TY - JOUR
T1 - Multimodal prehabilitation as strategy for reduction of postoperative complications after cardiac surgery
T2 - A randomised controlled trial protocol
AU - Coca-Martinez, Miquel
AU - Lopez-Hernandez, Antonio
AU - Montane-Muntane, Mar
AU - Arguis, Maria Jose
AU - Gimeno-Santos, Elena
AU - Navarro-Ripoll, Ricard
AU - Perdomo, Juan
AU - Lopez-Baamonde, Manuel
AU - Rios, Jose
AU - Moises, Jorge
AU - Sanz De La Garza, Maria
AU - Sandoval, Elena
AU - Romano, Barbara
AU - Sebio, Raquel
AU - Dana, Fernando
AU - Martinez-Palli, Graciela
N1 - Funding Information:
Funding Funding for the trial was provided by a grant from the Spanish Public Government Fondos de Investigación en Salud (FIS) Instituto Carlos III (PI17/00852), after a peer-reviewed process. The grant was awarded as a mean for the implementation of multimodal prehabilitation in cardiac surgery and the present trial is the main receiver of its funds along with a subproject of prehabilitation for cardiac transplant candidates. Protein supplementation with Fresubin Protein powder was provided and supported by Fresenius Kabi España.
Publisher Copyright:
© 2020 Author(s). Published by BMJ.
PY - 2020/12/22
Y1 - 2020/12/22
N2 - Introduction 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. Methods and analysis 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. Ethics and dissemination 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.
AB - Introduction 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. Methods and analysis 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. Ethics and dissemination 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.
KW - anaesthesia in cardiology
KW - cardiac surgery
KW - protocols & guidelines
KW - sports medicine
UR - http://www.scopus.com/inward/record.url?scp=85098125264&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2020-039885
DO - 10.1136/bmjopen-2020-039885
M3 - Article
C2 - 33371022
AN - SCOPUS:85098125264
SN - 2044-6055
VL - 10
JO - BMJ open
JF - BMJ open
IS - 12
M1 - e039885
ER -