Effect of Aerobic Training in Patients With Oculopharyngeal Muscular Dystrophy

Not Applicable

• Conditions: Oculopharyngeal Muscular Dystrophy
• Interventions: Behavioral: Exercise

• Registration Number: NCT02158156
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

The investigators want to investigate if patients with Oculopharyngeal Muscular Dystrophy can improve fitness by home-training on a cycle ergometer 30 minute, 3 times a week for 10 weeks.

Participants will be evaluated on maximal oxygen consumption and maximal workload measured by an incremental test at baseline and at the end of the exercise period.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Status Verified: 2014-06
• Study First Submitted: 2014-06-04
• Study First Submitted QC: 2014-06-05
• Last Update Submitted: 2014-06-05
• Study First Posted: 2014-06-06
• Last Update Posted: 2014-06-06
• Primary Completion: 2015-02
• Study Completion: 2015-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Danish patients with Oculopharyngeal muscular dystrophy

Exclusion Criteria

• Patients who are too week to train on an cycle-ergometer for 10 weeks
• Patients with other health issues wich confound the interpretation of the efficacy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Efficacy based on VO2max	10 weeks	Difference in VO2max measured before and after intervention

Secondary Outcome Measures

Name	Time	Method
Intensity in maximal load (Watt)	10 weeks	Changes in maximal load (watt) in the VO2max-test from baseline to end of intervention.
Dynamometry	10 weeks	Changes in external force production from baseline to end of intervention. Dynamometry are measured on hip flexion, dorsal foot flexion, plantar foot flexion, knee flexion, knee extension, and elbow flexion.
SF-36 Questionaire	10 weeks	Changes in self-rated health from baseline to end of intervention
6 minute walk test	10 weeks	Changes in walking distance in the test from baseline to end of intervention.
Level of plasma creatine kinase	10 weeks	Marker for exercise-induced muscle damage. Taken week 0,3 and 10.
Level of plasma myoglobin	10 weeks	Marker for excercise-induced muscle damage, taken week 0, 3 and 10.
A five-time-repetition-sit-to-stand-test	10 weeks	Changes in time of five repetitions from baseline to end of intervention
A 14-step-stair-test	10 weeks	Changes in time completing the test from baseline to end of intervention

Trial Locations

Locations (1)

Neuromuscular Research Unit; 🇩🇰 Copenhagen, Denmark