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Aerobic Training in Patients With Congenital Myopathies

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ClinicalTrials.gov Identifier: NCT02020187
Recruitment Status : Completed
First Posted : December 24, 2013
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
Gitte Hedermann Pedersen, Rigshospitalet, Denmark

Brief Summary:
Congenital myopathies are clinical and genetic heterogeneous disorders characterized by skeletal muscle weakness. Most patients experience muscle weakness and fatigue throughout their life. However, progression of symptoms is rare. There are no specific treatments for congenital myopathies. Training has been shown to benefit several other muscle diseases with weakness, but the defect in congenital myopathies involves contractile proteins of the sarcomere, why the effect of training is uncertain in these conditions. The investigators will therefore investigate the effect cycle-ergometer training for 30 minutes, three times weakly, for ten weeks in 15 patients with congenital myopathy. Another 5-10 congenital myopathy patients, who do not train, will serve as controls for the trained patients. The study starts and ends with a test day, where efficacy based on VO2max, performance in functional tests and a questionnaire will be assessed.

Condition or disease Intervention/treatment Phase
Congenital Myopathy Other: Exercise on a cycle-ergometer Not Applicable

Detailed Description:
10 weeks of cycle-ergometer training at home. Intensity at 70% of maximal VO2,max.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Aerobic Training in Patients With Congenital Myopathies
Study Start Date : September 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014


Arm Intervention/treatment
Experimental: Exercise
10 weeks of home training on a cycle-ergometer. Exercise 30 minutes every other day or at least three times a week.
Other: Exercise on a cycle-ergometer
Home training on an ergometer-cycle 30 minutes every other day or at least three times a week. Subject will exercise in a pulse interval corresponding to 70% of their maximal VO2.

No Intervention: Controls
Controls with diagnosed congenital myopathy. Subjects are tested two times on a cycle ergometer. There will be ten weeks between the tests. In between tests the subjects are living life as usual without any interventions.



Primary Outcome Measures :
  1. Efficacy based on VO2,max [ Time Frame: 10 weeks ]
    Difference in VO2,max from baseline to end of intervention.


Secondary Outcome Measures :
  1. Level of Creatine Kinase [ Time Frame: 10 weeks ]
    Marker for exercise-induced muscle damage. Taken week 0, 3 and 10.

  2. Intensity in maximal Watt [ Time Frame: 10 weeks ]
    Changes in the maximal intensity (watt) from baseline VO2,max test to after the intervention.

  3. 6 minute walk test [ Time Frame: 10 weeks ]
    Changes in the walking distance from baseline to after the intervention.

  4. SF-36 questionnaire [ Time Frame: 10 weeks ]
    Changes in SF-36 questionnaire from baseline to after the intervention.

  5. A timed five-repetitions-sit-to-stand-test [ Time Frame: 10 weeks ]
    Changes in time from baseline to after the intervention.

  6. A timed 14-step-stair-test [ Time Frame: 10 weeks ]
    Changes in time from baseline to after the intervention.

  7. Dynamometry [ Time Frame: 10 weeks ]
    Changes in external force production from baseline to after the intervention. Dynamometry measurements are done at hip flexion, dorsal foot flexion, plantar foot flexion, knee flexion, knee extension and elbow flexion.



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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:

  • Danish patients with gene verified congenital myopathy

Exclusion Criteria:

  • Patients who are to week to train at a cycle-ergometer for 10 weeks
  • Patients who have other health issues, which can disturb the interpretation of the efficacy

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): NCT02020187


Locations
Denmark
Neuromuscular Research Unit
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Gitte H Pedersen, Bsc Medicine Rigshospitalet, Denmark

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gitte Hedermann Pedersen, Medical student, Bsc, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02020187     History of Changes
Other Study ID Numbers: H2-2013-066
First Posted: December 24, 2013    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015

Keywords provided by Gitte Hedermann Pedersen, Rigshospitalet, Denmark:
Congenital myopathy
Exercise

Additional relevant MeSH terms:
Muscular Diseases
Muscular Dystrophies
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Muscular Disorders, Atrophic
Genetic Diseases, Inborn