OPAL: Online Prehabilitation for Patients Awaiting Liver Transplantation - a Multicenter Randomized Controlled Trial to Reduce Physical Frailty and Improve Health Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 177
- 试验地点
- 9
- 主要终点
- Change in time to do 5-sit-to-stands from baseline
研究概览
简要总结
Physical frailty is common in patients awaiting liver transplantation and has been associated with poor health outcomes. There is promising data from small studies showing that behavioural, nutrition, exercise therapy (prehabilitation) improves physical function in patients while they are waiting for a liver transplant.
The proposed trial will assess if a 12-week online prehabilitation program improves physical function in patients listed for liver transplantation. Over 4 years, 177 patients will be recruited from 6 transplant centres across Canada and will be randomized to receive either the online prehabilitation program or usual care.
The primary outcome of physical function will be evaluated using the FTSST at baseline and 12 weeks (or last timepoint before transplant) assessed virtually or in-person. Secondary outcomes include liver specific physical frailty, aerobic fitness, health-related quality of life (QoL), participant experience and acceptability. Exploratory outcomes include other virtual and in-person physical function measures, covert hepatic encephalopathy (CHE), sarcopenia, malnutrition, adherence, behaviour factors, clinical and post-transplant outcomes. Results will be compared between the intervention and usual care groups.
详细描述
This multi-centre randomized controlled trial (RCT) will be completed across the six major LT programs in Canada: Vancouver, Edmonton, Calgary, Toronto, London, and Montreal.
Participants involved in this study will be LT transplant candidates with cirrhosis who are receiving care at one of the six participating LT programs.
Participants will be assessed for eligibility, provided informed signed consent, complete baseline testing and then be randomized to the prehabilitation arm or usual care. Participants will be randomized in a 2:1 ratio between groups.
Prehabilitation Arm:
The 12 week prehabilitation program includes exercise, nutrition and psychological components that is accessed through the online digital web platform.
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
- •≥18 years old with cirrhosis (confirmed with transient elastography by FibroScan, histology, or imaging-based assessment with compatible clinical picture), referred for transplant and are assessed to have a high likelihood of being listed according to a preliminary review by hepatologist or are already listed for LT, are pre-frail or frail on the liver frailty index (LFI) or (added August 30, 2024) pre-frail or frail on the TeLeFI (prefrail LFI 3.2-4.3 and frail LFI ≥4.4), have English or French language proficiency, and own an internet-connected device.
排除标准
- •Listed for living related donor transplantation with expected time on the wait list <12 weeks, or model for end-stage liver disease (MELD-Na) Score >26 (Justification: time to transplant is very short)
- •Robust status on frailty testing (LFI 0-3.1) (Justification: unlikely to see benefit)
- •Unable to provide informed consent
- •Presence of a clinical condition that makes the intervention unsafe or infeasible (e.g. unable to follow instruction) or unsafe environment for virtual participation
- •Life expectancy less than 6 months, compassionate care (clinician judgment) (Justification: unlikely to see benefit)
- •Recent variceal bleed or history of varices not on adequate prophylaxis (Justification: acute exercise increases portal pressure
- •Transplant indication is cholangiocarcinoma.
研究组 & 干预措施
Prehabilitation Group
The prehabilitation group will be provided with access to the online digital web platform which contains the weekly acceptance and commitment therapy based education videos, nutrition intervention, and exercise intervention.
干预措施: Prehabilitation Programming (Behavioral)
Usual Care
This group will receive standard care for LT candidates with cirrhosis and will be provided with standard online exercise, nutrition, and behavioural resources. Control participants will not receive access to the online digital platform.
结局指标
主要结局
Change in time to do 5-sit-to-stands from baseline
时间窗: Week 12
A time to complete 5 chair stands of \>15 seconds predicts morbidity and mortality in patients with cirrhosis. This test shows promise as a frailty measure that could be evaluated over a virtual platform
Change in time to do 5-sit-to-stands from baseline
时间窗: Week 0
A time to complete 5 chair stands of \>15 seconds predicts morbidity and mortality in patients with cirrhosis. This test shows promise as a frailty measure that could be evaluated over a virtual platform
次要结局
- Change in liver frailty index from baseline(Week 0)
- Changes in virtual physical function testing over time (2-min step test)(Week 0)
- Change in health-related quality of life from baseline (CLDQ)(Week 0)
- Change in health-related quality of life from baseline (EQ5D5L and EQVAS)(Week 0)
- Change in liver frailty index from baseline(Week 12)
- Changes in virtual physical function testing over time (2-min step test)(Week 12)
- Change in health-related quality of life from baseline (CLDQ)(Week 12)
- Change in health-related quality of life from baseline (EQ5D5L and EQVAS)(Week 12)
- Qualitative Acceptability Data(Week 12)