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Randomized Controlled Pilot Study (randomized + controlled_pilot_study)
Selected AbstractsEffect of 6-Month Whole Body Vibration Training on Hip Density, Muscle Strength, and Postural Control in Postmenopausal Women: A Randomized Controlled Pilot Study,JOURNAL OF BONE AND MINERAL RESEARCH, Issue 3 2004Sabine MP Verschueren Abstract High-frequency mechanical strain seems to stimulate bone strength in animals. In this randomized controlled trial, hip BMD was measured in postmenopausal women after a 24-week whole body vibration (WBV) training program. Vibration training significantly increased BMD of the hip. These findings suggest that WBV training might be useful in the prevention of osteoporosis. Introduction: High-frequency mechanical strain has been shown to stimulate bone strength in different animal models. However, the effects of vibration exercise on the human skeleton have rarely been studied. Particularly in postmenopausal women,who are most at risk of developing osteoporosis,randomized controlled data on the safety and efficacy of vibration loading are lacking. The aim of this randomized controlled trial was to assess the musculoskeletal effects of high-frequency loading by means of whole body vibration (WBV) in postmenopausal women. Materials and Methods: Seventy volunteers (age, 58,74 years) were randomly assigned to a whole body vibration training group (WBV, n = 25), a resistance training group (RES, n = 22), or a control group (CON, n = 23). The WBV group and the RES group trained three times weekly for 24 weeks. The WBV group performed static and dynamic knee-extensor exercises on a vibration platform (35,40 Hz, 2.28,5.09g), which mechanically loaded the bone and evoked reflexive muscle contractions. The RES group trained knee extensors by dynamic leg press and leg extension exercises, increasing from low (20 RM) to high (8 RM) resistance. The CON group did not participate in any training. Hip bone density was measured using DXA at baseline and after the 6-month intervention. Isometric and dynamic strength were measured by means of a motor-driven dynamometer. Data were analyzed by means of repeated measures ANOVA. Results: No vibration-related side effects were observed. Vibration training improved isometric and dynamic muscle strength (+15% and + 16%, respectively; p < 0.01) and also significantly increased BMD of the hip (+0.93%, p < 0.05). No changes in hip BMD were observed in women participating in resistance training or age-matched controls (,0.60% and ,0.62%, respectively; not significant). Serum markers of bone turnover did not change in any of the groups. Conclusion: These findings suggest that WBV training may be a feasible and effective way to modify well-recognized risk factors for falls and fractures in older women and support the need for further human studies. [source] Improving the Mental Health, Healthy Lifestyle Choices, and Physical Health of Hispanic Adolescents: A Randomized Controlled Pilot StudyJOURNAL OF SCHOOL HEALTH, Issue 12 2009Bernadette M. Melnyk PhD, CPNP/NPP, FAAN ABSTRACT BACKGROUND: Obesity and mental health disorders are 2 major public health problems in American adolescents, with prevalence even higher in Hispanic teens. Despite the rapidly increasing incidence and adverse health outcomes associated with overweight and mental health problems, very few intervention studies have been conducted with adolescents to improve both their healthy lifestyles and mental health outcomes. Even fewer studies have been conducted with Hispanic youth. The purpose of this study was to evaluate the preliminary efficacy of the COPE (Creating Opportunities for Personal Empowerment) Healthy Lifestyles TEEN (Thinking, Emotions, Exercise, and Nutrition) program, a manualized educational and cognitive behavioral skills-building program, on Hispanic adolescents' healthy lifestyle choices as well as mental and physical health outcomes. METHODS: A cluster randomized controlled pilot study was conducted with 19 Hispanic adolescents enrolled in 2 health classes in a southwestern high school. One class received COPE and the other received an attention control program. RESULTS: Adolescents in the COPE program increased their healthy lifestyle choices and reported a decrease in depressive and anxiety symptoms from baseline to postintervention follow-up. A subset of 7 overweight adolescents in the COPE program had a decrease in triglycerides and an increase in high-density lipoproteins. In addition, these overweight adolescents reported increases in healthy lifestyle beliefs and nutrition knowledge