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

Facioscapulohumeral Muscle Dystrophy Clinical Trial

— FSHD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01618331
• Other study ID #: H-1-2011-149
• Status: Completed
• Phase: N/A
• First received: June 7, 2012
• Last updated: June 4, 2014
• Start date: March 2012
• Est. completion date: October 2013

Study information

• Verified date: June 2014
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Facioscapulohumeral Muscle Dystrophy
• Muscular Dystrophies
• Muscular Dystrophy, Facioscapulohumeral

Intervention

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.

Locations

Country	Name	City	State
Denmark	Neuromuscular Research Unit, Department of Neurology, Rigshospitalet	Copenhagen

Sponsors (5)

Lead Sponsor	Collaborator
Grete Andersen, MD	Aase and Ejnar Danielsens Foundation, AP Moeller Foundation, The Augustinus Foundation, Denmark., The Danish Rheumatism Association

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	6MWT	6 min walk test. Outcome in meter.	up to Week 12	No
Secondary	Risk of falls	Measuring of: Muscle strength, balance, 5-times-up-and-down-chair-test, 14-steps-stair-test.	week: 0 and 12	No
Secondary	Daily activity level	assessment of daily-activity level by accelerometer daily-activity level questionary SP36 life quality questionary	week: 0 and 12	No
Secondary	Blood samples	Creatine Kinase and myoglobin levels (safe parameter) Inflammatory level	week: 0, 4, 7, 10, 12	Yes