Facioscapulohumeral Muscle Dystrophy Clinical Trial
Official title:
The Effect of Protein Supplementation Doing Regular Exercise in Patients With Facioscapulohumeral Muscular Dystrophy - a Blinded RCT Study
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care