Functional Capacity Through HRV in Multimodal Rehabilitation for Adult Surgery

Recruiting

• Conditions: Frailty in Adult Surgery
• Interventions: Device: Analgesia Nociception Index (ANI) Monitor; Behavioral: Trimodal Prehabilitation

• Registration Number: NCT06436417
• Lead Sponsor: Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon

Brief Summary

This prospective, observational cohort study investigates heart rate variability (HRV) monitoring using the Analgesia Nociception Index (ANI) monitor in adult patients undergoing major surgery within a multimodal rehabilitation program. The objective is to correlate HRV indices with functional capacity, physiological reserve, and frailty during the prehabilitation phase.

Detailed Description

The study evaluates HRV using the ANI monitor to determine adaptation to training load, optimize analgesic and anesthetic dosing, and predict postoperative complications. The HRV indices of Energy (SDNN) and ANI (HFnu) are monitored at two points: the initial pre-anesthesia consultation and one week before surgery. Results will be compared with the 6-minute walk test, MUST nutrition screening scale, and clinical frailty and FRAIL scales.

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-24
• Study First Submitted QC: 2024-05-24
• Last Update Submitted: 2024-05-24
• Study First Posted: 2024-05-31
• Last Update Posted: 2024-05-31
• Primary Completion: 2025-06-01
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 490

Inclusion Criteria

• Patients over 18 years of age
• Scheduled for major adult surgery
• Any ASA classification
• Signed informed consent

Exclusion Criteria

• Urgent surgery
• Severe cognitive impairment
• Patient refusal to participate
• Pediatric patients
• Cardiac arrhythmia or atrial fibrillation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prehabilitation	Analgesia Nociception Index (ANI) Monitor	Patients who undergo trimodal prehabilitation including physical exercise, nutritional supplementation, and psychological support.
Control	Analgesia Nociception Index (ANI) Monitor	Patients who do not undergo prehabilitation.
Prehabilitation	Trimodal Prehabilitation	Patients who undergo trimodal prehabilitation including physical exercise, nutritional supplementation, and psychological support.

Primary Outcome Measures

Name	Time	Method
Correlation of HRV indices with functional capacity and frailty	From initial pre-anesthesia consultation to 30 days postoperatively	Evaluation of the correlation between HRV indices (Energy and ANI) and current parameters used to assess functional capacity, physiological reserve, and frailty.

Secondary Outcome Measures

Name	Time	Method
Reduction of postoperative complications	30 days postoperatively	Evaluation of the relationship between higher preoperative functional reserve and lower number of complications, mortality, and hospital stay at 30 days postoperatively.
Intraoperative decisions based on HRV	During the perioperative period	Analysis of whether HRV monitoring guides the workload during prehabilitation and the titration of drugs during surgery.

Trial Locations

Locations (1)

Miguel Servet University Hospital; 🇪🇸 Zaragoza, Spain