NCT01618331

Protein Supplementation and Exercise in Patients With FSH Muscular Dystrophy- a Randomized Placebo Controlled Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Grete Andersen, MD · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Facioscapulohumeral Muscle Dystrophy

Interventions

Type	Name	Description
BEHAVIORAL	Regular exercise	Duration: 3 session each week, in 12 week. Intensity: 70 % of VO2max. Type: cycle-ergometer exercise.
DIETARY_SUPPLEMENT	Protein-carbohydrate supplementation	Dosage: 45g powder mixed in 0.5 L water After each exercise session, 3 times each week, in 12 weeks.

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2012-06-13
• Last updated: 2014-06-05

Locations

1 site across 1 country: Denmark