Relations Between Myotonia and Fitness
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|ClinicalTrials.gov Identifier: NCT02161835|
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : May 14, 2015
|Condition or disease||Intervention/treatment||Phase|
|Congenital Myotonia||Other: Training||Not Applicable|
Investigators aimed to investigate whether a 10-week bicycle exercise program can increase fitness levels in patients with myotonia, and thereby reduce the symptom of myotonia in everyday life. The effect on myotonia is assessed by a standardized myotonia scale with six statements concerning self-rated myotonia, and a number of performance tests that objectively describes the degree of myotonia.
The effect of the training program is assessed by an incremental test, measuring maximal oxygen uptake, maximal heart rate and maximal workload. The muscle enzyme creatine kinase (CK) is measured in plasma to follow muscle injury and safety during the training.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Relations Between Fitness Status and the Severity of Myotonia in Patients With Congenital Myotonia|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
Participants exercise 3 times a week, 30 minute, on an ergometer bike.
30 minutes of home based pulse watch regulated cycle-ergometer exercise, three times a week at 75% of maximal oxygen consumption.
No Intervention: Control
Participants is tested with the 4 objective myotonia test and measurements of self-assessed myotonia by the Myotonia Behavior Scale is collected.
- Changes in myotonia [ Time Frame: Week 0 and week 10 ]Changes in myotonia is assessed before and after 10 weeks of exercise training. Myotonia is measured as self-assessment of myotonia using the Myotonia Behavior Scale every day in a week before training start and every day in a week before training finish. Furthermore, myotonia is measured as changes in time climbing a 14 steps stair before and after the 10 weeks training period.
- Changes in fitness [ Time Frame: baseline and after week 10 ]An incremental test is performed at baseline and in the end of 10 weeks training. The primary outcome is change between the two tests in maximal oxygen consumption and work load.
- Changes in creatine Kinase [ Time Frame: baseline, week 2, week 4, week 7 and week 10 ]Creatine Kinase (CK) is measure in plasma to follow muscle injury during the trial.
- Changes in other myotonia [ Time Frame: baseline and after week 10 ]
Myotonia assessed by eye-open-close test, hand open-close test, and by up-and-go test. The three performance tests describe objectively the degree of myotonia.
The outcome measure is changes between before and after training.
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): NCT02161835
|Neuromuscular Research Unit, Department of Neurology, Rigshospitalet|
|Copenhagen, Denmark, 2100|
|Principal Investigator:||Grete Andersen, MD||Neuromuscular research unit Copenhagen|