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NCT Number: NCT07338929

Physical Performance Assessment in Kidney Transplant Evaluation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrej Kollar, MD

CONTACT

[email protected]

+421434203184

Katarina Sevcikova, MD

CONTACT

[email protected]

+421434203184

Sponsors and collaborators

Lead sponsor

University Hospital, Martin

Other

Registry information

Official study title

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

Acronym: FRAIL-KTx

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 14, 2026
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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