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Remote vs In-Person Prehabilitation for Kidney Transplant Candidates (KIDFIT)

8 juli 2026 bijgewerkt door: Hospital Clinic of Barcelona

Implementation of a Multimodal Prehabilitation Program for Patients With Advanced Chronic Kidney Disease Awaiting Deceased-Donor Kidney Transplantation: A Comparison of In-Person and Remote Delivery Models

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

84

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Beatriz Tena, MD, PhD
  • Telefoonnummer: +34625193128
  • E-mail: btena@clinic.cat

Studie Locaties

  • Spanje
    • Barcelona
      • Barcelona, Barcelona, Spanje, 08036
        • Hospital Clinic Barcelona
        • Contact:
          • Graciela Martínez-Pallí, MD, PhD
          • Telefoonnummer: +34932275558
          • E-mail: gmartin@clinic.cat
        • Hoofdonderzoeker:
          • Beatriz Tena, MD, PhD
        • Onderonderzoeker:
          • Graciela Martínez-Pallí, MD, PhD
        • Onderonderzoeker:
          • Antonio López, MD
        • Onderonderzoeker:
          • Fritz Diekman, MD, PhD
        • Onderonderzoeker:
          • Alicia Molina, MD
        • Onderonderzoeker:
          • Arana Carolt, MD, PhD
        • Onderonderzoeker:
          • Marta Arias, MD, PhD
        • Onderonderzoeker:
          • Enrique Montagud, MD
        • Onderonderzoeker:
          • Mireia Musquera, MD, PhD
        • Onderonderzoeker:
          • Fernando Dana, RN
        • Onderonderzoeker:
          • Raquel Sebio-Garcia, PT, PhD
        • Onderonderzoeker:
          • Anna Yuguero, PT
        • Onderonderzoeker:
          • Barbara Romano, RD
        • Onderonderzoeker:
          • Miguel Garriz, PsyD
        • Onderonderzoeker:
          • Yolanda Amarilla, RN
        • Onderonderzoeker:
          • Sonia Perea, RN
        • Onderonderzoeker:
          • Ana María Pérez, RN

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: In-Person Multimodal Prehabilitation
Behavioral: In-Person Multimodal Prehabilitation
Gedragsmatig: In-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.
Experimenteel: Remote Multimodal Prehabilitation
Behavioral: Remote Multimodal Prehabilitation
Gedragsmatig: Remote 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in functional capacity measured by the 6-Minute Walk Test (6MWT)
Tijdsspanne: Baseline and 8 weeks
Change in walking distance (meters) between baseline and post-intervention assessment measured using the 6-Minute Walk Test.
Baseline and 8 weeks
Kidney disease-specific quality of life (KDQOL-36)
Tijdsspanne: 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.
Baseline, 8 weeks, and 6 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Program adherence
Tijdsspanne: 8 weeks
Percentage of scheduled exercise sessions completed during the supervised intervention period.
8 weeks
Physical activity level
Tijdsspanne: 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.
Baseline, 8 weeks, and 6 months
Functional mobility (Timed Up and Go Test)
Tijdsspanne: 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.
Baseline, 8 weeks, and 6 months
Frailty status
Tijdsspanne: 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.
Baseline, 8 weeks, and 6 months
Handgrip strength
Tijdsspanne: 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.
Baseline, 8 weeks, and 6 months
Nutritional status
Tijdsspanne: Baseline, 8 weeks, and 6 months
Nutritional status assessed according to Global Leadership Initiative on Malnutrition (GLIM) criteria.
Baseline, 8 weeks, and 6 months
Lean body mass
Tijdsspanne: 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.
Baseline, 8 weeks, and 6 months
Phase angle
Tijdsspanne: 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.
Baseline, 8 weeks and 6 months
Anxiety and depression symptoms
Tijdsspanne: 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.
Baseline, 8 weeks, and 6 months
Anxiety related to surgery
Tijdsspanne: 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.
Baseline, 8 weeks, and 6 months
Postoperative quality of recovery
Tijdsspanne: 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 day 5 and postoperative day 30
Postoperative complications
Tijdsspanne: Within 30 days after transplantation
Overall burden of postoperative complications assessed using the Comprehensive Complication Index (CCI).
Within 30 days after transplantation
Lenght of postoperative hospital stay
Tijdsspanne: 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.
From surgery to hospital discharge, assessed up to 30 days postoperatively.
Intensive care unit admission
Tijdsspanne: From surgery through hospital discharge, assessed up to 30 days.
Requirement for intensive care unit admission after kidney transplantation during hospital stay.
From surgery through hospital discharge, assessed up to 30 days.
Length of Intensive Care Unit (ICU) Stay
Tijdsspanne: 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
From ICU admission to ICU discharge, assessed up to 30 days

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hospital Clinic of Barcelona

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

1 mei 2028

Studie voltooiing (Geschat)

1 mei 2029

Studieregistratiedata

Eerst ingediend

27 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

8 juli 2026

Eerst geplaatst (Werkelijk)

14 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

8 juli 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • HCB/2026/0063

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

De-identified individual participant data (IPD) underlying the published results, including demographic, clinical, functional, and patient-reported outcome data collected during the study, may be shared upon reasonable request to the principal investigator after publication of the primary results. Data sharing will be considered for methodologically sound research proposals and following approval by the study investigators and institutional policies. All shared data will be fully anonymized in accordance with applicable data protection regulations. Supporting documents such as the study protocol, statistical analysis plan, and informed consent form may also be made available upon request.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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