Using CoQ10 and exercise to improve muscle function in kidney disease patients
Role of Mitochondrial Dysfunction in the Response to Exercise in Patients With Advance Kidney Disease
This study is testing whether taking CoQ10 along with high-intensity exercise can help improve muscle strength and overall physical performance in patients with kidney disease who are on dialysis.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 156 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 2 sites (Sacramento, California and 1 other locations) |
| Trial ID | NCT05422534 on ClinicalTrials.gov |
What this trial studies
This study investigates the combined effects of CoQ10, a mitochondrial-targeted therapy, and high-intensity interval training (HIIT) on improving mitochondrial function and physical performance in patients with end-stage renal disease (ESRD) undergoing maintenance hemodialysis. It aims to address frailty and sarcopenia, which are common and serious conditions in this population. By understanding how CoQ10 and exercise interact, the study seeks to enhance the effectiveness of exercise interventions and ultimately improve patient outcomes. The trial will include a comparison between CoQ10, placebo, and HIIT interventions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 years who have been on maintenance hemodialysis for at least six months.
Not a fit: Patients with a body mass index over 35 or those with certain acute or chronic health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance muscle function and overall physical health in patients with end-stage renal disease.
How similar studies have performed: While there have been studies on exercise in ESRD patients, the specific combination of CoQ10 and HIIT is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects age 18 to 75 years * On thrice-weekly chronic hemodialysis for at least 6 months (only applicable for patients with ESRD on maintenance hemodialysis). * Clinically stable, adequately dialyzed (single-pool Kt/V \>1.2) thrice weekly, for at least 3 consecutive months prior to the study (only applicable for patients with ESRD on maintenance hemodialysis) Exclusion Criteria: * Body mass index \> 35 mg/kg2 * History of functional transplant less than 6 months prior to study * Use of immunosuppressive drugs within 1 month prior to study * Active connective tissue disease * Acute infectious disease within 1 month prior to study * AIDS (HIV seropositivity is not an exclusion criterion) * Acute myocardial infarction or cerebrovascular event within 3 months * Uncontrolled blood pressure * New or worsening mitral regurgitation murmur * Hypotension, bradycardia, or tachycardia * Prolonged ongoing (greater than 20 minutes) angina at rest * Angina at rest with transient ST changes greater than 0.05 mV on ECG * Sustained ventricular tachycardia on ECG * Elevated cardiac enzymes (e.g., troponin Tor I greater than 0.1mg/ml) * Advanced liver disease, with a modified Child-Turcotte-Pugh score equal or greater than 10. * Gastrointestinal dysfunction requiring parental nutrition * Active malignancy excluding basal cell carcinoma of the skin * Ejection fraction less than 30% * Pre-dialysis potassium repeatedly higher than 5.5 mmol/L (confirmed on a repeated blood draw) * Anticipated live donor kidney transplant * History of poor adherence to hemodialysis or medical regimen * Inability to provide consent * Subjects with cardiac pacemaker, artificial heart valve, any metallic implant, permanent tattoo, or any retained foreign metallic bodies. * Inability to perform exercise * Contraindication for exercise such as electrolyte abnormalities, uncontrolled arrhythmias, or pulmonary congestion.
Where this trial is running
Sacramento, California and 1 other locations
- University of California Davis Health — Sacramento, California, United States (Not_yet_recruiting)
- Vanderbilt University Medical Center-GCRC — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Jorge Gamboa, MD/PhD — Vumc
- Study coordinator: Delia M Woods, BSN/MSL
- Email: delia.woods@vumc.org
- Phone: 615-322-1749
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.