Transplantoux Health Evaluation Study

• Register: ClinicalTrials.gov
• Last refreshed on: 7 September 2015
• Main ID: NCT02533245
• Date of registration: 19/08/2015
• Prospective Registration: No
• Primary sponsor: Universitaire Ziekenhuizen Leuven
• Public title: Transplantoux Health Evaluation Study THES
• Scientific title: 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
• Date of first enrolment: January 2015
• Target sample size: 500
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02533245
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
• Phase: N/A

Countries of recruitment

Belgium

Contacts

• Name: Diethard Monbaliu, MD, PhD
• Affiliation: University Hospital Leuven, Abdominal Transplant Surgery

• Name: Evi Masschelein, PhD

Key inclusion & exclusion criteria

1. 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

2. 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

3. Healthy exercise group:

Inclusion Criteria:

- Age between 18 - 70 years

Exclusion Criteria:

- Contra-indication for severe exercise

- Insufficient knowledge of Dutch language



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Quality of Life

Intervention(s)

Other: Supervised group training sessions

Other: Climb of the Mont Ventoux

Other: Home-based indiviualized exercise training program

Primary Outcome(s)

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 [Time Frame: baseline, 3, 6, 9 and 12 months]

Secondary Outcome(s)

Compare perceived barriers and motivators for physical exercise/activity in the three groups [Time Frame: 12 months]

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 [Time Frame: 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 [Time Frame: baseline]

Secondary ID(s)

THES1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Basel