CoQ10 and Exercise for Mitochondrial Dysfunction in Advance Kidney Disease

Part of paid clinical trials in Sacramento, California.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT05422534
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • End Stage Renal Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • CoQ10 — DIETARY_SUPPLEMENT
    Participants will receive 1800 mg/day for 12 weeks
  • Placebo — DRUG
    Participants will receive placebo or CoQ10/day for 12 weeks
  • HB-HIIT — BEHAVIORAL
    Participants will be performed on non dialysis days. It will be video supervised exercise sessions with self directed exercises using pre-recorded bodyweight and strength exercise videos.
  • Observational — BEHAVIORAL
    Participant regular activities

Study Details

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.

Key Dates

Start date
Jun 1, 2023
Status verified
Dec 2025
Primary completion
Jun 20, 2027
Completion
Oct 1, 2027

Study Design

Enrollment
156 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION

Arms

  • Placebo Comparator: Observational + placebo
    Participants will receive placebo with standard of care or regular activity for 12 weeks.
  • Active Comparator: Observational+ CoQ10
    Participants will receive CoQ10 1800 mg/day with standard of care or regular activity for 12 weeks.
  • Placebo Comparator: HB HIIT +placebo
    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).
  • Active Comparator: HB HIIT + CoQ10
    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).

Primary Outcome Measure

PCr recovery measured by 31 phosphorus magnetic resonance spectroscopy [ Time Frame: 12 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California Davis HealthSacramentoCalifornia95817
Geraldine Portillo
[email protected]
Vanderbilt University Medical Center-GCRCNashvilleTennessee37232
Delia Woods, RN
[email protected]

Find similar trials in Sacramento, CA

By research site
University of California Davis Health· Sacramento, CAVanderbilt University Medical Center-GCRC· Nashville, TN

Related Studies