Surgical Prehabilitation on Autonomic Nervous System (TUNE)
The Effect of Surgical Prehabilitation on Autonomic Nervous System Regulation
Università Vita-Salute San Raffaele
100 participants
Jul 29, 2024
INTERVENTIONAL
Conditions
Summary
This study will be a multicenter interventional randomized trial evaluating the effect of a multimodal prehabilitation program on heart rate variability (HRV). In the same protocol the impact of HRV on hospital length of stay will be identified. One hundred patients aged 18 years or older scheduled for elective surgery will be eligible for enrolment, if they will not present any exclusion criteria. Patients will be randomized with a 1:1 allocation to receive either prehabilitation or standard of care.
Eligibility
Inclusion Criteria3
- Patients scheduled to undergo major thoracic surgery including lobectomy, bilobectomy, anatomical segmentectomy, and pneumonectomy with general anesthesia;
- Patients ≥18 years of age at the time of randomization;
- Patients who provide written informed consent to participate.
Exclusion Criteria7
- New York Heart Association classes 3-4;
- End-stage organ dysfunction;
- American Society of Anesthesiologists physical status classes 4-5;
- Disabling orthopedic, neuromuscular, and psychiatric diseases;
- Other medical conditions that preclude safe training.
- Atrial fibrillation or other arrhythmia (e.g. bigeminy, trigeminy) that preclude heart rate variability analysis.
- Unable to provide written informed consent to participate
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Interventions
A tailored intervention will be prescribed if specific physical, nutritional or psychological impairments will be identified during the assessment phase. Based on the data obtained during the multimodal assessment, different domains and levels of care will be prescribed, focusing on exercise training, and/or nutrition optimization, and/or distress-coping techniques. Different combinations of three domains will be utilized to maximize their synergistic anabolic effect. The duration of program will be set at 4 weeks. All activities will be performed in dedicated suites at each site, under supervision of qualified health professionals.
Locations(2)
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NCT06398301