PREhabilitation of Candidates for REnal Transplantation

NCT05489432 | Recruiting

• 1 other identifier: 10812
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

In this study a personalized, multi modal prehabilitation intervention will be offered to n = 64 patients on the kidney transplant waiting-list. The control group (n = 64) will receive care as usual. Based on a screening, comprised of questionnaires and physical test, eligible kidney transplant candidates who have modifiable problems on the domains of physical capacity, nutritional status or psychological well-being, will be randomly assigned to either the intervention or control group. The intervention will consist of a 12-week prehabilitation program followed by a 12 week consolidation program. Primary outcome will be frailty status as an indicator of overall health status and will be measured at screening (T0), 13 weeks (T1) and 26 weeks (T2)

Conditions

Prehabilitation; Kidney Transplant Candidates; Frailty

Outcome Measures

Primary Outcomes (2)

• Change in frailty status

  Frailty will be measured with the Tilburg Frailty Index, which measures the physical, psychological and social domain of frailty with 15 items. The total score ranges from 0-15, in which higher a score indicates a higher level of frailty

  Baseline-week 13

• Change in frailty status

  Frailty will be measured with the Tilburg Frailty Index, which measures the physical, psychological and social domain of frailty with 15 items. The total score ranges from 0-15, in which higher a score indicates a higher level of frailty

  week 13- week 26

Secondary Outcomes (16)

• Change in functional capacity

  Baseline-week 13

• Change in functional capacity

  week 13- week 26

• Change in handgrip strength

  Baseline-week 13

• Change in handgrip strength

  week 13- week 26

• Change in Fat Free Mass

  Baseline-week 13

Study Arms (2)

prehabilitation group

EXPERIMENTAL

care as usual and pre habilitation intervention

Behavioral: Exercise

control group

NO INTERVENTION

care as usual

Interventions

Exercise BEHAVIORAL

A twelve-week prehabilitation program consisting of physical exercises, nutritional measures and psychosocial interventions based on the KTCs personal needs as indicated by an assessment consisting of questionnaires and physical tests. The prehabilitation program will be followed by a twelve-week consolidation program, in which the intensity and frequency of the interventions will be lower, in order to enhance the incorporation of the interventions into the daily life of the KTC. During the intervention period, participants will receive counseling by a lifestyle coach.

Also known as: nutritional measures, stress reduction

prehabilitation group

Eligibility Criteria

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

You may qualify if:

• Adult kidney transplant candidates (≥18 years)

You may not qualify if:

• Inability to read and/or speak Dutch
• Combined organ transplantation (e.g., kidney+pancreas, kidney+liver)
• In case of living donor kidney transplant: a transplantation planned within 3 months
• Involved in a lifestyle intervention program

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

RECRUITING

Related Publications (1)

• Quint EE, Haanstra AJ, van der Veen Y, Maring H, Berger SP, Ranchor A, Bakker SJL, Finnema E, Pol RA, Annema C; PreCareTx Investigators. PREhabilitation of CAndidates for REnal Transplantation (PreCareTx) study: protocol for a hybrid type I, mixed method, randomised controlled trial. BMJ Open. 2023 Jul 27;13(7):e072805. doi: 10.1136/bmjopen-2023-072805.

  PMID: 37500274 DERIVED

MeSH Terms

Conditions

Frailty

Interventions

Exercise; Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Coby Annema, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Coby C Annema, PhD

CONTACT

+31621551352; j.h.annema@umcg.nl

Avril Haanstra, MsC

CONTACT

+31503611490; a.j.haanstra@umcg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: An effectiveness-implementation hybrid type 1 study design comprised of a randomized controlled trial to test the effectiveness of prehabilitation to improve the overall health status of KTCs, and a mixed-methods study to gather information on its potential for further implementation.

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 5, 2022
• Study Start: January 23, 2023
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)