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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic kidney disease undergoing dialysis or pre-transplant evaluation prior to kidney transplantation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katarina Sevcikova, MD | Contact | +421434203184 | tc@unm.sk | |
| Andrej Kollar, MD | Contact | +421434203184 | tc@unm.sk |
| Name | Affiliation | Role |
|---|---|---|
| Ivana Dedinska, prof. MD., PhD. | Unievrsity Hospital Martin and Jessenius Faculty of Medicine Comenius University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Transplant-nephrology department | Recruiting | Martin | 03601 | Slovakia |
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.
from 01/OCT/2025 for 20 years
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 5, 2025 | Nov 5, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
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| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |