Prehabilitation Exercise for Kidney Failure

Overseen By Christopher Nguan, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Unstable pulmonary, cardiac disease, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a home-based exercise program before kidney transplants can improve recovery and reduce complications afterward. The research aims to determine if exercising at home can boost strength, walking speed, and overall quality of life for individuals with chronic kidney disease or end-stage renal disease. Participants will either follow a guided exercise routine or continue with their usual care. Suitable candidates have been cleared for a kidney transplant, can exercise at home, and receive care at specific hospitals. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance recovery for future kidney transplant patients.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for guidance.

What prior data suggests that this exercise program is safe for kidney transplant patients?

Research has shown that exercise can be safe and beneficial for people with kidney problems. Exercise programs for those with chronic kidney disease often lead to increased physical activity and high satisfaction. Studies indicate that these programs can boost exercise ability and improve muscle function and size.

Exercise rehabilitation has proven effective in many long-term conditions, including severe kidney disease. It lowers health risks and enhances quality of life, suggesting that exercise programs are generally safe and well-received by people with kidney issues.

Although specific safety details for the exercise program in this study aren't provided, following established exercise guidelines and adjusting intensity for each person supports its potential safety. Participants receive monitoring to ensure they exercise at safe levels, making the program suitable for individual needs and limits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial of prehabilitation exercise for kidney failure because it explores a proactive approach to patient care. Unlike the standard treatments for kidney failure, which typically involve medication and dialysis, this trial emphasizes the role of exercise in preparing patients for medical interventions. By using a structured exercise regimen based on the FITT principle (frequency, intensity, time, and type), the program aims to improve patients' overall fitness and potentially enhance their resilience to treatment. This approach could lead to better outcomes by addressing physical health holistically, offering a new dimension to kidney failure management.

What evidence suggests that this exercise and prehabilitation program is effective for improving outcomes in kidney transplantation?

Research has shown that exercise can greatly benefit people with chronic kidney disease (CKD) and end-stage renal disease (ESRD). One study found that 12 weeks of moderate to vigorous aerobic exercise improved physical abilities in individuals with advanced CKD. Exercise during dialysis also enhances quality of life, including better physical health and social interactions. Another study discovered that exercising before surgery, known as prehabilitation, led to high satisfaction and increased activity levels. This trial will compare an Exercise Group, where participants engage in a structured prehabilitation program, to a Control Group receiving regular care. These findings suggest that starting exercise before a kidney transplant can aid recovery and reduce post-surgery complications. ^{1 2 6 7 8}

Who Is on the Research Team?

Christopher Nguan, MD

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

This trial is for adults aged 19 or older with chronic kidney failure who are able to do a home-based exercise program and have been cleared for kidney transplantation. They must be patients at Vancouver General Hospital or St. Paul's Hospital, able to read and write in English, and have physician clearance.

Inclusion Criteria

Ability to read and write in English to respond to study questionnaires

Received physician clearance to participate

I have been evaluated and considered suitable for a kidney transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants engage in a home-based exercise program to improve physical functioning before kidney transplantation

Minimum 4 weeks

In-person instruction at initial consultation

Surgery and Immediate Post-Operative Recovery

Participants undergo kidney transplantation and are monitored for immediate post-operative recovery outcomes

1 week

Daily monitoring in hospital

Follow-up

Participants are monitored for safety and effectiveness after treatment, including physical fitness assessments and quality of life surveys

6 months

Monthly visits for assessments

What Are the Treatments Tested in This Trial?

Interventions

• Exercise and Prehabilitation

Trial Overview The study tests if exercising before a kidney transplant can help improve walking speed, strength, endurance, quality of life, fatigue levels pre-operatively and lead to better recovery outcomes post-transplantation such as fewer complications and shorter hospital stays.

How Is the Trial Designed?

