Aerobic Training in Patients With Congenital Myopathies

NCT ID: NCT02020187

Last Updated: 2015-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-11-30

Brief Summary

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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

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

Conditions

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Congenital Myopathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Exercise

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

Group Type EXPERIMENTAL

Exercise on a cycle-ergometer

Intervention Type OTHER

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Gitte Hedermann Pedersen

Medical student, Bsc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gitte H Pedersen, Bsc Medicine

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Neuromuscular Research Unit

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 26751952 (View on PubMed)

Other Identifiers

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H2-2013-066

Identifier Type: -

Identifier Source: org_study_id

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