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.
ID
Source
Brief title
Condition
- Nephropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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. Endpoints will be measured at T0 (baseline assessment), T1
(13 weeks after T0) and T2 (26 weeks after T0).
Secondary outcome
Secondary endpoints include changes in physical fitness (hand grip strength,
leg muscle strength, functional capacity, nutritional status (BMI, Fat free
mass, psychological well-being (fatigue, symptoms of anxiety and depression)
and quality of life. Endpoints will be measured at T0 (baseline assessment), T1
(13 weeks after T0) and T2 (26 weeks after T0).
Background summary
The health status of kidney transplant candidates (KTCs) is often compromised
due to their chronic kidney disease, comorbidities and/or dialysis. To be able
to handle the stress of the upcoming transplant surgery and enhance
post-operative recovery, it is important for KTCs to be in an optimal physical
and psychological condition. Prehabilitation, the enhancement of a person*s
functional capacity in order to improve the ability to withstand a future
stressor, may be an effective intervention to improve the overall health status
of KTCs. Although research investigating prehabilitation in transplant
populations is limited, studies showed that prehabilitation during the
waiting-list period is safe and feasible, and may have a positive effect on
pre- and postoperative outcomes. We hypothesized that, compared to usual care,
a prehabilitation program tailored to individual patients* needs will improve
the overall health status of KTCs.
Study 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.
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. Progress in physical
activity will be monitored using an online platform.
The control group will recieve care as usual
Study burden and risks
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.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
1. Adult kidney transplant candidates (>=18 years)
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 (November
2022 - March 2025).
Exclusion criteria
1. Inability to read and/or speak Dutch
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05489432 |
| CCMO | NL82273.042.22 |