The Effect of Aerobic Exercise, on Fitness and Functional Muscle Strength, in Patients With Muscular Dystrophy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Christoffer Rasmus Vissing, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01895283
First received: July 3, 2013
Last updated: October 21, 2013
Last verified: October 2013
  Purpose

Muscular dystrophy is a group of disorders that are characterized by progressive muscle weakening and loss of muscle mass, caused by defects in muscle proteins. Muscular dystrophy is almost always inherited disorders, and so far, no curative treatments exist.

Previous studies have shown that endurance training significantly improves fitness and self-assessed muscle function in a variety of muscular dystrophies. In this study, we wish to investigate whether patients with Bethlem myopathy (a specific form of muscular dystrophy) also benefit from endurance training.

The study consists of two test days, a 10-week training period and five blood tests.

Patients will be required to train, three times per week, for 10 weeks, on a bike ergometer with a specific training intensity, under pulse rate monitoring.

The training period will be flanked by two test days, where we will determine, and compare the patients' muscle strength and fitness level, from before to after the training program. The patients conditioning level will be determined from a 15 minute cycle ergometer test and patients will undergo three functional tests to determine their functional muscle strength.

We will as a safety measure analyze blood tests before, during and after the training program for the muscle enzyme creatine kinase (an indicator of muscle damage) and through adverse effects as reported by patients during weekly telephone-consultations with the Principal investigator.

We anticipate, that Bethlem myopathy patients will have a similar rise in fitness level and functional muscle strength, as that seen in patients with other forms of muscular dystrophy, who undertake a similar training program.


Condition Intervention
Bethlem Myopathy
Behavioral: Moderate-intensity training

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effect of a Bike Ergometer Training Program in Patients With Bethlem Myopathy

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Maximal oxygen uptake (VO2max) [ Time Frame: after 10 week bike ergometer training program ] [ Designated as safety issue: No ]
    VO2max will be determined during an incremental bike test to exhaustion. VO2max is a physiological measure of physical fitness. VO2max relies on a persons ability to supply and consume oxygen ("energy") in muscle tissue.


Secondary Outcome Measures:
  • Functional muscle strength [ Time Frame: After completion of a 10 week training program ] [ Designated as safety issue: No ]
    Functional muscle strength will be determined by performance in three functional tests: a five-repetition-sit-to-stand-test, a 6 minute walk test and a 14 step stair test.

  • Muscle strength determined by dynamometry [ Time Frame: After completion of a 10 week training program ] [ Designated as safety issue: No ]
  • Self-assessed improvements in muscle function [ Time Frame: After completion of a 10 week training program ] [ Designated as safety issue: No ]
  • Self-assessed improvements in incidence of problems that are related to inactivity (in patients who are confined to a wheel-chair) [ Time Frame: After a 10 week training program ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Safety [ Time Frame: During a 10 week training program ] [ Designated as safety issue: Yes ]
    The safety of undertaking a 10-week training program will be determined by analyzing reports of adverse effects faced during the training program, and by interpretation of Creatine Kinase levels measured before, during and after the training program.


Estimated Enrollment: 8
Study Start Date: September 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Moderate-intensity training
Regular supervised moderate-intensity training on a bike ergometer, three times per week, for 30 minutes a total of 10 weeks.
Behavioral: Moderate-intensity training
Training at 70% of VO2max, for 1/2 hour, three times weekly, for 10 weeks, on a bike ergometer.

  Eligibility

Ages Eligible for Study:   16 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with Bethlem myopathy

Exclusion Criteria:

  • Patients with disorders that would confound the interpretation of the effect from training (cardiomyopathy, pregnant women, etc.)
  • Patients who are deemed mentally unfit for cooperation with the training program
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01895283

Locations
Denmark
Rigshospitalet, Neuromuscular Research Unit, section 3342
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Christoffer R Vissing, BsC Rigshospitalet, Neuromuscular Research Unit
  More Information

No publications provided

Responsible Party: Christoffer Rasmus Vissing, BsC, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01895283     History of Changes
Other Study ID Numbers: H-2-2013-066
Study First Received: July 3, 2013
Last Updated: October 21, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Rigshospitalet, Denmark:
Aerobic training
VO2max
Bethlem myopathy

Additional relevant MeSH terms:
Muscular Diseases
Muscular Dystrophies
Contracture
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Muscular Disorders, Atrophic
Genetic Diseases, Inborn
Joint Diseases

ClinicalTrials.gov processed this record on July 23, 2014