Protein Supplementation and Exercise in Patients With FSH Muscular Dystrophy- a Randomized Placebo Controlled Study (FSHD)
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|ClinicalTrials.gov Identifier: NCT01618331|
Recruitment Status : Completed
First Posted : June 13, 2012
Last Update Posted : June 5, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Facioscapulohumeral Muscle Dystrophy||Behavioral: Regular exercise Dietary Supplement: Protein-carbohydrate supplementation||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Effect of Protein Supplementation Doing Regular Exercise in Patients With Facioscapulohumeral Muscular Dystrophy - a Blinded RCT Study|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
Active Comparator: Protein supplementation
Patients consume a drink after each exercise session. The drink consist of whey protein, maltodextrin, and flavors mixed in water.
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.
Placebo Comparator: Placebo supplement
Patients consume a drink after each exercise session. The drink consist of flavors mixed in water.
Behavioral: Regular exercise
Duration: 3 session each week, in 12 week. Intensity: 70 % of VO2max. Type: cycle-ergometer exercise.
No Intervention: Control
Patients will be tested before and after a none-intervention period of 12 weeks.
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01618331
|Neuromuscular Research Unit, Department of Neurology, Rigshospitalet|
|Copenhagen, Denmark, 2100|