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

8. července 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

84

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Beatriz Tena, MD, PhD
  • Telefonní číslo: +34625193128
  • E-mail: btena@clinic.cat

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: In-Person Multimodal Prehabilitation
Behavioral: In-Person Multimodal Prehabilitation
Behaviorální: 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.
Experimentální: Remote Multimodal Prehabilitation
Behavioral: Remote Multimodal Prehabilitation
Behaviorální: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in functional capacity measured by the 6-Minute Walk Test (6MWT)
Časové okno: 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)
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Program adherence
Časové okno: 8 weeks
Percentage of scheduled exercise sessions completed during the supervised intervention period.
8 weeks
Physical activity level
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Hospital Clinic of Barcelona

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. července 2026

Primární dokončení (Odhadovaný)

1. května 2028

Dokončení studie (Odhadovaný)

1. května 2029

Termíny zápisu do studia

První předloženo

27. května 2026

První předloženo, které splnilo kritéria kontroly kvality

8. července 2026

První zveřejněno (Aktuální)

14. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

14. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

8. července 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • HCB/2026/0063

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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