Surgical Prehabilitation on Autonomic Nervous System (TUNE)

NCT06398301 | Active Not Recruiting

• 1 other identifier: TUNE - CET 199-2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

This study will be a multicenter interventional randomized trial evaluating the effect of a multimodal prehabilitation program on heart rate variability (HRV). In the same protocol the impact of HRV on hospital length of stay will be identified. One hundred patients aged 18 years or older scheduled for elective surgery will be eligible for enrolment, if they will not present any exclusion criteria. Patients will be randomized with a 1:1 allocation to receive either prehabilitation or standard of care.

Conditions

Thoracic Surgery

Keywords

Thoracic surgery; Prehabilitation; Multimodal prehabilitation program; Standard care treatment; Hospital stay; Functional walking; Nutrition; Diet; Exercise; Relaxation; Functional recovery; Anesthesiology

Outcome Measures

Primary Outcomes (1)

• Impact of prehabilitation on heart rate variability

  The primary outcome measure will be standard deviation of normal to normal index (SDNN) of heart rate variability from baseline to the days before surgery.

  30 days after prehabilitation

Secondary Outcomes (1)

• Lenght of hospital stay

  60 days follow up post surgery

Study Arms (2)

Prehabilitation

EXPERIMENTAL

Prehabilitation arm groups will receive preoperative intervention which includes exercise training, nutritional therapy and anxiety reducing techniques, aimed at preventing or attenuating surgery-driven functional decline.

Behavioral: Multimodal prehabilitation Program

Control group

NO INTERVENTION

Standard care treatment. Application of ERAS pathways (Enhanced Recovery After Surgery)

Interventions

Multimodal prehabilitation Program BEHAVIORAL

A tailored intervention will be prescribed if specific physical, nutritional or psychological impairments will be identified during the assessment phase. Based on the data obtained during the multimodal assessment, different domains and levels of care will be prescribed, focusing on exercise training, and/or nutrition optimization, and/or distress-coping techniques. Different combinations of three domains will be utilized to maximize their synergistic anabolic effect. The duration of program will be set at 4 weeks. All activities will be performed in dedicated suites at each site, under supervision of qualified health professionals.

Prehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled to undergo major thoracic surgery including lobectomy, bilobectomy, anatomical segmentectomy, and pneumonectomy with general anesthesia;
• Patients ≥18 years of age at the time of randomization;
• Patients who provide written informed consent to participate.

You may not qualify if:

• New York Heart Association classes 3-4;
• End-stage organ dysfunction;
• American Society of Anesthesiologists physical status classes 4-5;
• Disabling orthopedic, neuromuscular, and psychiatric diseases;
• Other medical conditions that preclude safe training.
• Atrial fibrillation or other arrhythmia (e.g. bigeminy, trigeminy) that preclude heart rate variability analysis.
• Unable to provide written informed consent to participate

Sponsors & Collaborators

• Università Vita-Salute San Raffaele: lead
• Katia Donadello: collaborator
• Giulia Veronesi: collaborator

Study Sites (2)

IRCCS San Raffaele Scientific Institute

Milan, 20132, Italy

Location

Università degli studi di Verona

Verona, Italy

Location

Related Publications (19)

• Weinstein AS, Sigurdsson MI, Bader AM. Comparison of Preoperative Assessment of Patient's Metabolic Equivalents (METs) Estimated from History versus Measured by Exercise Cardiac Stress Testing. Anesthesiol Res Pract. 2018 Sep 3;2018:5912726. doi: 10.1155/2018/5912726. eCollection 2018.

  PMID: 30250484 BACKGROUND

• Pedziwiatr M, Mavrikis J, Witowski J, Adamos A, Major P, Nowakowski M, Budzynski A. Current status of enhanced recovery after surgery (ERAS) protocol in gastrointestinal surgery. Med Oncol. 2018 May 9;35(6):95. doi: 10.1007/s12032-018-1153-0.

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• Pedziwiatr M, Kisialeuski M, Wierdak M, Stanek M, Natkaniec M, Matlok M, Major P, Malczak P, Budzynski A. Early implementation of Enhanced Recovery After Surgery (ERAS(R)) protocol - Compliance improves outcomes: A prospective cohort study. Int J Surg. 2015 Sep;21:75-81. doi: 10.1016/j.ijsu.2015.06.087. Epub 2015 Jul 29.

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  PMID: 15585997 BACKGROUND

• Wynter-Blyth V, Moorthy K. Prehabilitation: preparing patients for surgery. BMJ. 2017 Aug 8;358:j3702. doi: 10.1136/bmj.j3702. No abstract available.

  PMID: 28790033 BACKGROUND

• Orange ST, Northgraves MJ, Marshall P, Madden LA, Vince RV. Exercise prehabilitation in elective intra-cavity surgery: A role within the ERAS pathway? A narrative review. Int J Surg. 2018 Aug;56:328-333. doi: 10.1016/j.ijsu.2018.04.054. Epub 2018 May 3.

  PMID: 29730070 BACKGROUND

• Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.

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  PMID: 31547969 BACKGROUND

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• Anderson TA. Heart rate variability: implications for perioperative anesthesia care. Curr Opin Anaesthesiol. 2017 Dec;30(6):691-697. doi: 10.1097/ACO.0000000000000530.

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  PMID: 11455865 BACKGROUND

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• Bernardi L, Valle F, Coco M, Calciati A, Sleight P. Physical activity influences heart rate variability and very-low-frequency components in Holter electrocardiograms. Cardiovasc Res. 1996 Aug;32(2):234-7. doi: 10.1016/0008-6363(96)00081-8.

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• Nunan D, Sandercock GR, Brodie DA. A quantitative systematic review of normal values for short-term heart rate variability in healthy adults. Pacing Clin Electrophysiol. 2010 Nov;33(11):1407-17. doi: 10.1111/j.1540-8159.2010.02841.x.

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• Tarvainen MP, Niskanen JP, Lipponen JA, Ranta-Aho PO, Karjalainen PA. Kubios HRV--heart rate variability analysis software. Comput Methods Programs Biomed. 2014;113(1):210-20. doi: 10.1016/j.cmpb.2013.07.024. Epub 2013 Aug 6.

  PMID: 24054542 BACKGROUND

• Carli F, Gillis C, Scheede-Bergdahl C. Promoting a culture of prehabilitation for the surgical cancer patient. Acta Oncol. 2017 Feb;56(2):128-133. doi: 10.1080/0284186X.2016.1266081. Epub 2017 Jan 9.

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• Colado JC, Pedrosa FM, Juesas A, Gargallo P, Carrasco JJ, Flandez J, Chupel MU, Teixeira AM, Naclerio F. Concurrent validation of the OMNI-Resistance Exercise Scale of perceived exertion with elastic bands in the elderly. Exp Gerontol. 2018 Mar;103:11-16. doi: 10.1016/j.exger.2017.12.009. Epub 2017 Dec 17.

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MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 3, 2024
• Study Start: July 29, 2024
• Primary Completion: April 19, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)