SheppHeartCABG trial—comprehensive early rehabilitation after coronary artery bypass grafting: a protocol for a randomised clinical trial

Abstract

IntroductionPatients 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.Methods/analysisSheppHeartCABG 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.Ethics and disseminationSheppHeartCABG 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.Trial registration numberNCT02290262; pre-results.

Early physical and psycho-educational rehabilitation in patients with coronary artery bypass grafting: A randomized controlled trial

“…The SheppHeartCABG trial ("Shaping outcomes by Exercise training and Psychoeducation in Phase 1 for Heart patients") is an investigator-initiated randomized controlled trial (RCT) (14). The trial followed the principles of the Declaration of Helsinki and was approved by the Regional Ethics Committee (H-4-2014-109) and the Danish Data Protection Agency .…”

“…An outline of the trial interventions (14) is shown in Fig. 1 including the intervention components, the timeline for the 2 groups, and the outcome measures.…”

Efficiency and Safety of Early Physical Trainings During Rehabilitation of Patients After Coronary Bypass Grafting

“…Несмотря на такие ранние сроки начала велотренировок, серьезных осложнений у пациентов не было зарегистрировано ни со стороны сердечно-сосудистой и дыхательной систем, ни со стороны послеоперационной раны. Найдено, что прирост дистанции, определяемой с помощью ТшХ через 4 недели после Кш был выше в группе с ранней реабилитацией, однако значимых различий между двумя группами не получено [15]. Вероятно, отсутствие статистической значимости связано с малой выборкой и низкой информативностью ТшХ.…”

Early Rehabilitation After Coronary Artery Bypass Grafting: Limitations and Prospects

“…In addition, patients are taught respirato ry exercises and breathing techniques from the beginning of Phase 1 rehabilitation. This cardiac rehabilitation pro gram has been successfully implemented in more than 10 European cardiac centers [16].…”

“…However, some researchers did not found any significant differences while assessing the impact of early rehabilitation on postoperative sutures [17,22,28]. Moreover, the number of international and national studies proved that early cardiac rehabilitation is safe and does not provoke any cardiovascular and pulmonary complications [15, 16,22,29,30].…”