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

Not Applicable

Completed

• Conditions: Facioscapulohumeral Muscle Dystrophy
• Interventions: Behavioral: Regular exercise; Dietary Supplement: Protein-carbohydrate supplementation

• Registration Number: NCT01618331
• Lead Sponsor: Grete Andersen, MD

Brief 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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-06-07
• Study First Submitted QC: 2012-06-12
• Study First Posted: 2012-06-13
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-04
• Last Update Posted: 2014-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Verified FSHD
• Age 18-65
• Untrained. Less than two hours cardio-training each week the last 4 month.

Exclusion Criteria

• Competitive disorders
• Pregnant and breastfeeding
• Unable to walk 200 m within 6 min.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Protein supplementation	Regular exercise	Patients consume a drink after each exercise session. The drink consist of whey protein, maltodextrin, and flavors mixed in water.
Protein supplementation	Protein-carbohydrate supplementation	Patients consume a drink after each exercise session. The drink consist of whey protein, maltodextrin, and flavors mixed in water.
Placebo supplement	Regular exercise	Patients consume a drink after each exercise session. The drink consist of flavors mixed in water.

Primary Outcome Measures

Name	Time	Method
6MWT	up to Week 12	6 min walk test. Outcome in meter.
Maximal oxygen consumption test	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.

Secondary Outcome Measures

Name	Time	Method
Daily activity level	week: 0 and 12	assessment of daily-activity level by accelerometer daily-activity level questionary SP36 life quality questionary
Risk of falls	week: 0 and 12	Measuring of: Muscle strength, balance, 5-times-up-and-down-chair-test, 14-steps-stair-test.
Blood samples	week: 0, 4, 7, 10, 12	Creatine Kinase and myoglobin levels (safe parameter) Inflammatory level

Trial Locations

Locations (1)

Neuromuscular Research Unit, Department of Neurology, Rigshospitalet; 🇩🇰 Copenhagen, Denmark