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The Effects of Exercise Versus Inactivity on People With Mitochondrial Muscle Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00457314
First Posted: April 6, 2007
Last Update Posted: May 19, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  Purpose
Mitochondrial myopathies include various inherited diseases that are caused by damage to the mitochondria, energy-producing structures that fuel the body's processes. The main symptoms are muscle weakness, reduced muscle mass, and difficulty with exercising. The purpose of this study is to determine the effects of exercise training versus inactivity on mitochondrial function in muscle and muscle performance in people with mitochondrial myopathies.

Condition Intervention Phase
Mitochondrial Myopathy Behavioral: Exercise Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exercise Training and Deconditions: Implications for Therapy in Mitochondrial Myopathy

Resource links provided by NLM:


Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:
  • Changes in wild-type (normal), mutant, and total mitochondrial DNA copy number [ Time Frame: Measured at Week 26 ]
  • Physiological measure of oxidative metabolism [ Time Frame: Measured at Week 26 ]

Estimated Enrollment: 50
Study Start Date: June 2007
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Exercise
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.
Behavioral: Exercise
Regular exercise training

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT00457314


Contacts
Contact: Ronald Haller, MD 214-345-4621 rhaller2@earthlink.net
Contact: Marta Newny 214-345-4655 martanewby@texshealth.org

Locations
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75321
Principal Investigator: Ronald Haller, MD         
Sponsors and Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Ronald Haller, MD University of Texas Southwestern Medical Center
  More Information

Responsible Party: Ronald Haller, Universit y of Texas Southwestern Medical School
ClinicalTrials.gov Identifier: NCT00457314     History of Changes
Other Study ID Numbers: R01AR050597 ( U.S. NIH Grant/Contract )
1R01AR050597-01A1 ( U.S. NIH Grant/Contract )
First Submitted: April 5, 2007
First Posted: April 6, 2007
Last Update Posted: May 19, 2009
Last Verified: May 2009

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
single-large scale deletions
point mutations in mtDNA

Additional relevant MeSH terms:
Muscular Diseases
Mitochondrial Myopathies
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Mitochondrial Diseases
Metabolic Diseases


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