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Functional Capacity Through HRV in Multimodal Rehabilitation for Adult Surgery (PreANI)

I

Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon

Status

Enrolling

Conditions

Frailty in Adult Surgery

Treatments

Behavioral: Trimodal Prehabilitation
Device: Analgesia Nociception Index (ANI) Monitor

Study type

Observational

Funder types

NETWORK

Identifiers

NCT06436417
PreANI001

Details and patient eligibility

About

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.

Full 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.

Enrollment

490 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

490 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Cristian Aragón-Benedí, M.D., Ph.D.,

Data sourced from clinicaltrials.gov

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