CoQ10 and Exercise for Mitochondrial Dysfunction in Advance Kidney Disease
End Stage Renal Disease
About this trial
This is an interventional prevention trial for End Stage Renal Disease focused on measuring mitochondrial dysfunction, CoQ10, sarcopenia, frailty, High-intensity interval training (HIIT), exercise, magnetic resonance spectroscopy (P-MRS), physical performance tests
Eligibility 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.
Sites / Locations
- University of California Davis Health
- Vanderbilt University Medical Center-GCRCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Active Comparator
Placebo Comparator
Active Comparator
Observational + placebo
Observational+ CoQ10
HB HIIT +placebo
HB HIIT + CoQ10
Participants will receive placebo with standard of care or regular activity for 12 weeks.
Participants will receive CoQ10 1800 mg/day with standard of care or regular activity for 12 weeks.
Participants will receive placebo and home based high intensity interval training for 12 weeks. Exercise will be performed on a non-dialysis day, it will be video-supervised exercise sessions, three days per week for 12 weeks. The three weekly sessions will include: 1 session of 1) body weight high-intensity interval training (bodyweight HIIT), 2) strength training, and 3) walking high-intensity interval training (walking HIIT).
Participants will received CoQ10 1800/day with home based high intensity interval training for 12 weeks. Exercise will be performed on a non-dialysis day, it will be video-supervised exercise sessions, three days per week for 12 weeks The three weekly sessions will include: 1 session of 1) body weight high-intensity interval training (bodyweight HIIT), 2) strength training, and 3) walking high-intensity interval training (walking HIIT).