Surgical Prehabilitation on Autonomic Nervous System (TUNE)

NCT06398301 · tracked via the Priya Life Science Italy tracker

Sponsor

Università Vita-Salute San Raffaele

Phase

Not applicable

Started

2024-07-29

Last updated

2026-05-06

Condition(s) studied

Thoracic Surgery

Investigational drug(s) / intervention(s)

Multimodal prehabilitation Program

Multimodal prehabilitation Program: 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.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

Impact of prehabilitation on heart rate variability — 30 days after prehabilitation
The primary outcome measure will be standard deviation of normal to normal index (SDNN) of heart rate variability from baseline to the days before surgery.

Trial sites (2)

Facility	City	Region	Status
IRCCS San Raffaele Scientific Institute	Milan	Italy
Università degli studi di Verona	Verona	Italy

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06398301 on ClinicalTrials.gov ↗ ← All trials in Italy