Effect of Aerobic Training in Patients With Oculopharyngeal Muscular Dystrophy
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|ClinicalTrials.gov Identifier: NCT02158156|
Recruitment Status : Unknown
Verified June 2014 by Karen Brorup Heje Pedersen, Rigshospitalet, Denmark.
Recruitment status was: Recruiting
First Posted : June 6, 2014
Last Update Posted : June 6, 2014
The investigators want to investigate if patients with Oculopharyngeal Muscular Dystrophy can improve fitness by home-training on a cycle ergometer 30 minute, 3 times a week for 10 weeks.
Participants will be evaluated on maximal oxygen consumption and maximal workload measured by an incremental test at baseline and at the end of the exercise period.
|Condition or disease||Intervention/treatment||Phase|
|Oculopharyngeal Muscular Dystrophy||Behavioral: Exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effect of Aerobic Training in Patients With Oculopharyngeal Muscular Dystrophy|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||February 2015|
|Estimated Study Completion Date :||February 2015|
10 weeks of home training on a cycle-ergometer. Exercise 30 minutes every other day or at least three times a week.
Ten weeks of home-training on a cycle ergometer 3 times a week for 30 minutes.
- Efficacy based on VO2max [ Time Frame: 10 weeks ]Difference in VO2max measured before and after intervention
- SF-36 Questionaire [ Time Frame: 10 weeks ]Changes in self-rated health from baseline to end of intervention
- 6 minute walk test [ Time Frame: 10 weeks ]Changes in walking distance from baseline to end of intervention
- Intensity in maximal load (Watt) [ Time Frame: 10 weeks ]Changes in maximal load (watt) in the VO2max-test from baseline to end of intervention.
- Level of plasma creatine kinase [ Time Frame: 10 weeks ]Marker for exercise-induced muscle damage. Taken week 0,3 and 10.
- Level of plasma myoglobin [ Time Frame: 10 weeks ]Marker for excercise-induced muscle damage, taken week 0, 3 and 10.
- 6 minute walk test [ Time Frame: 10 weeks ]Changes in walking distance in the test from baseline to end of intervention.
- A five-time-repetition-sit-to-stand-test [ Time Frame: 10 weeks ]Changes in time of five repetitions from baseline to end of intervention
- A 14-step-stair-test [ Time Frame: 10 weeks ]Changes in time completing the test from baseline to end of intervention
- Dynamometry [ Time Frame: 10 weeks ]Changes in external force production from baseline to end of intervention. Dynamometry are measured on 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): NCT02158156
|Neuromuscular Research Unit||Recruiting|
|Copenhagen, Denmark, 2100|
|Contact: Vissing +4535451842|
|Principal Investigator: Karen BH Pedersen, Med. student, Bsc|
|Principal Investigator:||Karen BH Pedersen, Bsc.med.||Neuromuscular Research Unit, Rigshospitalet, Denmark|