An interventional study of Exercise on a cycle-ergometer in Congenital Myopathy, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-05-12.
Sponsored by Rigshospitalet, Denmark · Not applicable, Interventional, and Supportive care
Congenital myopathies are clinical and genetic heterogeneous disorders characterized by skeletal muscle weakness. Most patients experience muscle weakness and fatigue throughout their life. However, progression of symptoms is rare. There are no specific treatments for congenital myopathies. Training has been shown to benefit several other muscle diseases with weakness, but the defect in congenital myopathies involves contractile proteins of the sarcomere, why the effect of training is uncertain in these conditions. The investigators will therefore investigate the effect cycle-ergometer training for 30 minutes, three times weakly, for ten weeks in 15 patients with congenital myopathy. Another 5-10 congenital myopathy patients, who do not train, will serve as controls for the trained patients. The study starts and ends with a test day, where efficacy based on VO2max, performance in functional tests and a questionnaire will be assessed.
10 weeks of cycle-ergometer training at home. Intensity at 70% of maximal VO2,max.
280 studies on the registry are indexed under Muscular Diseases; 63 are open to participants now.
This study's enrollment of 16 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.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
10 weeks of home training on a cycle-ergometer. Exercise 30 minutes every other day or at least three times a week.
Other: Exercise on a cycle-ergometer
Controls with diagnosed congenital myopathy. Subjects are tested two times on a cycle ergometer. There will be ten weeks between the tests. In between tests the subjects are living life as usual without any interventions.
Home training on an ergometer-cycle 30 minutes every other day or at least three times a week. Subject will exercise in a pulse interval corresponding to 70% of their maximal VO2.
Efficacy based on VO2,max
Difference in VO2,max from baseline to end of intervention.
Time frame: 10 weeks
Level of Creatine Kinase
Marker for exercise-induced muscle damage. Taken week 0, 3 and 10.
Time frame: 10 weeks
Intensity in maximal Watt
Changes in the maximal intensity (watt) from baseline VO2,max test to after the intervention.
Time frame: 10 weeks
6 minute walk test
Changes in the walking distance from baseline to after the intervention.
Time frame: 10 weeks
SF-36 questionnaire
Changes in SF-36 questionnaire from baseline to after the intervention.
Time frame: 10 weeks
A timed five-repetitions-sit-to-stand-test
Changes in time from baseline to after the intervention.
Time frame: 10 weeks
A timed 14-step-stair-test
Changes in time from baseline to after the intervention.
Time frame: 10 weeks
Dynamometry
Changes in external force production from baseline to after the intervention. Dynamometry measurements are done at hip flexion, dorsal foot flexion, plantar foot flexion, knee flexion, knee extension and elbow flexion.
Time frame: 10 weeks
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Rigshospitalet, Denmark