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Transplantoux Health Evaluation Study (THES)

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ClinicalTrials.gov Identifier: NCT02533245
Recruitment Status : Unknown
Verified August 2015 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
First Posted : August 26, 2015
Last Update Posted : August 28, 2015
Sponsor:
Collaborator:
University of Basel
Information provided by (Responsible Party):
Universitaire Ziekenhuizen 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.

Condition or disease Intervention/treatment Phase
Quality of Life Other: Home-based indiviualized exercise training program Other: Supervised group training sessions Other: Climb of the Mont Ventoux Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official 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
Study Start Date : January 2015
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Other: 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).

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

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

No Intervention: 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.
Experimental: 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
Other: Supervised group training sessions
7 supervised group training sessions (cycling/hiking) are organized by a physiotherapist

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




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

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Compare perceived barriers and motivators for physical exercise/activity in the three groups [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02533245


Contacts
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Contact: Evi Masschelein, PhD +3216372622 evi.masschelein@kuleuven.be
Contact: Ceulemans

Locations
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Belgium
University Hospitals Leuven Recruiting
Leuven, Belgium, 3000
Sub-Investigator: Laurens Ceulemans, MD         
Sub-Investigator: Sabina De Geest, RN, PhD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
University of Basel
Investigators
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Principal Investigator: Diethard Monbaliu, MD, PhD University Hospital Leuven, Abdominal Transplant Surgery
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02533245    
Other Study ID Numbers: THES1
First Posted: August 26, 2015    Key Record Dates
Last Update Posted: August 28, 2015
Last Verified: August 2015
Keywords provided by Universitaire Ziekenhuizen Leuven:
Exercise Training
Quality of Life
Patient Reported Outcomes
Organ Transplantation