An interventional study of Moderate-intensity training in Bethlem Myopathy, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to participants aged 16 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-06.
Sponsored by Rigshospitalet, Denmark · Not applicable, Interventional, and Prevention
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.
280 studies on the registry are indexed under Muscular Diseases; 63 are open to participants now.
This study's enrollment of 7 is below the median of 34 across 157 interventional studies indexed under Muscular Diseases.
Browse Muscular Diseases studies →Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.
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Exclusion Criteria:
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.
Maximal oxygen uptake (VO2max)
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.
Time frame: after 10 week bike ergometer training program
Functional muscle strength
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.
Time frame: After completion of a 10 week training program
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
Safety
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.
Time frame: During a 10 week training program
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Rigshospitalet, Denmark