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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

June 7, 2012
June 4, 2014
March 2012
October 2013   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01618331 on ClinicalTrials.gov Archive Site
  • 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
  • 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 ]
    assesment of daily-activity level by accelerometer daily-activity level qustionsnairy SP36 life quality qustionsnairy
  • Blood samples [ Time Frame: week: 0, 4, 7, 10, 12 ] [ Designated as safety issue: Yes ]
    Creatine Kinase and myoglobin levels (safe parameter) Inflammatory level
Not Provided
Not Provided
 
Protein Supplementation and Exercise in Patients With FSH Muscular Dystrophy- a Randomized Placebo Controlled Study
The Effect of Protein Supplementation Doing Regular Exercise in Patients With Facioscapulohumeral Muscular Dystrophy - a Blinded RCT 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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Facioscapulohumeral Muscle Dystrophy
  • 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.
  • Active Comparator: Protein supplementation
    Patients consume a drink after each exercise session. The drink consist of whey protein, maltodextrin, and flavors mixed in water.
    Interventions:
    • Behavioral: Regular exercise
    • Dietary Supplement: Protein-carbohydrate supplementation
  • Placebo Comparator: Placebo supplement
    Patients consume a drink after each exercise session. The drink consist of flavors mixed in water.
    Intervention: Behavioral: Regular exercise
  • No Intervention: Control
    Patients will be tested before and after a none-intervention period of 12 weeks.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
October 2013
October 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01618331
H-1-2011-149
No
Grete Andersen, MD, Rigshospitalet, Denmark
Grete Andersen, MD
  • The Augustinus Foundation, Denmark.
  • Aase and Ejnar Danielsens Foundation
  • The Danish Rheumatism Association
  • AP Moeller Foundation
Not Provided
Rigshospitalet, Denmark
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP