Implementation of a Multimodal Prehabilitation Program for Patients With Advanced Chronic Kidney Disease Awaiting Deceased-Donor Kidney Transplantation: A Comparison of In-Person and Remote Delivery Models
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change in functional capacity measured by the 6-Minute Walk Test (6MWT)
研究概览
简要总结
Patients with advanced chronic kidney disease awaiting deceased-donor kidney transplantation frequently experience progressive functional decline, frailty, reduced mobility, and poor quality of life while on the transplant waiting list. Although multimodal prehabilitation programs based on exercise, nutritional optimization, and psychological support have shown promising benefits in major surgery, their implementation in kidney transplant candidates remains limited due to barriers related to accessibility, fatigue, transportation, and treatment burden.
This randomized single-center clinical trial aims to evaluate the feasibility, adherence, and effectiveness of a multimodal prehabilitation program in patients awaiting deceased-donor kidney transplantation, comparing an in-person supervised model with a remote home-based model supported by a digital platform. The primary outcome will be the change in functional capacity measured by the 6-Minute Walk Test (6MWT). Secondary outcomes include physical activity level, frailty, nutritional status, kidney disease-specific quality of life (KDQOL-36), postoperative recovery quality (QoR-15), postoperative complications, and program adherence.
The study seeks to generate clinically applicable evidence regarding the implementation and scalability of remote prehabilitation strategies in patients with advanced chronic kidney disease, with the potential to improve accessibility, sustainability, and perioperative outcomes in kidney transplantation.
详细描述
Patients with advanced chronic kidney disease (CKD) awaiting deceased-donor kidney transplantation frequently experience progressive deterioration in functional capacity, mobility, and quality of life during the waiting-list period. Frailty, sarcopenia, cardiovascular comorbidity, anemia, fatigue, and physical inactivity are highly prevalent in this population and may adversely affect perioperative outcomes, postoperative recovery, and healthcare utilization after transplantation. Reduced cardiorespiratory reserve has been associated with increased postoperative morbidity and poorer clinical outcomes in kidney transplant recipients.
Prehabilitation has emerged as a perioperative optimization strategy aimed at enhancing functional reserve before surgical stress through multimodal interventions that combine structured exercise training, nutritional optimization, and psychological support. Previous studies in major surgery and solid organ transplantation suggest that prehabilitation may improve exercise tolerance, physical functioning, postoperative recovery, and patient-reported outcomes. However, implementation of prehabilitation programs in patients with advanced CKD remains limited because of barriers related to dialysis schedules, transportation burden, fatigue, reduced mobility, and limited access to specialized hospital-based programs.
Remote or home-based prehabilitation models supported by digital technologies may improve accessibility, adherence, and scalability while maintaining clinical effectiveness. Nevertheless, evidence comparing remote and in-person multimodal prehabilitation strategies in kidney transplant candidates remains scarce.
This study is a prospective randomized single-center clinical trial designed to evaluate the feasibility, adherence, and effectiveness of a multimodal prehabilitation program in adult patients with advanced CKD awaiting deceased-donor kidney transplantation. Participants will be randomized in a 1:1 ratio to either an in-person supervised prehabilitation program or a remote home-based program delivered through a digital platform.
Both intervention groups will receive the same multimodal components, differing only in the delivery format. The intervention includes structured individualized exercise training combining aerobic exercise, strength training, mobility, and balance exercises; individualized nutritional counseling focused on optimization of protein-energy status and prevention of sarcopenia; and psychological support aimed at stress management, motivation, and behavioral reinforcement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
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
- •Adults aged 18 years or older.
- •Patients with advanced chronic kidney disease on the waiting list for deceased-donor kidney transplantation.
- •Ability to perform moderate-intensity physical exercise.
- •Able and willing to provide written informed consent.
排除标准
- •Absolute contraindication to physical exercise.
- •Severe cognitive impairment limiting participation in the intervention or assessments.
- •Active infection at the time of enrollment.
- •Clinically unstable medical condition.
- •Physical or musculoskeletal limitations preventing participation in the exercise program.
研究组 & 干预措施
In-Person Multimodal Prehabilitation
Behavioral: In-Person Multimodal Prehabilitation
干预措施: In-Person Multimodal Prehabilitation (Behavioral)
Remote Multimodal Prehabilitation
Behavioral: Remote Multimodal Prehabilitation
干预措施: Remote Multimodal Prehabilitation (Behavioral)
结局指标
主要结局
Change in functional capacity measured by the 6-Minute Walk Test (6MWT)
时间窗: Baseline and 8 weeks
Change in walking distance (meters) between baseline and post-intervention assessment measured using the 6-Minute Walk Test.
Kidney disease-specific quality of life (KDQOL-36)
时间窗: Baseline, 8 weeks, and 6 months
Change in quality-of-life scores measured using the Kidney Disease Quality of Life-36 questionnaire. Domain scores range from 0 to 100, with higher scores indicating better health-related quality of life, including fewer kidney disease-related symptoms, less burden of kidney disease, and less interference of kidney disease with daily life.
次要结局
- Program adherence(8 weeks)
- Physical activity level(Baseline, 8 weeks, and 6 months)
- Functional mobility (Timed Up and Go Test)(Baseline, 8 weeks, and 6 months)
- Frailty status(Baseline, 8 weeks, and 6 months)
- Handgrip strength(Baseline, 8 weeks, and 6 months)
- Nutritional status(Baseline, 8 weeks, and 6 months)
- Lean body mass(Baseline, 8 weeks, and 6 months)
- Phase angle(Baseline, 8 weeks and 6 months)
- Anxiety and depression symptoms(Baseline, 8 weeks, and 6 months)
- Anxiety related to surgery(Baseline, 8 weeks, and 6 months)
- Postoperative quality of recovery(Postoperative day 5 and postoperative day 30)
- Postoperative complications(Within 30 days after transplantation)
- Lenght of postoperative hospital stay(From surgery to hospital discharge, assessed up to 30 days postoperatively.)
- Intensive care unit admission(From surgery through hospital discharge, assessed up to 30 days.)
- Length of Intensive Care Unit (ICU) Stay(From ICU admission to ICU discharge, assessed up to 30 days)