Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00457314
Status:
UNKNOWN
Last Update Posted:
2009-05-19
First Post:
2007-04-05
Brief Title:
The Effects of Exercise Versus Inactivity on People With Mitochondrial Muscle Disease
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Study Overview
Official Title:
Exercise Training and Deconditions Implications for Therapy in Mitochondrial Myopathy
Status:
UNKNOWN
Status Verified Date:
2009-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Mitochondrial myopathies include various inherited diseases that are caused by damage to the mitochondria energy-producing structures that fuel the bodys 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01AR050597-01A1 | NIH | None | httpsreporternihgovquickSearch1R01AR050597-01A1 |