Effect of Aerobic Training in Patients With Oculopharyngeal Muscular Dystrophy

• Sponsor: Rigshospitalet, Denmark (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02158156
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arm: 1
• Duration (Months): 12
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 8 participants
• Allocation: N/A
• 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: Feb 1, 2014
• Anticipated Primary Completion Date: Feb 1, 2015
• Anticipated Study Completion Date: Feb 1, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Efficacy based on VO2max [10 weeks]

   Difference in VO2max measured before and after intervention

Secondary Outcome Measures

1. SF-36 Questionaire [10 weeks]

   Changes in self-rated health from baseline to end of intervention

2. 6 minute walk test [10 weeks]

   Changes in walking distance from baseline to end of intervention

3. Intensity in maximal load (Watt) [10 weeks]

   Changes in maximal load (watt) in the VO2max-test from baseline to end of intervention.

4. Level of plasma creatine kinase [10 weeks]

   Marker for exercise-induced muscle damage. Taken week 0,3 and 10.

5. Level of plasma myoglobin [10 weeks]

   Marker for excercise-induced muscle damage, taken week 0, 3 and 10.

6. 6 minute walk test [10 weeks]

   Changes in walking distance in the test from baseline to end of intervention.

7. A five-time-repetition-sit-to-stand-test [10 weeks]

   Changes in time of five repetitions from baseline to end of intervention

8. A 14-step-stair-test [10 weeks]

   Changes in time completing the test from baseline to end of intervention

9. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neuromuscular Research Unit	Copenhagen		Denmark	2100

Sponsors and Collaborators

• Rigshospitalet, Denmark

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Karen Brorup Heje Pedersen, Bsc Medicine, Rigshospitalet, Denmark
• ClinicalTrials.gov Identifier: NCT02158156
• Other Study ID Numbers: H2-2013-066(A)
• First Posted: Jun 6, 2014
• Last Update Posted: Jun 6, 2014
• Last Verified: Jun 1, 2014

• Additional relevant MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Oculopharyngeal

Study Results

No Results Posted as of Jun 6, 2014