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CopenHeartVR - Integrated Rehabilitation of Patients After Heart Valve Surgery

NCT01558765 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2015-11-13

No results posted yet for this study

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.

Conditions

  • Heart Valve Disease

Interventions

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).

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Kirstine Laerum Sibilitz, MD · Rigshospitalet, Denmark

  • Ann-Dorthe Zwisler, MD, Ph.d. · Rigshospitalet / Copenhagen University Hospital, National Institute of Public Health, University of Southern Denmark

  • Selina Kikkenborg Berg, Ph.d. · Rigshospitalet, Denmark

  • Christian Hassager, MD, DMSc · Rigshospitalet, Denmark

  • Lars Køber, MD, DMSc · Rigshospitalet, Denmark

  • Daniel Steinbrüchel, MD, DMSc · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01558765 on ClinicalTrials.gov