Protein Supplementation and Exercise in FSHD Patients - a Blinded RCT Study
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Purpose
The hypotheses is that regular post exercise supplementation increase fitness and daily activity level in patients with 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 | Intervention |
|---|---|
|
Facioscapulohumeral Muscle Dystrophy |
Behavioral: Regular exercise Dietary Supplement: Protein-carbohydrate supplementation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
- Maximal oxygen consumption test [ Time Frame: up to Week 12 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]6 min walk test. Outcome in meter.
- Risk of falls [ Time Frame: week: 0 and 12 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]Creatine Kinase and myoglobin levels (safe parameter) Inflammatory level
| Estimated Enrollment: | 30 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Denmark | |
| Neuromuscular Research Unit, Department of Neurology, Rigshospitalet | |
| Copenhagen, Denmark, 2100 | |
More Information
No publications provided
| Responsible Party: | Grete Andersen, MD, MD, Rigshospitalet, Denmark |
| ClinicalTrials.gov Identifier: | NCT01618331 History of Changes |
| Other Study ID Numbers: | H-1-2011-149 |
| Study First Received: | June 7, 2012 |
| Last Updated: | June 12, 2012 |
| Health Authority: | Denmark: Danish Dataprotection Agency Denmark: Ethics Committee |
Keywords provided by Rigshospitalet, Denmark:
|
FSHD Endurance exercise Protein supplementation Placebo RCT |
Additional relevant MeSH terms:
|
Muscular Dystrophies Muscular Dystrophy, Facioscapulohumeral Muscular Disorders, Atrophic Muscular Diseases |
Musculoskeletal Diseases Neuromuscular Diseases Nervous System Diseases Genetic Diseases, Inborn |
ClinicalTrials.gov processed this record on June 17, 2013