Remote vs In-Person Prehabilitation for Kidney Transplant Candidates
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Clinic of Barcelona
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
In-Person Multimodal Prehabilitation
BehavioralParticipants 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.
Remote Multimodal Prehabilitation
BehavioralParticipants 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.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: In-Person Multimodal PrehabilitationExperimental treatment 1 intervention
Group B: Remote Multimodal PrehabilitationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in functional capacity measured by the 6-Minute Walk Test (6MWT)
Change in walking distance (meters) between baseline and post-intervention assessment measured using the 6-Minute Walk Test.
Time frame
Baseline and 8 weeks2
Kidney disease-specific quality of life (KDQOL-36)
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.
Time frame
Baseline, 8 weeks, and 6 monthsSecondary outcomes
1
Program adherence
Percentage of scheduled exercise sessions completed during the supervised intervention period.
Time frame
8 weeks2
Physical activity level
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.
Time frame
Baseline, 8 weeks, and 6 months3
Functional mobility (Timed Up and Go Test)
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.
Time frame
Baseline, 8 weeks, and 6 months4
Frailty status
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.
Time frame
Baseline, 8 weeks, and 6 monthsSponsors and contacts
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Source ClinicalTrials.gov
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