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临床试验/NCT03565081
NCT03565081已完成不适用

Effects of Progressive Elastic Band Resistance Training on Body Composition and Motor Performance in Adults With Prader-Willi Syndrome: a Pilot Study

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation0 个研究点目标入组 6 人开始时间: 2016年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
6
主要终点
Changes in the balance functional physical assessment

研究概览

简要总结

Abnormal body composition with increased body fat mass and decreased lean body mass has been found in adults with Prader-Willi syndrome (PWS), contributing to reduced physical capacity and impairment. The aim of this study was to investigate whether progressive elastic band resistance training can improve physical motor performance and regional body composition in adults with PWS.

详细描述

Six participants were enrolled in this pilot study. Following 24 weeks of progressive elastic band resistance exercise training, significant reduction was observed in their body weight, BMI, and regional extremities fat mass and percentage. Regarding the functional performances, there were also significant improvements in their hand grip strength, 3 meter timed up and go, 30 seconds sit to stand, and 2-min step up tests, as early as the 8th week of training. Balance function achieved significant improvements after 16 weeks of training.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • PWS individuals who can cooperate with motor performances

排除标准

  • arthritis, fracture, or severe musculoskeletal deformities that would interfere with exercise training or motor performance
  • severe cognitive impairment or parents who cannot read nor write.

研究组 & 干预措施

PWS elastic band training group

Experimental

Genetically confirmed diagnosis of PWS participants were recruited. The PWS participants needed to have sufficient command of the Mandarin language to understand the study information and motivated to conduct the training program.

干预措施: PWS elastic band training group (Device)

结局指标

主要结局

Changes in the balance functional physical assessment

时间窗: Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks

Berg Balance Scale (0-56 points; 0-20= high fall risk; 21-40= medium fall risk; 41-56= low fall risk)

Change in the BMI body composition

时间窗: Change from Baseline body composition components at 6 months

Body weight (km) and height (m) will be combined to report as BMI (kg/m2)

Change in the lean body mass of body composition

时间窗: Change from Baseline body composition components at 6 months

Lean body mass (kg)

Changes in the handgrip strength functional physical assessment

时间窗: Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks

hand grip strength (pounds),

Changes in the 30 second chair stand functional physical assessment

时间窗: Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks

30-second chair stand test (times)

Changes in the timed up and go functional physical assessment

时间窗: Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks

timed up-and-go test (seconds)

Change in the body fat mass of body composition

时间窗: Change from Baseline body composition components at 6 months

Fat mass (kg)

Changes in the two minute step up functional physical assessment

时间窗: Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks

2 minute step up test (times)

Change in the percentage of body fat of body composition

时间窗: Change from Baseline body composition components at 6 months

Regional percentage body fat (%)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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