The Effect of Aerobic Exercise, on Fitness and Functional Muscle Strength, in Patients With Muscular Dystrophy
Primary Purpose
Bethlem Myopathy
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Moderate-intensity training
Sponsored by
About this trial
This is an interventional prevention trial for Bethlem Myopathy focused on measuring Aerobic training, VO2max, Bethlem myopathy
Eligibility Criteria
Inclusion Criteria:
- Patients with Bethlem myopathy
Exclusion Criteria:
- Patients with disorders that would confound the interpretation of the effect from training (cardiomyopathy, pregnant women, etc.)
- Patients who are deemed mentally unfit for cooperation with the training program
Sites / Locations
- Rigshospitalet, Neuromuscular Research Unit, section 3342
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Moderate-intensity training
Arm Description
Regular supervised moderate-intensity training on a bike ergometer, three times per week, for 30 minutes a total of 10 weeks.
Outcomes
Primary Outcome Measures
Maximal oxygen uptake (VO2max)
VO2max will be determined during an incremental bike test to exhaustion. VO2max is a physiological measure of physical fitness. VO2max relies on a persons ability to supply and consume oxygen ("energy") in muscle tissue.
Secondary Outcome Measures
Functional muscle strength
Functional muscle strength will be determined by performance in three functional tests: a five-repetition-sit-to-stand-test, a 6 minute walk test and a 14 step stair test.
Muscle strength determined by dynamometry
Self-assessed improvements in muscle function
Self-assessed improvements in incidence of problems that are related to inactivity (in patients who are confined to a wheel-chair)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01895283
Brief Title
The Effect of Aerobic Exercise, on Fitness and Functional Muscle Strength, in Patients With Muscular Dystrophy
Official Title
The Effect of a Bike Ergometer Training Program in Patients With Bethlem Myopathy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Muscular dystrophy is a group of disorders that are characterized by progressive muscle weakening and loss of muscle mass, caused by defects in muscle proteins. Muscular dystrophy is almost always inherited disorders, and so far, no curative treatments exist.
Previous studies have shown that endurance training significantly improves fitness and self-assessed muscle function in a variety of muscular dystrophies. In this study, we wish to investigate whether patients with Bethlem myopathy (a specific form of muscular dystrophy) also benefit from endurance training.
The study consists of two test days, a 10-week training period and five blood tests.
Patients will be required to train, three times per week, for 10 weeks, on a bike ergometer with a specific training intensity, under pulse rate monitoring.
The training period will be flanked by two test days, where we will determine, and compare the patients' muscle strength and fitness level, from before to after the training program. The patients conditioning level will be determined from a 15 minute cycle ergometer test and patients will undergo three functional tests to determine their functional muscle strength.
We will as a safety measure analyze blood tests before, during and after the training program for the muscle enzyme creatine kinase (an indicator of muscle damage) and through adverse effects as reported by patients during weekly telephone-consultations with the Principal investigator.
We anticipate, that Bethlem myopathy patients will have a similar rise in fitness level and functional muscle strength, as that seen in patients with other forms of muscular dystrophy, who undertake a similar training program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bethlem Myopathy
Keywords
Aerobic training, VO2max, Bethlem myopathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Moderate-intensity training
Arm Type
Experimental
Arm Description
Regular supervised moderate-intensity training on a bike ergometer, three times per week, for 30 minutes a total of 10 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Moderate-intensity training
Intervention Description
Training at 70% of VO2max, for 1/2 hour, three times weekly, for 10 weeks, on a bike ergometer.
Primary Outcome Measure Information:
Title
Maximal oxygen uptake (VO2max)
Description
VO2max will be determined during an incremental bike test to exhaustion. VO2max is a physiological measure of physical fitness. VO2max relies on a persons ability to supply and consume oxygen ("energy") in muscle tissue.
Time Frame
after 10 week bike ergometer training program
Secondary Outcome Measure Information:
Title
Functional muscle strength
Description
Functional muscle strength will be determined by performance in three functional tests: a five-repetition-sit-to-stand-test, a 6 minute walk test and a 14 step stair test.
Time Frame
After completion of a 10 week training program
Title
Muscle strength determined by dynamometry
Time Frame
After completion of a 10 week training program
Title
Self-assessed improvements in muscle function
Time Frame
After completion of a 10 week training program
Title
Self-assessed improvements in incidence of problems that are related to inactivity (in patients who are confined to a wheel-chair)
Time Frame
After a 10 week training program
Other Pre-specified Outcome Measures:
Title
Safety
Description
The safety of undertaking a 10-week training program will be determined by analyzing reports of adverse effects faced during the training program, and by interpretation of Creatine Kinase levels measured before, during and after the training program.
Time Frame
During a 10 week training program
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with Bethlem myopathy
Exclusion Criteria:
Patients with disorders that would confound the interpretation of the effect from training (cardiomyopathy, pregnant women, etc.)
Patients who are deemed mentally unfit for cooperation with the training program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoffer R Vissing, BsC
Organizational Affiliation
Rigshospitalet, Neuromuscular Research Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet, Neuromuscular Research Unit, section 3342
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
The Effect of Aerobic Exercise, on Fitness and Functional Muscle Strength, in Patients With Muscular Dystrophy
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