Chronic Kidney Disease (CKD), Frailty, Kidney Transplant, Prehabilitation
Conditions
Keywords
advanced chronic kidney disease, kidney transplantation, prehabilitation, functional capacity, perioperative care, quality of life, multimodal prehabilitation
Brief summary
Patients with advanced chronic kidney disease awaiting deceased-donor kidney transplantation frequently experience progressive functional decline, frailty, reduced mobility, and poor quality of life while on the transplant waiting list. Although multimodal prehabilitation programs based on exercise, nutritional optimization, and psychological support have shown promising benefits in major surgery, their implementation in kidney transplant candidates remains limited due to barriers related to accessibility, fatigue, transportation, and treatment burden. This randomized single-center clinical trial aims to evaluate the feasibility, adherence, and effectiveness of a multimodal prehabilitation program in patients awaiting deceased-donor kidney transplantation, comparing an in-person supervised model with a remote home-based model supported by a digital platform. The primary outcome will be the change in functional capacity measured by the 6-Minute Walk Test (6MWT). Secondary outcomes include physical activity level, frailty, nutritional status, kidney disease-specific quality of life (KDQOL-36), postoperative recovery quality (QoR-15), postoperative complications, and program adherence. The study seeks to generate clinically applicable evidence regarding the implementation and scalability of remote prehabilitation strategies in patients with advanced chronic kidney disease, with the potential to improve accessibility, sustainability, and perioperative outcomes in kidney transplantation.
Detailed description
Patients with advanced chronic kidney disease (CKD) awaiting deceased-donor kidney transplantation frequently experience progressive deterioration in functional capacity, mobility, and quality of life during the waiting-list period. Frailty, sarcopenia, cardiovascular comorbidity, anemia, fatigue, and physical inactivity are highly prevalent in this population and may adversely affect perioperative outcomes, postoperative recovery, and healthcare utilization after transplantation. Reduced cardiorespiratory reserve has been associated with increased postoperative morbidity and poorer clinical outcomes in kidney transplant recipients. Prehabilitation has emerged as a perioperative optimization strategy aimed at enhancing functional reserve before surgical stress through multimodal interventions that combine structured exercise training, nutritional optimization, and psychological support. Previous studies in major surgery and solid organ transplantation suggest that prehabilitation may improve exercise tolerance, physical functioning, postoperative recovery, and patient-reported outcomes. However, implementation of prehabilitation programs in patients with advanced CKD remains limited because of barriers related to dialysis schedules, transportation burden, fatigue, reduced mobility, and limited access to specialized hospital-based programs. Remote or home-based prehabilitation models supported by digital technologies may improve accessibility, adherence, and scalability while maintaining clinical effectiveness. Nevertheless, evidence comparing remote and in-person multimodal prehabilitation strategies in kidney transplant candidates remains scarce. This study is a prospective randomized single-center clinical trial designed to evaluate the feasibility, adherence, and effectiveness of a multimodal prehabilitation program in adult patients with advanced CKD awaiting deceased-donor kidney transplantation. Participants will be randomized in a 1:1 ratio to either an in-person supervised prehabilitation program or a remote home-based program delivered through a digital platform. Both intervention groups will receive the same multimodal components, differing only in the delivery format. The intervention includes structured individualized exercise training combining aerobic exercise, strength training, mobility, and balance exercises; individualized nutritional counseling focused on optimization of protein-energy status and prevention of sarcopenia; and psychological support aimed at stress management, motivation, and behavioral reinforcement. During the initial 8-week intervention phase, participants assigned to the in-person group will attend supervised exercise sessions at the hospital gym three times per week. Participants assigned to the remote group will perform supervised online exercise sessions through the Surgifit® digital platform three times per week in small groups. Following completion of the structured phase, both groups will continue with a personalized community-based physical activity