Functional Capacity Through HRV in Multimodal Rehabilitation for Adult Surgery

NCT06436417 | Recruiting

• 1 other identifier: PreANI001
• Study Type: observational
• Target: 490
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty in Adult Surgery

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Correlation of HRV indices with functional capacity and frailty

  Evaluation of the correlation between HRV indices (Energy and ANI) and current parameters used to assess functional capacity, physiological reserve, and frailty.

  From initial pre-anesthesia consultation to 30 days postoperatively

Secondary Outcomes (2)

• Reduction of postoperative complications

  30 days postoperatively

• Intraoperative decisions based on HRV

  During the perioperative period

Study Arms (2)

Control

Patients who do not undergo prehabilitation.

Device: Analgesia Nociception Index (ANI) Monitor

Prehabilitation

Patients who undergo trimodal prehabilitation including physical exercise, nutritional supplementation, and psychological support.

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

Interventions

Analgesia Nociception Index (ANI) Monitor DEVICE

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

Control; Prehabilitation

Trimodal Prehabilitation BEHAVIORAL

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

Prehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing major surgery within a multimodal rehabilitation program in various hospitals in Spain.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon: lead

Study Sites (1)

Miguel Servet University Hospital

Zaragoza, 50009, Spain

RECRUITING

MeSH Terms

Conditions

Frailty

Interventions

Monitoring, Physiologic

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Cristian Aragón-Benedí, M.D., Ph.D.,

  Miguel Servet University Hospital

  STUDY CHAIR

Central Study Contacts

Cristian Aragón-Benedí, M.D., Ph.D.,

CONTACT

+34625408866; cristianaragon@outlook.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: May 31, 2024
• Study Start: January 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)