Effect of Aerobic Training in Patients With Oculopharyngeal Muscular Dystrophy

June 5, 2014 updated by: Karen Brorup Heje Pedersen, Rigshospitalet, Denmark

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Neuromuscular Research Unit
        • Contact:
          • Vissing
          • Phone Number: +4535451842
        • Principal Investigator:
          • Karen BH Pedersen, Med. student, Bsc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Excercise
10 weeks of home training on a cycle-ergometer. Exercise 30 minutes every other day or at least three times a week.
Behavioral: Exercise
Ten weeks of home-training on a cycle ergometer 3 times a week for 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy based on VO2max
Time Frame: 10 weeks
Difference in VO2max measured before and after intervention
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SF-36 Questionaire
Time Frame: 10 weeks
Changes in self-rated health from baseline to end of intervention
10 weeks
6 minute walk test
Time Frame: 10 weeks
Changes in walking distance from baseline to end of intervention
10 weeks
Intensity in maximal load (Watt)
Time Frame: 10 weeks
Changes in maximal load (watt) in the VO2max-test from baseline to end of intervention.
10 weeks
Level of plasma creatine kinase
Time Frame: 10 weeks
Marker for exercise-induced muscle damage. Taken week 0,3 and 10.
10 weeks
Level of plasma myoglobin
Time Frame: 10 weeks
Marker for excercise-induced muscle damage, taken week 0, 3 and 10.
10 weeks
6 minute walk test
Time Frame: 10 weeks
Changes in walking distance in the test from baseline to end of intervention.
10 weeks
A five-time-repetition-sit-to-stand-test
Time Frame: 10 weeks
Changes in time of five repetitions from baseline to end of intervention
10 weeks
A 14-step-stair-test
Time Frame: 10 weeks
Changes in time completing the test from baseline to end of intervention
10 weeks
Dynamometry
Time Frame: 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.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Karen BH Pedersen, Bsc.med., Neuromuscular Research Unit, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

February 1, 2015

Study Completion (Anticipated)

February 1, 2015

Study Registration Dates

First Submitted

June 4, 2014

First Submitted That Met QC Criteria

June 5, 2014

First Posted (Estimate)

June 6, 2014

Study Record Updates

Last Update Posted (Estimate)

June 6, 2014

Last Update Submitted That Met QC Criteria

June 5, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H2-2013-066(A)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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