program until transplantation. All participants will receive access to the Surgifit® platform, which provides educational resources, exercise guidance, nutritional recommendations, healthy recipes, and mindfulness activities. The platform will also facilitate monitoring of adherence and remote supervision of exercise sessions. Functional, nutritional, frailty, psychological, and quality-of-life assessments will be performed at baseline, at 8 weeks, and at 6 months if transplantation has not yet occurred. Postoperative recovery and clinical outcomes will be assessed in patients undergoing transplantation during the study period. The primary outcome measure of the study is the change in functional capacity measured by the 6-Minute Walk Test (6MWT). Secondary outcome measures include adherence to the intervention, habitual physical activity level, frailty measures, nutritional status, body composition, kidney disease-specific quality of life, postoperative quality of recovery, postoperative complications, and healthcare utilization outcomes. The study also incorporates an implementation-oriented framework focused on feasibility, adherence, accessibility, and scalability of multimodal prehabilitation in advanced CKD. Additional exploratory analyses will evaluate patient-perceived barriers and facilitators to participation through questionnaires and qualitative assessments. Environmental and organizational sustainability indicators associated with remote delivery models, including reduction in transportation-related burden and accessibility for patients living far from the transplant center, will also be explored. The trial is expected to generate clinically applicable evidence regarding the integration of multimodal prehabilitation programs in kidney transplant candidates and to inform future patient-centered and scalable perioperative optimization strategies for patients with advanced chronic kidney disease.
Interventions
BEHAVIORALIn-Person Multimodal Prehabilitation
Participants will receive an 8-week supervised multimodal prehabilitation program including moderate-to-high intensity aerobic exercise, strength training, mobility, and balance exercises performed three times per week at the hospital gym under physiotherapist supervision. The intervention also includes individualized nutritional counseling focused on optimization of protein-energy status and prevention of sarcopenia, as well as psychological support aimed at motivation and stress management. After the supervised phase, participants will continue with a personalized community-based physical activity program until kidney transplantation.
BEHAVIORALRemote Multimodal Prehabilitation
Participants will receive an 8-week remote multimodal prehabilitation program including supervised online exercise sessions performed three times per week through the Surgifit® digital platform. The exercise program includes aerobic exercise, strength training, mobility, and balance exercises adapted to the participant's functional status. Participants will also receive individualized nutritional counseling and psychological support focused on motivation and stress management. After the supervised phase, participants will continue with a personalized community-based physical activity program until kidney transplantation.
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years or older. * Patients with advanced chronic kidney disease on the waiting list for deceased-donor kidney transplantation. * Ability to perform moderate-intensity physical exercise. * Able and willing to provide written informed consent.
Exclusion criteria
* Absolute contraindication to physical exercise. * Severe cognitive impairment limiting participation in the intervention or assessments. * Active infection at the time of enrollment. * Clinically unstable medical condition. * Physical or musculoskeletal limitations preventing participation in the exercise program.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in functional capacity measured by the 6-Minute Walk Test (6MWT) | Baseline and 8 weeks | Change in walking distance (meters) between baseline and post-intervention assessment measured using the 6-Minute Walk Test. |
| Kidney disease-specific quality of life (KDQOL-36) | Baseline, 8 weeks, and 6 months | Change in quality-of-life scores measured using the Kidney Disease Quality of Life-36 questionnaire. Domain scores range from 0 to 100, with higher scores indicating better health-related quality of life, including fewer kidney disease-related symptoms, less burden of kidney disease, and less interference of kidney disease with daily life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Program adherence | 8 weeks | Percentage of scheduled exercise sessions completed during the supervised intervention period. |
