- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00457314
The Effects of Exercise Versus Inactivity on People With Mitochondrial Muscle Disease
Exercise Training and Deconditions: Implications for Therapy in Mitochondrial Myopathy
Study Overview
Detailed Description
Mitochondrial myopathies are caused by mutant mitochondrial DNA, genetic defects in parts of the mitochondrial DNA. These defects can include missing or deleted DNA that typically codes for certain proteins involved in energy production. These mutations cause individual mitochondria and the body on a whole to produce energy less efficiently. Because muscle cells require extensive energy to function properly, they are particularly impaired by mitochondrial dysfunction. The onset of most mitochondrial myopathies occurs before the age of 20. Initially a person may experience muscle weakness and fatigue during physical activity. Other symptoms may include limited eye mobility, heart arrhythmias, slurred speech, swallowing difficulties, and impaired movement.
There is no cure yet for mitochondrial myopathies, nor is there any adequate treatment to stall disease progression. Exercise, known to boost the production and function of mitochondria in healthy people, may reduce symptoms in people with mitochondrial myopathies by increasing the number and function of normal mitochondria in an individual muscle cell. The purpose of this study is to determine the effects of exercise training versus inactivity on the expression of normal and mutant mitochondrial DNA and on mitochondrial production within muscle cells in people with mitochondrial myopathies. The study will also assess how cell function, physical endurance, heart function, and quality of life are affected by exercise training and inactivity.
Participants in this 2-year study will first undergo physiological exercise testing, magnetic resonance imaging (MRI) of heart and skeletal muscles, a needle biopsy of muscle, and a questionnaire on quality of life. Participants will then be randomly assigned to partake in regular exercise training or no training for 6 months. After 6 months, all participants will undergo repeat testing of initial evaluations. Participants who had been in the exercising group will then switch to no exercise training for 6 months, and participants who had been in the non-exercising group will switch to regular exercise training for 6 months. The second 6-month period will also be followed by repeat testing of initial evaluations. Participants will then be encouraged to continue exercise training for an additional 1 year, with retesting at the end of the second year. Each of the four evaluations will take about 15 hours over 5 days.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Ronald Haller, MD
- Phone Number: 214-345-4621
- Email: rhaller2@earthlink.net
Study Contact Backup
- Name: Marta Newny
- Phone Number: 214-345-4655
- Email: martanewby@texshealth.org
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75321
- Recruiting
- University of Texas Southwestern Medical Center
-
Principal Investigator:
- Ronald Haller, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of mitochondrial myopathy
- Single-large scale deletions of mitochondrial DNA
- Point mutations in mitochondrial DNA
Exclusion Criteria:
- Symptoms or electrocardiogram-generated signs of coronary artery disease
- Symptoms of congestive heart failure; peripheral vascular disease; or lung, kidney, or liver disease
- History of alcohol or substance abuse
- Metal implants or related devices that contraindicate MRI
- Current use of or require any medications that have significant systemic cardiovascular effects
- Diabetes
- Obesity (body mass index [BMI] greater than 30)
- Resting systolic blood pressure greater than 140 mmHg and/or diastolic blood pressure greater than 90 mmHg at three different times
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Participants will partake in regular exercise training for 6 months.
After 6 months, they will switch to no exercise training for 6 months.
Participants will then be encouraged to continue exercise training for an additional 1 year.
|
Regular exercise training
|
Experimental: 2
Participants will not partake in regular exercise training for 6 months.
After 6 months, they will switch to exercise training for 6 months.
Participants will then be encouraged to continue exercise training for an additional 1 year.
|
Regular exercise training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in wild-type (normal), mutant, and total mitochondrial DNA copy number
Time Frame: Measured at Week 26
|
Measured at Week 26
|
Physiological measure of oxidative metabolism
Time Frame: Measured at Week 26
|
Measured at Week 26
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ronald Haller, MD, University of Texas Southwestern Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01AR050597 (U.S. NIH Grant/Contract)
- 1R01AR050597-01A1 (U.S. NIH Grant/Contract)
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.
Clinical Trials on Mitochondrial Myopathy
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Reneo Pharma LtdTerminatedPrimary Mitochondrial MyopathySpain, Australia, Belgium, Denmark, Canada, United Kingdom, France, Germany, Hungary, Italy, Netherlands, New Zealand
-
The Emmes Company, LLCUnited Mitochondrial Disease Foundation; PolG Foundation Mito AustraliaRecruitingPolG, Primary Mitochondrial MyopathyUnited States
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Reneo Pharma LtdCompletedPrimary Mitochondrial MyopathyUnited States, Spain, Australia, France, United Kingdom, New Zealand, Denmark, Norway, Czechia, Belgium, Canada, Germany, Hungary, Italy, Netherlands
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Stealth BioTherapeutics Inc.TerminatedPrimary Mitochondrial MyopathyUnited States, Germany, Canada, Italy, United Kingdom, Denmark, Hungary
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Reneo Pharma LtdTerminatedPrimary Mitochondrial MyopathyUnited Kingdom
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Astellas Pharma IncActive, not recruitingPrimary Mitochondrial MyopathyUnited States
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Stealth BioTherapeutics Inc.CompletedMitochondrial MyopathyUnited States
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