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

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ClinicalTrials.gov Identifier: NCT01895283
Recruitment Status : Completed
First Posted : July 10, 2013
Last Update Posted : April 6, 2016
Sponsor:
Information provided by (Responsible Party):
Christoffer Rasmus Vissing, Rigshospitalet, Denmark

July 3, 2013
July 10, 2013
April 6, 2016
September 2013
December 2014   (Final data collection date for primary outcome measure)
Maximal oxygen uptake (VO2max) [ Time Frame: after 10 week bike ergometer training program ]
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.
Same as current
Complete list of historical versions of study NCT01895283 on ClinicalTrials.gov Archive Site
  • Functional muscle strength [ Time Frame: After completion of a 10 week training program ]
    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 ]
  • Self-assessed improvements in muscle function [ Time Frame: After completion of a 10 week training program ]
  • 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 ]
Same as current
Safety [ Time Frame: During a 10 week training program ]
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.
Same as current
 
The Effect of Aerobic Exercise, on Fitness and Functional Muscle Strength, in Patients With Muscular Dystrophy
The Effect of a Bike Ergometer Training Program in Patients With Bethlem Myopathy

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.

Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Bethlem Myopathy
Behavioral: Moderate-intensity training
Training at 70% of VO2max, for 1/2 hour, three times weekly, for 10 weeks, on a bike ergometer.
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.
Intervention: Behavioral: Moderate-intensity training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
8
January 2015
December 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
16 Years to 90 Years   (Child, Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01895283
H-2-2013-066
Yes
Not Provided
Not Provided
Christoffer Rasmus Vissing, Rigshospitalet, Denmark
Rigshospitalet, Denmark
Not Provided
Principal Investigator: Christoffer R Vissing, BsC Rigshospitalet, Neuromuscular Research Unit
Rigshospitalet, Denmark
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP