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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01618331

Acronym

FSHD

Enrollment

Registered

2012-06-13

Start date

2012-03-31

Completion date

2013-10-31

Last updated

2014-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facioscapulohumeral Muscle Dystrophy

Keywords

FSHD, Endurance exercise, Protein supplementation, Placebo RCT

Brief 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.

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.

Interventions

BEHAVIORALRegular exercise

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

DIETARY_SUPPLEMENTProtein-carbohydrate supplementation

Dosage: 45g powder mixed in 0.5 L water After each exercise session, 3 times each week, in 12 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Maximal oxygen consumption test	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.
6MWT	up to Week 12	6 min walk test. Outcome in meter.

Secondary

Measure	Time frame	Description
Risk of falls	week: 0 and 12	Measuring of: Muscle strength, balance, 5-times-up-and-down-chair-test, 14-steps-stair-test.
Daily activity level	week: 0 and 12	assessment of daily-activity level by accelerometer daily-activity level questionary SP36 life quality questionary
Blood samples	week: 0, 4, 7, 10, 12	Creatine Kinase and myoglobin levels (safe parameter) Inflammatory level

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026