along with a decrease in depressive symptoms. CONCLUSION: The COPE TEEN program is a promising school-based strategy for improving both physical and mental health outcomes in adolescents. [source] Treatment of irritable bowel syndrome with osteopathy: Results of a randomized controlled pilot studyJOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, Issue 9 2007Henry WC Hundscheid Abstract Background and Aim:, Effective treatment for irritable bowel syndrome (IBS) is not yet available. Osteopathy is a manual treatment which relies on mobilizing and manipulating procedures in order to relieve complaints. In the present study, a randomized controlled trial was carried out to evaluate the effects of osteopathic treatment for IBS. Methods:, Eligible IBS patients were randomized between osteopathy and standard care. Follow-up was 6 months and validated means of follow-up were used. After 1, 3 and 6 months an overall assessment of symptoms was noted and a symptom score was obtained on a 5-point Likert scale. Quality of life (QOL) was scored with the standardized IBSQOL 2000 questionnaire and the Functional Bowel Disorder Severity Index was used. Results:, Twenty patients were randomized into the osteopathy group (OG) and 19 patients were included in the standard care group (SCG). Sixty-eight percent of patients in the OG noted definite overall improvement in symptoms and 27% showed slight improvement. One patient (5%) was free of symptoms at the end of the study. In the SCG, 18% noted definite improvement, 59% showed slight improvement, and in 17% worsening of symptoms was present. The difference in change in overall symptomatic improvement was statistically significant in favor of the osteopathic treatment (P < 0.006). Mean Functional Bowel Disorder Severity Index (FBDSI) score in the OG decreased from 174 to 74 at 6 months (P < 0.0001). Also, a significant decrease was noted in the SCG from 171 to 119 (P < 0.0001). However, the decrease in the OG was significantly higher compared with the standard treatment (P = 0.02). Mean symptom score in the OG decreased from 9.1 to 6.8 but this did not reach statistical significance. In the SCG, no change in symptom score occurred (8.7 vs 10). At 6 months, the score in the OG was significantly lower (6.8 vs 10; P = 0.02). The QOL score increased in the OG at 111 versus 129 (P < 0.009). In the SCG an increase was also noted, but this was not statistically significant (109 vs 121). Conclusion:, Osteopathic therapy is a promising alternative in the treatment of patients with IBS. Patients treated with osteopathy overall did better, with respect to symptom score and QOL. [source] Randomized Study of Early Intravenous Esmolol Versus Oral Beta-Blockers in Preventing Post-CABG Atrial Fibrillation in High Risk Patients Identified by Signal-Averaged ECG: Results of a Pilot StudyANNALS OF NONINVASIVE ELECTROCARDIOLOGY, Issue 2 2002Nomeda Balcetyte-Harris M.D. Background: Patients with prolonged signal-averaged ECG have four times higher risk for development of atrial fibrillation (AF) after coronary artery bypass surgery (CABG). Incidence of AF is reduced, but not eliminated by prophylaxis with beta-blockers. The limitations of prophylaxis with oral beta-blockers may be related to the delayed effect of oral therapy. We performed a pilot study of the efficacy of early intravenous esmolol and an oral beta-blocker regimen for prevention of postoperative AF. Methods: Fifty patients referred for CABG and considered to be at high risk for postoperative AF on the basis of prolonged signal-averaged ECG P wave duration > 140 ms were randomized to receive either a 24-hour infusion of esmolol 6,18 hours after CABG, at an average dose 67 ± 7 ,/kg/min, followed by oral beta-blockers versus oral beta-blockers only beginning on postoperative day 1. Results: Seven of 27 patients (26%) in the esmolol group and 6 of 23 patients (26%) in the oral beta-blocker group developed postoperative AF, P = NS. The mean time of onset of AF (2.7 ± 0.5 vs 2.7 ± 0.3 postoperative day, P = NS) and the median duration of AF (10 [2192] vs 7 [1.16] hours, P = NS) were similar between the two groups. Eleven (41%) patients treated with esmolol developed adverse events (hypotension: 8, bradycardia requiring temporary pacing: 2, left ventricular failure:1 patient) as compared to only one patient (4%) in the beta-blocker group who developed hypotension, P = 0.006. Conclusions: This randomized controlled pilot study suggests that intravenous esmolol is less well tolerated and offers no advantages to standard beta-blocker in preventing AF after CABG. A.N.E. 2002;7(2):86,91 [source] |