Aerobic Training in Patients With Congenital Myopathies

May 11, 2015 updated by: Gitte Hedermann Pedersen, Rigshospitalet, Denmark
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Neuromuscular Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy based on VO2,max
Time Frame: 10 weeks
Difference in VO2,max from baseline to end of intervention.
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of Creatine Kinase
Time Frame: 10 weeks
Marker for exercise-induced muscle damage. Taken week 0, 3 and 10.
10 weeks
Intensity in maximal Watt
Time Frame: 10 weeks
Changes in the maximal intensity (watt) from baseline VO2,max test to after the intervention.
10 weeks
6 minute walk test
Time Frame: 10 weeks
Changes in the walking distance from baseline to after the intervention.
10 weeks
SF-36 questionnaire
Time Frame: 10 weeks
Changes in SF-36 questionnaire from baseline to after the intervention.
10 weeks
A timed five-repetitions-sit-to-stand-test
Time Frame: 10 weeks
Changes in time from baseline to after the intervention.
10 weeks
A timed 14-step-stair-test
Time Frame: 10 weeks
Changes in time from baseline to after the intervention.
10 weeks
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.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Gitte H Pedersen, Bsc Medicine, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

November 28, 2013

First Submitted That Met QC Criteria

December 18, 2013

First Posted (ESTIMATE)

December 24, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 12, 2015

Last Update Submitted That Met QC Criteria

May 11, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H2-2013-066

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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