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

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.

Study Overview

• Status: Completed
• Conditions: Facioscapulohumeral Muscle Dystrophy
• Intervention / Treatment: Behavioral: Regular exercise; Dietary supplement: Protein-carbohydrate supplementation

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Neuromuscular Research Unit, Department of Neurology, Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	week: 0 and 12
Blood samples	Creatine Kinase and myoglobin levels (safe parameter) Inflammatory level	week: 0, 4, 7, 10, 12

Collaborators and Investigators

• Sponsor: Grete Andersen, MD
• Collaborators: AP Moeller Foundation; The Danish Rheumatism Association; Aase and Ejnar Danielsens Foundation; The Augustinus Foundation, Denmark.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: June 7, 2012
• First Submitted That Met QC Criteria: June 12, 2012
• First Posted (Estimate): June 13, 2012

Study Record Updates

• Last Update Posted (Estimate): June 5, 2014
• Last Update Submitted That Met QC Criteria: June 4, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Endurance exercise; FSHD; Protein supplementation; Placebo RCT
• Additional Relevant MeSH Terms: Nervous System Diseases; Genetic Diseases, Inborn; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Muscular Disorders, Atrophic; Muscular Dystrophies
• Other Study ID Numbers: H-1-2011-149