The Effects of Exercise Versus Inactivity on People With Mitochondrial Muscle Disease
Exercise Training and Deconditions: Implications for Therapy in Mitochondrial Myopathy
2 other identifiers
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2007
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2007
CompletedFirst Posted
Study publicly available on registry
April 6, 2007
CompletedStudy Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedMay 19, 2009
May 1, 2009
5 years
April 5, 2007
May 18, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
1
EXPERIMENTALParticipants 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.
2
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of mitochondrial myopathy
- Single-large scale deletions of mitochondrial DNA
- Point mutations in mitochondrial DNA
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas Southwestern Medical Center
Dallas, Texas, 75321, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald Haller, MD
University of Texas Southwestern Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- NIH
Study Record Dates
First Submitted
April 5, 2007
First Posted
April 6, 2007
Study Start
June 1, 2007
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
May 19, 2009
Record last verified: 2009-05