Physical Performance Assessment in Kidney Transplant Evaluation

NCT07338929 | Recruiting

• 1 other identifier: TNO FRAIL
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty Syndrome

Keywords

kidney transplantation; chronic kidney diseases; frailty

Outcome Measures

Primary Outcomes (1)

• To assess changes in physical performance using SPPB scores before and after kidney transplantation.

  Characterization of physical performance levels in patients considered for kidney transplantation.

  3-5 years

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Martin: lead

Study Sites (1)

Transplant-nephrology department

Martin, 03601, Slovakia

RECRUITING

MeSH Terms

Conditions

Frailty; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes

Study Officials

• Ivana Dedinska, prof. MD., PhD.

  Unievrsity Hospital Martin and Jessenius Faculty of Medicine Comenius University

  STUDY CHAIR

Central Study Contacts

Katarina Sevcikova, MD

CONTACT

+421434203184; tc@unm.sk

Andrej Kollar, MD

CONTACT

+421434203184; tc@unm.sk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: January 14, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2028
• Last Updated: January 14, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: from 01/OCT/2025 for 20 years

Locations

SL (1)