Frailty in Adult SurgeryPreANINCT06436417
Functional Capacity Through HRV in Multimodal Rehabilitation for Adult Surgery
An observational study of Frailty in Adult Surgery, run by Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty in Adult Surgery
- What is being tested?
- Analgesia Nociception Index (ANI) Monitor and Trimodal Prehabilitation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 490 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2024to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients undergoing major surgery within a multimodal rehabilitation program in various hospitals in Spain.
Who may be able to join
- Patients over 18 years of age
- Scheduled for major adult surgery
- Any ASA classification
- Signed informed consent
Who cannot join
- Urgent surgery
- Severe cognitive impairment
- Patient refusal to participate
- Pediatric patients
- Cardiac arrhythmia or atrial fibrillation
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Miguel Servet University Hospital
Zaragoza, 50009
Cristian Aragón-Benedí, cristianaragon@outlook.com
About this study
Official title: Monitoring Functional Capacity Through Heart Rate Variability Within the Multimodal Rehabilitation Program in Adult Surgery
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.
Read the 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
- Frailty in Adult Surgery
- Being tested
- Analgesia Nociception Index (ANI) Monitor, Trimodal Prehabilitation
- Keywords
- Heart rate variability, prehabilitation, major surgery, frailty, physiological reserve
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analgesia Nociception Index (ANI) MonitorDevice
Non-invasive monitoring of HRV to evaluate autonomic nervous system activity using the indices of Energy (SDNN) and ANI (HFnu).
Trimodal PrehabilitationBehavioural
Program of physical exercise, nutritional supplementation, and psychological support according to the RICA guidelines of the Spanish Group for Multimodal Rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Control | Patients who do not undergo prehabilitation. Receives: Device: Analgesia Nociception Index (ANI) Monitor | |
| Prehabilitation | Patients who undergo trimodal prehabilitation including physical exercise, nutritional supplementation, and psychological support. Receives: Device: Analgesia Nociception Index (ANI) Monitor; Behavioral: Trimodal Prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From initial pre-anesthesia consultation to 30 days postoperatively
Secondary outcomes (2)
Reduction of postoperative complications
Evaluation of the relationship between higher preoperative functional reserve and lower number of complications, mortality, and hospital stay at 30 days postoperatively.
Measured: 30 days postoperatively
Intraoperative decisions based on HRV
Analysis of whether HRV monitoring guides the workload during prehabilitation and the titration of drugs during surgery.
Measured: During the perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start1 Jan 2024
- Primary completion1 Jun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frailty in Adult SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 490 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Cristian Aragón-Benedí, M.D., Ph.D.,, Study chair, Miguel Servet University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436417
- Sponsor's protocol ID
- PreANI001
- Acronym
- PreANI
- Status last verified
- May 2024
- First submitted
- 24 May 2024
- Last updated
- 31 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share individual participant data (IPD) with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Functional Capacity Through Heart Rate Variability Within the Multimodal Rehabilitation Program in Adult Surgery
- ClinicalTrials.gov ID
- NCT06436417
- Acronym / sponsor ID
- PreANI / PreANI001
- Conditions
- Frailty in Adult Surgery
- Keywords
- Heart rate variability, prehabilitation, major surgery, frailty, physiological reserve
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of AragonResearch network
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Device: Analgesia Nociception Index (ANI) MonitorPatients who do not undergo prehabilitation. |
| Prehabilitation | – | Device: Analgesia Nociception Index (ANI) Monitor, Behavioral: Trimodal PrehabilitationPatients who undergo trimodal prehabilitation including physical exercise, nutritional supplementation, and psychological support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing major surgery within a multimodal rehabilitation program in various hospitals in Spain.
Key inclusion criteria (4 listed)
- Patients over 18 years of age
- Scheduled for major adult surgery
- Any ASA classification
- Signed informed consent
Key exclusion criteria (5 listed)
- Urgent surgery
- Severe cognitive impairment
- Patient refusal to participate
- Pediatric patients
- Cardiac arrhythmia or atrial fibrillation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analgesia Nociception Index (ANI) MonitorNon-invasive monitoring of HRV to evaluate autonomic nervous system activity using the indices of Energy (SDNN) and ANI (HFnu). | Device | Control, Prehabilitation |
| Trimodal PrehabilitationProgram of physical exercise, nutritional supplementation, and psychological support according to the RICA guidelines of the Spanish Group for Multimodal Rehabilitation. | Behavioural | Prehabilitation |
Primary outcome
Correlation of HRV indices with functional capacity and frailty
Time frame: 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.
2 secondary outcomes
Reduction of postoperative complications
Time frame: 30 days postoperatively
Intraoperative decisions based on HRV
Time frame: During the perioperative period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Individual participant dataSharing planned: No. There are no plans to share individual participant data (IPD) with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristian Aragón-Benedí, M.D., Ph.D., study chair
Miguel Servet University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty in Adult Surgery, run by Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cristian Aragón-Benedí, M.D., Ph.D., (+34625408866, cristianaragon@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of HRV indices with functional capacity and frailty (time frame: From initial pre-anesthesia consultation to 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.