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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.

Sponsor: Grete Andersen, MD

Current Primary Outcome:

• Maximal oxygen consumption test [ Time Frame: 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.
• 6MWT [ Time Frame: up to Week 12 ]
  6 min walk test. Outcome in meter.

Original Primary Outcome: Same as current

Current Secondary Outcome:

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

Original Secondary Outcome:

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

Information By: Rigshospitalet, Denmark

Dates:
Date Received: June 7, 2012
Date Started: March 2012
Date Completion:
Last Updated: June 4, 2014
Last Verified: June 2014