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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
Sponsor:
Information provided by (Responsible Party):
Grete Andersen, MD, Rigshospitalet, Denmark

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

Condition or disease Intervention/treatment Phase
Congenital Myotonia Other: Training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: Training
Participants exercise 3 times a week, 30 minute, on an ergometer bike.
Other: Training
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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.




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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Denmark
Neuromuscular Research Unit, Department of Neurology, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Grete Andersen, MD
Investigators
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Principal Investigator: Grete Andersen, MD Neuromuscular research unit Copenhagen
Additional Information:
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Responsible Party: Grete Andersen, MD, Medical Doctor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02161835    
Other Study ID Numbers: H-4-2014-026
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: May 14, 2015
Last Verified: May 2015
Keywords provided by Grete Andersen, MD, Rigshospitalet, Denmark:
Congenital myotonia
Myotonia congenita
Thomsons disease
Becker type
Training
Exercise
Additional relevant MeSH terms:
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Myotonia Congenita
Myotonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Myotonic Disorders
Muscular Diseases
Musculoskeletal Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Neuromuscular Diseases
Genetic Diseases, Inborn