Transplantoux Health Evaluation Study

NCT ID: NCT02533245

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2025-01-31

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).

Conditions

Quality of Life

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Tx exercise group

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

Group Type: EXPERIMENTAL

Home-based indiviualized exercise training program

Intervention Type: OTHER

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).

Supervised group training sessions

Intervention Type: OTHER

7 supervised group training sessions (cycling/hiking) are organized by a physiotherapist

Climb of the Mont Ventoux

Intervention Type: OTHER

Cycle or hike up the Mont Ventoux (25.7 km, average slope 4.5%)

Tx matched control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Healthy exercise group

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

Group Type: EXPERIMENTAL

Supervised group training sessions

Intervention Type: OTHER

7 supervised group training sessions (cycling/hiking) are organized by a physiotherapist

Climb of the Mont Ventoux

Intervention Type: OTHER

Cycle or hike up the Mont Ventoux (25.7 km, average slope 4.5%)

Interventions

Home-based indiviualized exercise training program

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).

Intervention Type: OTHER

Supervised group training sessions

7 supervised group training sessions (cycling/hiking) are organized by a physiotherapist

Intervention Type: OTHER

Climb of the Mont Ventoux

Cycle or hike up the Mont Ventoux (25.7 km, average slope 4.5%)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Tx recipient (heart, lung, liver, kidney, pancreas or small bowel)
• Age between 18 - 70 years
• More than 1y post-transplant

• Tx recipient (heart, lung, liver, kidney, pancreas or small bowel)
• Age between 18 - 70 years
• More than 1y post-transplant

• Age between 18 - 70 years

Exclusion Criteria

• Rejection last 6 months
• Severe co-morbidity
• Contra-indication for severe exercise (e.g. cardiovascular disease)
• Insufficient knowledge of Dutch language

2. Tx matched control group

• Rejection last 6 months
• Insufficient knowledge of Dutch language

3. Healthy exercise group:

• Contra-indication for severe exercise
• Insufficient knowledge of Dutch language

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Basel

OTHER

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Diethard Monbaliu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Leuven, Abdominal Transplant Surgery

Locations

University Hospitals Leuven

Leuven, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Evi Masschelein, PhD

Role: CONTACT

evi.masschelein@kuleuven.be

+3216372622

Ceulemans

Role: CONTACT

Other Identifiers

THES1

Identifier Type: -

Identifier Source: org_study_id