PREhabilitation of CAndidates for REnal Transplantation: a Hybrid Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Change in frailty status
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult kidney transplant candidates (≥18 years)
- •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).
排除标准
- •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
结局指标
主要结局
Change in frailty status
时间窗: week 13- week 26
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
次要结局
- Change in functional capacity(week 13- week 26)
- Change in handgrip strength(week 13- week 26)
- Change in Fat Free Mass(week 13- week 26)
- Change in symptoms of anxiety(week 13- week 26)
- Change in Body Mass Index(week 13- week 26)
- Change in Health related Quality of Life(week 13- week 26)
- Change in symptoms of fatigue(week 13- week 26)
- Change in symptoms of depression(week 13- week 26)
研究者
Coby Annema (J.H.)
PhD
University Medical Center Groningen