Relations Between Myotonia and Fitness

Not Applicable

Completed

• Conditions: Congenital Myotonia
• Interventions: Other: Training

• Registration Number: NCT02161835
• Lead Sponsor: Grete Andersen, MD

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 Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-06-06
• Study First Submitted QC: 2014-06-10
• Study First Posted: 2014-06-12
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-13
• Last Update Posted: 2015-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Training	Training	Participants exercise 3 times a week, 30 minute, on an ergometer bike.

Primary Outcome Measures

Name	Time	Method
Changes in myotonia	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 Outcome Measures

Name	Time	Method
Changes in fitness	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	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	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.

Trial Locations

Locations (1)

Neuromuscular Research Unit, Department of Neurology, Rigshospitalet; 🇩🇰 Copenhagen, Denmark