Multimodal prehabilitation as strategy for reduction of postoperative complications after cardiac surgery: a randomised controlled trial protocol

Abstract

IntroductionPrehabilitation 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 analysisThis 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 disseminationThis 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.Trial registration numberNCT03466606.

Cost-effectiveness of prehabilitation prior to elective surgery: a systematic review of economic evaluations

“…Information on the completed and ongoing EEs’ funding and conflict of interest can be found in Additional file 1 : Appendix 6. Nine EEs did not report any information, one received parts of its funding from a commercial funder [ 57 ], one from a private donor [ 46 ] and in one, it was unclear [ 68 ]. Two EEs declared a relevant conflict of interest [ 29 , 42 ], as authors were related to companies contracted to organise the prehabilitation.…”

Physical Effects, Safety and Feasibility of Prehabilitation in Patients Awaiting Orthotopic Liver Transplantation, a Systematic Review

“…In our opinion, home-based training, which is supervised by a dedicated physical therapist and is combined with nutritional and educational support by a dietician, could be suitable for preoperative optimization until OLT. Patients might make some progress during these weeks of training, but, most importantly, deterioration of aerobic capacity could be prevented ( 27 ) and the number of hospital admissions due to decompensated liver disease during the waiting period could be reduced ( 45 ). To the best of our knowledge, the economic burden of the implementation of a prehabilitation program in this patient population has not been studied yet.…”

“…Therefore, this review emphasizes the need for large (multicentre) longitudinal trials that not only study the physical effects, but also focus on possible improvement of surgical outcomes after a longer duration of training during the waiting period prior to OLT. Randomizing between training and no training is, in our opinion, not ethically justifiable, because various studies ( 45 , 47 , 48 ) have shown the benefits of improved physical capacity, activity, and muscle status with surgical outcome.…”

Frailty and cardiac surgery: to operate or not?

“…Overall, this area of research is young with some early positive results. Ongoing trials [41,42] look to increase the amount and quality of evidence behind using prehabilitation to improve not only short-term postoperative outcomes but also long-term quality of life. Still, more work needs to be done in standardizing the definition of prehabilitation and outcomes across studies if any strong generalizations are to be made regarding this potential therapy.…”