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Functional Capacity Through HRV in Multimodal Rehabilitation for Adult Surgery

Monitoring Functional Capacity Through Heart Rate Variability Within the Multimodal Rehabilitation Program in Adult Surgery

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06436417
Acronym
PreANI
Enrollment
490
Registered
2024-05-31
Start date
2024-01-01
Completion date
2025-12-31
Last updated
2024-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty in Adult Surgery

Keywords

Heart rate variability, prehabilitation, major surgery, frailty, physiological reserve

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.

Interventions

Non-invasive monitoring of HRV to evaluate autonomic nervous system activity using the indices of Energy (SDNN) and ANI (HFnu).

Program of physical exercise, nutritional supplementation, and psychological support according to the RICA guidelines of the Spanish Group for Multimodal Rehabilitation.

Sponsors

Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation of HRV indices with functional capacity and frailtyFrom initial pre-anesthesia consultation to 30 days postoperativelyEvaluation of the correlation between HRV indices (Energy and ANI) and current parameters used to assess functional capacity, physiological reserve, and frailty.

Secondary

MeasureTime frameDescription
Reduction of postoperative complications30 days postoperativelyEvaluation 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 HRVDuring the perioperative periodAnalysis of whether HRV monitoring guides the workload during prehabilitation and the titration of drugs during surgery.

Countries

Spain

Contacts

Primary ContactCristian Aragón-Benedí, M.D., Ph.D.,
cristianaragon@outlook.com+34625408866

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026