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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a combined exercise program, including aerobic and resistance exercises, can improve muscle function in individuals with chronic kidney disease (CKD) who are not on dialysis. The researchers aim to determine if these exercises can enhance energy use in muscles and improve overall physical activity levels, potentially reducing risks such as disability and hospitalization. Participants will either follow a supervised exercise routine via videoconferencing or receive usual care with general health advice. Individuals with moderate to severe CKD who are not regularly exercising more than once a week might be suitable for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

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 prior data suggests that this exercise program is safe for individuals with chronic kidney disease?

Research has shown that both aerobic and resistance exercises are safe for people with chronic kidney disease (CKD). One study found that this type of exercise improved kidney and physical function without causing serious side effects. Another review confirmed that exercise plays a crucial role in breaking the cycle of weakness often seen in CKD. These findings suggest that, when properly supervised, exercise is well-tolerated and beneficial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a unique exercise program tailored for individuals with chronic kidney disease (CKD). Unlike standard care, which often focuses on medication and diet control, this approach combines aerobic and resistance exercises delivered via videoconferencing, making it more accessible and adaptable for patients at home. The program involves both supervised and self-directed sessions, providing a balanced mix of guidance and independence. By targeting a specific range of perceived exertion, it aims to optimize physical health without overburdening the body, potentially offering a new way to improve the quality of life for those with CKD.

What evidence suggests that this exercise program is effective for chronic kidney disease?

This trial will compare a Combined Aerobic and Resistance Exercise program with Usual Care for individuals with chronic kidney disease (CKD). Research has shown that combining aerobic and resistance exercises can improve physical abilities in people with CKD. Studies have found that this exercise type supports kidney health and enhances overall quality of life. Regular exercise can ease walking and increase physical strength in patients not on dialysis. It may also slow disease progression and help manage other health issues related to CKD. Overall, participating in a structured exercise program could lead to better health outcomes for those with CKD. ^{3 6 7 8 9}

Who Is on the Research Team?

Baback Roshanravan, MD MS MSPH

Principal Investigator

UC Davis

Javier Lopez, MD

Principal Investigator

UC Davis Department of Medicine/Division of Cardiology

Are You a Good Fit for This Trial?

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.

You regularly take opioids for long-term pain.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11743718/

The impact of different exercise modalities on chronic kidney ... This study sought to summarize the effects of different exercise modalities on the main outcomes impacted by CKD.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32513020/

Effects of combined aerobic and resistance exercise on ... Conclusion: The study results support the concept that CARE intervention improves renal function. It provides strong evidence for guiding ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S246802492401862X

Review of Exercise Interventions to Improve Clinical ... The potential benefits of exercise training in CKD range from slowing disease progression to improving comorbidities and quality of life.

4. europeanreview.org europeanreview.org/wp/wp-content/uploads/6098-6106.pdf

Effect of twelve-week concurrent aerobic and resisted ... This study was implemented to evaluate the effectiveness of combined exercise training on non-dialysis days on the functional capacity and. QOL of CKD patients ...

5. nature.com nature.com/articles/s41598-020-75405-x

Effects of exercise on kidney and physical function in ... Regular aerobic and/or resistance training improves physical and walking capacity for patients with non-dialysis CKD. The effect on mortality, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11217122/

Digital Physical Activity and Exercise Interventions for ... Physical activity is essential to interrupt the cycle of deconditioning associated with chronic kidney disease (CKD).

7. kireports.org kireports.org/article/S2468-0249(24)01862-X/fulltext

Review of Exercise Interventions to Improve Clinical ... This review explores the potential benefits of exercise training in NDD, draws lessons from previous interventions and other fields, and provides several basic ...

8. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/0269215520924459

Effects of combined aerobic and resistance exercise on ... The study results support the concept that CARE intervention improves renal function. It provides strong evidence for guiding clinical decisions.

9. bmcnephrol.biomedcentral.com bmcnephrol.biomedcentral.com/articles/10.1186/s12882-023-03173-7

The effect of a novel, digital physical activity and emotional ... The Kidney BEAM trial aims to evaluate whether an evidence-based physical activity and emotional wellbeing self-management programme (Kidney ...