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临床试验/NCT02571322
NCT02571322撤回不适用

The Effect of Whole Body Vibration Training on Body Composition, Physical Fitness, and Quality of Life

University of Miami2 个研究点 分布在 1 个国家开始时间: 2016年1月19日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Change from baseline in aerobic capacity

研究概览

简要总结

The purpose of the study is to determine the effect of whole-body vibration (WBV) on body composition, physical fitness, and quality of life.

详细描述

The purpose of the study is to determine the effect of whole-body vibration (WBV) on body composition, physical fitness, and quality of life.Twenty healthy adult males and females (ages 18-65) with no contraindications for exercise training will be recruited to participate in the study. Subjects will participate in a randomized, crossover trial for 24 weeks. Subjects will be assigned to either: (1) WBV for the first 12 weeks and then aerobic exercise training for the second 12 weeks 3 times per week (n=10) or (2) aerobic exercise training for the first 12 weeks and then WBV for the second 12 weeks 3 times per week (n=10). Subjects will be assessed at baseline and at 12 and 24 weeks on aerobic capacity (estimated VO2max), upper and lower body strength (1-repetition maximum on bench press and leg press, respectively), compartmental and total body fat mass, fat free mass, and bone mineral density (using dual energy x-ray absorptiometry (DEXA)), body mass index (height relative to weight), weight, skin fold and body part circumferences, resting blood pressure and pulse, and subjective health-related quality of life (SF-36). Participants will be trained and assessed at the University of Miami Miller School of Medicine UHealth Fitness and Wellness Center, in UHealth Champions Executive Medicine, and in the Department of Psychiatry and Behavioral Sciences.

No substantial psychological, medical, or social risks exist to the participants. Although all measures to protect confidentiality will be put in place, the possibility exists that electronic data could be jeopardized. In the remote case that such event occurs, it will be immediately reported to the Institutional Review Board (IRB).

Exercise has been shown to be safe among every population, including those with chronic diseases and/or other complications. A DEXA scan is the equivalent of about 4 extra days' worth of naturally-occurring radiation.

The use of the HyperVibe WBV training device should be harmless without any known negative effects, as WBV is even lower risk than aerobic exercise, as the participant simply stands on the platform without moving while being exposed to full-body vibration. The system is completely non-invasive, and no serious, untoward side effects have been reported to the manufacturer (HyperVibe) of this system. All study personnel will follow instructions for operating the system. Participants will incur no additional appreciable psychological or social risks by participating in this study.

The results obtained in this study may demonstrate a way to increase exercise efficiency through the use of WBV in helping overweight/obese participants to lose weight, gain muscular weight, and improve physical fitness levels. By participating in the study, subjects may improve their overall health status in a unique approach to exercise training. The minimal risk of participating in this study is reasonable because the potential information gained can be worthwhile for helping people to lose weight, which is significant, given the inordinate prevalence of overweight/obesity and its co morbid chronic diseases in the United States today.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women ages 18 to 65 years old
  • Interest in participating in a study to investigate the effects of a novel exercise training style
  • Willing to follow recommendations for participating in the study
  • Able to provide informed consent to participate in the study

排除标准

  • Women who are pregnant or attempting pregnancy during the next 24 weeks
  • Anyone with a cardiovascular, orthopedic, or other physical condition that would be contraindicated for an exercise training program
  • Any condition where WBV is contraindicated, e.g., seizure disorder
  • Currently enrolled in another exercise intervention research study
  • Currently undergoing internal defibrillation, like with an implantable heart device
  • Erratic, accelerated, or mechanically controlled irregular heart rhythms
  • Atrial fibrillation/flutter
  • Atrioventricular block
  • Recently had dyes introduced into the bloodstream, such as methylene blue, indocyanine green, indigo carmine, and fluorescein
  • Any implanted electronic device

结局指标

主要结局

Change from baseline in aerobic capacity

时间窗: Baseline,12 weeks and 24 weeks

Aerobic capacity and strength will be assessed by Graded Exercise Test

Change from baseline in body strength

时间窗: Baseline,12 weeks and 24 weeks

Overall upper and lower body strength will be assessed by one-repetition maximum strength tests

Change from baseline in bone mineral density

时间窗: Baseline,12 weeks and 24 weeks

Bone mineral density will be assessed by DEXA scan

Change from baseline in body composition

时间窗: Baseline,12 weeks and 24 weeks

Body composition will be evaluated by DEXA scan which measure fat free mass , total body and compartmental fat mass

次要结局

  • Change from baseline in systolic blood pressure(Baseline,12 weeks and 24 weeks)
  • Change from baseline in physical activity(Baseline,12 weeks and 24 weeks)
  • Change from baseline in quality of life(Baseline,12 weeks and 24 weeks)
  • Change from baseline in diastolic blood pressure(Baseline,12 weeks and 24 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

John E. Lewis

Principal Investigator

University of Miami

研究点 (2)

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