CopenHeartVR - Integrated Rehabilitation of Patients After Heart Valve Surgery

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Completed

CT.gov ID

NCT01558765

Collaborator

(none)

147

Enrollment

Location

Arms

Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Valve Disease	Other: Integrated rehabilitation	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

147 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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.

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

May 1, 2015

Actual Study Completion Date :

May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Change in physical capacity [1,4,12 months]
Measured by Vo2peak by ergospirometry testing

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rigshospitalet / Copenhagen University Hospital	Copenhagen		Denmark	2100

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

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, 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