Prehabilitation to Improve Heart Rate Variability (PRIME)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversità Vita-Salute San Raffaele

About this trial

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 assessment measures to evaluate its effectiveness. Developing validated outcome measures is essential to enhance the impact of prehabilitation on surgical outcomes and long-term care for cancer patients. Heart rate variability (HRV) is a physiological parameter that measures the variation in time intervals between consecutive heartbeats, reflecting the autonomic nervous system activity which might serve as a valuable solution for objective outcome measures in evaluating the effectiveness of prehabilitation for cancer patients, providing an objective tool to assess and monitor physiological response to stress, recovery capacity, and autonomic nervous system activity. A multicenter randomized controlled trial will be conducted to assess the impact of a multimodal prehabilitation program on HRV. Patients aged 18 or older, scheduled for elective major cancer surgery will be randomized to receive either prehabilitation or standard care. The prehabilitation arm will receive a program involving home-based physical, nutritional, and psychological interventions for at least four weeks. Participants allocated to the control group will receive usual care. Patients will be followed throughout the study using an innovative mobile application, allowing for real-time monitoring and data collection during the prehabilitation program. The study has two primary outcomes: A) to assess the impact of prehabilitation on increasing preoperative HRV in chronic cancer patients undergoing surgery; B) to assess the effect of prehabilitation on length of hospital stay.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Scheduled to undergo elective major abdominal or thoracic cancer surgery;

Scheduled to undergo surgery at least three weeks after enrollment;

Age ≥ 18 years;

Provide written informed consent;

Disqualifiers

Presenting with very poor functional capacity;

American Society of Anesthesiologists (ASA) physical status classes 5-6;

Disabling orthopedic, neuromuscular, and psychiatric diseases or other conditions that preclude participation in a prehabilitation program.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multimodal prehabilitation program

    Behavioral

    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 these three domains will be utilized to maximize their synergistic anabolic effect. The duration of the program will be set at 4 weeks.

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: PrehabilitationExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Assess the impact of prehabilitation on heart rate variability

This primary outcome measure will be the change in the standard deviation of normal-to-normal intervals (SDNN) from baseline to the day before surgery.

Time frame
Preoperative
2

Days at home within first 30 days after surgery

The mean number of days at home in the first 30 days after surgery will be compared between groups

Time frame
30-days after surgery

Secondary outcomes

1

Quality of life at 30 days

Assess quality of life in the first 30 days at home after surgery using the EuroQol-5 Dimension (EQ-5D-5L) questionnaire, a validated tool for evaluating health-related quality of life. The outcome will be reported as the mean EQ-5D-5L index score and the mean EQ-VAS score measured at 30 days postoperatively.

Time frame
30-days after surgery
2

30-days postoperative complication

Assess the occurrence of postoperative complications in the first 30 days after surgery

Time frame
30-days after surgery
3

Correlation between preoperative standard deviation of all normal to normal R-R intervals (SDNN) and quality of life at 30 days postoperatively

Investigate the association between preoperative heart rate variability (HRV) and life at 30 days postoperatively

Time frame
30-days after surgery
4

Correlation between preoperative SDNN and DAH-30

Investigate the association between preoperative heart rate variability (HRV) and the days alive and at home within 30 days after surgery (DAH-30)

Time frame
30-days after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Università Vita-Salute San Raffaele

Lead sponsor

Dott. Fabio Guarracino

Collaborator

Prof. Gilda Cinnella

Collaborator

Dott. Filippo Sanfilippo

Collaborator