Exercise Program for Chronic Kidney Disease
(ESTEEM-VIDA Trial)

Recruiting in Palo Alto (17 mi)

Overseen byBaback Roshanravan, MD MS MSPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of California, Davis

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?Skeletal muscle dysfunction (sarcopenia) is an under-recognized target organ complication of CKD with substantial adverse clinical consequences of disability, hospitalization, and death. Sarcopenia in this proposal is defined by impaired metabolism and physical function associated with decreased skeletal muscle mass or function. Skeletal muscle tissue relies on mitochondria to efficiently utilize oxygen to generate ATP. Impaired mitochondrial energetics is a central mechanism of sarcopenia in CKD. The investigators propose a series of studies designed to shed light on the pathophysiology of sarcopenia in persons with CKD not treated with dialysis. Investigators will conduct a randomized-controlled intervention trial of combined resistance training and aerobic exercise vs. health education to assess changes in skeletal muscle mitochondrial function, metabolism and physical function. Investigators hypothesize that exercise improves mitochondrial function and physical function in persons with CKD. If successful, these experiments will identify novel pathophysiologic mechanisms for CKD-associated sarcopenia. The proposed study will provide useful insight into benefits associated with exercise among patients with CKD and investigate mechanisms associated with improved metabolism, muscle function and physical function in population.

Eligibility Criteria

This trial is for adults aged 30-75 with moderate to severe chronic kidney disease (CKD) who are not on dialysis and lead a sedentary lifestyle. They must have an eGFR <60ml/min per 1.73m2, not be taking certain medications that affect mitochondria or blood clotting, and cannot have serious heart conditions or other health issues that would make exercise unsafe.

Inclusion Criteria

My kidney function is reduced, with an eGFR under 60.

I have never been on long-term dialysis.

I am between 30 and 75 years old.

+2 more

Exclusion Criteria

Currently using drugs or alcohol excessively.

I am on long-term dialysis.

I am not taking high doses of Vitamin C or E.

+31 more

Participant Groups

The study tests whether combined resistance training and aerobic exercise via videoconferencing can improve mitochondrial function and physical performance in CKD patients compared to those receiving only health education. It aims to understand how exercise affects muscle metabolism in CKD without dialysis.

2Treatment groups

Experimental Treatment

Active Control

Group I: Combined Aerobic and Resistance ExerciseExperimental Treatment1 Intervention

Exercise will be supervised by exercise trainers 3 days per week for 12 weeks via videoconferencing. Each session will start at 30 minutes in duration and include either high-intensity interval targeting a relative perceived exertion (RPE) of greater than 14 (on a scale of 6-20) or strength training (RPE 12-14) or power walking (RPE 12-14). Each 1 week of supervised sessions will alternate with 1 week of self-directed sessions with mid-week trainer check-in.

Group II: Usual CareActive Control1 Intervention

The control group will receive a one-time counseling session on appropriate dietary and physical activity recommendations. They will receive a "Go4Life Workout to go" sample exercise routing created by the national institutes on aging (NIA).