Multimodal prehabilitation as strategy for reduction of postoperative complications after cardiac surgery : a randomised controlled trial protocol
Coca-Martinez, Miquel (Hospital Clínic i Provincial de Barcelona)
Lopez-Hernandez, Antonio (Hospital Clínic i Provincial de Barcelona)
Montane-Muntane, Mar (Hospital Clínic i Provincial de Barcelona)
Arguis, Maria Jose (Institut d'Investigacions Biomèdiques August Pi i Sunyer)
Gimeno-Santos, Elena (Hospital Clínic i Provincial de Barcelona)
Navarro-Ripoll, Ricard (Hospital Clínic i Provincial de Barcelona)
Perdomo, Juan (Hospital Clínic i Provincial de Barcelona)
Lopez-Baamonde, Manuel (Hospital Clínic i Provincial de Barcelona)
Rios, Jose (Universitat Autònoma de Barcelona. Departament de Pediatria, Obstetrícia i Ginecologia i Medicina Preventiva i Salut Pública)
Moises, Jorge (Hospital Clínic i Provincial de Barcelona)
Sanz de la Garza, Maria (Hospital Clínic i Provincial de Barcelona)
Sandoval, Elena (Hospital Clínic i Provincial de Barcelona)
Romano, Barbara (Hospital Clínic i Provincial de Barcelona)
Sebio, Raquel (Hospital Clínic i Provincial de Barcelona)
Dana, Fernando (Hospital Clínic i Provincial de Barcelona)
Martinez-Palli, Graciela (Hospital Clínic i Provincial de Barcelona)

Date:	2020
Abstract:	Prehabilitation programmes that combine exercise training, nutritional support and emotional reinforcement (multimodal prehabilitation) have demonstrated efficacy reducing postoperative complications in the context of abdominal surgery. However, such programmes have seldom been studied in cardiac surgery, one of the surgeries associated with higher postoperative morbidity and mortality. This trial will assess the feasibility and efficacy in terms of reduction of postoperative complications and cost-effectiveness of a multimodal prehabilitation programme comparing to the standard of care in cardiac surgical patients. This is a single-centre, randomised, open-label, controlled trial with a 1:1 ratio. Consecutive 160 elective valve replacement and/or coronary revascularisation surgical patients will be randomised to either standard of care or 4-6 weeks of multimodal prehabilitation that will consist in (1) two times/week supervised endurance and strength exercise training sessions, (2) promotion of physical activity and healthy lifestyle, (3) respiratory physiotherapy, (4) nutrition counselling and supplementation if needed, and (5) weekly mindfulness sessions. Baseline, preoperative and 3-month postoperative data will be collected by an independent blinded evaluator. The primary outcome of this study will be the incidence of postoperative complications. This study has been approved by the Ethics Committee of Clinical investigation of Hospital Clinic de Barcelona (HCB/2017/0708). The results will be disseminated in a peer-reviewed journal.
Grants:	Instituto de Salud Carlos III PI17/00852
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Published in:	BMJ open, Vol. 10 (december 2020) , ISSN 2044-6055

DOI: 10.1136/bmjopen-2020-039885
PMID: 33371022

9 p, 547.7 KB

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