Transplantoux Health Evaluation Study
THES
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
1 other identifier
interventional
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable quality-of-life
Started Jan 2015
Longer than P75 for not_applicable quality-of-life
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 19, 2015
CompletedFirst Posted
Study publicly available on registry
August 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedJuly 12, 2024
July 1, 2024
10 years
August 19, 2015
July 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (3)
Tx exercise group
EXPERIMENTALConvenience 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 matched control group
NO INTERVENTIONControls 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.
Healthy exercise group
EXPERIMENTALConvenience 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
Interventions
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).
7 supervised group training sessions (cycling/hiking) are organized by a physiotherapist
Cycle or hike up the Mont Ventoux (25.7 km, average slope 4.5%)
Eligibility Criteria
You may qualify if:
- Tx recipient (heart, lung, liver, kidney, pancreas or small bowel)
- Age between 18 - 70 years
- More than 1y post-transplant
You may not qualify if:
- 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
- Tx recipient (heart, lung, liver, kidney, pancreas or small bowel)
- Age between 18 - 70 years
- More than 1y post-transplant
- Rejection last 6 months
- Insufficient knowledge of Dutch language
- Healthy exercise group:
- Age between 18 - 70 years
- Contra-indication for severe exercise
- Insufficient knowledge of Dutch language
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universitaire Ziekenhuizen KU Leuvenlead
- University of Baselcollaborator
Study Sites (1)
University Hospitals Leuven
Leuven, 3000, Belgium
Study Officials
- PRINCIPAL INVESTIGATOR
Diethard Monbaliu, MD, PhD
University Hospital Leuven, Abdominal Transplant Surgery
Central Study Contacts
Ceulemans
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2015
First Posted
August 26, 2015
Study Start
January 1, 2015
Primary Completion
January 1, 2025
Study Completion
January 1, 2025
Last Updated
July 12, 2024
Record last verified: 2024-07