title: SheppHeartCABG trial-comprehensive early rehabilitation after coronary artery bypass grafting: a protocol for a randomised clinical trial.
abstract: Patients undergoing coronary artery bypass graft surgery often experience a range of symptoms. Studies indicate that non-pharmacological interventions such as exercise training and psychoeducation have a positive physiological and psychological effect in early outpatient rehabilitation. The SheppHeartCABG trial will investigate the effect of early comprehensive rehabilitation in early phase rehabilitation versus usual care. The aim of this paper is to present the protocol for the SheppHeartCABG trial.
  
  
  
  SheppHeartCABG is an investigator-initiated randomised clinical superiority trial with blinded outcome assessment, employing 1:1 central randomisation to rehabilitation plus usual care versus usual care alone. On the basis of a sample size calculation, 326 patients undergoing coronary artery bypass grafting will be included from two clinical sites. All patients receive usual care and patients allocated to the experimental intervention follow 4 weeks rehabilitation consisting of an exercise programme, psycho-educative consultations and a compact mindfulness programme. The primary outcome is physical function measured by the 6-min walk test. The secondary outcomes are mental health and physical activity measured by the Medical Outcome Study Short Form (SF-12), anxiety and depression measured by the Hospital Anxiety and Depression Scale questionnaire, physical, emotional and global scores by the HeartQoL questionnaire, sleep measured by the Pittsburgh Sleep Quality Index, pain measured by the Örebro Musculoskeletal Screening Questionnaire and muscle endurance measured by the sit-to-stand test. A number of explorative analyses will also be conducted.
  
  
  
  SheppHeartCABG is approved by the regional ethics committee (no. H-4-2014-109) and the Danish Data Protection Agency (no. 30-1309) and is performed in accordance with good clinical practice and the Declaration of Helsinki in its latest form. Positive, neutral and negative results of the trial will be submitted to international peer-reviewed journals. Furthermore, results will be presented at national and international conferences relevant to the subject fields.
  
  
  
  NCT02290262; pre-results.
authors.affiliation: Department of Cardiothoracic Surgery, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Ida Elisabeth
authors.identifier: 0000-0002-1461-8931
authors.initials: IE
authors.lastname: Højskov
authors.affiliation: KU Leuven Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium.|Institute of Health and Care Sciences, University of Gothenburg, Gothenburg, Sweden.
authors.forename: Philip
authors.initials: P
authors.lastname: Moons
authors.affiliation: Interacting Minds Center, Aarhus University, Aarhus, Denmark.
authors.forename: Niels Viggo
authors.initials: NV
authors.lastname: Hansen
authors.affiliation: The Centre for Research in Existence and Society, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Søren
authors.initials: S
authors.lastname: La Cour
authors.affiliation: Department of Cardiothoracic Surgery, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Peter Skov
authors.initials: PS
authors.lastname: Olsen
authors.affiliation: Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Christian
authors.initials: C
authors.lastname: Gluud
authors.affiliation: Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Per
authors.initials: P
authors.lastname: Winkel
authors.affiliation: Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Jane
authors.initials: J
authors.lastname: Lindschou
authors.affiliation: National Institute of Public Health, University of Southern Denmark, Copenhagen, Denmark.
authors.forename: Lau Caspar
authors.initials: LC
authors.lastname: Thygesen
authors.affiliation: Department of Neuroanaesthesiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Ingrid
authors.initials: I
authors.lastname: Egerod
authors.affiliation: Department of Cardiothoracic Surgery, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Selina Kikkenborg
authors.initials: SK
authors.lastname: Berg
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001026:Coronary Artery Bypass / Q000534:rehabilitation*; D005081:Exercise Therapy / Q000379:methods*; D006331:Heart Diseases / Q000534:rehabilitation / Q000601:surgery; D006801:Humans; D008875:Middle Aged; D064866:Mindfulness / Q000379:methods; D010353:Patient Education as Topic / Q000379:methods; D011613:Psychotherapy / Q000379:methods; D011788:Quality of Life; D013147:Spirometry; D011795:Surveys and Questionnaires; D016138:Walking / Q000502:physiology; D055815:Young Adult
keywords: REHABILITATION MEDICINE