Transplantoux Health Evaluation Study
- Conditions
- Quality of Life
- Interventions
- Other: Home-based indiviualized exercise training programOther: Supervised group training sessionsOther: Climb of the Mont Ventoux
- Registration Number
- NCT02533245
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief Summary
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
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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- Tx recipient (heart, lung, liver, kidney, pancreas or small bowel)
- Age between 18 - 70 years
- More than 1y post-transplant
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tx exercise group Supervised group training sessions 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 Healthy exercise group Climb of the Mont Ventoux 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 Tx exercise group Home-based indiviualized exercise training program 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 Tx exercise group Climb of the Mont Ventoux 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 Healthy exercise group Supervised group training sessions 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
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
University Hospitals Leuven
🇧🇪Leuven, Belgium