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

Trial Summary

What is the purpose of this trial?

Pre-operative physical functioning has been acknowledged as a factor influencing post-operative complication risk, recovery progression and mortality risk. Current guidelines have yet to focus on the pre-operative period as a potential target to improve levels of physical functioning before renal transplantation. This project proposes the introduction of an exercise intervention pre-operatively to mitigate functional decline pre-operatively and improve post-operative outcomes following renal transplantation. We hypothesize that a home-based exercise prehabilitation program prior to kidney transplantation will result in improved functional outcomes including the 6-minute walk test, 60-second timed sit to stand, Fried Frailty Score, quality of life and fatigue. Further we hypothesize that prehabilitation will result in improved outcomes regarding post-operative recovery, complication rate, length of stay and mortality. Objectives A) Identify whether a prehabilitation program can mitigate functional decline pre-operatively regarding walking speed, strength, endurance, quality of life and fatigue B) To determine whether a tailored home-based exercise program prior to kidney transplantation is feasible with regards to adherence in patients with Chronic Kidney Disease (CKD) and End Stage Renal Disease (ESRD). C) To determine if a prehabilitation program results in improved clinical outcomes within one week following Kidney Transplantation (KT) as well as at 30 and 90 days including but not limited to time to first ambulation, time to first bowel movement, postoperative complications (Clavien-Dindo classification), mortality and length of stay. D) Quantify the differences described above, if any exist.

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 data supports the idea that Prehabilitation Exercise for Kidney Failure is an effective treatment?

The available research shows that prehabilitation exercise, which includes physical activity before surgery, can improve a patient's health and recovery. For example, it has been found to enhance fitness and reduce complications after surgery, as seen in patients undergoing heart and cancer surgeries. This suggests that similar benefits might be expected for kidney failure patients. Prehabilitation can also shorten hospital stays and improve quality of life, making it a promising approach compared to usual care. ^{1 2 3 4 5}

What safety data exists for prehabilitation exercise in kidney failure treatment?

The available research suggests that prehabilitation exercise, including physical therapy and multimodal interventions, is generally safe and feasible for patients with chronic kidney disease (CKD) awaiting kidney transplantation. Studies like the FRAILMar study and a pilot study on prehabilitation prior to kidney transplantation indicate improvements in physical activity, reduced length of hospital stay, and high patient satisfaction. However, contraindications for exercise include recent myocardial infarction, uncontrolled arrhythmia, and other severe conditions. While the benefits are promising, more research is needed to establish standardized protocols and confirm safety across diverse patient populations. ^{3 5 6 7 8}

Is Exercise and Prehabilitation a promising treatment for kidney failure?

Yes, Exercise and Prehabilitation is a promising treatment for kidney failure. It helps improve physical fitness before surgery, which can lead to better recovery and shorter hospital stays after a kidney transplant. Studies show that patients who participate in prehabilitation report high satisfaction and improved physical activity, making it a valuable approach to enhance health outcomes for those awaiting kidney transplants. ^{2 3 6 7 9}

Research Team

Christopher Nguan, MD

Principal Investigator

University of British Columbia

Eligibility Criteria

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

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

Received physician clearance to participate

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

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

Pre-Operative Scapular Rehabilitation for Arthroscopic Repair of Traumatic Rotator Cuff Tear: Results of a Randomized Clinical Trial. [2022]

2. Scotland pubmed.ncbi.nlm.nih.gov

Barriers and facilitators to physical activity prehabilitation in patients with kidney cancer. [2023]

3. Czech Republic pubmed.ncbi.nlm.nih.gov

Prehabilitation, improving postoperative outcomes. [2021]

4. England 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. [2022]

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

Prehabilitation programs for individuals with cancer: a systematic review of randomized-controlled trials. [2023]

6. Switzerland 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. [2021]

7. Denmark pubmed.ncbi.nlm.nih.gov

Prehabilitation prior to kidney transplantation: Results from a pilot study. [2023]

8. Iran pubmed.ncbi.nlm.nih.gov

Physical Exercise of Patients on Hemodialysis, Optimistic or Pessimistic. [2023]

9. England pubmed.ncbi.nlm.nih.gov

PREhabilitation of CAndidates for REnal Transplantation (PreCareTx) study: protocol for a hybrid type I, mixed method, randomised controlled trial. [2023]