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

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a pilot trial of a 16-week physical activity and power training program among 30 Veterans/arm with advanced chronic kidney disease. The trial aims to test whether the program is tolerable to Veterans.

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.

Is exercise safe for people with chronic kidney disease?

Exercise programs for people with chronic kidney disease are generally safe, but some may experience low blood pressure (hypotension) and muscle cramps during exercise. It's important to have trained professionals involved and to monitor for these potential issues. ^{1 2 3 4 5}

How does the treatment 'Attention Control for Pro-social Power training Activity for Aging and Well-being with Chronic Kidney Disease' differ from other treatments for chronic kidney disease?

This treatment is unique because it combines exercise with social engagement activities, aiming to improve both physical and social functioning in individuals with chronic kidney disease. Unlike standard treatments that focus solely on medical management, this approach addresses the social aspects of health, which can enhance overall well-being and quality of life. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Attention Control for Pro-social Power training Activity for Aging and Well-being with Chronic Kidney Disease?

Research shows that exercise programs can improve physical function, fitness, and quality of life in people with chronic kidney disease. Additionally, exercise has been used to address social frailty and improve social engagement, which are important for overall well-being. ^{5 6 8 9 11}

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. England pubmed.ncbi.nlm.nih.gov

Intradialytic exercise in the treatment of social frailty: a single-center prospective study-preliminary results during the unexpected COVID-19 pandemic. [2022]

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

Advancing Exercise Science for Better Health Outcomes Across the Spectrum of Chronic Kidney Disease. [2023]

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

Physical Activity Intensity and Biopsychosocial Correlates in Chinese Middle-Aged and Older Adults With Chronic Kidney Disease. [2020]

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

Pilot Intervention Addressing Social Support and Functioning of Low Socioeconomic Status Older Adults With ESRD: The Seniors Optimizing Community Integration to Advance Better Living with ESRD (SOCIABLE) Study. [2023]

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

Quasi-cluster randomized trial of a six-month low-intensity group-based resistance exercise for hemodialysis patients on depression and cognitive function: a 12-month follow-up. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Differential impact of age on verbal memory and executive functioning in chronic kidney disease. [2007]

7. 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]

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

Exercise training during hemodialysis in Brazil: A national survey. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

A "nephrological" approach to physical activity. [2014]

10. England pubmed.ncbi.nlm.nih.gov

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

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

Endurance exercise training. An effective therapeutic modality for hemodialysis patients. [2019]