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

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ClinicalTrials.gov Identifier: NCT00457314
Recruitment Status : Unknown
Verified May 2009 by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
Recruitment status was:  Recruiting
First Posted : April 6, 2007
Last Update Posted : May 19, 2009
Sponsor:
Information provided by:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Tracking Information
First Submitted Date  ICMJE April 5, 2007
First Posted Date  ICMJE April 6, 2007
Last Update Posted Date May 19, 2009
Study Start Date  ICMJE June 2007
Estimated Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2007)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 5, 2007)
  • Changes in wild-type (normal), mutant, and total mitochondrial DNA copy number measured at Week 26
  • physiological measure of oxidative metabolism measured at Week 26
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Exercise Versus Inactivity on People With Mitochondrial Muscle Disease
Official Title  ICMJE Exercise Training and Deconditions: Implications for Therapy in Mitochondrial Myopathy
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mitochondrial Myopathy
Intervention  ICMJE Behavioral: Exercise
Regular exercise training
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Exercise
  • 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.
    Intervention: Behavioral: Exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 5, 2007)
50
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2012
Estimated Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00457314
Other Study ID Numbers  ICMJE R01AR050597( U.S. NIH Grant/Contract )
1R01AR050597-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ronald Haller, Universit y of Texas Southwestern Medical School
Study Sponsor  ICMJE National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ronald Haller, MD University of Texas Southwestern Medical Center
PRS Account National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Verification Date May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP