Evidence map›Paper›PMID 23782510›Full record

Trial reportTrials2013

Effect of comprehensive cardiac rehabilitation after heart valve surgery (CopenHeartVR): study protocol for a randomised clinical trial.

Kirstine Laerum Sibilitz, Selina Kikkenborg Berg, Tina Birgitte Hansen, Signe Stelling Risom, Trine Bernholdt Rasmussen, Christian Hassager, Lars Køber, Daniel Steinbrüchel, Christian Gluud, Per Winkel and 6 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01558765 (CopenHeartVR - A Randomized Clinical Trial Investigating the Effect of Integrated Rehabilitation Versus Usual Care Without Physical Exercise After Heart Valve Surgery.), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01558765 phase2completednot on this map

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

TypeinterventionalSponsorRigshospitalet, DenmarkRan2012 to 2015Enrolled147ConditionsHeart Valve DiseaseArmsIntegrated rehabilitation
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.

  1. Psychological interventions for acute pain after open heart surgery.The Cochrane database of systematic reviews · 2017
    Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. Measuring HRQoL following heart valve surgery: the HeartQoL questionnaire is a valid and reliable core heart disease instrument.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2019
    Article
  8. Article
  9. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 6 institutions in 2 countries.

Kirstine Laerum SibilitzThe Heart Centre, Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. kirstine.laerum.sibilitz@rh.regionh.dk
Selina Kikkenborg Berg
Tina Birgitte Hansen
Signe Stelling Risom
Trine Bernholdt Rasmussen
Christian Hassager
Lars Køber
Daniel Steinbrüchel
Christian Gluud
Per Winkel
Lau Caspar Thygesen
Jane Lindschou Hansen
Jean Paul Schmid
Viviane Conraads
Barbara Christina Brocki
Ann-Dorthe Zwisler
Rigshospitalet · DKCopenhagen University Hospital · DKAalborg University Hospital · DKAntwerp University Hospital · BERoskilde Sygehus · DKUniversity of Southern Denmark · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHeart valve diseases are common with an estimated prevalence of 2.5% in the Western world. The number is rising due to an ageing population. Once symptomatic, heart valve diseases are potentially lethal, and heavily influence daily living and quality of life. Surgical treatment, either valve replacement or repair, remains the treatment of choice. However, post surgery, the transition to daily living may become a physical, mental and social challenge. We hypothesise that a comprehensive cardiac rehabilitation programme can improve physical capacity and self-assessed mental health and reduce hospitalisation and healthcare costs after heart valve surgery.

methodsA randomised clinical trial, CopenHeartVR, aims to investigate whether cardiac rehabilitation in addition to usual care is superior to treatment as usual after heart valve surgery. The trial will randomly allocate 210 patients, 1:1 intervention to control group, using central randomisation, and blinded outcome assessment and statistical analyses. The intervention consists of 12 weeks of physical exercise, and a psycho-educational intervention comprising five consultations. Primary outcome is peak oxygen uptake (VO2 peak) measured by cardiopulmonary exercise testing with ventilatory gas analysis. Secondary outcome is self-assessed mental health measured by the standardised questionnaire Short Form 36. Also, long-term healthcare utilisation and mortality as well as biochemistry, echocardiography and cost-benefit will be assessed. A mixed-method design is used to evaluate qualitative and quantitative findings encompassing a survey-based study before the trial and a qualitative pre- and post-intervention study. DISCUSSION: The study is approved by the local regional Research Ethics Committee (H-1-2011-157), and the Danish Data Protection Agency (j.nr. 2007-58-0015).

trial registrationClinicalTrials.gov (http://NCT01558765).

Indexed as

Exercise TherapyHealth Knowledge, Attitudes, PracticePatient Education as TopicReferral and ConsultationResearch DesignCardiac Surgical ProceduresClinical ProtocolsCombined Modality TherapyCost-Benefit AnalysisDenmarkExercise TestHealth Care CostsHeart Valve DiseasesHumansMental HealthOxygen Consumption

Identifiers

PMID23782510
PMCPMC3748823
OpenAlexW2139098397

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.