CopenHeartVR - A Randomized Clinical Trial Investigating the Effect of Integrated Rehabilitation Versus Usual Care Without Physical Exercise After Heart Valve Surgery.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 147
- Locations
- 1
- Primary Endpoint
- Change in physical capacity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Intervention group
Patients receive integrated rehabilitation
Intervention: Integrated rehabilitation (Other)
Control group
Patients receive usual follow-up care without physical exercise
Outcomes
Primary Outcomes
Change in physical capacity
Time Frame: 1,4,12 months
Measured by Vo2peak by ergospirometry testing
Secondary Outcomes
- Change in self-rated mental health and quality of life(0, 1, 4, 6, 12 and 24 months)
Investigators
Selina Kikkenborg Berg
Principal Investigator, RN, MSN, PhD, FESC.
Rigshospitalet, Denmark