NCT07701382

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
34mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Jul 2026May 2029

First Submitted

Initial submission to the registry

May 27, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

July 14, 2026

Status Verified

May 1, 2026

Enrollment Period

1.8 years

First QC Date

May 27, 2026

Last Update Submit

July 8, 2026

Conditions

Chronic Kidney Disease (CKD)Kidney TransplantFrailtyPrehabilitation

Keywords

advanced chronic kidney diseasekidney transplantationprehabilitationfunctional capacityperioperative carequality of lifemultimodal prehabilitation

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline and 8 weeks

  • 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.

    Baseline, 8 weeks, and 6 months

Secondary Outcomes (15)

  • Program adherence

    8 weeks

  • Physical activity level

    Baseline, 8 weeks, and 6 months

  • Functional mobility (Timed Up and Go Test)

    Baseline, 8 weeks, and 6 months

  • Frailty status

    Baseline, 8 weeks, and 6 months

  • Handgrip strength

    Baseline, 8 weeks, and 6 months

  • +10 more secondary outcomes

Study Arms (2)

In-Person Multimodal Prehabilitation

EXPERIMENTAL

Behavioral: In-Person Multimodal Prehabilitation

Behavioral: In-Person Multimodal Prehabilitation

Remote Multimodal Prehabilitation

EXPERIMENTAL

Behavioral: Remote Multimodal Prehabilitation

Behavioral: Remote Multimodal Prehabilitation

Interventions

In-Person Multimodal PrehabilitationBEHAVIORAL

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.

In-Person Multimodal Prehabilitation
Remote Multimodal PrehabilitationBEHAVIORAL

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.

Remote Multimodal Prehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Related Publications (4)

  • Quint EE, Haanstra AJ, van der Veen Y, Maring H, Berger SP, Ranchor A, Bakker SJL, Finnema E, Pol RA, Annema C; PreCareTx Investigators. PREhabilitation of CAndidates for REnal Transplantation (PreCareTx) study: protocol for a hybrid type I, mixed method, randomised controlled trial. BMJ Open. 2023 Jul 27;13(7):e072805. doi: 10.1136/bmjopen-2023-072805.

    PMID: 37500274BACKGROUND

  • Kirkman DL, Kidd JM, Carbone S, Pontinha VM, Tanriover B, Kumar D, Gupta G. Frailty and Prehabilitation: Navigating the Road to a Successful Transplant. J Am Soc Nephrol. 2024 Nov 1;35(11):1607-1609. doi: 10.1681/ASN.0000000000000485. Epub 2024 Aug 13. No abstract available.

    PMID: 39137041BACKGROUND

  • Cheng XS, Myers JN, Chertow GM, Rabkin R, Chan KN, Chen Y, Tan JC. Prehabilitation for kidney transplant candidates: Is it time? Clin Transplant. 2017 Aug;31(8). doi: 10.1111/ctr.13020. Epub 2017 Jul 10.

    PMID: 28564126BACKGROUND

  • McAdams-DeMarco MA, Ying H, Van Pilsum Rasmussen S, Schrack J, Haugen CE, Chu NM, Gonzalez Fernandez M, Desai N, Walston JD, Segev DL. Prehabilitation prior to kidney transplantation: Results from a pilot study. Clin Transplant. 2019 Jan;33(1):e13450. doi: 10.1111/ctr.13450. Epub 2018 Dec 21.

    PMID: 30462375BACKGROUND

Related Links

MeSH Terms

Conditions

Renal Insufficiency, ChronicFrailty

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Beatriz Tena, MD, PhD

CONTACT

+34625193128btena@clinic.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2026

First Posted

July 14, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2029

Last Updated

July 14, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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.

Locations

ES(1)