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Prehabilitation to Improve Heart Rate Variability (PRIME)

RecruitingNAAges 18 Years - anyAllUniversità Vita-Salute San Raffaele
NCT06744413 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Cancer patients require chronic management and care. For those individuals living with cancer, a comprehensive approach that acknowledges the interdisciplinary nature of their condition can help guide appropriate care strategies and support their overall well-being. Approximately 45% of patients diagnosed with cancer undergo surgery to remove their tumor. Despite the advancements in surgical techniques, anesthesia, and perioperative care, major cancer surgeries still pose a significant challenge leading to a considerable decline in physiological and functional capacity. Traditionally, efforts focused on postoperative rehabilitation to enhance recovery. Recently, prehabilitation, a form of rehabilitation which aims to improve functional capacity before surgery, has gained attention for its potential benefits in improving surgical outcomes. However, prehabilitation lacks objective assessme

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Scheduled to undergo elective major abdominal or thoracic cancer surgery; 2. Scheduled to undergo surgery at least three weeks after enrollment; 3. Age ≥ 18 years; 4. Provide written informed consent; 5. Willing and able to use smartphone application. Exclusion Criteria: 1. Presenting with very poor functional capacity; 2. American Society of Anesthesiologists (ASA) physical status classes 5-6; 3. Disabling orthopedic, neuromuscular, and psychiatric diseases or other conditions that preclude participation in a prehabilitation program.
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What it tests

  • Multimodal prehabilitation program
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Where

4 sites
Azienda Ospedaliero Universitaria Policlinico San Marco di Catania
Catania, Italy
Università di Foggia
Foggia, Italy
IRCCS Ospedale San Raffaele
Milan, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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