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.
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.14569
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 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.23489
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.23467
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
I have been evaluated and considered suitable for a kidney transplant.
I am 19 years old or older.
Treatment Details
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Exercise GroupExperimental Treatment1 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 GroupActive Control1 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
Find a clinic near you
Research locations nearbySelect from list below to view details:
Vancouver General HospitalVancouver, Canada
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Who is running the clinical trial?
University of British ColumbiaLead Sponsor
References
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]Evidence suggests that elective cardiac patients are at risk of functional and psychological deterioration in the time preceding surgery. This poses a risk to successful post-operative rehabilitation. This prospective one-group pre-test, post-test evaluation was designed to assess a clinical Pre-operative Rehabilitation (PREHAB) home-based exercise programme, to optimise pre-operative physical function and frailty in patients awaiting elective Coronary Artery By-Pass Graft (CABG) or Valve Surgery.
Prehabilitation prior to kidney transplantation: Results from a pilot study. [2023]Prehabilitation is the process of enhancing preoperative functional capacity to improve tolerance for the upcoming stressor; it was associated with improved postoperative outcomes in a handful of studies, but never evaluated in transplantation. Kidney transplant (KT) candidates may be uniquely suited for prehabilitation because they experience a profound loss of functional capacity while waiting years on dialysis. To better understand the feasibility and effectiveness of prehabilitation in KT, we conducted a pilot study of center-based prehabilitation for candidates; this intervention consisted of weekly physical therapy sessions at an outpatient center with at-home exercises. We enrolled 24 participants; 18 participated in prehabilitation (75% of enrolled; 17% of eligible). 61% were male, 72% were African American, and mean age = 52 (SD = 12.9); 71% of participants had lower-extremity impairment, and 31% were frail. By 2 months of prehabilitation, participants improved their physical activity by 64% (P = 0.004) based on accelerometry. Participants reported high satisfaction. Among 5 prehabilitation participants who received KT during the study, length of stay was shorter than for age-, sex-, and race-matched control (5 vs 10 days; RR = 0.69; 95% CI:0.50-0.94; P = 0.02). These pilot study findings suggest that prehabilitation is feasible in pretransplant patients and may potentially be a strategy to improve post-KT outcomes.
The FRAILMar Study Protocol: Frailty in Patients With Advanced Chronic Kidney Disease Awaiting Kidney Transplantation. A Randomized Clinical Trial of Multimodal Prehabilitation. [2021]Introduction: Frailty is very frequent among patients with chronic kidney disease (CKD) who are awaiting deceased donor kidney transplantation (KT), and transplant outcomes are worsened in those frail recipients. Frailty and poor fitness powerfully predict mortality, kidney graft survival, and healthcare utilization after KT. Intervention is essential to improve survival and quality of life for frail CKD patients, regardless of their age. Studies of post-transplant physical therapy intervention have been met with limited success, in large part due to high dropout rates. A pre-transplant clinical framework for multimodal prehabilitation interventions including physical therapy, nutritional measures, and psychological support scheduled during the KT waiting list period may improve patient retention and compliance, better mitigate the effects of frailty and poor fitness after KT, and improve main outcomes in frail CKD patients. Main Objective: To study the effectiveness, feasibility, and safety of multimodal prehabilitation (exercise, nutritional plans, psychological advice) in KT candidates. Methods: Randomized controlled clinical trial in 38 frail and 76 non-frail KT candidates. The prehabilitation program will consist of physical exercise (24 sessions, 8 weeks), nutritional supplementation, and psychological advice. The primary endpoint will be a composite achievement of clinical and functional main outcomes in frail and non-frail KT candidates at 90 days post-transplantation. Secondary outcomes include changes in exercise capacity, physical activity, gait speed, respiratory and peripheral muscle strength, muscle size, body composition, performance in activities of daily living (basic and instrumental), anxiety and depression symptoms, and health-related quality of life. Feasibility of the intervention will be also analyzed. Expected Results: Multimodal prehabilitation is a feasible and effective intervention to decrease bad outcomes at 90 days post-KT by 25 and 12.5% in frail and non-frail patients, respectively. Clinical Trial Registration: clinicaltrials.gov (NCT04701398), date: 2021, January 8th (Protocol version: Frailmar_vers2).
Prehabilitation, improving postoperative outcomes. [2021]Cardiopulmonary fitness impacts upon post-operative outcomes. Improved fitness may lead to a reduction in postoperative morbidity, mortality, reduced length of stay and improvements in patients quality of life. Prehabilitation can be defined as a group of interventions undertaken prior to a surgical procedure, with the aim of reducing peri-operative risk, improving post-operative recovery and outcomes. This is an evolving field which is generating significant scientific and clinical interest. There is growing evidence demonstrating the effectiveness of this approach. It has been proven that prehabilitation could lead to improvement in cardiopulmonary fitness and reduction of postoperative morbidity. Physical exercise composed of aerobic and strengthening exercise is a mainstay of prehabilitation. Multimodal interventions are preferred nowadays and therefore these programmes are commonly enhanced by nutritional and psychological support. Prehabilitation has its place in elective surgery and should be commenced immediately after diagnosis is made. It can be home-based or within hospitals under supervision. Prehabilitation programmes should be individualised, based on patients diagnosis, age, comorbidities, background physical activity and social circumstances in order to achieve the highest possible effectivity of the programmes. It remains unclear as to what the optimal programme looks like in terms of frequency, length and intensity of exercise. High-intensity interval training has been shown to be highly effective. There is a need to answer many questions and bring more substantial evidence of prehabilitation effectivity before this can become part of a routine clinical care. There are several ongoing large randomised clinical in prehabilitation that can help address this knowledge gap.
Pre-Operative Scapular Rehabilitation for Arthroscopic Repair of Traumatic Rotator Cuff Tear: Results of a Randomized Clinical Trial. [2022]Pre-operative rehabilitation aims to improve the functional capacity of the individual to enable him/her to prepare for the period of inactivity associated with the surgical procedure.
Barriers and facilitators to physical activity prehabilitation in patients with kidney cancer. [2023]Timely and effective physical activity (PA) prehabilitation is an evidence-based approach for improving a patient's health status preoperatively. Identifying barriers and facilitators to PA prehabilitation can help inform best practices for exercise prehabilitation program implementation. We explore the barriers and facilitators to PA prehabilitation in patients undergoing nephrectomy.
PREhabilitation of CAndidates for REnal Transplantation (PreCareTx) study: protocol for a hybrid type I, mixed method, randomised controlled trial. [2023]Kidney transplant candidates (KTCs) need to be in optimal physical and psychological condition prior to surgery. However, KTCs often experience compromised functional capacity which can be characterised as frailty. Prehabilitation, the enhancement of a person's functional capacity, may be an effective intervention to improve the health status of KTCs. The PREhabilitation of CAndidates for REnal Transplantation (PreCareTx) study aims to examine the effectiveness of a multimodal prehabilitation programme on the health status of KTCs, and to explore the potential of implementation of prehabilitation in daily clinical practice.
Physical Exercise of Patients on Hemodialysis, Optimistic or Pessimistic. [2023]Chronic kidney disease leads to significant functional limitations and severe disability, which requires the application of an appropriate physical rehabilitation strategy that helps patients achieve social well-being and significant health benefits. Data sources MEDLINE, PubMed, Google Scholar and Web of Science were electronically searched, by using search terms: physical exercise, hemodialysis, barriers, risks of exercise, expected benefits. The contraindications for exercise are recent myocardial infarction, uncontrolled arrhythmia and hypertension, unstable angina pectoris, unregulated diabetes mellitus, the presence of neurological and muscular dysfunctions, malignancies, and pregnancy. The implementation of the physical exercise program for hemodialysis patients confirmed all the expected benefits: improvement of cardiovascular functions, stabilization of blood pressure, increased muscle strength, improvement of nutritional status and quality of dialysis, reduction of negative emotions, anxiety and depression, as well as social interaction of patients and their families. Despite the fact that a large number of studies have proven the beneficial effects of exercise during hemodialysis, a physical rehabilitation program as a standard form of treatment has not yet been introduced. Although there is no doubt that the effects of physical activity on the survival and the quality of life of patients on hemodialysis are positive, rehabilitation program still falls under the routine practice program in a small number of dialysis centers. One of the biggest obstacles to the implementation of the physical therapy program in hemodialysis patients is the lack of a clearly defined program that defines all the needs of dialysis patients. DOI: 10.52547/ijkd.7570.
Prehabilitation programs for individuals with cancer: a systematic review of randomized-controlled trials. [2023]Prehabilitation programs focusing on exercise training as the main component are known as a promising alternative for improving patients' outcomes before cancer surgery. This systematic review determined the benefits and harms of prehabilitation programs compared with usual care for individuals with cancer.