Heart Valve Disease
Conditions
Keywords
Rehabilitation, Integrated rehabilitation programme, Exercise training, Psycho-educational care
Brief summary
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.
Detailed description
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.
Interventions
OTHERIntegrated 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).
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Admitted to hospital for elective heart valve surgery at Rigshospitalet, Denmark * 18 years or older * Speak and understand Danish * Providing written informed consent
Exclusion criteria
* Known ischemic heart disease prior to heart valve surgery * Is included in an other clinical trial investigating the effects of physical training and psycho-educational intervention * Unable to understand and cooperate to study instructions * Pregnant and/or breast feeding * Performing exercise training at high level and several times a week * No written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in physical capacity | 1,4,12 months | Measured by Vo2peak by ergospirometry testing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in self-rated mental health and quality of life | 0, 1, 4, 6, 12 and 24 months | Measured by total score and the mental health component scale (MSC) in the SF-36 questionnaire. |
Countries
Denmark
Outcome results
None listed