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

This study has been completed.
Sponsor:
Collaborators:
The Augustinus Foundation, Denmark.
Aase and Ejnar Danielsens Foundation
The Danish Rheumatism Association
AP Moeller Foundation
Information provided by (Responsible Party):
Grete Andersen, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01618331
First received: June 7, 2012
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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.


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

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]
    assessment of daily-activity level by accelerometer daily-activity level questionary SP36 life quality questionary

  • Blood samples [ Time Frame: week: 0, 4, 7, 10, 12 ] [ Designated as safety issue: Yes ]
    Creatine Kinase and myoglobin levels (safe parameter) Inflammatory level


Enrollment: 42
Study Start Date: March 2012
Study Completion Date: October 2013
Primary Completion Date: October 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01618331

Locations
Denmark
Neuromuscular Research Unit, Department of Neurology, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Grete Andersen, MD
The Augustinus Foundation, Denmark.
Aase and Ejnar Danielsens Foundation
The Danish Rheumatism Association
AP Moeller Foundation
  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 4, 2014
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 August 28, 2014