Group I: Exercise Group Experimental Treatment 1 Intervention

All participants who are allocated to the exercise group will be asked to complete 4-5 days per week of mixed modality exercise incorporating aerobic, resistance, and flexibility training. The exercise intervention is prescribed based on the FITT principle: frequency, intensity, time and type. The 10-point Rating of Perceived Exertion (RPE) scale, which has been well correlated to target HR levels, will be used to monitor exercise intensity levels throughout the intervention, with participants instructed to maintain their intensity level at 3-5 during exercise sessions. Participant progression will be individualized and based on their subjective perceived intensity level using the RPE scale. In person instruction, from a member of the research team with standard first aid and CPR-C training, and an instructional handout and exercise log will be provided, as well as exercise resistance bands to perform resistance exercises.

Group II: Control Group Active Control 1 Intervention

This will consist of regular care, which is standard procedure.

Exercise and Prehabilitation is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Prehabilitation Exercise Program for:

• Improvement of physical functioning before kidney transplantation
• Reduction of postoperative complications

Approved in United States as Prehabilitation Exercise Program for:

• Enhancement of preoperative functional capacity
• Improvement of postoperative outcomes in kidney transplant patients

Approved in Canada as Prehabilitation Exercise Program for:

• Mitigation of functional decline in patients awaiting kidney transplantation
• Improvement of quality of life

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Published Research Related to This Trial

A study involving 20 patients undergoing nephrectomy identified key barriers to physical activity prehabilitation, including mental factors, personal responsibilities, physical capacity, health conditions, and lack of exercise facilities.

Facilitators that could enhance adherence to prehabilitation included holistic health approaches, social and professional support, recognition of health benefits, appropriate exercise guidance, and effective communication channels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and facilitators to physical activity prehabilitation in patients with kidney cancer. Paulo, CM., Ali, AA., Schmeusser, BN., et al.[2023]

Prehabilitation, which includes physical exercise, nutritional, and psychological support before surgery, has been shown to improve cardiopulmonary fitness and reduce postoperative complications, leading to better recovery outcomes.

Current evidence suggests that individualized prehabilitation programs, which can be home-based or supervised in hospitals, are essential for maximizing effectiveness, although more research is needed to determine the optimal structure of these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation, improving postoperative outcomes. Chmelo, J., Chmelová, I., Phillips, AW.[2021]

A home-based pre-operative rehabilitation (PREHAB) program for patients awaiting elective cardiac surgery showed significant improvements in physical function, including a reduction in clinical frailty scores and increased walking distance and speed, with no reported adverse events.

The study suggests that PREHAB may help reduce hospital length of stay for frail patients undergoing CABG or valve surgery, indicating its potential efficacy, but further research with a larger randomized controlled trial is needed to confirm these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based preoperative rehabilitation (prehab) to improve physical function and reduce hospital length of stay for frail patients undergoing coronary artery bypass graft and valve surgery. Waite, I., Deshpande, R., Baghai, M., et al.[2022]

Preoperative scapular rehabilitation significantly reduced pain and improved shoulder function in patients undergoing arthroscopic repair for rotator cuff injuries, with notable benefits observed after one year.

Patients who received scapular rehabilitation showed greater improvements in shoulder abduction and overall quality of life compared to those who did not, indicating that targeted preoperative exercises can enhance recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-Operative Scapular Rehabilitation for Arthroscopic Repair of Traumatic Rotator Cuff Tear: Results of a Randomized Clinical Trial. de Almeida, LL., Mendes Júnior, AF., Neto, JDM., et al.[2022]

A systematic review of 25 randomized-controlled trials involving 2682 cancer patients found that prehabilitation programs focusing on exercise training did not show clear benefits over usual care in improving health-related quality of life or reducing postoperative complications.

The overall certainty of the evidence was assessed as very low due to serious methodological concerns, indicating that more research is needed to determine the true effectiveness of prehabilitation programs for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation programs for individuals with cancer: a systematic review of randomized-controlled trials. Meneses-Echavez, JF., Loaiza-Betancur, AF., Díaz-López, V., et al.[2023]

A randomized controlled trial involving 114 kidney transplant candidates (38 frail and 76 non-frail) is investigating the effectiveness of a multimodal prehabilitation program that includes exercise, nutritional support, and psychological advice to improve outcomes after kidney transplantation.

