Congenital Myotonia Clinical Trial
Official title:
Relations Between Fitness Status and the Severity of Myotonia in Patients With Congenital Myotonia
Investigators aimed to investigate whether training can increase fitness levels in patients with myotonia, and thereby reduce the symptom of myotonia.
| Status | Completed |
| Enrollment | 9 |
| Est. completion date | February 2015 |
| Est. primary completion date | February 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Diagnosed with either Myotonia congenita or Paramyotonia congenita. - Patients who have symptoms of myotonia while they are walking stairs. Exclusion Criteria: - Pregnant or breastfeeding women. - Physical or mental condition, which prevent participating in the study protocol or which could influence the results. - Participating in other studies, which could influence the results. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Neuromuscular Research Unit, Department of Neurology, Rigshospitalet | Copenhagen |
| Lead Sponsor | Collaborator |
|---|---|
| Grete Andersen, MD |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes in myotonia | 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. | Week 0 and week 10 | No |
| Secondary | Changes in fitness | 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. | baseline and after week 10 | No |
| Secondary | Changes in creatine Kinase | Creatine Kinase (CK) is measure in plasma to follow muscle injury during the trial. | baseline, week 2, week 4, week 7 and week 10 | Yes |
| Secondary | Changes in other myotonia | 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. |
baseline and after week 10 | No |