Role of Mitochondrial Dysfunction in the Response to Exercise in Patients with Advance Kidney Disease

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral, Drug, Dietary supplement
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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)

Locations
United States
California
University of California Davis Health
NOT_YET_RECRUITING
Sacramento
Tennessee
Vanderbilt University Medical Center-GCRC
RECRUITING
Nashville
Contact Information
Primary
Delia M Woods, BSN/MSL
delia.woods@vumc.org
615-322-1749
Backup
Patricia Wright, BSN
patricia.wright@vumc.org
615-322-8837
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2027-10-01
Participants
Target number of participants: 156
Treatments
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).
Related Therapeutic Areas
Sponsors
Leads: Vanderbilt University Medical Center
Collaborators: University of California, Davis

This content was sourced from clinicaltrials.gov