Transplant Wellness Program

NCT06367244 | Recruiting DMC

• 1 other identifier: TWP2023
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Transplantation

Keywords

Organ transplantation; Exercise; Prehabilitation; Health promotion; Behavior change; Rehabilitation

Outcome Measures

Primary Outcomes (4)

• 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).

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

• 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.

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

• 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.

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

• 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.

  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 (12)

• Frailty

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

• 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

• Aerobic Endurance

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

Study Arms (2)

Kidney transplant arm

EXPERIMENTAL

Kidney transplant patients will be assigned to the kidney transplant arm and receive the standard 12-week exercise intervention in the TWP. Specific to the kidney arm will be certain patient reported outcomes (PROs). The Kidney Disease Quality of Life-36 (KDQOL-36) is a short form survey widely used to measure patient-reported QOL in patients on dialysis and is a validated tool in kidney transplant patients. Participants in the kidney arm will also receive disease-specific exercise and wellness materials to support their behaviour change.

Behavioral: Transplant Wellness Program - Kidney and Liver

Liver transplant arm

EXPERIMENTAL

Liver transplant patients will be assigned to the liver transplant arm and receive the standard 12-week exercise intervention in the TWP. Specific to the liver arm will be certain PROs and functional fitness measures. The Chronic Liver Disease Questionnaire (CLQD) measures health-related QOL in patients with advanced liver disease and has been previously used in patients awaiting transplant. Liver arm participants will also complete the Liver frailty index, which requires a timed 5 sit-to-stands in addition to the other measures collected for the Fried Frailty Index. Participants in this arm will receive liver-specific exercise and wellness materials to support their behaviour change.

Behavioral: Transplant Wellness Program - Kidney and Liver

Interventions

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.

Kidney transplant arm; Liver transplant arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

RECRUITING

Related Publications (1)

• Sim JAP, Perinpanayagam MA, Bahry V, Wytsma-Fisher K, Burak KW, Isaac DL, Mustata S, Culos-Reed SN. An Exercise and Wellness Behavior Change Program for Solid Organ Transplant: A Clinical Research Protocol for the Transplant Wellness Program. Can J Kidney Health Dis. 2024 Oct 21;11:20543581241289196. doi: 10.1177/20543581241289196. eCollection 2024.

  PMID: 39449962 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Liver Extracts

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Tissue Extracts; Complex Mixtures

Study Officials

• Stefan Mustata, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maneka Perinpanayagam, PhD

CONTACT

403-944-3699; maneka.perinpanayagam@ucalgary.ca

Stefan Mustata, MD

CONTACT

smustata@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: The TWP is a parallel study design with two arms. Participants are assigned to either the kidney or liver arm depending on the organ transplant they are listed or in evaluation for. Each arm will have a pre- or post- transplant group. Participants will be assigned to group depending on length of time between study enrollment and transplant surgery. Those with more than 12-weeks until surgery will complete the TWP pre-transplant and those with less than 12-weeks will complete the TWP post-transplant.

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 16, 2024
• Study Start: November 16, 2023
• Primary Completion (Estimated): November 1, 2033
• Study Completion (Estimated): November 1, 2033
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)