Development and Testing of a Prehabilitation Intervention to Maximize Early Recovery (PRIMER) in Liver Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Feasibility of the Intervention
研究概览
简要总结
This is a single center, 2-arm, patient-randomized study evaluating the feasibility and potential efficacy of the PRIMER intervention in improving physical function and reducing frailty in adult Liver Transplant candidates. The intervention will consist of a patient-tailored prehabilitation program designed to reduce frailty, improve physical function and nutritional status, and optimize pre- and post-transplant outcomes.
详细描述
The investigator will pilot-test a two-arm, randomized trial of a prehabilitation intervention in 38 pre-liver transplant patients with End Stage Liver Disease (ESLD). The investigator estimates an attrition rate of 20%, resulting n=30 participants; 10 participants in Arm 1 (control arm) and 20 participants in Arm 2 (intervention arm). To be eligible, patients must be waitlisted or "Penn-Ready" with a MELD-Na less than or equal to 25, English-speaking, able to safely participant in an exercise program, have a smartphone, and be identified as frail. The purpose of this trial is to develop and implement a program of medical optimization, physical activity, and nutrition recommendations specifically tailored to ESLD and designed to reduce frailty, improve physical function, and optimize pre- and post-transplant outcomes.
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
- Single (Investigator)
入排标准
- 年龄范围
- 21 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be wait-listed, in transplant evaluation, or "Penn Ready" with a MELD-Na score less than or equal to 25;
- •Patients must be English speaking and own/use a smartphone and cognitively able to consent;
- •Patient and physician feel that individual can safely participate in an exercise program;
- •Meeting at least one 'at risk' criterion for impaired physical performance, frailty, or malnutrition (by SPPB, abPG-SG, dynamometer measured grip strength), or physical deconditioning as determined by physical therapist, or treating clinician.
排除标准
- •The patient is unable to provide informed consent;
- •The patient has been hospitalized within the last 30 days;
- •A score of 0-3 points on the SPPB assessment indicating inability to participate in a physical activity program or a score of 12 in the absence of frailty or malnutrition (indicating low risk for poor physical or performance or malnutrition);
- •The patient is at risk for falling as defined by clinician assessment results or if the patient states that he/she has a history of falling (record of a fall(s) in the past 30 days);
- •The patient is already enrolled in a financial incentive-based exercise program using a wearable device;
- •Any other medical conditions that would prohibit participation in a physical activity program as determined by transplant clinicians or severe vision, hearing, or mobility impairment precluding participation.
结局指标
主要结局
Feasibility of the Intervention
时间窗: 14 weeks
Feasibility of the intervention will be evaluated by the percentage of patients that complete the study intervention.
Acceptability of the Intervention
时间窗: 14 weeks
Acceptability will be measured using a patient satisfaction questionnaire upon study completion.
次要结局
- Grip strength level relative to BMI(14 weeks)
- Grip strength(14 weeks)
- Performance on the Short Physical Performance Battery (SPPB)(14 weeks)
- Body composition/BIA(14 weeks)
研究者
Marina Serper, MD, MS
Assistant Professor of Medicine
University of Pennsylvania