One-leg exercise training to improve muscle energy and function in adults with mitochondrial myopathy
Official title: Deciphering Muscle-Nerve Communication Via Mitochondrial Myopathy Insights: Exploring the Effects of Exercise Training
Run by University of Copenhagen · NCT07450690 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 22 (estimated) |
| Sponsor | University of Copenhagen Academic / other |
| Locations | 1 site (Copenhagen) |
| Status | Recruiting |
| Started | January 9, 2026 |
| Main results expected | October 30, 2026 |
| Study ends | October 30, 2030 |
| Registry record updated | March 5, 2026 |
| Trial ID | NCT07450690 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.