The Effect of Protein Supplementation Doing Regular Exercise in Patients With Facioscapulohumeral Muscular Dystrophy - a Blinded RCT Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- 6MWT
研究概览
简要总结
The hypotheses is that regular post exercise supplementation increase fitness and daily activity level in patients with Fascioscapulohumeral (FSH) muscular dystrophy.
All patients are tested before and after 12 weeks of cycle-ergometer exercise. Maximal oxygen consumption and 6MWT is used as primarily effect goals. Secondary effect goals are risk of falls and daily activity level.
详细描述
The purpose of this study is to investigate the response to protein-carbohydrate supplementation doing regular exercise in patients with FSHD. All patients are tested before and after 12 weeks of cycle-ergometer exercise. Maximal oxygen consumption and a functional 6 min walk test(6MWT) is used as primarily effect goals. Secondary effect goals are risk of falls and daily activity level. We measure manuel muscle strength, a balance test, a 5-time-up-and-down-chair-test, a 14 steps-stair-test, accelerometer measuring, daily activity level questionnaire and SP36.
We use a blinded randomized controlled trail. The interventions are 12 weeks regular exercise and consumption of a post-exercise drink. The exercise consists of 30 session of 30 minutes moderate exercise on a cycle-ergometer. After each exercise session patients consume a protein or a non-caloric placebo drink.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- •Verified FSHD
- •Age 18-65
- •Untrained. Less than two hours cardio-training each week the last 4 month.
排除标准
- •Competitive disorders
- •Pregnant and breastfeeding
- •Unable to walk 200 m within 6 min.
结局指标
主要结局
6MWT
时间窗: up to Week 12
6 min walk test. Outcome in meter.
Maximal oxygen consumption test
时间窗: up to Week 12
All participant are tested with a standardized maximal oxygen consumption test. Maximal oxygen uptake pr. minute pr. kg body (VO2max) weight and maximal work load (Wmax) is measured. The effect of intervention is found in different between groups in relative and absolute improvement in VO2max and Wmax.
次要结局
- Daily activity level(week: 0 and 12)
- Risk of falls(week: 0 and 12)
- Blood samples(week: 0, 4, 7, 10, 12)
研究者
Grete Andersen, MD
MD
Rigshospitalet, Denmark
