CopenHeartVR - Integrated Rehabilitation of Patients After Heart Valve Surgery

Heart Valve Disease Clinical Trial

— CopenHeartVR  

Official title:

CopenHeartVR - A Randomized Clinical Trial Investigating the Effect of Integrated Rehabilitation Versus Usual Care Without Physical Exercise After Heart Valve Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01558765
• Other study ID #: RHCopenHeartVR
• Status: Completed
• Phase: Phase 2
• First received: March 16, 2012
• Last updated: November 12, 2015
• Start date: March 2012
• Est. completion date: May 2015

Study information

• Verified date: November 2015
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Valve Disease
• Heart Valve Diseases

Intervention

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).

Locations

Country	Name	City	State
Denmark	Rigshospitalet / Copenhagen University Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in physical capacity	Measured by Vo2peak by ergospirometry testing	1,4,12 months	Yes
Secondary	Change in self-rated mental health and quality of life	Measured by total score and the mental health component scale (MSC) in the SF-36 questionnaire.	0, 1, 4, 6, 12 and 24 months	No