Recruiting
Phase 2

Exercise vs. Inactivity

Sponsor:

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Code:

NCT00457314

Conditions

Mitochondrial Myopathy

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Exercise

Study Details

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.

Conditions

Mitochondrial Myopathy

Study ID

NCT00457314

Start date

Jun, 2007

Status verified date

May, 2009

Completion date

Jun, 2012

Anticipated

Primary completion date

Jun, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Exercise

Regular exercise training

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Ronald Haller, MD

214-345-4621rhaller2@earthlink.net

Marta Newny

214-345-4655martanewby@texshealth.org

Locations

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75321

Principal Investigator:

Ronald Haller, MD

More Information

Sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Last update posted

May 19, 2009

Last verified

May, 2009

Keywords

  • single-large scale deletions
  • point mutations in mtDNA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) on 2009-05-19.