CopenHeartVR - Integrated Rehabilitation of Patients After Heart Valve Surgery
The aim of the study is to investigate the effect of an integrated rehabilitation programme, consisting of physical exercise training and psycho-educational consultations, for patients after heart valve surgery.
The hypothesis is that integrated rehabilitation can improve physical capacity measured by V02 peak, self-rated mental health and life quality by validated questionnaires such as SF-36, and other objective parameters such as cardiac-specific biomarkers and echocardiographic measurements.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||CopenHeartVR - A Randomized Clinical Trial Investigating the Effect of Integrated Rehabilitation Versus Usual Care Without Physical Exercise After Heart Valve Surgery.|
- Change in physical capacity [ Time Frame: 1,4,12 months ] [ Designated as safety issue: Yes ]Measured by Vo2peak by ergospirometry testing
- Change in self-rated mental health and quality of life [ Time Frame: 0, 1, 4, 6, 12 and 24 months ] [ Designated as safety issue: No ]Measured by total score and the mental health component scale (MSC) in the SF-36 questionnaire.
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Experimental: Intervention group
Patients receive integrated rehabilitation
Other: Integrated rehabilitation
Integrated rehabilitation consisting of exercise training (3 times per week (1 hour) for 12 weeks) and psycho-educational care (5 consultations over 6 months by special trained nurses).
No Intervention: Control group
Patients receive usual follow-up care without physical exercise
Worldwide, the incidence of heart valve disease is increasing. Improved surgical techniques, rising age and possibility for re-operation leads to a rising number of patients having heart valve surgery. The gap between hospital discharge and returning to normal life is obvious. Integrated rehabilitation could probably reduce hospital readmissions, increase physical capacity and increase self-rated mental health and quality of life. Therefore the aim of this study is to explore if patients after heart valve surgery will benefit from an integrated rehabilitation programme consisting of physical exercise and psycho-educational intervention.
A randomized clinical trial is conducted to investigate the effect and meaning of an integrated rehabilitation programme on the physical and psychosocial functioning of patients after heart valve surgery. The trial is a parallel arm design.
A mixed methods embedded experimental design is chosen to include both quantitative and qualitative data to evaluate the intervention. The intervention consists of five psycho-educational consultations provided by specialized nurses and a twelve week individualized exercise training programme provided by physiotherapists. A qualitative post-intervention study will explore rehabilitation participation experiences.
Along with the above stated hypothesis, it will be observed whether integrated rehabilitation can reduce anxiety, depression, health care utilisation, mortality and work cessation.
210 patients will be included.
Validated questionnaires (e.g. SF-36), cardiopulmonary exercise testing, 6 minute walking test, echocardiography, cardiac-specific biomarkers and qualitative interviews will be used to evaluate the effect and meaning of the programme.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01558765
|Rigshospitalet / Copenhagen University Hospital|
|Copenhagen, Denmark, 2100|
|Principal Investigator:||Kirstine Laerum Sibilitz, MD||Rigshospitalet, Denmark|
|Principal Investigator:||Ann-Dorthe Zwisler, MD, Ph.d.||Rigshospitalet / Copenhagen University Hospital, National Institute of Public Health, University of Southern Denmark|
|Principal Investigator:||Selina Kikkenborg Berg, RN, MScN, Ph.d.||Rigshospitalet, Denmark|
|Principal Investigator:||Christian Hassager, MD, DMSc||Rigshospitalet, Denmark|
|Principal Investigator:||Lars Køber, MD, DMSc||Rigshospitalet, Denmark|
|Principal Investigator:||Daniel Steinbrüchel, MD, DMSc||Rigshospitalet, Denmark|