Frailty SyndromeFRAIL-KTxNCT07338929
Physical Performance Assessment in Kidney Transplant Evaluation
An observational study of Frailty Syndrome, run by University Hospital, Martin at 1 site in Slovakia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frailty Syndrome
- How many people
- 50 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 Oct 2025to 31 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic kidney disease undergoing dialysis or pre-transplant evaluation prior to kidney transplantation.
Who may be able to join
- Adult patients (≥18 years) undergoing evaluation for kidney transplantation.
- Patients on dialysis.
- Ability and consent to participate.
Who cannot join
- Non-adult patients.
- Patients unable to provide informed consent.
- Acute medical conditions prohibiting SPPB assessment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovakia1 site, 1 recruiting
- Recruiting
Transplant-nephrology department
Martin, 03601
Katarina Sevcikova, MD, +421434203184, tc@unm.sk
Ivana Dedinska, prof., MD, PhD., +421434203184, tc@unm.sk
About this study
Official title: 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.
Read the 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
- Keywords
- kidney transplantation, chronic kidney diseases, frailty
- Medical subject headings
- Frailty, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start1 Oct 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frailty SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Martin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matej Vnucak, University Hospital, Martin
- Investigators
- Ivana Dedinska, prof. MD., PhD., Study chair, Unievrsity Hospital Martin and Jessenius Faculty of Medicine Comenius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338929
- Sponsor's protocol ID
- TNO FRAIL
- Acronym
- FRAIL-KTx
- Status last verified
- Nov 2025
- First submitted
- 27 Nov 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Performance Assessment in Kidney Transplant Evaluation Using the Short Physical Performance Battery (SPPB)
- ClinicalTrials.gov ID
- NCT07338929
- Acronym / sponsor ID
- FRAIL-KTx / TNO FRAIL
- Conditions
- Frailty Syndrome
- Keywords
- kidney transplantation, chronic kidney diseases, frailty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, MartinUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic kidney disease undergoing dialysis or pre-transplant evaluation prior to kidney transplantation.
Key inclusion criteria (3 listed)
- Adult patients (≥18 years) undergoing evaluation for kidney transplantation.
- Patients on dialysis.
- Ability and consent to participate.
Key exclusion criteria (3 listed)
- Non-adult patients.
- Patients unable to provide informed consent.
- Acute medical conditions prohibiting SPPB assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ivana Dedinska, prof. MD., PhD. study chair
Unievrsity Hospital Martin and Jessenius Faculty of Medicine Comenius University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty Syndrome, run by University Hospital, Martin at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katarina Sevcikova, MD (+421434203184, tc@unm.sk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess changes in physical performance using SPPB scores before and after kidney transplantation. (time frame: 3-5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.