Prehabilitation Exercise for Kidney Failure

Recruiting in Palo Alto (17 mi)

Overseen by Christopher Nguan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of British Columbia

Disqualifiers: Unstable pulmonary, cardiac disease, others

No Placebo Group

Approved in 3 Jurisdictions

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

Trial 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 (Behavioural Intervention)

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 Canada for the following indications:

Approved in Canada as Prehabilitation Exercise Program for:

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Vancouver General Hospital Vancouver, Canada

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1506

Patients Recruited

2,528,000+

Findings from Research

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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]

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]

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]