Surgical Prehabilitation on Autonomic Nervous System (TUNE) (NCT06398301) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Surgical Prehabilitation on Autonomic Nervous System (TUNE)
Italy100 participantsStarted 2024-07-29
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Impact of prehabilitation on heart rate variability