Transplantoux Health Evaluation Study

Quality of Life Clinical Trial

— THES  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02533245
• Other study ID #: THES1
• Status: Recruiting
• Phase: N/A
• First received: August 19, 2015
• Last updated: August 27, 2015
• Start date: January 2015
• Est. completion date: January 2016

Study information

• Verified date: August 2015
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Evi Masschelein, PhD
• Phone: +3216372622
• Email: evi.masschelein[@]kuleuven.be
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Quality of Life

Intervention

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).
• Supervised group training sessions
7 supervised group training sessions (cycling/hiking) are organized by a physiotherapist
• Climb of the Mont Ventoux
Cycle or hike up the Mont Ventoux (25.7 km, average slope 4.5%)

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	University of Basel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Compare perceived barriers and motivators for physical exercise/activity in the three groups		12 months	No