Clinical Research Directory

Feasibility of Physical Prehabilitation for High-Risk Patients Undergoing Cardiac Surgery Via Sternotomy

Sponsor: Maastricht University Medical Center

Summary

Rationale Cardiac surgery via median sternotomy carries an elevated risk of postoperative complications and delayed functional recovery. Preoperative physical therapy aims to reduce the incidence and severity of postoperative adverse outcomes and to accelerate functional recovery. However, current evidence on prehabilitation is inconsistent due to methodological heterogeneity. This study addresses the limitations of previous studies in four ways. First, a validated preoperative prediction model is used to select patients at high risk of in-hospital postoperative complications and delayed functional recovery. Second, a Cardiopulmonary Exercise Test (CPET) is performed at baseline to guide safe and effective intensity prescription. Third, as different patient populations are expected to benefit from different training programs, the prehabilitation program is tailored to the surgical indication: patients undergoing coronary artery bypass grafting (CABG) receive high-intensity interval training (HIIT), and patients undergoing aortic valve replacement (AVR) receive moderate continuous training. Fourth, physical activity and self-management are promoted by using a wearable physical activity monitor and Shared Decision-Making (SDM) to stimulate and track daily physical activity. Primary Objective To investigate the feasibility of a personalized, procedure-specific prehabilitation program (four to six weeks) for high-risk patients scheduled for elective cardiac surgery via sternotomy, with respect to recruitment, adherence, drop-out, safety, and acceptance. The program consists of two physiotherapist-supervised group training sessions per week, promotion of physical activity, and unsupervised home-based exercise. Secondary Objective To provide a preliminary evaluation of participant responses to the intervention, focusing on changes in cardiorespiratory fitness (WRpeak), peripheral muscle strength (1RM), inspiratory muscle strength (MIP), physical activity (time spent active per day), and health-related quality of life (SF-36). Study design A prospective, single-center, longitudinal, mixed-methods pilot study conducted at Maastricht University Medical Center (MUMC+). Study population High-risk patients (n=24), defined by EuroSCORE II, who are scheduled for elective cardiac surgery via sternotomy (CABG or AVR). Main study parameters/endpoints The primary endpoint is the feasibility of the prehabilitation intervention with respect to recruitment, adherence, drop-out, safety, and acceptance. Burden Participation involves a structured time commitment with clinic and home components. Total supervised clinic time is estimated at 11-15 hours, covering two baseline assessments, 8-12 training sessions, and the final evaluation and interview. Total time at home is estimated at 16.5-19 hours, covering daily diary completion and unsupervised home exercises. These ranges depend on the patient's time to surgery. Risks and mitigation The risk of acute cardiac events during exercise is elevated in this high-risk population. This risk is mitigated by strict adherence to NVVC/MUMC+ absolute stop criteria, continuous medical supervision during all testing and training sessions, and individualized intensity prescription based on CPET. The risk is considered acceptable in relation to the scientific value of studying this specific high-risk cohort, which makes the study group-related. Benefit and group relatedness Direct clinical benefit cannot be guaranteed, as this is a feasibility study. However, patients receive an intensive, personalized prehabilitation program that is designed to reduce the incidence and severity of postoperative adverse outcomes.

Official title: Feasibility of a Physical Prehabilitation Programme for Patients at High Risk of In-Hospital Complications and Delayed Functional Recovery Awaiting Elective CABG or AVR Surgery Via Sternotomy: PREPA-STER

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