One-leg exercise training to improve muscle energy and function in adults with mitochondrial myopathy
Deciphering Muscle-Nerve Communication Via Mitochondrial Myopathy Insights: Exploring the Effects of Exercise Training
This project tests whether a short program of one-leg high-intensity interval exercise changes muscle energy production and molecular signals in adults with mitochondrial myopathy compared with healthy adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Copenhagen Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT07450690 on ClinicalTrials.gov |
What this trial studies
The study uses a 3-4 week supervised unilateral high-intensity interval training program (10 sessions) with the trained leg randomized and the opposite leg serving as an internal untrained control. Participants complete comprehensive baseline testing of strength, aerobic capacity, body composition, and physical activity before the intervention. Muscle biopsies are taken from both legs after the training period to measure mitochondrial respiratory function, energy pathways, stress responses, and markers of muscle-nerve communication. Comparing trained versus untrained muscle within individuals and between patients and matched healthy controls will clarify molecular adaptations to exercise in mitochondrial myopathy.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18 years) with genetically confirmed mtDNA or nuclear gene mutations causing mitochondrial myopathy who are medically stable and able to perform supervised one-leg high-intensity exercise and undergo muscle biopsies.
Not a fit: Patients who are medically unfit for high-intensity exercise, pregnant, taking medications that interfere with outcome measures, unable to tolerate muscle biopsy, or otherwise unlikely to complete the protocol are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could guide safer, evidence-based exercise programs that improve muscle energy production and function for people with mitochondrial myopathy.
How similar studies have performed: Prior exercise trials in mitochondrial myopathy have shown improvements in mitochondrial oxidative capacity and function, but this protocol is novel in using unilateral training and deep molecular profiling to define mechanisms.
Eligibility criteria
Show full inclusion / exclusion criteria
Eligibility criteria for Mitochondrial Myopathy-group: Inclusion Criteria * Known mtDNA or nuclear (nDNA) mutations * Age above or equal to 18 years Exclusion Criteria: * Medical conditions which deem the MM patient unfit to complete the study * Current use of medications known to interact with outcome measures. (see below) * Pregnancy * The participant is for any other reason unlikely to complete the study Inclusion Criteria for healthy controls * Age above or equal to 18 years Exclusion Criteria: * Chronic medical conditions suspected to influence outcome measures * Frequent use of medicine * Pregnancy * The participant is for any other reason unlikely to complete the study
Where this trial is running
Copenhagen
- University of Copenhagen, Dept of Biomedical Sciences — Copenhagen, Denmark (Recruiting)
Study contacts
- Study coordinator: Tue L Nielsen, MD
- Email: tue.leth.nielsen.01@regionh.dk
- Phone: +45 3545 8748
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.