The study aims to evaluate a prehabilitation protocol for patients undergoing cardiac and abdominal surgery. The project for a preparation program for cardiac surgery was developed within the framework of ERAS (Enhanced Recovery After Surgery), which aims to ensure optimal recovery after surgery and a Surgery), which aims to ensure optimal recovery after surgery and an early and safe return to daily activities.
The study focuses on the preoperative phase, with the introduction of the concept of prehabilitation, i.e., a program to enhance the functional abilities of individuals in preparation for major surgery. The study focuses on the preoperative phase, introducing the concept of prehabilitation, i.e., a program to enhance the functional abilities of individuals in preparation for major surgery, such as cardiac surgery, on an elective basis.
This program, which currently represents best clinical practice, lasts four weeks and addresses several areas: strengthening respiratory and muscular functions, optimizing nutrition, and cognitive stimulation. Patients will be assessed at enrollment and up to 180 days post-surgery to evaluate their clinical status compared to pre-surgery on these four aspects mentioned above.
Elective major abdominal surgery or elective cardio surgery
American Society of Anaesthesiologists Physical Status Classification ≤ 3
Performance Status according to ECOG Scale ≤ 2
Emergency surgery
Unstable angina
Malignant arrythmias
Severe/ very severe COPD
This prospective, observational, single-center study will enroll approximately 50 adult patients (≥18 years old) undergoing elective cardiac or major abdominal surgery at Ospedale di Circolo e Fondazione Macchi, Varese, Italy. Eligible patients for abdominal surgery must have ASA I-III and PS ECOG ≤2. Key exclusion criteria include emergency surgery, unstable angina, malignant arrhythmias, severe or very severe COPD, dementia, pregnancy, or inability to provide informed consent. Participants will be screened by the surgical team and followed during a personalized prehabilitation program starting about one month before surgery.
Case-only
Prospective
Not listed
10% improvement from baseline at 6-minutes-walking-test-distance
The primary outcome of this study is to evaluate whether prehabilitation translates into an improvement in quality of life before surgery, assessed in terms of functional status. This objective is assessed using the 6-minute walking distance test. A significant improvement is considered to be a positive delta in the six-minute walking test of ≥10% obtained at the assessment performed on the day of admission compared to the value recorded during the first assessment.
Increased thickness of the quadriceps femoris muscle
An increase in the thickness of the quadriceps femoris muscle will be assessed via ultrasound as a direct sign of an increase in the number and volume of muscle fibres
Increased cross-sectional area of the quadriceps femoris muscle
An increase in the cross-sectional area of the quadriceps femoris muscle will be assessed via ultrasound as a direct sign of an increase in the number and volume of muscle fibres
Increased pennation angle of the quadriceps femoris muscle
An increase in the pennation angle of the quadriceps femoris muscle, assessed by ultrasound, is a direct sign of increased contractility of the muscle itself, and therefore an indirect index of an increase in muscle strength.
Change in Pulmonary Function Parameters
Change in pulmonary volumes including Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC), and Tiffeneau Index (FEV1/FVC ratio) measured through spirometry at baseline and after completion of prehabilitation.
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ASST Sette Laghi
Lead sponsor
Ospedale di Circolo - Fondazione Macchi
Sponsor institution
