Exercise and Wellness Behaviour Change for Solid Organ Transplant: A Hybrid Effectiveness-Implementation Trial of the Transplant Wellness Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 420
- 试验地点
- 2
- 主要终点
- Liver disease quality of life
研究概览
简要总结
Wellness is defined as the active pursuit of activities, choices and lifestyles that lead to a state of overall health. Prehabilitation, or using rehabilitation in the period before surgery, can improve the pre, during, and post operative experience for the patient. Although exercise as prehabilitation has been well established in organ transplant, the investigators believe a multiphase approach will help to better serve patients and support patient wellness in the long-term. Supporting wellness behaviour change, such as exercise, stress reduction, and sleep, is associated with improved quality of life (QoL), mood, and improvements in well-being. Including behaviour change support in an exercise program can help support transplant patients in long-term positive lifestyle changes. The Transplant Wellness Program (TWP) is an exercise behaviour change program that includes additional wellness components such as nutrition, stress reduction, and sleep programs to support overall health and QoL of transplant patients. Specifically, the TWP will implement physical activity and behaviour change support for patients pre- and post-transplant surgery, addressing functional (frailty, indices of fitness, physical activity levels) and mental (anxiety, stress) outcomes to improve overall QoL. The TWP includes a 12-week exercise program that is delivered either pre-transplant or post-transplant, depending on length of time from study enrollment to transplant surgery. In addition to the exercise intervention, the TWP includes maintenance resources (access to group exercise classes, wellness webinars, group wellness coaching etc.), and wellness behaviour change support. The goal of the TWP is to improve outcomes of participants throughout their transplant journey, as well as reduce health services use. Collected outcomes will include program reach, effectiveness measures such as changes in physical fitness, adoption by healthcare practitioners, implementation of the program, and maintenance. In addition, will also collect health care use measures as the investigators believe the TWP will result in the reduction of several health care use outcomes, such as the number of hospital admissions (including intensive care unit admissions), length of hospital stays and emergency room utilization.
详细描述
Background and Rationale:
Wellness is defined as the active pursuit of activities, choices and lifestyles that lead to a state of holistic health. Prehabilitation, or using rehabilitation in the period before surgery, can help to optimize the surgical candidate and can improve the pre, peri and post operative experience for the patient. Although exercise as prehabilitation has been well established in solid organ transplant, the investigators believe a multiphasic approach will help to better serve patients and establish further health behavior change to support patient wellness in the long-term. Supporting wellness behaviour change, including using tenets from health coaching and patient-directed motivational counselling is associated with improved QOL, mood, and lowered perceived stress, as well as improvements in functional well-being. Incorporating behaviour change support in a multiphasic exercise prehabilitation program will support transplant patients in making positive lifestyle behaviour changes. Wellness programs need to be personalized and include behaviour change support to maintain motivation, provide feedback, and modify the program content as needed.
Research Question and Objectives: The Transplant Wellness Program (TWP) will target lifestyle behaviour change to enhance wellness, with a focus on improving exercise behaviour change. Specifically, the TWP will implement physical activity and behaviour change support for patients pre- and post-transplant surgery, addressing functional (frailty, indices of fitness, physical activity levels) and mental (anxiety, stress) outcomes to improve overall QOL. The goal of the TWP is to improve outcomes of participants throughout their transplant journey, as well as reduce health services utilization. In addition, the investigators believe the TWP will result in the reduction of several health care utilization outcomes, including the number of hospital admissions (including intensive care unit admissions), length of hospital stays and emergency room utilization. Finally, the TWP will also work in conjunction with additional resources across wellness, including nutrition services, stress reduction, and sleep programs, to support an integration of lifestyle modifiable behaviours that support enhanced well-being and quality of life.
Methods: The transplant wellness program (TWP) is intended to enhance wellness across the transplant trajectory. Introducing exercise and wellness behaviour change to support physical and psychosocial well-being before and after transplant surgery, the TWP will work closely with participants to tailor programming to meet their needs. The TWP specifically includes the Exercise Intervention (EI), which is a 12-week exercise program. EI is delivered either pre-transplant (EI-Pre-Transplant) or after transplant (EI-Post-Transplant) if patients are unable to participate before transplant. In addition to the exercise intervention, the TWP includes maintenance resources (access to group exercise classes, wellness webinars, group wellness coaching etc.), and wellness behaviour change support. The exercise intervention will be multiphasic (pre-transplant and post-transplant) and include wellness behavior change support. Implementation outcomes will be evaluated using the reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework.
