Exercise Program for Chronic Kidney Disease

Overseen By Sonya L Williams, MS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Heart disease, Hypertension, Stroke, others

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

Compensation: Varies

Number of Visits: 2

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new 16-week exercise program for Veterans with advanced chronic kidney disease. The program, which includes power training and motivational coaching, aims to determine its manageability for participants. Two groups will participate: one will receive educational materials and check-in calls as an attention control for the pro-social power training activity, while the other will engage in supervised exercise sessions. Veterans who struggle to walk a mile or climb stairs due to health reasons might be suitable candidates for this trial. As an unphased trial, it offers Veterans a unique chance to contribute to research that could enhance exercise programs for those with chronic kidney disease.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that exercise programs for people with chronic kidney disease (CKD) are generally safe. One study found that a 12-month supervised exercise program for older adults with advanced CKD was safe and well-tolerated, with participants not experiencing significant negative effects. Another study also supports that physical activity and exercise, when done carefully, are safe for CKD patients.

For this trial, which includes a 16-week power training and physical activity program, these findings suggest that participants can expect the activities to be manageable. The program includes exercises both at a center and at home, with regular check-ins to ensure everything proceeds smoothly. Overall, current research supports the safety of this type of exercise program for those with CKD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to enhance well-being in those with Chronic Kidney Disease (CKD) through physical activity and motivation. Unlike standard treatments that primarily focus on medications and dietary changes, this trial investigates the impact of a power-training program combined with motivational coaching. This approach not only aims to improve physical health but also boosts mental well-being by encouraging an active lifestyle. By using accelerometers to track activity, the program offers a personalized and engaging way to manage CKD, potentially leading to better health outcomes and quality of life.

What evidence suggests that this trial's treatments could be effective for chronic kidney disease?

Research has shown that regular exercise greatly benefits people with chronic kidney disease (CKD). Studies have found that staying active leads to better health, such as improved physical abilities and increased strength. Exercise can help those with CKD prevent the physical decline often associated with the condition. In this trial, participants in the power training and monitored physical activity arm will follow a structured exercise routine, including power training, to potentially enhance their quality of life. Meanwhile, the attention control arm will focus on physical activity education without power training or motivational coaching. ^{1 3 5 6 7}

Who Is on the Research Team?

Devika Nair, MD

Principal Investigator

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Are You a Good Fit for This Trial?

This trial is for Veterans with advanced chronic kidney disease who experience difficulty walking or climbing stairs, and are considered pre-frail. They must be cleared by their doctor to participate, not wheelchair-bound, living outside long-term care facilities, not facing terminal illness or major surgery soon, and not enrolled in other exercise programs.

Inclusion Criteria

I am considered pre-frail because it takes me more than 6 seconds to walk 15 feet.

I have trouble walking a mile or climbing stairs due to health issues.

Participant's nephrologist and/or primary care physician agree that participant may enroll in trial

Exclusion Criteria

You are unable to see.

You are currently participating in physical therapy or a structured exercise program.

You have a serious problem with memory or thinking, as shown in your medical records or by yourself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 16-week power-training and physical activity-focused intervention with in-center and at-home components

16 weeks

2-3 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and fidelity assessments

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Attention Control for Pro-social Power training Activity for Aging and Well-being with Chronic Kidney Disease
• Pro-social Power Training Activity for Aging and Well-being With Chronic Kidney Disease

Trial Overview The study tests a 16-week physical activity and power training program's tolerability among participants. It involves two groups: one receiving the Pro-social Power Training Activity and another undergoing an Attention Control condition as a comparison.

How Is the Trial Designed?

Group I: Power training and monitored physical activity Experimental Treatment 1 Intervention

This is a 16-week power-training and physical activity-focused intervention that contains in-center and at-home components and motivational coaching. Participants will meet 2-3 times per week for the in-center power training. Participants will also be asked to wear accelerometers at home in order for their physical activity frequency to be measured.

Group II: Attention control Active Control 1 Intervention

This will be the attention control arm that will involve receipt of a physical activity education booklet, use of an accelerometer, and weekly check-in calls. No power training or motivational coaching will be delivered.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Exercise training has been shown to significantly improve physical function, fitness, and quality of life in individuals with chronic kidney disease, yet it is not commonly included in standard kidney care programs.

To integrate exercise rehabilitation into kidney care, it is essential to focus on clinically relevant outcomes for patients, implement evidence-based strategies, and treat exercise as a legitimate medical therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancing Exercise Science for Better Health Outcomes Across the Spectrum of Chronic Kidney Disease. Bohm, C., Bennett, P., Lambert, K., et al.[2023]

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]

Only 15.7% of the 261 surveyed dialysis units in Brazil offered exercise training during hemodialysis, with resistance training being the most common component (92.7%).

The main barriers to implementing and maintaining exercise programs were identified as a lack of resources and poor patient adherence, with hypotension and muscle cramps being the most frequently reported adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training during hemodialysis in Brazil: A national survey. Barros, FS., Pinheiro, BV., Lucinda, LMF., 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11519309/

Physical activity and exercise in chronic kidney disease Overall, the statements affirm that regular physical activity and exercise training offer numerous benefits to CKD patients, including improved physical ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11537625/

Exercise and physical activity for people with chronic ... The aim of this study was to examine nephrologist practice patterns concerning exercise and PA in CKD patients.

3. academic.oup.com academic.oup.com/ckj/article/14/3/768/5903066

Assessing physical activity and function in patients with ... Physical activity potentially improves health outcomes in patients with chronic kidney disease (CKD) and recipients of kidney transplants.

4. link.springer.com link.springer.com/article/10.1007/s10916-024-02081-z

A Systematic Review of Health Outcomes and Feasibility Physical activity is essential to interrupt the cycle of deconditioning associated with chronic kidney disease (CKD).

5. nature.com nature.com/articles/s41598-023-50507-4

The development and internal pilot trial of a digital physical ... This trial assessed the feasibility and acceptability of Kidney BEAM, a physical activity and emotional well-being self-management digital health intervention ...

6. withpower.com withpower.com/trial/phase-kidney-diseases-3-2024-ad837

Exercise Program for Chronic Kidney Disease 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 ...

7. bmcnephrol.biomedcentral.com bmcnephrol.biomedcentral.com/articles/10.1186/s12882-021-02618-1

Clinical practice guideline exercise and lifestyle in chronic ... This is the first document of its kind to set out the evidence for those people living with kidney disease, including those on haemodialysis and with a kidney ...