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

Phase 2

Waitlist Available

Led By Baback Roshanravan, MD MS MSPH

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderate-severe CKD determined by estimated glomerular filtration rate (eGFR) <60ml/min per 1.73m2

No history chronic treatment with dialysis

Must not have

On chronic dialysis

High dose antioxidants (Vitamine C, Vitamin E)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how well a combined resistance training and aerobic exercise program works compared to a health education program in improving physical function in people with kidney dysfunction.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the intervention primarily involves physical activity which typically has benefits like improved fitness, potential side effects may include typical exercise-related injuries or discomfort such as muscle strains, joint pain, or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have never been on long-term dialysis.

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I am between 30 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on long-term dialysis.

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

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My diabetes is not under control, with HgbA1c over 8.5.

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I am not currently pregnant.

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I am taking blood thinners.

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I do not speak English.

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I am not taking medication that affects my cell's energy factories.

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I am not living in an institution.

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I use a wheelchair or have a disability that stops me from exercising.

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I need oxygen therapy for my COPD.

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I get short of breath walking less than 100 steps on flat ground.

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I have HIV or hepatitis.

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My liver is severely damaged and cannot function properly.

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I regularly take medication to suppress my immune system.

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I have a history of clotting or bleeding disorders.

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I have a history of severe heart disease, including CABG surgery or atrial fibrillation.

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My thyroid condition is currently not under control.

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I have an active cancer that is not a non-melanoma skin cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Indium

Quadriceps muscle work efficiency

Secondary study objectives

Change in Systemic oxidative stress (markers of arachidonic acid peroxidation)

Change in physical performance

Connor-Davidson Resilience Scale 25 (CD-RISC-25)

+15 more

Other study objectives

Walking economy during 6 minute walk

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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).

0 / 21Eligibility criteria met