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

NCT01618331 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2014-06-05

No results posted yet for this study

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.

Conditions

  • Facioscapulohumeral Muscle Dystrophy

Interventions

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.

Sponsors & Collaborators

  • The Augustinus Foundation, Denmark.

    collaborator OTHER

  • Aase and Ejnar Danielsens Foundation

    collaborator OTHER

  • The Danish Rheumatism Association

    collaborator OTHER

  • AP Moeller Foundation

    collaborator OTHER

  • Grete Andersen, MD

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01618331 on ClinicalTrials.gov