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Effect of Aerobic Training in Patients With Oculopharyngeal Muscular Dystrophy

Primary Purpose

Oculopharyngeal Muscular Dystrophy

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Exercise
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Oculopharyngeal Muscular Dystrophy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Neuromuscular Research UnitRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Excercise

Arm Description

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

Outcomes

Primary Outcome Measures

Efficacy based on VO2max
Difference in VO2max measured before and after intervention

Secondary Outcome Measures

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

Full Information

First Posted
June 4, 2014
Last Updated
June 5, 2014
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT02158156
Brief Title
Effect of Aerobic Training in Patients With Oculopharyngeal Muscular Dystrophy
Official Title
Effect of Aerobic Training in Patients With Oculopharyngeal Muscular Dystrophy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 2015 (Anticipated)
Study Completion Date
February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oculopharyngeal Muscular Dystrophy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Excercise
Arm Type
Experimental
Arm Description
10 weeks of home training on a cycle-ergometer. Exercise 30 minutes every other day or at least three times a week.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Ten weeks of home-training on a cycle ergometer 3 times a week for 30 minutes.
Primary Outcome Measure Information:
Title
Efficacy based on VO2max
Description
Difference in VO2max measured before and after intervention
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
SF-36 Questionaire
Description
Changes in self-rated health from baseline to end of intervention
Time Frame
10 weeks
Title
6 minute walk test
Description
Changes in walking distance from baseline to end of intervention
Time Frame
10 weeks
Title
Intensity in maximal load (Watt)
Description
Changes in maximal load (watt) in the VO2max-test from baseline to end of intervention.
Time Frame
10 weeks
Title
Level of plasma creatine kinase
Description
Marker for exercise-induced muscle damage. Taken week 0,3 and 10.
Time Frame
10 weeks
Title
Level of plasma myoglobin
Description
Marker for excercise-induced muscle damage, taken week 0, 3 and 10.
Time Frame
10 weeks
Title
6 minute walk test
Description
Changes in walking distance in the test from baseline to end of intervention.
Time Frame
10 weeks
Title
A five-time-repetition-sit-to-stand-test
Description
Changes in time of five repetitions from baseline to end of intervention
Time Frame
10 weeks
Title
A 14-step-stair-test
Description
Changes in time completing the test from baseline to end of intervention
Time Frame
10 weeks
Title
Dynamometry
Description
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.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen BH Pedersen, Bsc.med.
Organizational Affiliation
Neuromuscular Research Unit, Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neuromuscular Research Unit
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vissing
Phone
+4535451842
First Name & Middle Initial & Last Name & Degree
Karen BH Pedersen, Med. student, Bsc

12. IPD Sharing Statement

Links:
URL
http://www.neuromuscular.dk
Description
Website of the Neuromuscular Research Unit, Rigshospitalet, Copenhagen, Denmark

Learn more about this trial

Effect of Aerobic Training in Patients With Oculopharyngeal Muscular Dystrophy

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