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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Facioscapulohumeral Muscle Dystrophy

Intervention / Treatment
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* Behavioral: Regular exercise
* Dietary Supplement: Protein-carbohydrate supplementation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Protein supplementation<br>Patients consume a drink after each exercise session. The drink consist of whey protein, maltodextrin, and flavors mixed in water. | Behavioral: Regular exercise<br>* Duration: 3 session each week, in 12 week. Intensity: 70 % of VO2max. Type: cycle-ergometer exercise.<br>Dietary Supplement: Protein-carbohydrate supplementation<br>* Dosage: 45g powder mixed in 0.5 L water After each exercise session, 3 times each week, in 12 weeks.<br>|
| Placebo Comparator: Placebo supplement<br>Patients consume a drink after each exercise session. The drink consist of flavors mixed in water. | Behavioral: Regular exercise<br>* Duration: 3 session each week, in 12 week. Intensity: 70 % of VO2max. Type: cycle-ergometer exercise.<br>|
| No Intervention: Control<br>Patients will be tested before and after a none-intervention period of 12 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal oxygen consumption test | 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. | up to Week 12 | 
| 6MWT | 6 min walk test. Outcome in meter. | up to Week 12 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FSHD, Endurance exercise, Protein supplementation, Placebo RCT