The study aims to demonstrate that this prehabilitation approach can reduce negative outcomes by 25% in frail patients and 12.5% in non-frail patients at 90 days post-transplant, highlighting its potential to enhance recovery and quality of life for patients with chronic kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The FRAILMar Study Protocol: Frailty in Patients With Advanced Chronic Kidney Disease Awaiting Kidney Transplantation. A Randomized Clinical Trial of Multimodal Prehabilitation. Pérez-Sáez, MJ., Morgado-Pérez, A., Faura, A., et al.[2021]

A pilot study involving 24 kidney transplant candidates showed that a prehabilitation program, consisting of weekly physical therapy and at-home exercises, significantly improved physical activity levels by 64% over two months.

Participants who underwent prehabilitation had a shorter hospital stay after kidney transplant (5 days) compared to matched controls (10 days), suggesting that prehabilitation may enhance recovery outcomes post-transplant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation prior to kidney transplantation: Results from a pilot study. McAdams-DeMarco, MA., Ying, H., Van Pilsum Rasmussen, S., et al.[2023]

Physical exercise for patients undergoing hemodialysis has been shown to provide significant health benefits, including improved cardiovascular function, better blood pressure control, increased muscle strength, and enhanced quality of life.

Despite the proven advantages of exercise, physical rehabilitation programs are not yet standard practice in most dialysis centers, primarily due to the absence of a well-defined program tailored to the specific needs of dialysis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Exercise of Patients on Hemodialysis, Optimistic or Pessimistic. Stolic, RV., Zdravkovic, N., Mitrovic, V., et al.[2023]

The PreCareTx study will assess the effectiveness of a 12-week multimodal prehabilitation program for kidney transplant candidates, focusing on improving their frailty status and overall health before surgery, with 128 participants split between prehabilitation and usual care groups.

The study will also evaluate the safety, feasibility, and acceptability of the prehabilitation program, aiming to identify barriers and facilitators for its implementation in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PREhabilitation of CAndidates for REnal Transplantation (PreCareTx) study: protocol for a hybrid type I, mixed method, randomised controlled trial. Quint, EE., Haanstra, AJ., van der Veen, Y., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10552838/

Exercise as a therapeutic intervention in chronic kidney ... This article reviews recent research, and discusses the challenges and potential solutions, for providing exercise-based therapeutic options for people living ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0828282X23016215

Exercise Rehabilitation for People With End-Stage Kidney ... In a randomised trial that included people with stages 3-5 CKD, Kirkman et al. demonstrated that 12 weeks of moderate to vigourous aerobic exercise improved ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10816861/

Renal Rehabilitation: Present and Future Perspectives - PMC This review focused on the history and benefits of RR in patients with CKD. Based on current evidence, RR is an effective, feasible, and safe ...

4. withpower.com withpower.com/trial/phase-kidney-failure-chronic-7-2019-9833d

Prehabilitation Exercise for Kidney Failure Studies show that patients who participate in prehabilitation report high satisfaction and improved physical activity, making it a valuable approach to enhance ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04674930

Effects of Exercise Program on Physical Functioning ... The physiotherapeutic exercise program during hemodialysis improves the quality of life (QOL) of chronic renal patients in physical, social, environmental and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8145577/

Renal Rehabilitation: Exercise Intervention and Nutritional ... It recommends up to 180 min of aerobic exercise with an intensity of 11–13 on the rating of perceived exertion (RPE) scale, 8–12 sessions of resistance ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0272638625009709

Exercise-Based Prehabilitation for Kidney Transplant ... Conclusions. An 8-week exercise-based prehabilitation program may improve KT candidates' exercise capacity, muscle function, and muscle size, and these effects ...

8. onlinecjc.ca onlinecjc.ca/article/S0828-282X(23)01621-5/fulltext

Exercise Rehabilitation for People With End-Stage Kidney ... Exercise rehabilitation is a well established therapy for reducing morbidity and mortality and improving quality of life and function across chronic conditions.