Prehabilitation program for patients undergoing thoracic surgery
The Effect of Surgical Prehabilitation on Autonomic Nervous System Regulation
This study is testing if a special exercise and wellness program before surgery can help patients having thoracic surgery recover faster and stay in the hospital for a shorter time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Università Vita-Salute San Raffaele Academic / other |
| Locations | 2 sites (Milan and 1 other locations) |
| Trial ID | NCT06398301 on ClinicalTrials.gov |
What this trial studies
This multicenter interventional trial evaluates the effects of a multimodal prehabilitation program on heart rate variability (HRV) in patients scheduled for elective thoracic surgery. One hundred patients aged 18 and older will be randomized to receive either the prehabilitation program or standard care. The study aims to determine if prehabilitation can reduce hospital length of stay and improve postoperative recovery by enhancing patients' functional capacity before surgery. HRV will be used as a measure to assess the physiological recovery and stress response related to the prehabilitation interventions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for major thoracic surgeries such as lobectomy or pneumonectomy.
Not a fit: Patients with severe heart conditions, end-stage organ dysfunction, or other significant medical issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could lead to shorter hospital stays and improved recovery outcomes for patients undergoing thoracic surgery.
How similar studies have performed: Other studies have shown promising results with prehabilitation approaches, suggesting potential benefits in surgical recovery.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Milan and 1 other locations
- IRCCS San Raffaele Scientific Institute — Milan, Italy (Recruiting)
- Università degli studi di Verona — Verona, Italy (Not_yet_recruiting)
Study contacts
- Study coordinator: Giulia Veronesi, Prof
- Email: veronesi.giulia@hsr.it
- Phone: +39022643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.