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Completed

NCT Number: NCT01618331

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

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.

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Key information

Conditions

Facioscapulohumeral Muscle Dystrophy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neuromuscular Research Unit, Department of Neurology, Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Regular exercise

Behavioral

Duration: 3 session each week, in 12 week. Intensity: 70 % of VO2max. Type: cycle-ergometer exercise.

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.

Primary outcomes

  1. 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.

  2. 6MWT

    Time frame: up to Week 12

    6 min walk test. Outcome in meter.

Secondary outcomes

  1. 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.

  2. Daily activity level

    Time frame: week: 0 and 12

    assessment of daily-activity level by accelerometer daily-activity level questionary SP36 life quality questionary

  3. Blood samples

    Time frame: week: 0, 4, 7, 10, 12

    Creatine Kinase and myoglobin levels (safe parameter) Inflammatory level

Sponsors and collaborators

Lead sponsor

Grete Andersen, MD

Other

Collaborators

  • AP Moeller Foundation
  • Aase and Ejnar Danielsens Foundation
  • The Augustinus Foundation, Denmark.
  • The Danish Rheumatism Association

Registry information

Official study title

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

Acronym: FSHD

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 13, 2012
Registry last updated
Jun 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.