Frailty in Liver Transplant Exercise (FLEX) Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Rate of enrollment
研究概览
简要总结
Frailty is common in patients with end-stage liver disease. It's characterized by reduced strength, low endurance and reduced physical function. While exercise intervention can improve frailty in geriatric patients without liver disease, whether or not exercise intervention can improve frailty in liver transplant candidates remains unknown.
详细描述
The long-term goal is to better understand how exercise impacts frailty in order to identify treatments that can improve both patient-oriented outcomes and access to liver transplantation for end-stage liver disease patients. The specific objective of this proposal is to generate pilot feasibility data required for future multicenter R01 application to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) which will test the novel central hypothesis that exercise improves frailty and lessens waiting-list mortality. Additionally, another goal of the study is to establish an optimal frailty tool for liver transplant candidates.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age ≥18 or ≤75 years
- •Frail as defined by a LFI score of >4.5
- •Under evaluation or listed for liver transplant
排除标准
- •Active cardiac symptoms (e.g., chest pain, shortness of breath at rest, palpitations)
- •Positive response to Get Active Questionnaire (GAQ) (validated activity questionnaire that indicates if exercise is unsafe)
- •Institutionalized/prisoner
- •Severe medical comorbidities/psychiatric illness at the discretion of the Study Principal Investigator (PI)
研究组 & 干预措施
Exercise intervention
Private supervised strength training exercise (e.g., body weight or dumbbell exercises) will occur in the Cancer Center Exercise Medicine Unit or the Hershey Center for Applied Research (HCAR) two days a week. In addition, subjects will be instructed to exercise on their own, at home, three days a week doing 30 minutes of moderate intensity aerobic exercise (e.g., walking at 45-55% maximum heart rate determined by the formula max heart rate = 220bpm - 0.64*age in years).
干预措施: Exercise intervention (Behavioral)
Control
Subjects in the control condition will be instructed to continue their medical care at the discretion of their treating medical professional and to maintain their current exercise level. Weekly phone calls will be performed to ensure adherence to the protocol (no changes in activity). Subjects will report to Penn State on a monthly basis for interim history and physical to confirm self-reports. Subjects will also be given a FitBit ChargeHR3 and downloaded data review will be performed monthly at the in-person visits.
结局指标
主要结局
Rate of enrollment
时间窗: up to 52 weeks
Net enrollment rates, which are calculated by dividing the number of subjects approached by the number of subjects that enroll in the trial. The work with the ongoing NASHFit and completed ENACT Trials and the work of others performing exercise-based trials in patients with cirrhosis(50) has established \>50% enrollment of subjects approached as a threshold of acceptability.
Number of participants able to complete the trial
时间窗: up to 52 weeks
Defined as 50% of subjects completing \>80% of the sessions.
Incidence of Treatment-Emergent Adverse Events as assessed by GCP guidelines
时间窗: up to 52 weeks
This study aims to examine the incidence of adverse events. If exercise in frail liver transplant candidates is safe. 5% serious adverse events or fewer will deem the trial as safe. If more than 5% serious adverse events occur, the trial is determined to be unsafe.
次要结局
未报告次要终点
研究者
Jonathan Stine
Assistant Professor of Medicine & Public Health Sciences
Milton S. Hershey Medical Center