Home-based EXercise and motivAtional Program Before and After Liver Transplantation: EXALT
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 269
- 试验地点
- 4
- 主要终点
- The physical component score (PCS) from the short form-36 version 2.0 (SF-36v2) health-related Quality of Life questionnaire
研究概览
简要总结
Liver disease is the 3rd commonest cause of death in adults of working age and liver transplantation (LT) remains the only cure for liver failure. LT exerts a huge stress on the body and mind, especially in people who are already physically and mentally frail because of their liver disease. Investigators know that being physically frailty prior to surgery results in a longer hospital stay because of postoperative complications and contributes to 1 in 10 patients either dying whilst still on the waiting list or shortly after LT. Exercise is one of the most powerful medical therapies available, with numerous proven benefits to patients with diseases like diabetes, heart disease and cancer. Despite this, exercise is not currently used in patients with liver failure or recovering from LT, due to a lack of robust evidence. Exercise may have the potential to improve the lives of people with liver disease and reduce the side-effects of LT surgery. The current standard of care for NHS patients awaiting LT is an advice leaflet. Evidence-based exercise programmes around the time of transplantation do not exist. Only a few small studies have indicated that supervised, hospital-based exercise can improve physical function and quality of life. AIMS: Investigators aim to determine the effect of a home-based exercise and motivation-support programme in patients undergoing LT on their quality of life after surgery. Investigators would also like to understand if exercise results in improvements in intricate measures of physical fitness and muscle function that account for changes in quality of life, and how the motivation-support component of the intervention enhances uptake and ongoing engagement of exercise pre and post LT.
详细描述
Investigators intend to perform a clinical trial, in which patients will be randomly allocated to receive either the home-based exercise/motivation support programme (intervention group) or a patient advice leaflet (control group) whilst on the LT waiting list. The intervention will begin whilst patients are on the LT waiting list and end 6 months after LT. The intervention will consist of regular strength and endurance exercises, tailored to each patient's level of fitness. During clinic visits and via telephone calls a physiotherapist will provide motivational support throughout the exercise programme. The trial will involve recruiting 266 patients over two years from two LT hospitals in England. Investigators shall assess the effectiveness of the intervention by measuring quality of life before and after the study period in both groups of patients. The intervention will be deemed effective if quality of life scores are higher with the intervention than the control group.
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 patients (aged 18 years or over)
- •Patients listed for a cadaveric, primary LT at QEUHB or the RFH
- •Being an out-patient at the time of baseline trial visit (consent)
排除标准
- •Patients listed for LT for any of the following reasons:
- •super-urgent LT (according to the Kings College criteria)
- •multi-organ transplantation (e.g. combined liver and kidney transplant)
- •live-related donor LT
- •re-graft LT
- •Patients with an inability to safely comply with the exercise intervention due to:
- •severe hepatic encephalopathy (grade 3 or 4; or as judged by the clinical investigators)
- •oxygen-dependent hepato-pulmonary syndrome
- •Patients without liver failure, including:
- •liver cancer in the absence of cirrhosis
- •polycystic liver disease
- •rare metabolic/genetic conditions (e.g. glycogen storage disorders)
- •Refusal or lacks capacity to give informed consent to participate in the trial, at the point of study visit 1 (baseline)
结局指标
主要结局
The physical component score (PCS) from the short form-36 version 2.0 (SF-36v2) health-related Quality of Life questionnaire
时间窗: Baseline (visit 1, week 0) up to 24 weeks post-LT
The primary outcome measure for this trial is the PCS from the SF-36v2 health-related QoL questionnaire at 24 weeks post LT. The SF-36v2 questionnaire includes 36 questions composed of eight multi-item scales, which reflect the impact of health problems on both the physical and mental condition of the patient.(A higher score reflects better quality of life. Two summary sub-scores can be calculated which are weighted combinations of the 8 scales, one to reflect the impact on physical function (PCS) and one to reflect the impact on psychological function, known as the mental component score (MCS).Scoring of the SF-36v2 questionnaire will based on the instructions provided in the SF-36v2 user's manual.
次要结局
- Surgical complications -Comprehensive Complication Index (CCI):(LT up to 24 weeks post-LT)
- Mental Component Score (MCS) of SF-36v2 health-related QoL questionnaire(Baseline (visit 1, week 0) up to 24 weeks post-LT)
- Duke activity status index (DASI):(Baseline (visit 1, week 0) up to 24 weeks post-LT)
- Re-listing for transplant(Between Liver transplant and Visit 9 (24 weeks post liver transplant))
- Liver Frailty Index (LFI)(Baseline (visit 1, week 0) up to 24 weeks post-LT)
- Post-LT length of ICU stay (hours)(Between Liver transplant and immediately post-LT)
- length of hospital stay(Between Liver transplant and immediately post-LT)
- Post-LT mortality:(Between Liver transplant and Visit 10 (48 weeks post liver transplant))
- "Dose" of exercise completed (measure of the frequency, intensity and duration of exercise)(Between Baseline ((visit 1, week 0) and 24 weeks post LT)
- Pre-LT mortality (*assessed up to day of LT)(Baseline (visit 1, week 0) up to LT or the 48 week visit.)
- Pre-LT unscheduled hospitalisations(Baseline (visit 1, week 0) up to LT or the 48 week visit.)
- Pre-LT UKELD(Baseline (visit 1, week 0) up to LT or the 48 week visit.)
- Pre-LT MELD-Na(Baseline (visit 1, week 0) up to LT or the 48 week visit.)
- Habitual physical activity levels(Between Baseline (visit 1, week 0) and 24 weeks post LT)
- Adherence to HBEP (intervention arm only)(Between study baseline (visit 1) and 24 weeks post LT)
- Perceptions of the health care climate (how need supportive/empowering the physiotherapist is)(Between Baseline (visit 1, week 0) and 24 weeks post LT)
- Basic psychological need satisfaction (i.e. feelings of autonomy, relatedness, competence)(Between Baseline (visit 1, week 0) and 24 weeks post LT)
- Self-determined motivation to exercise(Between Baseline (visit 1, week 0) and 24 weeks post LT)