Exercise Program for Chronic Kidney Disease

(ESTEEM-VIDA Trial)

Overseen By Baback Roshanravan, MD MS MSPH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, Davis

Must not be taking: Muscle relaxants, Antipsychotics, Anticoagulants, Antiplatelets

Disqualifiers: Transplantation, Pregnancy, COPD, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

32 Participants Needed

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications that affect mitochondrial function, such as muscle relaxants, oral steroids, some antiviral medications, oral calcineurin inhibitors, antiepileptic drugs, antipsychotics, anticoagulants, and antiplatelets. If you are on any of these, you may need to stop them to participate.

What data supports the effectiveness of the treatment Combined Aerobic and Resistance Exercise via videoconferencing for Chronic Kidney Disease?

Research shows that exercise programs, including combined aerobic and resistance exercises, can improve physical function and quality of life in patients with chronic kidney disease. Studies have found that such exercise can enhance aerobic capacity and muscle strength, which are important for overall health and well-being. ^{1 2 3 4 5}

Is the exercise program safe for people with chronic kidney disease?

Research suggests that exercise programs, including online home-based training, are generally safe for people with chronic kidney disease, as they have shown positive effects without side effects in studies. ^{1 5 6 7 8}

How does the treatment of combined aerobic and resistance exercise via videoconferencing differ from other treatments for chronic kidney disease?

This treatment is unique because it combines aerobic (heart and lung fitness) and resistance (muscle strength) exercises that can be done at home through videoconferencing, making it more accessible and convenient for patients with chronic kidney disease compared to traditional in-person exercise programs. ^{2 4 9 10 11}

Research Team

Baback Roshanravan, MD MS MSPH

Principal Investigator

UC Davis

Javier Lopez, MD

Principal Investigator

UC Davis Department of Medicine/Division of Cardiology

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo combined resistance and aerobic exercise supervised by trainers 3 days per week for 12 weeks via videoconferencing, alternating with self-directed sessions.

12 weeks

3 visits per week (virtual)

Follow-up

Participants are monitored for changes in skeletal muscle mitochondrial function, metabolism, and physical function.

4 weeks

Treatment Details

Interventions

• Combined Aerobic and Resistance Exercise via videoconferencing

Trial Overview 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.

Participant Groups

Group I: Combined Aerobic and Resistance Exercise Experimental Treatment 1 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 Care Active Control 1 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).

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Findings from Research

This nonrandomized trial aims to improve the physical function and quality of life in patients with end-stage kidney disease (ESKD) through various low-intensity exercise programs, highlighting the importance of patient choice in their exercise regimen.

The study will assess the feasibility, safety, and adherence to these exercise interventions over three months, with outcomes including aerobic capacity, quality of life, and long-term clinical results, providing valuable insights into effective strategies for increasing physical activity in ESKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Personalized Patient-Centered Intervention to Empower through Physical Activity the Patient in the Dialysis Center: Study Protocol for a Pragmatic Nonrandomized Clinical Trial. Manfredini, F., Lamberti, N., Battaglia, Y., et al.[2021]

A 12-week home-based exercise program significantly improved functional capacity in patients with chronic kidney disease (CKD) stage 5, as evidenced by better scores in physical performance tests like the short physical performance battery and the 6-minute walking test.

The program was well-received, with 70% of participants expressing high satisfaction and 64% feeling stronger after completing the exercises, indicating that it is a safe and effective intervention for enhancing quality of life in CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A nurse-led home-based exercise program for patients with chronic kidney disease. Junqué-Jiménez, A., Esteve-Simó, V., Andreu-Periz, L., et al.[2023]

A 12-week renal rehabilitation program for chronic kidney disease (CKD) patients led to significant improvements in exercise capacity (21-44%) and reductions in anxiety (15%) and depression (29%) among those who completed the program.

The study highlighted that self-reported fitness levels were linked to program completion, with pre-dialysis and post-transplant patients showing better adherence compared to those requiring haemodialysis, who had the highest dropout rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a pragmatic exercise rehabilitation programme in chronic kidney disease. Greenwood, SA., Lindup, H., Taylor, K., et al.[2022]

Aerobic or mixed exercise training significantly improves aerobic capacity in hemodialysis patients, while resistance training is more effective for increasing muscle strength, highlighting the importance of tailored exercise programs.

All types of exercise training enhance the quality of life for hemodialysis patients, but there is a need for standardized protocols and individualized goals to ensure safety and maximize adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise in patients on chronic hemodialysis: current evidence, knowledge gaps and future perspectives. Regolisti, G., Sabatino, A., Fiaccadori, E.[2021]

A 12-month supervised exercise program for older adults with advanced chronic kidney disease (CKD) was found to be safe and well-tolerated, with no significant increase in adverse events reported.

Participants in the exercise group showed significant improvements in physical functioning, including a greater distance walked in the 6-minute walk test and better performance on the Timed Up and Go Test, indicating that exercise can enhance physical capabilities in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Long-term Exercise Training on Physical Performance and Cardiorespiratory Function in Adults With CKD: A Randomized Controlled Trial. Weiner, DE., Liu, CK., Miao, S., et al.[2023]

A 6-month home-based exercise program significantly improved physical functioning in patients with Stage 4 chronic kidney disease (CKD), as evidenced by a greater increase in the incremental shuttle walking test compared to a control group.

The exercise program also enhanced health-related quality of life (HRQOL) in several domains, including work status and social interaction, while showing potential benefits on kidney function and related biomarkers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based aerobic exercise and resistance training for severe chronic kidney disease: a randomized controlled trial. Uchiyama, K., Adachi, K., Muraoka, K., et al.[2022]

A specially designed exercise program during hemodialysis, including low-intensity endurance training and strength exercises, has shown comparable benefits to traditional outpatient exercise programs for patients with end-stage renal failure, improving functional capacity and overall health.

This approach has been successfully implemented in about 200 German dialysis centers since 1995, with a high participation rate among patients, including the elderly and those with severe health issues, and no serious adverse effects reported, thanks to supervision by trained physiotherapists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise during hemodialysis. Daul, AE., Schäfers, RF., Daul, K., et al.[2005]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

A Personalized Patient-Centered Intervention to Empower through Physical Activity the Patient in the Dialysis Center: Study Protocol for a Pragmatic Nonrandomized Clinical Trial. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

A nurse-led home-based exercise program for patients with chronic kidney disease. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Evaluation of a pragmatic exercise rehabilitation programme in chronic kidney disease. [2022]

4. Spain pubmed.ncbi.nlm.nih.gov

[Exercise in haemodyalisis patients: a literature systematic review]. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Exercise in patients on chronic hemodialysis: current evidence, knowledge gaps and future perspectives. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Effect of Long-term Exercise Training on Physical Performance and Cardiorespiratory Function in Adults With CKD: A Randomized Controlled Trial. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Online Home-Based Training on Functional Capacity and Strength in Two CKD Patients: A Case Study. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Positive association of vigorous and moderate physical activity volumes with skeletal muscle mass but not bone density or metabolism markers in hemodialysis patients. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Home-based aerobic exercise and resistance training for severe chronic kidney disease: a randomized controlled trial. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Exercise during hemodialysis. [2005]

11. Hungary pubmed.ncbi.nlm.nih.gov

[Rehabilitative training program for end-stage renal disease patients]. [2017]