Clinical Trial: Relations Between Myotonia and Fitness

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Relations Between Fitness Status and the Severity of Myotonia in Patients With Congenital Myotonia

Brief Summary: Investigators aimed to investigate whether training can increase fitness levels in patients with myotonia, and thereby reduce the symptom of myotonia.

Detailed Summary:

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.


Sponsor: Grete Andersen, MD

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.



Original Secondary Outcome: Same as current

Information By: Rigshospitalet, Denmark

Dates:
Date Received: June 6, 2014
Date Started: April 2014
Date Completion:
Last Updated: May 13, 2015
Last Verified: May 2015