Physical Performance Assessment in Kidney Transplant Evaluation (FRAIL-KTx)

January 6, 2026 updated by: Matej Vnucak, University Hospital, Martin

Physical Performance Assessment in Kidney Transplant Evaluation Using the Short Physical Performance Battery (SPPB)

This prospective cohort study investigates physical frailty, assessed by the Short Physical Performance Battery (SPPB), in patients evaluated for kidney transplantation. The study aims to compare SPPB scores before listing, annually during the waiting period, and after transplantation at 6 and 12 months. It also includes a control group of dialysis patients not eligible for transplantation to evaluate differences in physical performance. The goal is to understand how frailty impacts transplant outcomes and patient recovery.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This longitudinal, prospective study focuses on assessing the role of physical frailty in patients undergoing evaluation for kidney transplantation using the Short Physical Performance Battery (SPPB). The study will enroll adult patients who are being assessed for kidney transplantation, including those who are deemed suitable and placed on the waiting list (Arm A) and those on dialysis who are considered unsuitable for transplant listing (Arm B).

Participants will undergo comprehensive SPPB assessments at baseline, during their evaluation process, and subsequently at annual follow-up intervals. For listed patients, the assessments will be performed upon initial evaluation, then annually while on the waiting list, and at 6 and 12 months following transplantation. For patients ineligible for the transplant list and on dialysis, the SPPB will be recorded at baseline and then annually, allowing cross-sectional comparison and understanding of their physical performance trajectory.

The primary objective is to evaluate changes in physical performance over time with the SPPB score, which ranges from 0 to 12. The scores will be used to categorize participants into frail, pre-frail, or non-frail groups, providing insights into the prevalence and evolution of frailty in this population.

Secondary objectives include comparing the baseline and follow-up SPPB scores between the two arms, correlating physical performance with post-transplant outcomes such as graft function and survival, and identifying potential predictors of frailty that could inform prehabilitation interventions.

This study may inform future strategies to optimize physical function in kidney transplant candidates and improve clinical outcomes through targeted interventions addressing physical frailty.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Katarina Sevcikova, MD
  • Phone Number: +421434203184
  • Email: tc@unm.sk

Study Contact Backup

  • Name: Andrej Kollar, MD
  • Phone Number: +421434203184
  • Email: tc@unm.sk

Study Locations

  • Slovakia
      • Martin, Slovakia, 03601
        • Recruiting
        • Transplant-nephrology department
        • Contact:
          • Katarina Sevcikova, MD
          • Phone Number: +421434203184
          • Email: tc@unm.sk
        • Contact:
          • Ivana Dedinska, prof., MD, PhD.
          • Phone Number: +421434203184
          • Email: tc@unm.sk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic kidney disease undergoing dialysis or pre-transplant evaluation prior to kidney transplantation.

Description

Inclusion Criteria:

  1. Adult patients (≥18 years) undergoing evaluation for kidney transplantation.
  2. Patients on dialysis.
  3. Ability and consent to participate.

Exclusion Criteria:

  1. Non-adult patients.
  2. Patients unable to provide informed consent.
  3. Acute medical conditions prohibiting SPPB assessment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
kidney transplant recipients
The study will enroll adult patients who are being assessed for kidney transplantation, including those who are deemed suitable and placed on the waiting list (Arm A) and those on dialysis who are considered unsuitable for transplant listing (Arm B).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess changes in physical performance using SPPB scores before and after kidney transplantation.
Time Frame: 3-5 years
Characterization of physical performance levels in patients considered for kidney transplantation.
3-5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Martin

Investigators

  • Study Chair: Ivana Dedinska, prof. MD., PhD., Unievrsity Hospital Martin and Jessenius Faculty of Medicine Comenius University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2028

Study Registration Dates

First Submitted

November 27, 2025

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNO FRAIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data underlying the reported results will be available upon reasonable request from qualified researchers after publication, subject to institutional and ethical approval. Supporting documents (study protocol, statistical analysis plan) may also be shared.

IPD Sharing Time Frame

from 01/OCT/2025 for 20 years

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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