PREhabilitation of Candidates for REnal Transplantation
NCT ID: NCT05489432
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
128 participants
INTERVENTIONAL
2023-01-23
2025-10-31
Brief Summary
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Detailed Description
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Objective: To examine the effect of a multi-modal prehabilitation program on frailty and other indicators of physical and psychological fitness of KTCs during the waiting-list period and its optimal implementation in a real-world situation.
Study design: 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 population: Adult patients, who are currently on the University Medical Center Groningen kidney transplant waiting-list or will be wait listed during the study period.
Intervention: 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.
Main study parameters/endpoints: Frailty will serve as a proxy for overall health status. Therefore, the primary endpoint of this study is change in frailty status as measured by the Tilburg Frailty Indicator. Secondary endpoints include changes in physical fitness, nutritional status, psychological well-being and quality of life. Endpoints will be measured at T0 (baseline assessment), T1 (13 weeks after T0) and T2 (26 weeks after T0).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden for all participants (intervention and control group) will consist of filling out questionnaires (T0, 60 minutes), T1 (30 minutes) and T2 (30 minutes), completing at all three measurement points a food diary (45 minutes per measurement), to wear an activity tracker for three days, and three study visits at the UMCG in which physical tests will be performed (50-60 minutes per measurement). In total this will take ≈7 hours of their time during the 26 weeks of the study. In addition, participants in the intervention group will be asked to exercise ≈30 minutes a day and will have a weekly 10-to-15-minute counselling session by (video)call with the lifestyle coach. Efforts will differ per patient as the prehabilitation program will be tailor-made. Although the risk that patients may get injured during exercise is negligible, this will be monitored weekly by the lifestyle coach. We believe it is justified to perform the proposed study given the scarcity of data on the effectiveness of prehabilitation in KTCs and the potential of major improvements in physical functioning and psychological well-being and transplantation outcomes in this vulnerable patient group.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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prehabilitation group
care as usual and pre habilitation intervention
Exercise
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.
control group
care as usual
No interventions assigned to this group
Interventions
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Exercise
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Listed for kidney transplantation on the UMCG kidney transplant waiting list at the start of the study or wait listed during the inclusion period (October 2022 - March 2025).
Exclusion Criteria
2. Combined organ transplantation (e.g., kidney+pancreas, kidney+liver)
3. In case of living donor kidney transplant: a transplantation planned within 3 months
4. Involved in a lifestyle intervention program
18 Years
ALL
No
Sponsors
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University Medical Center Groningen
OTHER
Responsible Party
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Coby Annema (J.H.)
PhD
Principal Investigators
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Coby Annema, PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
Locations
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University Medical Center Groningen
Groningen, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Coby Annema, PhD
Role: primary
Avril Haanstra, MSc
Role: backup
References
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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.
Other Identifiers
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10812
Identifier Type: -
Identifier Source: org_study_id