Transplantoux Health Evaluation Study

Study Overview
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Brief Summary
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The primary aim is to evaluate the short- and long-term effect of the 'Transplantoux' exercise training intervention in solid organ transplant recipients with matched control sample of transplant recipients in view of selected Patient Reported Outcomes (PRO), i.e. health-related quality-of-life (HRQOL), psychosocial and behavioral variables, using a quasi-experimental design.

Detailed Description
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During the last decades advances in solid organ transplantation, like e.g. organ preservation, surgical techniques and immunosuppressive treatment have contributed to improvements in postoperative survival. Thereby, solid organ transplantation (Tx) has moved from experimental treatment towards a clinical reality and a life-saving surgery, offering most patients a good long-term survival. However, further improvement in long-term survival remains a major challenge. It is increasingly recognized that non-pharmacological interventions hold the potential to improve long-term outcomes in transplantation as evidence shows that health behavior has been independently associated with transplant outcome (e.g. physical activity, non-smoking, medication adherence). Furthermore, exercise training interventions show positive outcome in a number of populations and limited research in transplantation shows positive outcomes in view of exercise capacity, muscle strength, cardiopulmonary variables and body composition. However, there is a lack of research that evaluates exercise training interventions in view of patient reported outcomes (PROs) in transplant recipients. In the University Hospitals of Leuven (Belgium) a project named 'Transplantoux' has been launched to enhance physical activity and exercise capacity in transplant recipients. Transplant recipients participate in the 'Transplantoux' exercise training intervention for 6-months with the ultimate goal to cycle or hike up the Mont Ventoux (France) (distance: 25.9 km, mean slope: 4.4%). Extending on a previous safety feasibility study in which we demonstrated that selected Transplant recipients can safely participate in an intense exercise program and that exercise capacity was significantly improved after training. The primary aim of the current study is to evaluate the short- and long-term effect of the 'Transplantoux' intervention in view of selected Patient Reported Outcomes (PROs), i.e. perceived health-related quality-of-life, depressive symptomatology, stress and well-being, physical activity, social contacts and social support, and barriers and motivators to exercise. The Transplantoux Health Evaluation Study (THES) uses a quasi-experimental design with three convenience samples: 1) a convenience sample of solid organ transplant (Tx)-recipients participating in the Transplantoux exercise training intervention, 2) matched control sample of Tx-recipients not participating in the Transplantoux exercise intervention, and 3) and a convenience sample of healthy controls participating in the Transplantoux exercise intervention. Selected PROs will be assessed using validated self-reported questionnaire. Data collection will be performed at baseline, 3 months (in the middle of the training intervention), 6 months (immediately following the intervention), 9 months (3 months follow-up period) and 12 months (6 months follow-up period).

Official Title
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Effect of an Exercise Training Intervention on Health-related Quality of Life and Psychosocial and Behavioral Variables in Adult Solid Organ Transplant Recipients: a Quasi-experimental Study Design

Conditions
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Quality of Life

Intervention / Treatment
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* Other: Home-based indiviualized exercise training program
* Other: Supervised group training sessions
* Other: Climb of the Mont Ventoux


Participation Criteria
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Eligibility Criteria
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Tx exercise group: Inclusion Criteria: Tx recipient (heart, lung, liver, kidney, pancreas or small bowel) Age between 18 - 70 years More than 1y post-transplant Exclusion Criteria: Rejection last 6 months Severe co-morbidity Contra-indication for severe exercise (e.g. cardiovascular disease) Insufficient knowledge of Dutch language Tx matched control group Inclusion Criteria: Tx recipient (heart, lung, liver, kidney, pancreas or small bowel) Age between 18 - 70 years More than 1y post-transplant Exclusion Criteria: Rejection last 6 months Insufficient knowledge of Dutch language Healthy exercise group: Inclusion Criteria: Age between 18 - 70 years Exclusion Criteria: Contra-indication for severe exercise Insufficient knowledge of Dutch language

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tx exercise group<br>Convenience sample of solid organ transplant recipients (heart, kidney, lung, liver, pancreas, small bowel) participating in the Transplantoux exercise training intervention. Intervention: Home-based individualized exercise training program Supervised group training sessions Climb of the Mont Ventoux | Other: Home-based indiviualized exercise training program<br>* Based on these results of the cardiopulmonary exercise test (CPET) on a cycle ergometer, an individualized training program (cycling/hiking) is prescribed by a physical therapist for 6 months (3x/week, ≥30min/session).<br>Other: Supervised group training sessions<br>* 7 supervised group training sessions (cycling/hiking) are organized by a physiotherapist<br>Other: Climb of the Mont Ventoux<br>* Cycle or hike up the Mont Ventoux (25.7 km, average slope 4.5%)<br>|
| No Intervention: Tx matched control group<br>Controls are retrieved from the Leuven University Hospital heart, kidney, lung, liver, pancreas, small bowel transplant database and matched (1:4 matching) based on type of transplant, gender, age and time since transplant. | |
| Experimental: Healthy exercise group<br>Convenience sample of health care providers (e.g. doctor, paramedic or medical companion involved in care programs for organ Tx) and patient's family members and friends participating in the Transplantoux exercise training intervention. Intervention: Supervised group training sessions Climb of the mont ventoux | Other: Supervised group training sessions<br>* 7 supervised group training sessions (cycling/hiking) are organized by a physiotherapist<br>Other: Climb of the Mont Ventoux<br>* Cycle or hike up the Mont Ventoux (25.7 km, average slope 4.5%)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PROs (i.e. perceived quality of life, depressive symptomatology, stress and well-being, physical activity, and social contacts and support) in the Tx exercise group compared with Tx matched control group |  | baseline, 3, 6, 9 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PROs (i.e. perceived quality of life, depressive symptomatology, stress and well-being, physical activity, and social contacts and support) in Tx exercise group compared with healthy exercise group |  | baseline, 3, 6, 9 and 12 months | 
| Compare PROs (i.e. perceived quality of life, depressive symptomatology, stress and well-being, physical activity, and social contacts and support) of the three groups with a representative sample of the Belgian population |  | baseline | 
| Compare perceived barriers and motivators for physical exercise/activity in the three groups |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise Training, Quality of Life, Patient Reported Outcomes, Organ Transplantation