To gain a better understanding of program implementation and to improve the quality of the program, participants will be requested to share their feedback upon completion of the exercise intervention through participant experience surveys and semi-structured interviews. Effectiveness outcomes include functional fitness outcomes (frailty and musculoskeletal function measures) and patient-reported outcomes (PROs). The PROs include QOL (using generic and disease specific measures), physical activity levels, sleep habits, nutrition, and mental health (anxiety and depression). Health economic evaluations will be performed to determine the cost-utility of implementing transplant wellness into the care pathway. Chart reviews will be done to collect information regarding outpatient and inpatient health care encounters, medication use, emergency visits, hospital admissions, length of hospital stays, intensive care unit admissions (length of stay and days intubated), patient and graft survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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 of age or older
- •In evaluation or listed (active or temporarily inactive) on the transplant waiting list (kidney or liver) - status 0, 1, or 2
- •Able to provide written informed consent and understand study information in English
- •Approval to exercise from Canadian Society for Exercise Physiology - Clinical Exercise Physiologist (CSEP-CEP)
- •Have access to an internet connected device
排除标准
- •Not cleared for participation in the TWP by attending physician
- •Unable to provide informed consent
- •Clinical condition that makes the intervention unsafe or infeasible (e.g., unable to follow instruction due to refractory encephalopathy)
- •Unsafe environment for virtual participation
- •Recent variceal bleeding and cannot tolerate prophylaxis with non-selective beta blockers
结局指标
主要结局
Liver disease quality of life
时间窗: Study intake, immediately post-exercise intervention, 12-weeks post transplant, 6-months post-intake, 1-, 2-, 3-, 4-, and 5- years post-intake.
Liver patients will rate their disease-specific QoL using the Chronic Liver Disease Questionnaire (CLDQ).The CLDQ has 5 domains, abdominal symptoms, fatigue, systemic symptoms, activity, emotional function, and worry, and is scored from 1-7, with higher scores indicating higher QoL. The mean of the 5 domains represents overall QoL in liver disease populations.
Kidney disease quality of life.
时间窗: Study intake, immediately post-exercise intervention, 12-weeks post transplant, 6-months post-intake, 1-, 2-, 3-, 4-, and 5- years post-intake.
Kidney patients will rate their disease-specific QoL using the Kidney Disease Quality of Life 36-item (KDQOL-36)The KDQOL-36 is scored on a 0-100 scale, with higher scores representing higher QoL. The CLDQ has 5 domains, abdominal symptoms, fatigue, systemic symptoms, activity, emotional function, and worry, and is scored from 1-7, with higher scores indicating higher QoL. The mean of the 5 domains represents overall QoL in liver disease populations.
Self-reported exercise
时间窗: Study intake, immediately post-exercise intervention, 12-weeks post transplant, 6-months post-intake, 1-, 2-, 3-, 4-, and 5- years post-intake.
Change in self-reported exercise as assessed using the modified Godin Leisure Time Exercise Questionnaire (m-GLTEQ). Participants recall their typical weekly strenuous, moderate, and mild exercise. Each type of exercise is given a score and multiplied by the number of days per week the activity is performed. The sum of the items is then interpreted as either active (\>24 points), moderately active (14-23 points), or insufficiently active/sedentary (\<14 points).
Generic self-reported quality of life
时间窗: Study intake, immediately post-exercise intervention, 12-weeks post transplant, 6-months post-intake, 1-, 2-, 3-, 4-, and 5- years post-intake.
Self-reported quality of life (QoL) is assessed by EuroQol- 5 Dimensions 5 Level (EQ-5D-5L). The EQ-5D-5L consists of the EQ-5D descriptive system and the and EQ - Visual Analog Scale (EQ-VAS). The EQ-5D descriptive system consists of 5 different different domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Participants rate their health in each domain which is then combined into a 5-digit score. The EQ-VAS is a measure of patient self-reported health on a vertical scale with endpoints of 100 being 'the best health you can imagine' and zero being 'the worst health you can imagine'. The two scales together represent the participant's self-reported generic QoL.
次要结局
- Program implementation and evaluation(Baseline to 5-years post exercise intervention)
- Health economic evaluation(Baseline to 5-years post exercise intervention)
- Lower extremity muscular strength(Study intake, immediately post-exercise intervention, 12-weeks post transplant, 12-weeks post-exercise intervention, 1-year post-exercise intervention)
- Aerobic Endurance(Study intake, immediately post-exercise intervention, 12-weeks post transplant, 12-weeks post-exercise intervention, 1-year post-exercise intervention)
- Frailty(Study intake, immediately post-exercise intervention, 12-weeks post transplant, 12-weeks post-exercise intervention, 1-year post-exercise intervention)
- Mental Health(Study intake, immediately post-exercise intervention, 12-weeks post transplant, 6-months post-intake, 1-, 2-, 3-, 4-, and 5- years post-intake.)
- Self-efficacy(Study intake, immediately post-exercise intervention, 12-weeks post transplant, 6-months post-intake, 1-, 2-, 3-, 4-, and 5- years post-intake.)
- Hand grip strength(Study intake, immediately post-exercise intervention, 12-weeks post transplant, 12-weeks post-exercise intervention, 1-year post-exercise intervention)
- Lower extremity flexibility(Study intake, immediately post-exercise intervention, 12-weeks post transplant, 12-weeks post-exercise intervention, 1-year post-exercise intervention)
- Balance(Study intake, immediately post-exercise intervention, 12-weeks post transplant, 12-weeks post-exercise intervention, 1-year post-exercise intervention)
- Nutrition(Study intake, immediately post-exercise intervention, 12-weeks post transplant, 6-months post-intake, 1-, 2-, 3-, 4-, and 5- years post-intake.)
- Sleep(Study intake, immediately post-exercise intervention, 12-weeks post transplant, 6-months post-intake, 1-, 2-, 3-, 4-, and 5- years post-intake.)
研究者
Stefan Mustata
Clinical Associate Professor
University of Calgary