protocolSection identificationModule nctId: NCT06367244, orgStudyIdInfo id: TWP2023, briefTitle: Transplant Wellness Program, acronym: TWP, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-16, primaryCompletionDateStruct date: 2033-11, completionDateStruct date: 2033-11, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Calgary, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Transplantation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 420, type: ESTIMATED, armsInterventionsModule interventions name: Transplant Wellness Program - Kidney and Liver, outcomesModule primaryOutcomes measure: Self-reported exercise, primaryOutcomes measure: Generic self-reported quality of life, primaryOutcomes measure: Kidney disease quality of life., primaryOutcomes measure: Liver disease quality of life, secondaryOutcomes measure: Frailty, secondaryOutcomes measure: Hand grip strength, secondaryOutcomes measure: Lower extremity flexibility, secondaryOutcomes measure: Aerobic Endurance, secondaryOutcomes measure: Lower extremity muscular strength, secondaryOutcomes measure: Balance, secondaryOutcomes measure: Nutrition, secondaryOutcomes measure: Sleep, secondaryOutcomes measure: Mental Health, secondaryOutcomes measure: Self-efficacy, secondaryOutcomes measure: Program implementation and evaluation, secondaryOutcomes measure: Health economic evaluation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Calgary, status: RECRUITING, city: Calgary, state: Alberta, zip: T2N 1N4, country: Canada, contacts name: Maneka Perinpanayagam, PhD, role: CONTACT, phone: 403-944-3699, email: maneka.perinpanayagam@ucalgary.ca, contacts name: S. Nicole Culos-Reed, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Kelly Burak, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Debra Isaac, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.05011, lon: -114.08529, hasResults: False