Aerobic Training in Patients With Congenital Myopathies

Congenital Myopathy Clinical Trial

Official title:

Aerobic Training in Patients With Congenital Myopathies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02020187
• Other study ID #: H2-2013-066
• Status: Completed
• Phase: N/A
• First received: November 28, 2013
• Last updated: May 11, 2015
• Start date: September 2013
• Est. completion date: November 2014

Study information

• Verified date: May 2015
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Congenital Myopathy
• Muscular Diseases

Intervention

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.

Locations

Country	Name	City	State
Denmark	Neuromuscular Research Unit	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy based on VO2,max	Difference in VO2,max from baseline to end of intervention.	10 weeks	No
Secondary	Level of Creatine Kinase	Marker for exercise-induced muscle damage. Taken week 0, 3 and 10.	10 weeks	Yes
Secondary	Intensity in maximal Watt	Changes in the maximal intensity (watt) from baseline VO2,max test to after the intervention.	10 weeks	No
Secondary	6 minute walk test	Changes in the walking distance from baseline to after the intervention.	10 weeks	No
Secondary	SF-36 questionnaire	Changes in SF-36 questionnaire from baseline to after the intervention.	10 weeks	No
Secondary	A timed five-repetitions-sit-to-stand-test	Changes in time from baseline to after the intervention.	10 weeks	No
Secondary	A timed 14-step-stair-test	Changes in time from baseline to after the intervention.	10 weeks	No
Secondary	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.	10 weeks	No