Effects of Therapeutic Elastic Band Training on Body Composition and Physical Capacity in Adults With Prader-Willi Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in lean tissue mass and adipose tissue mass
研究概览
简要总结
Adults aged over 18 years, with the diagnosis of Prader-willi syndrome will be recruited through the hospital's outpatient clinic for either as intervention group receiving therapeutic elastic band training, or as control group receiving usual care for a total of 16 weeks. Body composition, physical capacity, and serum changes will be assessed before and after the intervention.
详细描述
Participants that fulfill the inclusion criteria will be assigned into one of the two arms: elastic band intervention group (EB) or control group (CG). Both groups will received a baseline: dual X-ray absorptiometry body composition, physical capacity, and serum markers examinations. EB will then receive a 16-week progressive elastic band resistance exercise training, while the CG will receive usual care. After the 16 weeks from the baseline assessment, a followed-up: dual X-ray absorptiometry body composition, physical capacity, and serum examinations will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- 否
入选标准
- •Aged 18-65 years old.
- •Genetically diagnosis of Prader-willi syndrome.
- •Must be able to follow and understand mandarin instructions and cooperate to the exercise assessments and/or training.
排除标准
- •Prader-willi syndrome individuals unable to sit, stand and walk independently which make physical capacity assessment difficult.
- •Severe arthritis, fracture, or other musculoskeletal deformities that interfere with exercise training.
- •Severe cognitive impairment who cannot read, write the informed consent.
结局指标
主要结局
Change in lean tissue mass and adipose tissue mass
时间窗: Baseline and 4 month follow up
Lean tissue mass and adipose tissue mass will be determined by dual energy x-ray absorptiometry (DXA) (Hologic Densitometer Discovery A, USA).
Change in body mass index
时间窗: Baseline and 4 month follow up
Body mass index will be calculated as the body mass in kilograms divided by the square of the height in meters.
次要结局
- Change in 30-second sit to stand test(Baseline and 4 month follow up)
- Change in grip muscle strength(Baseline and 4 month follow up)
- Change in Berg balance scale(Baseline and 4 month follow up)
- Change in lipid profile(Baseline and 4 month follow up)
- Change in glycated hemoglobin(Baseline and 4 month follow up)
- Change in timed up and go test(Baseline and 4 month follow up)
- Change in fasting glucose(Baseline and 4 month follow up)
- Change in two minute step up test(Baseline and 4 month follow up)