Surgical Prehabilitation on Autonomic Nervous System (TUNE)
Launched by UNIVERSITÀ VITA-SALUTE SAN RAFFAELE · Apr 30, 2024
Trial Information
Current as of November 13, 2025
Recruiting
Keywords
ClinConnect Summary
The TUNE trial is studying how a special program called "prehabilitation" can help patients prepare for major thoracic surgery, such as lung procedures, by improving their heart health before the operation. Heart rate variability (HRV) is a measure of how well the heart can respond to stress, and this study aims to see if taking part in the prehabilitation program can make a difference in HRV and also reduce the time patients spend in the hospital after their surgery.
To qualify for the trial, participants must be at least 18 years old and scheduled for specific types of thoracic surgery. They cannot have certain serious heart or other medical conditions that could make it unsafe for them to participate. Those who join the study will be randomly assigned to either the prehabilitation program or to receive standard care before their surgery. The trial is currently recruiting, and all eligible patients are encouraged to consider participating to help improve care for future patients.
Gender
ALL
Eligibility criteria
- 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
About Università Vita Salute San Raffaele
Università Vita-Salute San Raffaele is a prestigious Italian academic institution renowned for its commitment to advancing healthcare through innovative research and education. Located in Milan, it integrates cutting-edge scientific inquiry with clinical practice, fostering interdisciplinary collaboration among healthcare professionals. The university is dedicated to improving patient outcomes and public health by conducting rigorous clinical trials that adhere to the highest ethical standards. Its focus spans various medical fields, leveraging state-of-the-art facilities and a strong network of partnerships to drive advancements in medical science and contribute to the global healthcare community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Milan, Italy
Verona, Italy
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported