## Protocol Section
### Identification Module
**NCT ID:** NCT06436417

**Acronym:** PreANI

**Brief Title:** Functional Capacity Through HRV in Multimodal Rehabilitation for Adult Surgery

**Official Title:** Monitoring Functional Capacity Through Heart Rate Variability Within the Multimodal Rehabilitation Program in Adult Surgery

#### Organization Study ID Info
**ID:** PreANI001
#### Organization
**Class:** NETWORK
**Full Name:** Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon
### Status Module
#### Completion Date
**Date:** 2025-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-24

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-06-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** NETWORK

**Name:** Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Frailty in Adult Surgery

**Keywords:**

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

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 490

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients who do not undergo prehabilitation.

**Intervention Names:**

- Device: Analgesia Nociception Index (ANI) Monitor

**Label:** Control

#### Arm Group 2

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

**Intervention Names:**

- Device: Analgesia Nociception Index (ANI) Monitor

- Behavioral: Trimodal Prehabilitation

**Label:** Prehabilitation

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control

- Prehabilitation

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

**Name:** Analgesia Nociception Index (ANI) Monitor

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Prehabilitation

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

**Name:** Trimodal Prehabilitation

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Correlation of HRV indices with functional capacity and frailty

**Time Frame:** From initial pre-anesthesia consultation to 30 days postoperatively

#### Secondary Outcomes

**Description:** Evaluation of the relationship between higher preoperative functional reserve and lower number of complications, mortality, and hospital stay at 30 days postoperatively.

**Measure:** Reduction of postoperative complications

**Time Frame:** 30 days postoperatively

**Description:** Analysis of whether HRV monitoring guides the workload during prehabilitation and the titration of drugs during surgery.

**Measure:** Intraoperative decisions based on HRV

**Time Frame:** During the perioperative period

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Adult patients undergoing major surgery within a multimodal rehabilitation program in various hospitals in Spain.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** cristianaragon@outlook.com

**Name:** Cristian Aragón-Benedí, M.D., Ph.D.,

**Phone:** +34625408866

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Zaragoza

**Contacts:**

***Contact 1:***

- **Email:** cristianaragon@outlook.com

- **Name:** Cristian Aragón-Benedí

- **Role:** CONTACT

**Country:** Spain

**Facility:** Miguel Servet University Hospital

**Status:** RECRUITING

**Zip:** 50009

#### Overall Officials

**Official 1:**

**Affiliation:** Miguel Servet University Hospital

**Name:** Cristian Aragón-Benedí, M.D., Ph.D.,

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**Description:** There are no plans to share individual participant data (IPD) with other researchers.

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M1175

- Name: Frailty

- Relevance: HIGH

- As Found: Frailty

### Condition Browse Module - Meshes

- ID: D000073496

- Term: Frailty

### Misc Info Module

- Version Holder: 2024-05-31
