Aerobic Training in Patients With Congenital Myopathies
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|ClinicalTrials.gov Identifier: NCT02020187|
Recruitment Status : Completed
First Posted : December 24, 2013
Last Update Posted : May 12, 2015
|Condition or disease||Intervention/treatment||Phase|
|Congenital Myopathy||Other: Exercise on a cycle-ergometer||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Aerobic Training in Patients With Congenital Myopathies|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
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
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.
No Intervention: Controls
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.
- Efficacy based on VO2,max [ Time Frame: 10 weeks ]Difference in VO2,max from baseline to end of intervention.
- Level of Creatine Kinase [ Time Frame: 10 weeks ]Marker for exercise-induced muscle damage. Taken week 0, 3 and 10.
- Intensity in maximal Watt [ Time Frame: 10 weeks ]Changes in the maximal intensity (watt) from baseline VO2,max test to after the intervention.
- 6 minute walk test [ Time Frame: 10 weeks ]Changes in the walking distance from baseline to after the intervention.
- SF-36 questionnaire [ Time Frame: 10 weeks ]Changes in SF-36 questionnaire from baseline to after the intervention.
- A timed five-repetitions-sit-to-stand-test [ Time Frame: 10 weeks ]Changes in time from baseline to after the intervention.
- A timed 14-step-stair-test [ Time Frame: 10 weeks ]Changes in time from baseline to after the intervention.
- Dynamometry [ Time Frame: 10 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020187
|Neuromuscular Research Unit|
|Copenhagen, Denmark, 2100|
|Principal Investigator:||Gitte H Pedersen, Bsc Medicine||Rigshospitalet, Denmark|