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

Grete Andersen, MD

Status: Completed

Conditions: Facioscapulohumeral Muscle Dystrophy

Treatments: Behavioral: Regular exercise; Dietary Supplement: Protein-carbohydrate supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT01618331

H-1-2011-149

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 3 patient groups, including a placebo group

Protein supplementation

Active Comparator group

Description:

Patients consume a drink after each exercise session. The drink consist of whey protein, maltodextrin, and flavors mixed in water.

Treatment:

Dietary Supplement: Protein-carbohydrate supplementation

Behavioral: Regular exercise

Placebo supplement

Placebo Comparator group

Description:

Patients consume a drink after each exercise session. The drink consist of flavors mixed in water.

Treatment:

Behavioral: Regular exercise

Control

No Intervention group

Description:

Patients will be tested before and after a none-intervention period of 12 weeks.