Relations Between Fitness Status and the Severity of Myotonia in Patients With Congenital Myotonia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 9
- Locations
- 2
- Primary Endpoint
- Changes in myotonia
Study Overview
Brief Summary
Investigators aimed to investigate whether training can increase fitness levels in patients with myotonia, and thereby reduce the symptom of myotonia.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Changes in fitness(baseline and after week 10)
- Changes in creatine Kinase(baseline, week 2, week 4, week 7 and week 10)
- Changes in other myotonia(baseline and after week 10)
Investigators
Grete Andersen, MD
Medical Doctor
Rigshospitalet, Denmark