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Aerobic Training in Patients With Congenital Myopathies

Primary Purpose

Congenital Myopathy

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Exercise on a cycle-ergometer
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Congenital Myopathy focused on measuring Congenital myopathy, Exercise

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Neuromuscular Research Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise

Controls

Arm Description

10 weeks of home training on a cycle-ergometer. Exercise 30 minutes every other day or at least three times a week.

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.

Outcomes

Primary Outcome Measures

Efficacy based on VO2,max
Difference in VO2,max from baseline to end of intervention.

Secondary Outcome Measures

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

Full Information

First Posted
November 28, 2013
Last Updated
May 11, 2015
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT02020187
Brief Title
Aerobic Training in Patients With Congenital Myopathies
Official Title
Aerobic Training in Patients With Congenital Myopathies
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Myopathy
Keywords
Congenital myopathy, Exercise

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
10 weeks of home training on a cycle-ergometer. Exercise 30 minutes every other day or at least three times a week.
Arm Title
Controls
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise on a cycle-ergometer
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy based on VO2,max
Description
Difference in VO2,max from baseline to end of intervention.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Level of Creatine Kinase
Description
Marker for exercise-induced muscle damage. Taken week 0, 3 and 10.
Time Frame
10 weeks
Title
Intensity in maximal Watt
Description
Changes in the maximal intensity (watt) from baseline VO2,max test to after the intervention.
Time Frame
10 weeks
Title
6 minute walk test
Description
Changes in the walking distance from baseline to after the intervention.
Time Frame
10 weeks
Title
SF-36 questionnaire
Description
Changes in SF-36 questionnaire from baseline to after the intervention.
Time Frame
10 weeks
Title
A timed five-repetitions-sit-to-stand-test
Description
Changes in time from baseline to after the intervention.
Time Frame
10 weeks
Title
A timed 14-step-stair-test
Description
Changes in time from baseline to after the intervention.
Time Frame
10 weeks
Title
Dynamometry
Description
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.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gitte H Pedersen, Bsc Medicine
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neuromuscular Research Unit
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
26751952
Citation
Hedermann G, Vissing CR, Heje K, Preisler N, Witting N, Vissing J. Aerobic Training in Patients with Congenital Myopathy. PLoS One. 2016 Jan 11;11(1):e0146036. doi: 10.1371/journal.pone.0146036. eCollection 2016.
Results Reference
derived

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Aerobic Training in Patients With Congenital Myopathies

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