| Physical activity level | Baseline, 8 weeks, and 6 months | Physical activity assessed using the Yale Physical Activity Survey (YPAS). The YPAS is a questionnaire designed to assess physical activity levels in older adults. The survey generates summary indices of physical activity, with higher scores indicating greater levels of physical activity. There is no fixed theoretical minimum or maximum. |
| Functional mobility (Timed Up and Go Test) | Baseline, 8 weeks, and 6 months | Functional mobility assessed using the Timed Up and Go Test. It assesses functional mobility by measuring the time required to stand up from a chair, walk 3 meters, turn around, walk back, and sit down. Scores are expressed in seconds, with lower scores indicating better functional mobility and physical performance, and higher scores indicating worse mobility. There is no fixed maximum. |
| Frailty status | Baseline, 8 weeks, and 6 months | Frailty assessed using the Clinical Frailty Scale (CFS). The CFS is a 9-point global measure of frailty ranging from 1 (very fit) to 9 (terminally ill). Higher scores indicate greater frailty and worse overall health status. |
| Handgrip strength | Baseline, 8 weeks, and 6 months | Handgrip strength was measured using a handheld dynamometer and expressed in kilograms (kg). The measure has no fixed minimum or maximum value. Higher values indicate greater muscle strength and generally a better outcome. |
| Nutritional status | Baseline, 8 weeks, and 6 months | Nutritional status assessed according to Global Leadership Initiative on Malnutrition (GLIM) criteria. |
| Lean body mass | Baseline, 8 weeks, and 6 months | Lean Body Mass (%), assessed by bioelectrical impedance analysis (BIA), ranges from 0% to 100%, with higher values indicating a greater proportion of lean tissue relative to total body weight. |
| Phase angle | Baseline, 8 weeks and 6 months | Phase Angle (PhA) was assessed using bioelectrical impedance analysis (BIA) and expressed in degrees (°). The measure has no fixed minimum or maximum value. Higher values indicate better cellular health, membrane integrity, and nutritional status, whereas lower values are associated with poorer nutritional and functional status. |
| Anxiety and depression symptoms | Baseline, 8 weeks, and 6 months | Symptoms assessed using the Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item questionnaire comprising two 7-item subscales assessing anxiety (HADS-A) and depression (HADS-D). Subscale scores range from 0 to 21, and the total score ranges from 0 to 42. Higher scores indicate greater symptoms of anxiety and depression and therefore a worse outcome. |
| Anxiety related to surgery | Baseline, 8 weeks, and 6 months | Preoperative anxiety assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS). The APAIS is a 6-item questionnaire assessing preoperative anxiety and need for information. The anxiety subscale ranges from 4 to 20, and the information subscale ranges from 2 to 10. The total score ranges from 6 to 30. Higher scores indicate greater preoperative anxiety and/or greater need for information. |
| Postoperative quality of recovery | Postoperative day 5 and postoperative day 30 | Quality of postoperative recovery assessed using the Quality of Recovery-15 questionnaire (QoR-15). The QoR-15 is a 15-item patient-reported outcome measure assessing postoperative recovery across multiple domains, including physical comfort, emotional state, physical independence, psychological support, and pain. Total scores range from 0 to 150, with higher scores indicating better quality of recovery and a better postoperative outcome. |
| Postoperative complications | Within 30 days after transplantation | Overall burden of postoperative complications assessed using the Comprehensive Complication Index (CCI). |
| Lenght of postoperative hospital stay | From surgery to hospital discharge, assessed up to 30 days postoperatively. | Length of Postoperative Hospital Stay is defined as the number of days from surgery until hospital discharge. The measure has no fixed minimum or maximum value. Lower values indicate a shorter postoperative hospitalization and generally a better outcome. |
| Intensive care unit admission | From surgery through hospital discharge, assessed up to 30 days. | Requirement for intensive care unit admission after kidney transplantation during hospital stay. |
| Length of Intensive Care Unit (ICU) Stay | From ICU admission to ICU discharge, assessed up to 30 days | Length of Intensive Care Unit (ICU) Stay was defined as the time from ICU admission to ICU discharge and was expressed in days (or hours). The measure has no fixed minimum or maximum value. Lower values indicate a shorter ICU stay and generally a better outcome |
Countries
Spain
Contacts
CONTACTBeatriz Tena, MD, PhD
Outcome results
None listed