Clinical trial NCT05489432: PREhabilitation of Candidates for REnal Transplantation
Official title: PREhabilitation of CAndidates for REnal Transplantation: a Hybrid Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prehabilitation
Kidney Transplant Candidates
Frailty
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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)

Detailed description: Rationale: 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.

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.

Eligibility criteria: 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 (October 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

Primary outcomes:
measure: Change in frailty status
timeFrame: Baseline-week 13
measure: Change in frailty status
timeFrame: week 13- week 26
Secondary outcomes:
measure: Change in functional capacity
timeFrame: Baseline-week 13
measure: Change in functional capacity
timeFrame: week 13- week 26
measure: Change in handgrip strength
timeFrame: Baseline-week 13
measure: Change in handgrip strength
timeFrame: week 13- week 26
measure: Change in Fat Free Mass
timeFrame: Baseline-week 13
measure: Change in Fat Free Mass
timeFrame: week 13- week 26
measure: Change in Body Mass Index
timeFrame: Baseline-week 13
measure: Change in Body Mass Index
timeFrame: week 13- week 26
measure: Change in symptoms of fatigue
timeFrame: Baseline-week 13
measure: Change in symptoms of fatigue
timeFrame: week 13- week 26
measure: Change in symptoms of anxiety
timeFrame: Baseline-week 13
measure: Change in symptoms of anxiety
timeFrame: week 13- week 26
measure: Change in symptoms of depression
timeFrame: Baseline-week 13
measure: Change in symptoms of depression
timeFrame: week 13- week 26
measure: Change in Health related Quality of Life
timeFrame: Baseline-week 13
measure: Change in Health related Quality of Life
timeFrame: week 13- week 26
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Coby Annema, PhD
role: PRINCIPAL_INVESTIGATOR
References: