Effect of Aerobic Training in Patients With Oculopharyngeal Muscular Dystrophy

Oculopharyngeal Muscular Dystrophy Clinical Trial

Official title:

Effect of Aerobic Training in Patients With Oculopharyngeal Muscular Dystrophy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02158156
• Other study ID #: H2-2013-066(A)
• Status: Recruiting
• Phase: N/A
• First received: June 4, 2014
• Last updated: June 5, 2014
• Start date: February 2014
• Est. completion date: February 2015

Study information

• Verified date: June 2014
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The National Committee on Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Muscular Dystrophies
• Muscular Dystrophy, Oculopharyngeal
• Oculopharyngeal Muscular Dystrophy

Intervention

Behavioral:
• Exercise
Ten weeks of home-training on a cycle ergometer 3 times a week for 30 minutes.

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 VO2max	Difference in VO2max measured before and after intervention	10 weeks	No
Secondary	SF-36 Questionaire	Changes in self-rated health from baseline to end of intervention	10 weeks	No
Secondary	6 minute walk test	Changes in walking distance from baseline to end of intervention	10 weeks	No
Secondary	Intensity in maximal load (Watt)	Changes in maximal load (watt) in the VO2max-test from baseline to end of intervention.	10 weeks	No
Secondary	Level of plasma creatine kinase	Marker for exercise-induced muscle damage. Taken week 0,3 and 10.	10 weeks	Yes
Secondary	Level of plasma myoglobin	Marker for excercise-induced muscle damage, taken week 0, 3 and 10.	10 weeks	Yes
Secondary	6 minute walk test	Changes in walking distance in the test from baseline to end of intervention.	10 weeks	No
Secondary	A five-time-repetition-sit-to-stand-test	Changes in time of five repetitions from baseline to end of intervention	10 weeks	No
Secondary	A 14-step-stair-test	Changes in time completing the test from baseline to end of intervention	10 weeks	No
Secondary	Dynamometry	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.	10 weeks	No

External Links

•   Website of the Neuromuscular Research Unit, Rigshospitalet, Copenhagen, Denmark