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临床试验/NCT01618331
NCT01618331已完成不适用

The Effect of Protein Supplementation Doing Regular Exercise in Patients With Facioscapulohumeral Muscular Dystrophy - a Blinded RCT Study

Grete Andersen, MD2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2012年3月最近更新:
适应症

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

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

发起方
Grete Andersen, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Grete Andersen, MD

MD

Rigshospitalet, Denmark

研究点 (2)

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