Physical Performance Assessment in Kidney Transplant Evaluation

NCT ID: NCT07338929

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2028-10-31

Brief Summary

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.

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.

Conditions

Frailty Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Martin

OTHER

Sponsor Role: lead

Responsible Party

Matej Vnucak

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ivana Dedinska, prof. MD., PhD.

Role: STUDY_CHAIR

Unievrsity Hospital Martin and Jessenius Faculty of Medicine Comenius University

Locations

Transplant-nephrology department

Martin, , Slovakia

Site Status: RECRUITING

Countries

Slovakia

Central Contacts

Katarina Sevcikova, MD

Role: CONTACT

tc@unm.sk

+421434203184

Andrej Kollar, MD

Role: CONTACT

tc@unm.sk

+421434203184

Facility Contacts

Katarina Sevcikova, MD

Role: primary

tc@unm.sk

+421434203184

Ivana Dedinska, prof., MD, PhD.

Role: backup

tc@unm.sk

+421434203184

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

TNO FRAIL

Identifier Type: -

Identifier Source: org_study_id