Actively Recruiting
CoQ10 and Exercise for Mitochondrial Dysfunction in Advance Kidney Disease
Led by Vanderbilt University Medical Center · Updated on 2026-01-02
156
Participants Needed
2
Research Sites
226 weeks
Total Duration
On this page
Sponsors
V
Vanderbilt University Medical Center
Lead Sponsor
U
University of California, Davis
Collaborating Sponsor
AI-Summary
What this Trial Is About
Frailty and sarcopenia are modifiable risk factors for morbidity and mortality in patients with ESRD. Exercise is the recommended intervention to prevent frailty and sarcopenia, however, many clinical trials have shown limited clinical improvement in muscle mass and physical function. We propose that mitochondrial dysfunction is one of the deterrents to the effectiveness of the exercise. We plan to evaluate the additive effect of HIIT and CoQ10, a mitochondrial-targeted therapy, on mitochondrial function and physical performance. Understanding the interplay among CoQ10, exercise, and mitochondrial function will identify novel mechanisms to improve the efficiency of exercise. This will also serve to prevent frailty, sarcopenia, and muscle dysfunction in patients with ESRD.
CONDITIONS
Official Title
CoQ10 and Exercise for Mitochondrial Dysfunction in Advance Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- On thrice-weekly chronic hemodialysis for at least 6 months
- Clinically stable and adequately dialyzed (single-pool Kt/V >1.2) for at least 3 consecutive months prior to the study
You will not qualify if you...
- Body mass index greater than 35 mg/kg2
- 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)
- Acute myocardial infarction or cerebrovascular event within 3 months
- Uncontrolled blood pressure
- New or worsening mitral regurgitation murmur
- Hypotension, bradycardia, or tachycardia
- Prolonged ongoing angina at rest (>20 minutes)
- Angina at rest with transient ST changes >0.05 mV on ECG
- Sustained ventricular tachycardia on ECG
- Elevated cardiac enzymes (e.g., troponin T or I >0.1 mg/ml)
- Advanced liver disease (Child-Turcotte-Pugh score ≥10)
- Gastrointestinal dysfunction requiring parenteral 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
- Anticipated live donor kidney transplant
- History of poor adherence to hemodialysis or medical regimen
- Inability to provide consent
- Cardiac pacemaker, artificial heart valve, metallic implant, permanent tattoo, or retained metallic foreign bodies
- Inability to perform exercise
- Contraindications for exercise such as electrolyte abnormalities, uncontrolled arrhythmias, or pulmonary congestion
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University of California Davis Health
Sacramento, California, United States, 95817
Not Yet Recruiting
2
Vanderbilt University Medical Center-GCRC
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
D
Delia M Woods, BSN/MSL
CONTACT
P
Patricia Wright, BSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
PREVENTION
Number of Arms
4
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