About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Transplant Wellness Program - Kidney and Liver
Behavioral
The exercise prescription for the intervention will be multimodal, , will follow current chronic disease exercise guidelines, and will be tailored to meet the unique needs of each participant. . All participants will receive two 30-45-minute individual session with a CEP during their first week and two additional sessions during the second week if needed. The individual sessions will be followed by group sessions. Each participant will get a total of 24 individual and group sessions combined. These sessions can be conducted either in-person or online, based on participant preference and TWP logistics. For aerobic-based activities, a moderate rate of perceived exertion of 4-6 on a scale of 0-10 will be used. Resistance exercise will begin with functional movements and bodyweight exercises targeting major muscle groups with modifications for beginners and exercise progressions when deemed. Balance and flexibility training activities will also be included.

Treatment groups

420 Participants

are divided into 2 treatment groups

Group A: Kidney transplant armExperimental treatment 1 intervention

Group B: Liver transplant armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Self-reported exercise

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).

Time frame

Study intake, immediately post-exercise intervention, 12-weeks post transplant, 6-months post-intake, 1-, 2-, 3-, 4-, and 5- years post-intake.

2

Generic self-reported quality of life

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.

Time frame

Study intake, immediately post-exercise intervention, 12-weeks post transplant, 6-months post-intake, 1-, 2-, 3-, 4-, and 5- years post-intake.

3

Kidney disease quality of life.

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.

Time frame

Study intake, immediately post-exercise intervention, 12-weeks post transplant, 6-months post-intake, 1-, 2-, 3-, 4-, and 5- years post-intake.

4

Liver disease quality of life

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.

Time frame

Study intake, immediately post-exercise intervention, 12-weeks post transplant, 6-months post-intake, 1-, 2-, 3-, 4-, and 5- years post-intake.

Secondary outcomes

1

Frailty

Frailty as assessed using the Fried Frailty Index and the Liver Frailty Index. Measures of unintentional weight loss, weakness, walking speed, and physical activity during fitness assessments and then calculate a Fried Frailty Index score If present, each criterion is given one point. A total score of equal to or less than one classifies the patient as non-frail, two points is pre-frail, and three or more points is considered frail. For participants who complete the fitness assessments online, a modified version of the Fried Frailty Index, without a measure of weakness, will be used. The Liver Frailty Index will also be used for liver-transplant arm participants. The liver frailty index is a three-variable model which assesses patient frailty based on hand grip strength, balance, and sit-to-stands. Scores range from 1-7, with ≥4.4 is considered frail and a score of 3.2-4.3 is considered pre-frail.

Time frame

Study intake, immediately post-exercise intervention, 12-weeks post transplant, 12-weeks post-exercise intervention, 1-year post-exercise intervention

2

Hand grip strength

Upper body strength will be assessed using a hand grip dynamometer. Participants will complete three trials per side and the highest value in kilograms from each will be taken and added together to get a cumulative value.

Time frame

Study intake, immediately post-exercise intervention, 12-weeks post transplant, 12-weeks post-exercise intervention, 1-year post-exercise intervention

3

Lower extremity flexibility

Chair sit-and-reach test as measured in cm. A reach short of the toes is recorded as a negative value and a reach beyond the toes is recorded as a positive value.

Time frame

Study intake, immediately post-exercise intervention, 12-weeks post transplant, 12-weeks post-exercise intervention, 1-year post-exercise intervention

4

Aerobic Endurance

Participants walk as many laps of a set and measured distance as possible during a six-minute time period.The distance of total laps is added to the final end point for a total distance (metres) walked in six-minutes.

Time frame

Study intake, immediately post-exercise intervention, 12-weeks post transplant, 12-weeks post-exercise intervention, 1-year post-exercise intervention

Transplant Wellness Program

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts