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Effect of Aerobic Training in Patients With Oculopharyngeal Muscular Dystrophy

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ClinicalTrials.gov Identifier: NCT02158156
Recruitment Status : Unknown
Verified June 2014 by Karen Brorup Heje Pedersen, Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
First Posted : June 6, 2014
Last Update Posted : June 6, 2014
Sponsor:
Information provided by (Responsible Party):
Karen Brorup Heje Pedersen, 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.


Condition or disease Intervention/treatment Phase
Oculopharyngeal Muscular Dystrophy Behavioral: Exercise Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of Aerobic Training in Patients With Oculopharyngeal Muscular Dystrophy
Study Start Date : February 2014
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : February 2015


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.




Primary Outcome Measures :
  1. Efficacy based on VO2max [ Time Frame: 10 weeks ]
    Difference in VO2max measured before and after intervention


Secondary Outcome Measures :
  1. SF-36 Questionaire [ Time Frame: 10 weeks ]
    Changes in self-rated health from baseline to end of intervention

  2. 6 minute walk test [ Time Frame: 10 weeks ]
    Changes in walking distance from baseline to end of intervention

  3. Intensity in maximal load (Watt) [ Time Frame: 10 weeks ]
    Changes in maximal load (watt) in the VO2max-test from baseline to end of intervention.

  4. Level of plasma creatine kinase [ Time Frame: 10 weeks ]
    Marker for exercise-induced muscle damage. Taken week 0,3 and 10.

  5. Level of plasma myoglobin [ Time Frame: 10 weeks ]
    Marker for excercise-induced muscle damage, taken week 0, 3 and 10.

  6. 6 minute walk test [ Time Frame: 10 weeks ]
    Changes in walking distance in the test from baseline to end of intervention.

  7. A five-time-repetition-sit-to-stand-test [ Time Frame: 10 weeks ]
    Changes in time of five repetitions from baseline to end of intervention

  8. A 14-step-stair-test [ Time Frame: 10 weeks ]
    Changes in time completing the test from baseline to end of intervention

  9. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02158156


Locations
Denmark
Neuromuscular Research Unit Recruiting
Copenhagen, Denmark, 2100
Contact: Vissing    +4535451842      
Principal Investigator: Karen BH Pedersen, Med. student, Bsc         
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Karen BH Pedersen, Bsc.med. Neuromuscular Research Unit, Rigshospitalet, Denmark

Additional Information:
Responsible Party: Karen Brorup Heje Pedersen, Bsc Medicine, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02158156     History of Changes
Other Study ID Numbers: H2-2013-066(A)
First Posted: June 6, 2014    Key Record Dates
Last Update Posted: June 6, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Muscular Dystrophies
Muscular Dystrophy, Oculopharyngeal
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn