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| Name | Class |
|---|---|
| The Augustinus Foundation, Denmark. | OTHER |
| Aase and Ejnar Danielsens Foundation | OTHER |
| The Danish Rheumatism Association | OTHER |
| AP Moeller Foundation |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Protein supplementation | Active Comparator | Patients consume a drink after each exercise session. The drink consist of whey protein, maltodextrin, and flavors mixed in water. |
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| Placebo supplement | Placebo Comparator | Patients consume a drink after each exercise session. The drink consist of flavors mixed in water. |
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| Control | No Intervention | Patients will be tested before and after a none-intervention period of 12 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regular exercise | Behavioral | Duration: 3 session each week, in 12 week. Intensity: 70 % of VO2max. Type: cycle-ergometer exercise. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuromuscular Research Unit, Department of Neurology, Rigshospitalet | Copenhagen | 2100 | Denmark |
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| OTHER |
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| Protein-carbohydrate supplementation | Dietary Supplement | Dosage: 45g powder mixed in 0.5 L water After each exercise session, 3 times each week, in 12 weeks. |
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| week: 0 and 12 |
| Blood samples | Creatine Kinase and myoglobin levels (safe parameter) Inflammatory level | week: 0, 4, 7, 10, 12 |