Preoperative PREhabilitation in Patients Planned for LIVER Transplantation (PRELIVERT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Program satisfaction
研究概览
简要总结
The objective of this study is to determine the feasibility and effectiveness of a home-based multimodal prehabilitation program in patients anticipated to be waitlisted for LT. Patients will participate in an eight week prehabilitation program consisting of physical exercise, nutritional support, smoking cessation and psychological counselling.
详细描述
Rationale: Patients who qualify for liver transplantation (LT) are mostly frail due to their underlying liver disease. Frailty is comprised by a decreased functional capacity, impaired aerobic capacity, and sarcopenia. It is well known that frailty leads to both increased pre- and post-transplantation morbidity as well as mortality. For various surgical populations prehabilitation was demonstrated to be feasible, effective, and to improve surgical outcomes. Few studies on this subject have been conducted in the patient population awaiting liver transplantation.
Objective: The primary objective is to determine the feasibility of a semi-supervised homebased prehabilitation program for patients to be waitlisted for LT. The secondary objectives are to assess the effectiveness of this program and possible improvements of surgical outcomes (e.g. less complications, faster recovery, and shorter length of hospital stay).
Study design: This is a multi-centre, single arm, prospective cohort (pilot) study. It will take place at the Erasmus Medical Center in Rotterdam, the Netherlands.
Study population: Adult patients who are anticipated to be waitlisted for LT, who have no contra-indications to physical exercise training.
Intervention: Patients will participate in an eight-week semi-supervised home based prehabilitation program. This program consists of physical exercise, nutritional support provided by a dietician, smoking cessation, and psychological counselling. The program will be personalized and consists of two training sessions per week. Through the Oefenportaal platform the physical therapist will supervise the exercises and monitor patients' adherence to the program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age ≥18 years,
- •Anticipated waitlisting for LT,
- •Speaks the Dutch language,
- •Understands the purpose of the study and has given written informed consent.
排除标准
- •Experienced a major adverse cardiovascular event in the past six months,
- •Experienced a cerebrovascular incident in the past six months,
- •Medical history of an uncontrolled heart rhythm disorder,
- •Hepatic encephalopathy grade 3 or 4,
- •Acute liver failure,
- •Acute-on-chronic liver failure,
- •Hospitalization at start of the study.
- •Non-treated esophageal varices (i.e., no previous variceal eradication endoscopy or adequately dosed NSBB)
研究组 & 干预措施
Home based prehabilitation
Participants will be subjected to a training period of eight weeks of a home-based multimodal prehabilitation program. The program consists of an exercise program, nutritional support, smoking cessation and psychological counselling.
干预措施: Prehabilitation program (Other)
结局指标
主要结局
Program satisfaction
时间窗: At completion of the prehabilitation program (8 weeks after baseline/screening for LT)
Self-designed questionnaire score (score between 1-10, higher score means higher satisfaction)
Program compliance
时间窗: At completion of the prehabilitation program (8 weeks after baseline/screening for LT)
Number of sessions that patient participates in the fitness training, the counselling on nutrition, smoking cessation and psychosocial sessions will be registered.
Percentage of patients willing to participate in the prehabilitation program
时间窗: At the outpatient clinic, when patients make their appointment for screening for LT
It will be registered which patients are willing and not willing to participate
次要结局
- Aerobic capacity(At start of the program, when patients are admitted for screening, they will perform a CPET as baseline. After eight weeks of home-based training the CPET will be reassessed.)
- Sarcopenia(At baseline (before start prehabilitation program) and after eight weeks.)
- Anthropometry(At baseline (before start prehabilitation program) and after eight weeks.)
- Functional capacity(At baseline (before start prehabilitation program) and after eight weeks.)
- Functional mobility(At baseline (before start prehabilitation program) and after eight weeks.)
- Physical activity level(At baseline (before start prehabilitation program) and after eight weeks patients will wear the ActiGraph accelerometer for 7 days.)
- Hand grip strength(At baseline (before start prehabilitation program) and after eight weeks.)
- Quadriceps strength(At baseline (before start prehabilitation program) and after eight weeks)
- Quality of life assessment(At baseline (before start prehabilitation program) and after eight weeks)
- Perceived fatigue assessment(At baseline (before start prehabilitation program) and after eight weeks)
- Postoperative outcomes up to 30 days post LT assessment(Through study completion (30 days after LT))
研究者
Roeland F. de Wilde
Principal Investigator
Erasmus Medical Center