision of cataract surgery to poor people and shows that a focus on blindness may

  18. Targeting condom distribution at high risk places increases condom utilization-evidence from an intervention study in Livingstone, Zambia

    PubMed Central

    2012-01-01

    Background The PLACE-method presumes that targeting HIV preventive activities at high risk places is effective in settings with major epidemics. Livingstone, Zambia, has a major HIV epidemic despite many preventive efforts in the city. A baseline survey conducted in 2005 in places where people meet new sexual partners found high partner turnover and unprotected sex to be common among guests. In addition, there were major gaps in on-site condom availability. This study aimed to assess the impact of a condom distribution and peer education intervention targeting places where people meet new sexual partners on condom use and sexual risk taking among people socializing there. Methods The 2005 baseline survey assessed the presence of HIV preventive activities and sexual risk taking in places where people meet new sexual partners in Livingstone. One township was selected for a non-randomised intervention study on condom distribution and peer education in high risk venues in 2009. The presence of HIV preventive activities in the venues during the intervention was monitored by an external person. The intervention was evaluated after one year with a follow-up survey in the intervention township and a comparison township. In addition, qualitative interviews and focus group discussions were conducted. Results Young people between 17-32 years of age were recruited as peer educators, and 40% were females. Out of 72 persons trained before the intervention, 38 quit, and another 11 had to be recruited. The percentage of venues where condoms were reported to always be available at least doubled in both townships, but was significantly higher in the intervention vs. the control venues in both surveys (84% vs. 33% in the follow-up). There was a reduction in reported sexual risk taking among guests socializing in the venues in both areas, but reporting of recent condom use increased more among people interviewed in the intervention (57% to 84%) than in the control community (55% to 68

  19. The Advanced Glaucoma Intervention Study (AGIS): 10. Variability among academic glaucoma subspecialists in assessing optic disc notching.

    PubMed Central

    Gaasterland, D E; Blackwell, B; Dally, L G; Caprioli, J; Katz, L J; Ederer, F

    2001-01-01

    PURPOSE: An analysis of data from the Advanced Glaucoma Intervention Study (AGIS) has found eyes reported to have partial optic disc rim notching (not to the edge) at baseline to have less risk of subsequent visual field loss than eyes with no notching. Because this is counterintuitive and because classification of notching had not been defined in the AGIS protocol, we have assessed AGIS ophthalmologists interobserver and intraobserver agreement on notching. METHODS: Fourteen glaucoma subspecialists classified notching in 26 pairs of stereoscopic disc photographs of eyes with mild to severe glaucomatous optic neuropathy. They classified images as showing either no notching, notching not to the edge, or notching to the edge. Several hours later, 10 of them classified the same images a second time. RESULTS: In an analysis of interobserver agreement, of 26 stereoscopic images, a plurality of ophthalmologists classified notching as absent in 9 (35%), as present but not to the edge in 7 (27%), and as present and not to the edge in 10 (38%). All 14 ophthalmologists (100%) agreed on the classification of 7 (27%) of the images, and 13 of the 14 ophthalmologists (93%) agreed on the classification of 4 additional images (15%). Of these 11 images with at least 93% agreement, notching was reported as absent in 3 (27%) and to the edge in 8 (73%). In the remaining 15 images, there was substantial disagreement about whether notching was present and, if so, whether it was to the edge. In an analysis of intraobserver agreement, none of the 10 ophthalmologists who completed the viewing a second time classified all eyes exactly the same as the first time, though 5 ophthalmologists made 4 or fewer reclassifications. Overall, 80% of the original classifications were reproduced on second reading. Of the initial classifications that were not reproduced, slightly more than half were first classified as having notching not to the edge. CONCLUSION: Without definitions or examples of optic

  20. An intervention study demonstrates effects of MC4R genotype on boar taint and performances of growing-finishing pigs.

    PubMed

    Van den Broeke, A; Aluwé, M; Tuyttens, F A M; Ampe, B; Vanhaecke, L; Wauters, J; Janssens, S; Coussé, A; Buys, N; Millet, S

    2015-03-01

    The Asp298Asn polymorphism of the melanocortin-4 receptor (MC4R) in pigs is known to affect economically important traits such as growth rate and backfat thickness. We have assessed the possible use of this polymorphism as a molecular marker to perform genetic selection toward lower boar taint levels without compromising growth performance and carcass and meat quality in commercial boars and gilts. Homozygous boars and gilts of the AA genotype and GG genotype were compared in an intervention study with a 2 × 2 design to assess main effects and possible interactions between sex and genotype. The concentrations of the 3 boar taint compounds androstenone ( = 0.044), skatole ( = 0.049), and indole ( = 0.006) were significantly higher in fat of AA boars compared to GG boars. However, no effect on the sensory analysis of the fat samples could be observed. Between 20 and 115 kg BW, AA pigs showed higher ADFI than GG pigs ( < 0.001). An interaction between genotype and sex was observed for ADG ( = 0.044): AA boars had a significantly higher ADG than GG boars but there was no significant difference between the gilts. Daily lean meat gain tended to be higher in boars compared to gilts ( = 0.051), independent of genotype. Similarly, boars showed higher G:F compared to gilts ( < 0.001), without effect of genotype. Genotype and sex affected several carcass quality parameters but there was no interaction. Pigs of the AA genotype displayed a lower dressing percentage ( = 0.005), lower ham width ( = 0.024), lower muscle thickness ( = 0.011), and higher fat thickness ( < 0.001), resulting in a lower lean meat percentage ( < 0.001) in comparison with GG pigs. Gilts had a significantly higher dressing percentage ( < 0.001), higher muscle thickness ( < 0.001), higher ham width ( < 0.001), and lower ham angle ( < 0.001) compared to boars. Other than the boar taint compounds, meat quality was not affected by genotype. Pork of gilts was darker ( = 0.014) and less exudative during

  1. Comparative Effectivenesses of Pulsed Radiofrequency and Transforaminal Steroid Injection for Radicular Pain due to Disc Herniation: a Prospective Randomized Trial.

    PubMed

    Lee, Dong Gyu; Ahn, Sang-Ho; Lee, Jungwon

    2016-08-01

    Transforaminal Epidural steroid injections (TFESI) have been widely adopted to alleviate and control radicular pain in accord with current guidelines. However, sometimes repeated steroid injections have adverse effects, and thus, this prospective randomized trial was undertaken to compare the effectivenesses of pulsed radiofrequency (PRF) administered to a targeted dorsal root ganglion (DRG) and TFESI for the treatment of radicular pain due to disc herniation. Subjects were recruited when first proved unsuccessful (defined as a score of > 4 on a visual analogue scale (VAS; 0-10 mm) and of > 30% according to the Oswestry Disability Index (ODI) or the Neck Disability Index (NDI)). Forty-four patients that met the inclusion criteria were enrolled. The 38 subjects were randomly assigned to receive either PRF (PRF group; n = 19) or additional TFESI (TFESI group; n = 19) and were then followed for 2, 4, 8, and 12 weeks. To evaluate pain intensity were assessed by VAS. ODI and NDI were applied to evaluate functional disability. Mean VAS scores for cervical and lumbar radicular pain were significantly lower 12 weeks after treatment in both study groups. NDI and ODI scores also declined after treatment. However, no statistically significant difference was observed between the PRF and TFESI groups in terms of VAS, ODI, or NDI scores at any time during follow-up. PRF administered to a DRG might be as effective as TFESI in terms of attenuating radicular pain caused by disc herniation, and its use would avoid the adverse effects of steroid. PMID:27478346

  2. Antioxidative Activity of Onion Peel Extract in Obese Women: A Randomized, Double-blind, Placebo Controlled Study

    PubMed Central

    Kim, Kyung-Ah; Yim, Jung-Eun

    2015-01-01

    Background: Quercetin, found abundantly in onion peel, has been known to have anticholesterol, antithrombotic and insulin-sensitizing properties. Here, we investigated the effect of quercetin-rich onion peel extract (OPE) on reactive oxygen species (ROS) production and antioxidative defense in obese woman. Methods: This study was randomized, double-blind, placebo controlled study. Thirty-seven healthy obese participants were randomly assigned that eighteen subjects received red soft capsuled OPE (100 mg/d, 50 mg bis in die), while the other nineteen subjects received same capsuled placebo for 12 weeks. ROS production and superoxide dismutase (SOD) activity in plasma were determined by using ROS and SOD assay kits, respectively. Results: Baseline characteristics of anthropometric indicators and blood metabolic profiles were not significantly different between the two groups. Compared with baseline values, OPE consumption significantly reduced waist and hip circumference. Plasma ROS level and SOD activity were decreased in both placebo and OPE groups compared with baseline values. However, plasma ROS level in OPE group was significantly lower than in placebo group while plasma SOD activity in OPE group was significantly higher than in placebo group after 12 weeks of consumption. Conclusions: These findings indicate that OPE consumption may exert antioxidative effect by preventing the decrease of SOD activity as well as the production of ROS in obese women. PMID:26473159

  3. Single-dose oral fluconazole versus topical clotrimazole in patients with pityriasis versicolor: A double-blind randomized controlled trial.

    PubMed

    Dehghan, Mohammad; Akbari, Negin; Alborzi, Nazila; Sadani, Somayeh; Keshtkar, Abas A

    2010-08-01

    This study was designed to compare the therapeutic effects of topical clotrimazole and systemic fluconazole in pityriasis versicolor. A double-blind randomized controlled trial was carried out in the dermatological clinic of Gorgan, northern Iran, between April 2006 and May 2007. All consecutive patients with pityriasis versicolor were included and randomly divided into two groups. In the first group (G1), patients underwent treatment with a single dose of fluconazole capsule (400 mg) and placebo cream. In the second group (G2), patients underwent treatment with clotrimazole cream (twice daily) and placebo capsule. The course of treatment was 2 weeks. All subjects were re-evaluated 2, 4 and 12 weeks after the end of the therapeutic course. After 2 weeks, the rate of complete resolution of disease was significantly higher in G2 than G1 (49.1% vs 30%). After 4 weeks, 41 patients (81.2%) of G1 and 52 patients (94.9%) of G2 showed complete resolution. After 12 weeks, 46 patients (92%) in G1 and 45 patients (81.8%) in G2 showed complete resolution. Recurrence rate in G1 and G2 were 6% and 18.2%, respectively. No complications were seen in either group. In this study, clinical response at week 4 was greater in the clotrimazole group than the fluconazole group. Recurrence at week 12 after treatment was less with oral fluconazole than clotrimazole cream. So, for better evaluation, more studies need to be done.

  4. Medical Yoga for Patients with Stress-Related Symptoms and Diagnoses in Primary Health Care: A Randomized Controlled Trial

    PubMed Central

    Köhn, Monica; Persson Lundholm, Ulla; Bryngelsson, Ing-Liss; Anderzén-Carlsson, Agneta; Westerdahl, Elisabeth

    2013-01-01

    An increasing number of patients are suffering from stress-related symptoms and diagnoses. The purpose of this study was to evaluate the medical yoga treatment in patients with stress-related symptoms and diagnoses in primary health care. A randomized controlled study was performed at a primary health care centre in Sweden from March to June, 2011. Patients were randomly allocated to a control group receiving standard care or a yoga group treated with medical yoga for 1 hour, once a week, over a 12-week period in addition to the standard care. A total of 37 men and women, mean age of 53 ± 12 years were included. General stress level (measured using Perceived Stress Scale (PSS)), burnout (Shirom-Melamed Burnout Questionnaire (SMBQ)), anxiety and depression (Hospital Anxiety and Depression Scale (HADS)), insomnia severity (Insomnia Severity Index (ISI)), pain (visual analogue scale (VAS)), and overall health status (Euro Quality of Life VAS (EQ-VAS)) were measured before and after 12 weeks. Patients assigned to the Yoga group showed significantly greater improvements on measures of general stress level (P < 0.000), anxiety (P < 0.019), and overall health status (P < 0.018) compared to controls. Treatment with medical yoga is effective in reducing levels of stress and anxiety in patients with stress-related symptoms in primary health care. PMID:23533465

  5. Evaluation of a Crataegus-Based Multiherb Formula for Dyslipidemia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

    PubMed Central

    Zeng, Weiwei; Tomlinson, Brian

    2014-01-01

    Background. We for the first time examined the effects of a multiherb formula containing Crataegus pinnatifida (1 g daily), Alisma orientalis, Stigma maydis, Ganoderma lucidum, Polygonum multiflorum, and Morus alba on plasma lipid and glucose levels in Chinese patients with dyslipidemia. Methods. In this randomized, double-blind, placebo-controlled study, 42 patients were randomized at a ratio of 1 : 1 to receive the herbal formula or placebo for 12 weeks and 40 patients completed the study. Lipid profiles, glucose, glycated haemoglobin (HbA1c), and laboratory safety parameters were performed before and after treatment. Results. The difference in the changes in low-density lipoprotein cholesterol (LDL-C) levels between placebo and active treatment (−9%) was significantly (P < 0.05) better with active treatment. HbA1c levels significantly decreased by −3.9% in the active treatment group, but the change was not significantly different from that with placebo (−1.1%) (P = 0.098). There were no apparent adverse effects or changes in laboratory safety parameters with either treatment. Conclusions. The multiherb formula had mild beneficial effects on plasma LDL-C after 12-weeks treatment in subjects with dyslipidemia without any noticeable adverse effects. PMID:24834096

  6. Comparative Effectivenesses of Pulsed Radiofrequency and Transforaminal Steroid Injection for Radicular Pain due to Disc Herniation: a Prospective Randomized Trial

    PubMed Central

    2016-01-01

    Transforaminal Epidural steroid injections (TFESI) have been widely adopted to alleviate and control radicular pain in accord with current guidelines. However, sometimes repeated steroid injections have adverse effects, and thus, this prospective randomized trial was undertaken to compare the effectivenesses of pulsed radiofrequency (PRF) administered to a targeted dorsal root ganglion (DRG) and TFESI for the treatment of radicular pain due to disc herniation. Subjects were recruited when first proved unsuccessful (defined as a score of > 4 on a visual analogue scale (VAS; 0-10 mm) and of > 30% according to the Oswestry Disability Index (ODI) or the Neck Disability Index (NDI)). Forty-four patients that met the inclusion criteria were enrolled. The 38 subjects were randomly assigned to receive either PRF (PRF group; n = 19) or additional TFESI (TFESI group; n = 19) and were then followed for 2, 4, 8, and 12 weeks. To evaluate pain intensity were assessed by VAS. ODI and NDI were applied to evaluate functional disability. Mean VAS scores for cervical and lumbar radicular pain were significantly lower 12 weeks after treatment in both study groups. NDI and ODI scores also declined after treatment. However, no statistically significant difference was observed between the PRF and TFESI groups in terms of VAS, ODI, or NDI scores at any time during follow-up. PRF administered to a DRG might be as effective as TFESI in terms of attenuating radicular pain caused by disc herniation, and its use would avoid the adverse effects of steroid. PMID:27478346

  7. Efficacy and effectiveness of infant vaccination against chronic hepatitis B in the Gambia Hepatitis Intervention Study (1986–90) and in the nationwide immunisation program

    PubMed Central

    2014-01-01

    Background Gambian infants were not routinely vaccinated against hepatitis B virus (HBV) before 1986. During 1986–90 the Gambia Hepatitis Intervention Study (GHIS) allocated 125,000 infants, by area, to vaccination or not and thereafter all infants were offered the vaccine through the nationwide immunisation programme. We report HBV serology from samples of GHIS vaccinees and unvaccinated controls, and from children born later. Methods During 2007–08, 2670 young adults born during the GHIS (1986-90) were recruited from 80 randomly selected villages and four townships. Only 28% (753/2670) could be definitively linked to their infant HBV vaccination records (255 fully vaccinated, 23 partially vaccinated [1–2 doses], 475 not vaccinated). All were tested for current HBV infection (HBV surface antigen [HBsAg]) and, if HBsAg-negative, evidence of past infection (HBV core-protein antibody [anti-HBc]). HBsAg-positive samples (each with two age- and sex-matched HBsAg-negative samples) underwent liver function tests. In addition, 4613 children born since nationwide vaccination (in 1990-2007) were tested for HBsAg. Statistical analyses ignore clustering. Results Comparing fully vaccinated vs unvaccinated GHIS participants, current HBV infection was 0.8% (2/255) vs 12.4% (59/475), p < 0.0001, suggesting 94% (95% CI 77-99%) vaccine efficacy. Among unvaccinated individuals, the prevalence was higher in males (p = 0.015) and in rural areas (p = 0.009), but adjustment for this did not affect estimated vaccine efficacy. Comparing fully vaccinated vs unvaccinated participants, anti-HBc was 27.4% (70/255) vs 56.0% (267/475), p < 0.00001. Chronic active hepatitis was not common: the proportion of HBsAg-positive subjects with abnormal liver function tests (ALT > 2 ULN) was 4.1%, compared with 0.2% in those HBsAg-negative. The prevalence of antibodies to hepatitis C virus was low (0.5%, 13/2592). In children born after the end of GHIS, HBsAg prevalence has

  8. Vitamin D₃ Supplementation in Batswana Children and Adults with HIV: A Pilot Double Blind Randomized Controlled Trial

    PubMed Central

    Steenhoff, Andrew P.; Schall, Joan I.; Samuel, Julia; Seme, Boitshepo; Marape, Marape; Ratshaa, Bakgaki; Goercke, Irene; Tolle, Michael; Nnyepi, Maria S.; Mazhani, Loeto; Zemel, Babette S.; Rutstein, Richard M.; Stallings, Virginia A.

    2015-01-01

    Objectives Since vitamin D insufficiency is common worldwide in people with HIV, we explored safety and efficacy of high dose cholecalciferol (D₃) in Botswana, and evaluated potential modifiers of serum 25 hydroxy vitamin D change (Δ25D). Design Prospective randomized double-blind 12-week pilot trial of subjects ages 5.0–50.9 years. Methods Sixty subjects randomized within five age groups to either 4000 or 7000IU per day of D₃ and evaluated for vitamin D, parathyroid hormone, HIV, safety and growth status. Efficacy was defined as serum 25 hydroxy vitamin D (25D) ≥32ng/mL, and safety as no simultaneous elevation of serum calcium and 25D. Also assessed were HIV plasma viral RNA viral load (VL), CD4%, anti-retroviral therapy (ART) regime, and height-adjusted (HAZ), weight-adjusted (WAZ) and Body Mass Index (BMIZ) Z scores. Results Subjects were 50% male, age (mean±SD) 19.5±11.8 years, CD4% 31.8±10.4, with baseline VL log₁₀ range of <1.4 to 3.8 and VL detectable (>1.4) in 22%. From baseline to 12 weeks, 25D increased from 36±9ng/ml to 56±18ng/ml (p<0.0001) and 68% and 90% had 25D ≥32ng/ml, respectively (p = 0.02). Δ25D was similar by dose. No subjects had simultaneously increased serum calcium and 25D. WAZ and BMIZ improved by 12 weeks (p<0.04). HAZ and CD4% increased and VL decreased in the 7000IU/d group (p<0.04). Younger (5–13y) and older (30–50y) subjects had greater Δ25D than those 14–29y (26±17 and 28±12 vs. 11±11ng/ml, respectively, p≤0.001). Δ25D was higher with efavirenz or nevirapine compared to protease inhibitor based treatment (22±12, 27±17, vs. 13±10, respectively, p≤0.03). Conclusions In a pilot study in Botswana, 12-week high dose D₃ supplementation was safe and improved vitamin D, growth and HIV status; age and ART regimen were significant effect modifiers. Trial Registration ClinicalTrials.gov NCT02189902 PMID:25706751

  9. Pregnancy-induced changes in the long-term pharmacokinetics of 1.1 mg vs. 5 mg folic acid: a randomized clinical trial.

    PubMed

    Shere, Mahvash; Nguyen, Patricia; Tam, Carolyn; Stern, Seth; Kapur, Bhushan; O'Connor, Deborah L; Koren, Gideon

    2015-02-01

    The objective of this randomized clinical trial was to compare steady-state gestational RBC and plasma folate concentrations in pregnant women supplementing daily with 1.1 mg (regular dose) vs. 5 mg (high dose) folic acid. Thirty-seven pregnant women, who were not previously taking folic acid, were enrolled in this open-label, 2-arm, randomized clinical trial after informed consent. Participants were randomly assigned either 1.1 or 5 mg of folic acid-containing prenatals until gestational age (g.a.) 30 weeks. Plasma and RBC folate concentrations were measured at baseline, g.a.6 weeks, g.a.12 weeks, and g.a.30 weeks using a chemiluminescent immunoassay. Results showed sustained significant increase in RBC folate in the 5 mg group between g.a.6 weeks and g.a.30 weeks (P < 0.001), and between g.a.12 weeks and g.a.30 weeks (P < 0.01), whereas a significant increase in RBC folate concentrations was observed in the 1.1 mg group only between g.a.12 weeks to g.a.30 weeks (P < 0.05). Plasma folate increased in both groups from baseline to g.a.6 weeks, and then decreased between g.a.6 weeks and g.a.30 weeks, but this was not statistically significant. Plasma concentrations at g.a.30 weeks in both groups were comparable to their respective baseline concentrations. Thus, physiological changes in pregnancy alter long-term folate pharmacokinetics. Despite supplementation over an extended period of time, steady-state does not seem to be achieved in either dose group within our study.

  10. The Effects of Computer Training and Internet Usage on the Use of Everyday Technology by Older Adults: A Randomized Controlled Study

    ERIC Educational Resources Information Center

    Slegers, Karin; van Boxtel, Martin P. J.; Jolles, Jelle

    2007-01-01

    According to the skill transfer concept, people may use general technological skills to solve new problems. To test this concept, a technological transfer test was included in a randomized controlled-intervention study aimed at the causal relationship between computer use and autonomy of older adults. Older adults with and without exposure to…

  11. A Mobile Health Lifestyle Program for Prevention of Weight Gain in Young Adults (TXT2BFiT): Nine-Month Outcomes of a Randomized Controlled Trial

    PubMed Central

    Partridge, Stephanie Ruth; McGeechan, Kevin; Balestracci, Kate; Hebden, Lana; Wong, Annette; Phongsavan, Philayrath; Denney-Wilson, Elizabeth; Harris, Mark F; Bauman, Adrian

    2016-01-01

    Background The unprecedented rise in obesity among young adults, who have limited interaction with health services, has not been successfully abated. Objective The objective of this study was to assess the maintenance outcomes of a 12-week mHealth intervention on prevention of weight gain in young adults and lifestyle behaviors at 9 months from baseline. Methods A two-arm, parallel, randomized controlled trial (RCT) with subjects allocated to intervention or control 1:1 was conducted in a community setting in Greater Sydney, Australia. From November 2012 to July 2014, 18- to 35-year-old overweight individuals with a body mass index (BMI) of 25-31.99 kg/m2 and those with a BMI ≥ 23 kg/m2 and a self-reported weight gain of ≥ 2 kg in the past 12 months were recruited. A 12-week mHealth program “TXT2BFiT” was administered to the intervention arm. This included 5 coaching calls, 96 text messages, 12 emails, apps, and downloadable resources from the study website. Lifestyle behaviors addressed were intake of fruits, vegetables, sugar-sweetened beverages (SSBs), take-out meals, and physical activity. The control group received 1 phone call to introduce them to study procedures and 4 text messages over 12 weeks. After 12 weeks, the intervention arm received 2 further coaching calls, 6 text messages, and 6 emails with continued access to the study website during 6-month follow-up. Control arm received no further contact. The primary outcome was weight change (kg) with weight measured at baseline and at 12 weeks and self-report at baseline, 12 weeks, and 9 months. Secondary outcomes were change in physical activity (metabolic equivalent of task, MET-mins) and categories of intake for fruits, vegetables, SSBs, and take-out meals. These were assessed via Web-based surveys. Results Two hundred and fifty young adults enrolled in the RCT. Intervention participants weighed less at 12 weeks compared with controls (model β=−3.7, 95% CI −6.1 to −1.3) and after 9 months

  12. Predictors of remission in depression to individual and combined treatments (PReDICT): study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Limited controlled data exist to guide treatment choices for clinicians caring for patients with major depressive disorder (MDD). Although many putative predictors of treatment response have been reported, most were identified through retrospective analyses of existing datasets and very few have been replicated in a manner that can impact clinical practice. One major confound in previous studies examining predictors of treatment response is the patient’s treatment history, which may affect both the predictor of interest and treatment outcomes. Moreover, prior treatment history provides an important source of selection bias, thereby limiting generalizability. Consequently, we initiated a randomized clinical trial designed to identify factors that moderate response to three treatments for MDD among patients never treated previously for the condition. Methods/design Treatment-naïve adults aged 18 to 65 years with moderate-to-severe, non-psychotic MDD are randomized equally to one of three 12-week treatment arms: (1) cognitive behavior therapy (CBT, 16 sessions); (2) duloxetine (30–60 mg/d); or (3) escitalopram (10–20 mg/d). Prior to randomization, patients undergo multiple assessments, including resting state functional magnetic resonance imaging (fMRI), immune markers, DNA and gene expression products, and dexamethasone-corticotropin-releasing hormone (Dex/CRH) testing. Prior to or shortly after randomization, patients also complete a comprehensive personality assessment. Repeat assessment of the biological measures (fMRI, immune markers, and gene expression products) occurs at an early time-point in treatment, and upon completion of 12-week treatment, when a second Dex/CRH test is also conducted. Patients remitting by the end of this acute treatment phase are then eligible to enter a 21-month follow-up phase, with quarterly visits to monitor for recurrence. Non-remitters are offered augmentation treatment for a second 12-week course of

  13. A 4% erythromycin and zinc combination (Zineryt) versus 2% erythromycin (Eryderm) in acne vulgaris: a randomized, double-blind comparative study.

    PubMed

    Habbema, L; Koopmans, B; Menke, H E; Doornweerd, S; De Boulle, K

    1989-10-01

    A double-blind, randomized multi-centre study was performed to evaluate the efficacy of a 4% erythromycin and zinc combination (Zineryt) versus 2% erythromycin (Eryderm). One-hundred and twenty-two patients suffering from acne vulgaris were treated with either Zineryt lotion or 2% erythromycin lotion. Acne grading and lesion counts for comedones, papules, pustules, nodules and macules were performed at each visit at 0, 1, 2, 4, 8 and 12 weeks. Treatment with Zineryt lotion was found to be more effective than with 2% erythromycin as regards the reduction in number of the acne lesions and the severity grade of the acne.

  14. Random bistochastic matrices

    NASA Astrophysics Data System (ADS)

    Cappellini, Valerio; Sommers, Hans-Jürgen; Bruzda, Wojciech; Życzkowski, Karol

    2009-09-01

    Ensembles of random stochastic and bistochastic matrices are investigated. While all columns of a random stochastic matrix can be chosen independently, the rows and columns of a bistochastic matrix have to be correlated. We evaluate the probability measure induced into the Birkhoff polytope of bistochastic matrices by applying the Sinkhorn algorithm to a given ensemble of random stochastic matrices. For matrices of order N = 2 we derive explicit formulae for the probability distributions induced by random stochastic matrices with columns distributed according to the Dirichlet distribution. For arbitrary N we construct an initial ensemble of stochastic matrices which allows one to generate random bistochastic matrices according to a distribution locally flat at the center of the Birkhoff polytope. The value of the probability density at this point enables us to obtain an estimation of the volume of the Birkhoff polytope, consistent with recent asymptotic results.

  15. Generating random density matrices

    NASA Astrophysics Data System (ADS)

    Życzkowski, Karol; Penson, Karol A.; Nechita, Ion; Collins, Benoît

    2011-06-01

    We study various methods to generate ensembles of random density matrices of a fixed size N, obtained by partial trace of pure states on composite systems. Structured ensembles of random pure states, invariant with respect to local unitary transformations are introduced. To analyze statistical properties of quantum entanglement in bi-partite systems we analyze the distribution of Schmidt coefficients of random pure states. Such a distribution is derived in the case of a superposition of k random maximally entangled states. For another ensemble, obtained by performing selective measurements in a maximally entangled basis on a multi-partite system, we show that this distribution is given by the Fuss-Catalan law and find the average entanglement entropy. A more general class of structured ensembles proposed, containing also the case of Bures, forms an extension of the standard ensemble of structureless random pure states, described asymptotically, as N → ∞, by the Marchenko-Pastur distribution.

  16. Randomness: Quantum versus classical

    NASA Astrophysics Data System (ADS)

    Khrennikov, Andrei

    2016-05-01

    Recent tremendous development of quantum information theory has led to a number of quantum technological projects, e.g. quantum random generators. This development had stimulated a new wave of interest in quantum foundations. One of the most intriguing problems of quantum foundations is the elaboration of a consistent and commonly accepted interpretation of a quantum state. Closely related problem is the clarification of the notion of quantum randomness and its interrelation with classical randomness. In this short review, we shall discuss basics of classical theory of randomness (which by itself is very complex and characterized by diversity of approaches) and compare it with irreducible quantum randomness. We also discuss briefly “digital philosophy”, its role in physics (classical and quantum) and its coupling to the information interpretation of quantum mechanics (QM).

  17. Quantum random number generator

    DOEpatents

    Pooser, Raphael C.

    2016-05-10

    A quantum random number generator (QRNG) and a photon generator for a QRNG are provided. The photon generator may be operated in a spontaneous mode below a lasing threshold to emit photons. Photons emitted from the photon generator may have at least one random characteristic, which may be monitored by the QRNG to generate a random number. In one embodiment, the photon generator may include a photon emitter and an amplifier coupled to the photon emitter. The amplifier may enable the photon generator to be used in the QRNG without introducing significant bias in the random number and may enable multiplexing of multiple random numbers. The amplifier may also desensitize the photon generator to fluctuations in power supplied thereto while operating in the spontaneous mode. In one embodiment, the photon emitter and amplifier may be a tapered diode amplifier.

  18. A randomized trial of contingency management delivered by community therapists

    PubMed Central

    Petry, Nancy M.; Alessi, Sheila M.; Ledgerwood, David M.

    2013-01-01

    Objective Contingency management (CM) is an evidence-based treatment, but few clinicians deliver this intervention in community-based settings. Method Twenty-three clinicians from three methadone maintenance clinics received training in CM. Following a didactics seminar and a training and supervision period in which clinicians delivered CM to pilot patients, a randomized trial evaluated the efficacy of CM when delivered entirely by clinicians. Sixteen clinicians treated 130 patients randomized to CM or standard care. In both conditions, urine and breath samples were collected twice weekly for 12 weeks. In the CM condition, patients earned the opportunity to win prizes ranging in value from $1 to $100 for submitting samples negative for cocaine and alcohol. Primary treatment outcomes were retention, longest continuous period of abstinence, and proportion of negative samples submitted. Results Patients randomized to CM remained in the study longer (9.5 ± 3.6 versus 6.7 ± 5.0 weeks), achieved greater durations of abstinence (4.7 ± 4.7 versus 1.7 ± 2.7 weeks), and submitted a higher proportion of negative samples (57.7% ± 40.0% versus 29.4% ± 33.3%) than those assigned to standard care. Conclusions These data indicate that, with appropriate training, community-based clinicians can effectively administer CM. This study suggests that resources ought to be directed toward training and supervising community-based providers in delivering CM, as patient outcomes can be significantly improved by integrating CM in methadone clinics. PMID:22250852

  19. Autonomous Byte Stream Randomizer

    NASA Technical Reports Server (NTRS)

    Paloulian, George K.; Woo, Simon S.; Chow, Edward T.

    2013-01-01

    Net-centric networking environments are often faced with limited resources and must utilize bandwidth as efficiently as possible. In networking environments that span wide areas, the data transmission has to be efficient without any redundant or exuberant metadata. The Autonomous Byte Stream Randomizer software provides an extra level of security on top of existing data encryption methods. Randomizing the data s byte stream adds an extra layer to existing data protection methods, thus making it harder for an attacker to decrypt protected data. Based on a generated crypto-graphically secure random seed, a random sequence of numbers is used to intelligently and efficiently swap the organization of bytes in data using the unbiased and memory-efficient in-place Fisher-Yates shuffle method. Swapping bytes and reorganizing the crucial structure of the byte data renders the data file unreadable and leaves the data in a deconstructed state. This deconstruction adds an extra level of security requiring the byte stream to be reconstructed with the random seed in order to be readable. Once the data byte stream has been randomized, the software enables the data to be distributed to N nodes in an environment. Each piece of the data in randomized and distributed form is a separate entity unreadable on its own right, but when combined with all N pieces, is able to be reconstructed back to one. Reconstruction requires possession of the key used for randomizing the bytes, leading to the generation of the same cryptographically secure random sequence of numbers used to randomize the data. This software is a cornerstone capability possessing the ability to generate the same cryptographically secure sequence on different machines and time intervals, thus allowing this software to be used more heavily in net-centric environments where data transfer bandwidth is limited.

  20. The Danish Centre for Strategic Research in Type 2 Diabetes (DD2) study: expected outcome from the DD2 project and two intervention studies.

    PubMed

    Beck-Nielsen, Henning; Solomon, Thomas Pj; Lauridsen, Jørgen; Karstoft, Kristian; Pedersen, Bente K; Johnsen, Søren P; Nielsen, Jens Steen; Kryger, Tine Bjerregaard; Sortsø, Camilla; Vaag, Allan

    2012-01-01

    The overall aim of the Danish Centre for Strategic Research in Type 2 Diabetes (DD2) is to near-normalize metabolic control in newly diagnosed patients with type 2 diabetes (T2D) using an individualized treatment approach. We hypothesize that this will not only prevent complications and improve quality of life for T2D patients but also result in increased cost efficiency compared with current treatment modalities. This paper provides an overview of the expected outcomes from DD2, focusing on the two main intervention studies. The main data for the DD2 project are collected during patient enrollment and stored using the individual civil registration number. This enables subsequent linking to other national databases where supplemental data can be obtained. All data will be used for designing treatment guidelines and continuously monitoring the development of diabetic complications, thereby obtaining knowledge about predictors for the long-term outcome and identifying targets for new interventions. Further data are being collected from two intervention studies. The aim of the first intervention study is to improve T2D treatment using an individualized treatment modality optimizing medication according to individual metabolic responses and phenotypic characteristics. The aim of the second intervention study is to develop an evidence-based training protocol to be implemented as a treatment modality for T2D and used for initiating lifelong changes in physical activity levels in patients with T2D. An initial pilot study evaluating an interval-based walking protocol is ongoing, and preliminary results indicate that this protocol is an optimal "free-living" training intervention. An initial health-economic analysis will also be performed as a basis for analysis of the data collected during the project. A cost-benefit analysis of the two intervention studies will be conducted. The DD2 project is expected to lead to improved treatment modalities and increased knowledge about

  1. A prospective, randomized study: Evaluation of the effect of rosuvastatin in patients with chronic obstructive pulmonary disease and pulmonary hypertension

    PubMed Central

    Chogtu, Bharti; Kuriachan, Sanitha; Magazine, Rahul; Shetty, K. Ranjan; Kamath, Asha; George, Manu Mathew; Tripathy, Amruta; Kumar, D. Mahesh

    2016-01-01

    Objectives: Statins by their anti-inflammatory and endothelial stabilizing effect can be beneficial in patients with chronic obstructive pulmonary disease (COPD) and pulmonary hypertension (PH). The present study was done to evaluate the effect of rosuvastatin on pulmonary functions and quality of life (QOL) in patients with concomitant COPD and PH. Materials and Methods: It was a prospective, randomized, double-blind, placebo-controlled, study conducted in patients with COPD and PH. A total of sixty patients were assigned to receive either rosuvastatin 10 mg or placebo once a day in addition to their conventional treatment for 12 weeks. Routine blood investigations, pulmonary functions, echocardiogram, exercise capacity, and QOL using a questionnaire were assessed at the baseline and after 12 weeks. Results: In patients of rosuvastatin group, there was a statistically significant increase in peak expiratory flow rate (PEFR) (P = 0.04) but no significant change in other pulmonary functions: Forced vital capacity (FVC), forced expiratory volume at 1 s (FVC, FEV1, FEV1/FVC), and echocardiogram parameters. There was a significant increase in 6-min walk test (6-min walk distance) (P = 0.03) at the end of 12 weeks. On comparing with placebo, rosuvastatin showed a significant reduction (P = 0.045) in COPD exacerbations while adverse effects did not differ. Conclusion: Statins have a favorable effect on patients with COPD and PH regarding the improvement in PEFR, COPD exacerbations, and exercise capacity. Such effects can be beneficial in these patients and more so in patients with concomitant coronary artery disease or hyperlipidemia where long-term benefits of statins have been established. PMID:27721534

  2. Cost-effectiveness of Extended Buprenorphine-Naloxone Treatment for Opioid-Dependent Youth: Data from a Randomized Trial

    PubMed Central

    Polsky, Daniel; Glick, Henry A.; Yang, Jianing; Subramaniam, Geetha A.; Poole, Sabrina A.; Woody, George E.

    2010-01-01

    Introduction The objective is to estimate cost, net social cost, and cost-effectiveness in a clinical trial of extended buprenorphine-naloxone treatment versus brief detoxification treatment in opioid-dependent youth. Methods Economic evaluation of a clinical trial conducted at 6 community outpatient treatment programs from July 2003 to December 2006 including 152 patients aged 15 to 21 years who were randomized to 12 weeks of buprenorphine-naloxone (BUP) or a 14-day taper (DETOX). BUP patients were prescribed up to 24 mg per day for 9 weeks and then tapered to zero at the end of week 12. DETOX patients were prescribed up to 14 mg per day and then tapered to zero on day 14. All were offered twice weekly drug counseling. Data were collected prospectively during the 12-week treatment and at follow-up interviews at months 6, 9, and 12. Results The 12-week outpatient study treatment cost was $1514 (p<0.001) higher for BUP relative to DETOX. One-year total direct medical cost was only $83 higher for BUP (p=0.97). The cost-effectiveness ratio of BUP relative to DETOX was $1,376 in terms of 1-year direct medical cost per quality-adjusted life year (QALY) and $25,049 in terms of outpatient treatment program cost per QALY. The acceptability curve suggests that the cost-effectiveness ratio of BUP relative to DETOX has an 86% chance of being accepted as cost-effective for a threshold of $100,000 per QALY. Conclusions Extended buprenorphine-naloxone treatment relative to brief detoxification is cost effective in the U.S. health care system for the outpatient treatment of opioid-dependent youth. PMID:20626379

  3. A Randomized Trial Comparing Yoga, Stretching, and a Self-care Book for Chronic Low Back Pain

    PubMed Central

    Sherman, Karen J.; Cherkin, Daniel C.; Wellman, Robert D.; Cook, Andrea J.; Hawkes, Rene J.; Delaney, Kristin; Deyo, Richard A.

    2012-01-01

    Background Chronic low back pain is a common problem lacking highly effective treatment options. Small trials suggest that yoga may have benefits for this condition. This trial was designed to determine whether yoga is more effective than conventional stretching exercises or a self-care book for primary care patients with chronic low back pain. Methods 228 adults with chronic low back pain were randomized to 12 weekly classes of yoga (n=92) or conventional stretching exercises (n=91) or a self-care book (n=45). Back-related functional status (modified Roland Disability Questionnaire, 23-point scale) and bothersomeness of pain (11-point numerical scale) at 12 weeks were the primary outcomes. Outcomes were assessed at baseline, 6, 12 and 26 weeks by interviewers unaware of treatment group. Results After adjustment for baseline values, 12-week outcomes for the yoga group were superior to those for the self-care group (mean difference for function = −2.5 [95% CI= −3.7 to −1.3; P<0.001]; mean difference for symptoms = −1.1 [95% CI= −1.7 to −0.4; P<0.001]). At 26 weeks, function for the yoga group remained superior (mean difference = −1.8 [95% CI= − 3.1 to −0.5; P<0.0001]). Yoga was not superior to conventional stretching exercises at any time point. Conclusions Yoga classes were more effective than a self-care book, but not stretching classes, in improving function and reducing symptoms due to chronic low back pain, with benefits lasting at least several months. PMID:22025101

  4. Randomized trial of a meditation-based stress reduction program and cognitive behavior therapy in generalized social anxiety disorder.

    PubMed

    Koszycki, Diana; Benger, Melodie; Shlik, Jakov; Bradwejn, Jacques

    2007-10-01

    Mindfulness-based stress reduction (MBSR) has been reported to reduce anxiety in a broad range of clinical populations. However, its efficacy in alleviating core symptoms of specific anxiety disorders is not well established. We conducted a randomized trial to evaluate how well MBSR compared to a first-line psychological intervention for social anxiety disorder (SAD). Fifty-three patients with DSM-IV generalized SAD were randomized to an 8-week course of MBSR or 12 weekly sessions of cognitive-behavioral group therapy (CBGT). Although patients in both treatment groups improved, patients receiving CBGT had significantly lower scores on clinician- and patient-rated measures of social anxiety. Response and remission rates were also significantly greater with CBGT. Both interventions were comparable in improving mood, functionality and quality of life. The results confirm that CBGT is the treatment of choice of generalized SAD and suggest that MBSR may have some benefit in the treatment of generalized SAD.

  5. Effectiveness of papain gel in venous ulcer treatment: randomized clinical trial1

    PubMed Central

    Rodrigues, Ana Luiza Soares; de Oliveira, Beatriz Guitton Renaud Baptista; Futuro, Débora Omena; Secoli, Silvia Regina

    2015-01-01

    OBJECTIVE: to assess the effectiveness of 2% papain gel compared to 2% carboxymethyl cellulose in the treatment of chronic venous ulcer patients. METHOD: randomized controlled clinical trial with 12-week follow-up. The sample consisted of 18 volunteers and 28 venous ulcers. In the trial group, 2% papain gel was used and, in the control group, 2% carboxymethyl cellulose gel. RESULTS: the trial group showed a significant reduction in the lesion area, especially between the fifth and twelfth week of treatment, with two healed ulcers and a considerable increase in the amount of epithelial tissue in the wound bed. CONCLUSION: 2% papain gel demonstrated greater effectiveness in the reduction of the lesion area, but was similar to 2% carboxymethyl cellulose gel regarding the reduction in the amount of exudate and devitalized tissue. Multicenter research is suggested to evidence the effectiveness of 2% papain gel in the healing of venous ulcers. UTN number: U1111-1157-2998 PMID:26155004

  6. Randomized double-blind study of botulinum toxin type B for sialorrhea in ALS patients.

    PubMed

    Jackson, Carlayne E; Gronseth, Gary; Rosenfeld, Jeffrey; Barohn, Richard J; Dubinsky, Richard; Simpson, C Blake; McVey, April; Kittrell, Pamela P; King, Ruth; Herbelin, Laura

    2009-02-01

    Twenty ALS patients with sialorrhea refractory to medical therapy were enrolled in this double-blind, randomized study to receive either 2,500 U of botulinum toxin type B (BTxb) or placebo into the bilateral parotid and submandibular glands using electromyographic guidance. Patients who received BTxb reported a global impression of improvement of 82% at 2 weeks compared to 38% of those who received placebo (P < 0.05). This significant effect was sustained at 4 weeks. At 12 weeks, 50% of patients who received BTxb continued to report improvement compared to 14% of those who received placebo. There were no significant adverse events, including dysphagia, in the BTxb group, and there was no significant increase in the rate of decline of vital capacity.

  7. A randomized trial comparing two approaches to weight loss: Differences in weight loss maintenance

    PubMed Central

    Carels, Robert A; Burmeister, Jacob M; Koball, Afton M; Oehlhof, Marissa W; Hinman, Nova; LeRoy, Michelle; Bannon, Erin; Ashrafioun, Lee; Storfer-Isser, Amy; Darby, Lynn A; Gumble, Amanda

    2013-01-01

    This study compared treatment outcomes for a new weight loss program that emphasized reducing unhealthy relationships with food, body image dissatisfaction, and internalized weight bias (New Perspectives) to a weight loss program that emphasizes environmental modification and habit formation and disruption (Transforming Your Life). Fifty-nine overweight and obese adults (body mass index ≥ 27 kg/m2) were randomly assigned to either a 12-week New Perspectives or Transforming Your Life intervention. Despite equivalent outcomes at the end of treatment, the Transforming Your Life participants were significantly more effective at maintaining their weight loss than New Perspectives participants during the 6-month no-treatment follow-up period. PMID:23349402

  8. Parent Training for Young Children With Developmental Disabilities: Randomized Controlled Trial

    PubMed Central

    McIntyre, Laura Lee

    2009-01-01

    A randomized controlled trial was used to evaluate a parent training intervention for caregivers with preschool-age children with developmental disabilities. The 21 families in the experimental group received usual care plus the 12-week Incredible Years Parent Training Program with developmental delay modifications. Families in the control group (n = 23) received usual care, including early childhood education and related services. Results suggest that this parent training intervention was superior to usual care for young children with developmental delays or disabilities in reducing negative parent–child interactions and child behavior problems. Participants in the experimental group indicated high satisfaction with treatment. Additional research is necessary to document maintenance and generalization of treatment outcomes. PMID:18702556

  9. Executive function in adults with attention-deficit/hyperactivity disorder during treatment with atomoxetine in a randomized, placebo-controlled, withdrawal study.

    PubMed

    Adler, Lenard; Tanaka, Yoko; Williams, David; Trzepacz, Paula T; Goto, Taro; Allen, Albert J; Escobar, Rodrigo; Upadhyaya, Himanshu P

    2014-08-01

    We assessed the executive function in adults with attention-deficit/hyperactivity disorder (ADHD) during atomoxetine treatment in a randomized withdrawal trial. Responders (Conners' ADHD Rating Scale-Investigator Rated: Screening Version [adult prompts] ≥30% reduction from baseline and Clinical Global Impression Scale-ADHD Severity score ≤3) to open-label atomoxetine (40-100 mg/d, 12 weeks) entered a 37-week double-blind maintenance period. Patients who maintained response (double-blind atomoxetine for 12 weeks) were randomized 1:1 to atomoxetine (80-100 mg/d, n = 266) or placebo (n = 258) for 25 weeks (total duration, 1 year). Patients and investigators were blinded to response criteria and randomization timing. Change in executive function was assessed with the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Self-Report and Informant T scores from the randomization to the last-observation-carried-forward postrandomization week 25 (after week 17). Of the enrolled patients (n = 2017; mean age, 33.2 years; male, 58.7%), 524 responders were randomized. During open-label atomoxetine, subscales and individual items on both BRIEF-A questionnaires showed significant improvement (P < 0.001). After randomization, the following T scores improved significantly (P ≤ 0.05) with patients in the atomoxetine group versus those in the placebo group: global executive composite, behavioral regulation, and metacognition indices; plan/organize, working memory, inhibit, task monitor and shift (both BRIEF-A questionnaires), emotional control and organization of materials (BRIEF-A Informant), and initiate (BRIEF-A Self-Report). Atomoxetine significantly improved the executive function compared with placebo, which was maintained for 25 weeks or more; the executive function of patients in the placebo group worsened but did not return to baseline levels after randomization.

  10. A Randomized Controlled Trial of Innovative Postpartum Care Model for Mother-Baby Dyads

    PubMed Central

    Laliberté, Corinne; Dunn, Sandra; Pound, Catherine; Sourial, Nadia; Yasseen, Abdool S.; Millar, David; Rennicks White, Ruth; Walker, Mark; Lacaze-Masmonteil, Thierry

    2016-01-01

    Objective To evaluate the efficacy, safety, and maternal satisfaction of a newly established integrative postpartum community-based clinic providing comprehensive support for mothers during the first month after discharge from the hospital. Our primary interests were breastfeeding rates, readmission and patient satisfaction. Methods A randomized controlled trial was conducted in Ottawa, Canada, where 472 mothers were randomized via a 1:2 ratio to either receive standard of care (n = 157) or to attend the postpartum breastfeeding clinic (n = 315). Outcome data were captured through questionnaires completed by the participants at 2, 4, 12 and 24 weeks postpartum. Unadjusted and adjusted logistic regression models were conducted to determine the effect of the intervention on exclusive breastfeeding at 12 weeks (primary outcome). Secondary outcomes included breastfeeding rate at 2, 4 and 24 weeks, breastfeeding self-efficacy scale, readmission rate, and satisfaction score. Results More mothers in the intervention group (n = 195, 66.1%) were exclusively breastfeeding at 12 weeks compared to mothers in the control group (n = 81, 60.5%), however no statistically significant difference was observed (OR = 1.28; 95% CI:0.84–1.95)). The rate of emergency room visits at 2 weeks for the intervention group was 11.4% compared to the standard of care group (15.2%) (OR = 0.69; 95% CI: 0.39–1.23). The intervention group was significantly more satisfied with the overall care they received for breastfeeding compared to the control group (OR = 1.96; 95% CI: 3.50–6.88)). Conclusion This new model of care did not significantly increase exclusive breastfeeding at 12 weeks. However, there were clinically meaningful improvements in the rate of postnatal problems and satisfaction that support this new service delivery model for postpartum care. A community-based multidisciplinary postpartum clinic is feasible to implement and can provide appropriate and highly satisfactory care to

  11. Creating a representative sample of small manufacturing businesses for an integrated workplace safety and smoking cessation intervention study

    PubMed Central

    Egelhoff, Claudia; Katz, Marc; Brosseau, Lisa M; Hennrikus, Deborah

    2015-01-01

    Objectives We aimed to recruit a representative sample of small manufacturing businesses (20-150 employees) for a group-randomized trial of an integrated workplace safety and smoking cessation program. Methods An initial sample was drawn from commercial databases, screened for duplicates or ineligibility and contacted. Participating and non-participating businesses were compared on size, location and type. Employee demographics of participating businesses were compared to a U.S. Census Bureau database of similar businesses. Results From an initial sample of 2716 businesses, 328 were eligible and 47 (9%) agreed to participate. Participating companies tended to be larger. Employees were similar to employees in the Census Bureau dataset. Conclusions Considerable resources were required to identify eligible businesses; commercial databases are the best resource but may not be comprehensive or current. The sample appeared to be representative of small manufacturing businesses in the study region. PMID:26147544

  12. Review: Assessment of completeness of reporting in intervention studies using livestock: an example from pain mitigation interventions in neonatal piglets.

    PubMed

    O'Connor, A; Anthony, R; Bergamasco, L; Coetzee, J F; Dzikamunhenga, R S; Johnson, A K; Karriker, L A; Marchant-Forde, J N; Martineau, G P; Millman, S T; Pajor, E A; Rutherford, K; Sprague, M; Sutherland, M A; von Borell, E; Webb, S R

    2016-04-01

    Accurate and complete reporting of study methods, results and interpretation are essential components for any scientific process, allowing end-users to evaluate the internal and external validity of a study. When animals are used in research, excellence in reporting is expected as a matter of continued ethical acceptability of animal use in the sciences. Our primary objective was to assess completeness of reporting for a series of studies relevant to mitigation of pain in neonatal piglets undergoing routine management procedures. Our second objective was to illustrate how authors can report the items in the Reporting guidElines For randomized controLled trials for livEstoCk and food safety (REFLECT) statement using examples from the animal welfare science literature. A total of 52 studies from 40 articles were evaluated using a modified REFLECT statement. No single study reported all REFLECT checklist items. Seven studies reported specific objectives with testable hypotheses. Six studies identified primary or secondary outcomes. Randomization and blinding were considered to be partially reported in 21 and 18 studies, respectively. No studies reported the rationale for sample sizes. Several studies failed to report key design features such as units for measurement, means, standard deviations, standard errors for continuous outcomes or comparative characteristics for categorical outcomes expressed as either rates or proportions. In the discipline of animal welfare science, authors, reviewers and editors are encouraged to use available reporting guidelines to ensure that scientific methods and results are adequately described and free of misrepresentations and inaccuracies. Complete and accurate reporting increases the ability to apply the results of studies to the decision-making process and prevent wastage of financial and animal resources.

  13. Effects of sodium and potassium supplementation on blood pressure and arterial stiffness: a fully controlled dietary intervention study.

    PubMed

    Gijsbers, L; Dower, J I; Mensink, M; Siebelink, E; Bakker, S J L; Geleijnse, J M

    2015-10-01

    We performed a randomised, placebo-controlled, crossover study to examine the effects of sodium and potassium supplementation on blood pressure (BP) and arterial stiffness in untreated (pre)hypertensive individuals. During the study, subjects were on a fully controlled diet that was relatively low in sodium and potassium. After a 1-week run-in period, subjects received capsules with supplemental sodium (3 g d(-1), equals 7.6 g d(-1) of salt), supplemental potassium (3 g d(-1)) or placebo, for 4 weeks each, in random order. Fasting office BP, 24-h ambulatory BP and measures of arterial stiffness were assessed at baseline and every 4 weeks. Of 37 randomized subjects, 36 completed the study. They had a mean pre-treatment BP of 145/81 mm Hg and 69% had systolic BP ⩾140 mm Hg. Sodium excretion was increased by 98 mmol per 24 h and potassium excretion by 63 mmol per 24 h during active interventions, compared with placebo. During sodium supplementation, office BP was significantly increased by 7.5/3.3 mm Hg, 24-h BP by 7.5/2.7 mm Hg and central BP by 8.5/3.6 mm Hg. During potassium supplementation, 24-h BP was significantly reduced by 3.9/1.6 mm Hg and central pulse pressure by 2.9 mm Hg. Pulse wave velocity and augmentation index were not significantly affected by sodium or potassium supplementation. In conclusion, increasing the intake of sodium caused a substantial increase in BP in subjects with untreated elevated BP. Increased potassium intake, on top of a relatively low-sodium diet, had a beneficial effect on BP. Arterial stiffness did not materially change during 4-week interventions with sodium or potassium.

  14. Randomness for Free

    NASA Astrophysics Data System (ADS)

    Chatterjee, Krishnendu; Doyen, Laurent; Gimbert, Hugo; Henzinger, Thomas A.

    We consider two-player zero-sum games on graphs. These games can be classified on the basis of the information of the players and on the mode of interaction between them. On the basis of information the classification is as follows: (a) partial-observation (both players have partial view of the game); (b) one-sided complete-observation (one player has complete observation); and (c) complete-observation (both players have complete view of the game). On the basis of mode of interaction we have the following classification: (a) concurrent (players interact simultaneously); and (b) turn-based (players interact in turn). The two sources of randomness in these games are randomness in transition function and randomness in strategies. In general, randomized strategies are more powerful than deterministic strategies, and randomness in transitions gives more general classes of games. We present a complete characterization for the classes of games where randomness is not helpful in: (a) the transition function (probabilistic transition can be simulated by deterministic transition); and (b) strategies (pure strategies are as powerful as randomized strategies). As consequence of our characterization we obtain new undecidability results for these games.

  15. Atomoxetine Does Not Alter Cocaine Use in Cocaine Dependent Individuals: A Double Blind Randomized Trial

    PubMed Central

    Middleton, Lisa S.; Wong, Conrad J.; Nuzzo, Paul A.; Campbell, Charles L.; Rush, Craig R.; Lofwall, Michelle R.

    2016-01-01

    Background Cocaine abuse continues to be a significant public health problem associated with morbidity and mortality. To date, no pharmacotherapeutic approach has proven effective for treating cocaine use disorders. Preclinical and clinical evidence suggests that noradrenergic activity may play a role in mediating some effects of cocaine and may be a rational target for treatment. Methods This double blind, placebo-controlled randomized, parallel group, 12-week outpatient clinical trial enrolled cocaine dependent individuals seeking treatment to examine the potential efficacy of the selective norepinephrine reuptake inhibitor, atomoxetine (80 mg/day; p.o.; n=25), compared to placebo (n=25). Subjects were initially stratified on cocaine use (<15 days or ≥15 days of the last 30), age and race using urn randomization. Attendance, medication adherence and study compliance were reinforced with contingency management, and weekly counseling was offered. An array of measures (vital signs, laboratory chemistries, cognitive and psychomotor tests, cocaine craving and urine samples for drug testing) was collected throughout the study and at follow-up. Results Survival analysis revealed no differences in study retention between the two groups, with approximately 56% of subjects completing the 12-week study (Cox analysis X2=.72; p=.40; Hazard Ratio 1.48 [CI 0.62–3.39]). GEE analysis of the proportion of urine samples positive for benzoylecgonine, a cocaine metabolite, revealed no differences between the atomoxetine and placebo groups (X2=0.2, p=.66; OR=0.89 [95% CI 0.41 – 1.74). Atomoxetine was generally well tolerated in this population. Conclusions These data provide no support for the utility of atomoxetine in the treatment of cocaine dependence. PMID:23200303

  16. Asthma control and hospitalizations among inner-city children: results of a randomized trial.

    PubMed

    Guendelman, Sylvia; Meade, Kelley; Chen, Ying Qing; Benson, Mindy

    2004-01-01

    Asthma prevalence is increasing among poor and minority children. We examined the effectiveness of a novel interactive device programmed for self-management of pediatric asthma in reducing asthma control problems and hospitalizations. A randomized controlled trial (66 children in the intervention group and 68 in the control group) was conducted at home and in an outpatient hospital clinic with 8-16-year-old inner-city children with physician-diagnosed asthma. During a 12-week period, children in the experimental group received an asthma self-management and education program, the Health Buddy (Health Hero Network), designed to enable them to monitor their symptoms and transmit this information to a case manager through a secure website. Control group participants used an asthma diary. After adjusting for baseline asthma control problems, asthma severity, and seasonality, children randomized to automated self-management had a significantly lower mean number of asthma control problems at 6 weeks (2.0, SD = 1.6) as compared to children assigned to the asthma diary (2.7, SD = 1.6) (p = 0.03). By 12 weeks, after adjusting for time and the other covariates, asthma control problems dropped markedly in both groups, and did not differ by intervention modality (p = .07). The intervention modality was not a significant predictor of hospitalization. Educational interventions that encourage children's active involvement in their own care and symptom monitoring would help children increase their control of asthma problems. Compared to the asthma diary, the automated self-management had a significant short-term impact on asthma control problems. Its initial effectiveness and more consistent use suggest that remote monitoring may be successfully used in short-term interventions and in settings where staffing for case management is weak.

  17. Flunarizine in the prophylaxis of migrainous vertigo: a randomized controlled trial.

    PubMed

    Lepcha, Anjali; Amalanathan, Sophia; Augustine, Ann Mary; Tyagi, Amit Kumar; Balraj, Achamma

    2014-11-01

    Migrainous vertigo is a common cause of dizziness presenting to an otorhinolaryngology/otoneurology clinic. Although it causes a substantial burden to the individual and society there are no randomized controlled trails on prophylactic medication for this condition. Flunarizine, a calcium channel blocker has been used effectively in both migraine and vestibular conditions. This randomized control trial was undertaken in a tertiary academic referral center to evaluate the efficacy of flunarizine in patients with migrainous vertigo when compared to non-specific vestibular treatment of betahistine and vestibular exercises. The effect of flunarizine on two particularly disabling symptoms of vertigo and headache was studied. A total of 48 patients who were diagnosed with definitive migrainous vertigo completed the study of 12 weeks duration. Patients in arm A received 10-mg flunarizine daily along with betahistine 16 mg and paracetamol 1 gm during episodes, and arm B received only betahistine and paracetamol during episodes. Symptom scores were noted at the start of the study and at the end of 12 weeks. Analysis of the frequency of vertiginous episodes showed a significant difference between arm A and arm B (p = 0.010) and improvement in severity of vertigo between the two groups (p = 0.046). Headache frequency and severity did not improve to a significant degree in arm A as compared to arm B. The main side effects were weight gain and somnolence and this was not significantly different between the two groups. Flunarizine (10 mg) is effective in patients with migrainous vertigo who suffer from considerable vestibular symptoms.

  18. Weight loss improves reproductive outcomes in obese women undergoing fertility treatment: a randomized controlled trial.

    PubMed

    Sim, K A; Dezarnaulds, G M; Denyer, G S; Skilton, M R; Caterson, I D

    2014-04-01

    For women attempting pregnancy, obesity reduces fertility and is an independent risk factor for obstetric and neonatal complications. The aim of this evaluator-blinded, randomized controlled trial was to evaluate a weight loss intervention on pregnancy rates in obese women undertaking fertility treatment. Forty-nine obese women, aged ≤ 37 years, presenting for fertility treatment were randomized to either a 12-week intervention (n = 27) consisting of a very-low-energy diet for the initial 6 weeks followed by a hypocaloric diet, combined with a weekly group multidisciplinary programme; or a control group (n = 22) who received recommendations for weight loss and the same printed material as the intervention. Anthropometric and reproductive parameters were measured at baseline and at 12 weeks. The 22 women who completed the intervention had greater anthropometric changes (-6.6 ± 4.6 kg and -8.7 ± 5.6 cm vs. -1.6 ± 3.6 kg and -0.6 ± 6.3 cm) compared with the control group (n = 17; P < 0.001). The intervention group achieved a pregnancy rate of 48% compared with 14% (P = 0.007), took a mean two fertility treatment cycles to achieve each pregnancy compared with four in the control group (P = 0.002), and had a marked increase in the number of live births (44% vs. 14%; P = 0.02). A group weight loss programme, incorporating dietary, exercise and behavioural components, is associated with a significant improvement in pregnancy rates and live births in a group of obese women undergoing fertility treatment. PMID:25826729

  19. Selecting people randomly.

    PubMed

    Broome, John

    1984-10-01

    This article considers what justification can be found for selecting randomly and in what circumstances it applies, including that of selecting patients to be treated by a scarce medical procedure. The author demonstrates that balancing the merits of fairness, common good, equal rights, and equal chance as they apply in various situations frequently leads to the conclusion that random selection may not be the most appropriate mode of selection. Broome acknowledges that, in the end, we may be forced to conclude that the only merit of random selection is the political one of guarding against partiality and oppression.