Acute Effect of the Thoraco-abdominal Rebalance Method Postoperative Cardiac Surgery

NCT06814951 | Recruiting

• 1 other identifier: 6075/23
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: The thoracoabdominal rebalancing (TAR) method aims to promote diaphragmatic juxtaposition, in addition to seeking to increase respiratory muscle strength and adjust muscle tone. However, scientific publications on this method in heart patients undergoing coronary artery bypass grafting (CABG) are still scarce, justifying the need to carry out this study for information, evaluation, diagnosis and treatment purposes in the health area with an emphasis on cardiology. Objective: To evaluate whether diaphragmatic ultrasound findings differ between the TAR method and conventional physiotherapy in post-CABG patients. Methods: This is a randomized, single-blind clinical trial. Adults (\>35 years), hemodynamically stable, who underwent CABG (\<24 hours) and had a prescription for physiotherapy will be included. Patients will be randomized into two groups: 1) intervention group \[IG\] - TAR; 2) control group \[CG\] - standard physiotherapy approach. Interventions will be performed at a single time and the following variables will be collected pre- and post-intervention: heart rate (HR), respiratory rate (RR), peripheral oxygen saturation (SpO2), mean arterial pressure (MAP), diaphragmatic ultrasound (US) to identify possible acute findings in both groups, respiratory distress scale and pulmonary complications scale will be applied at the end of the interventions. Keywords: Physiotherapy; Cardiology; Ultrasonography

Conditions

Respiratory Complications; Diaphragmatic Excursion; Pulmonary Spirometry

Keywords

Physiotherapy; Ultrasonography; Cardiology

Outcome Measures

Primary Outcomes (3)

• Diaphragmatic excursion

  Increase in measures

  Immediately before the intervention and within 30 minutes after the intervention

• Change in the Downes and Raphaelly respiratory distress scale

  Points 0-10, where 0 is best and 10 is worst

  Immediately before the intervention and within 30 minutes after the intervention

• Pulmonary spirometry

  Increase in measurements: CVF (L)

  Immediately before the intervention and within 30 minutes after the intervention

Secondary Outcomes (5)

• Respiratory rate

  Immediately before the intervention and within 30 minutes after the intervention

• Peripheral oxygen saturation

  Immediately before the intervention and within 30 minutes after the intervention

• Mean arterial pressure

  Immediately before the intervention and within 30 minutes after the intervention

• Lung auscultation assessment

  Immediately before the intervention and within 30 minutes after the intervention

• Heart rate

  Immediately before the intervention and within 30 minutes after the intervention

Study Arms (2)

Conventional physiotherapy

ACTIVE COMPARATOR

Patients selected for the control group (conventional physiotherapy) will be exposed to respiratory physiotherapy techniques such as vibrocompression, manual passive expiratory therapy, acceleration of expiratory flow, fractional inspiration in times, diaphragmatic breaths and aspiration when necessary.

Procedure: Conventional physiotherapy

TAR Method

ACTIVE COMPARATOR

Patients selected for the intervention group will undergo thoracoabdominal rebalancing treatment, such as abdominal and/or ileocostal space supports, inspiratory assistance, release of the shoulder girdle, thoracic balance, release of the pectoralis major and deltoid muscles, along with aspiration, if necessary.

Procedure: TAR Method

Interventions

TAR Method PROCEDURE

Patients selected for the intervention group will undergo thoracoabdominal rebalancing management such as abdominal supports and/or in the ileocostal space, inspiratory assistance, release of the shoulder girdle, thoracic balance, release of the pectoralis major and deltoid muscles together with aspiration if necessary.

TAR Method

Conventional physiotherapy PROCEDURE

Patients selected for the control group (conventional physiotherapy) will be exposed to respiratory physiotherapy techniques such as vibrocompression, manual passive expiratory therapy, acceleration of expiratory flow, fractional inspiration in times, diaphragmatic breaths and aspiration when necessary.

Conventional physiotherapy

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals over 35 years of age who undergo coronary artery bypass graft surgery with prescribed physiotherapy treatment will be included in the study.

You may not qualify if:

• Patients who are intubated and/or have remained on mechanical ventilation for more than twelve hours, or who require non-invasive mechanical ventilation (NIV) before or during the collection period will be excluded.

Sponsors & Collaborators

• Instituto de Cardiologia do Rio Grande do Sul: lead

Study Sites (1)

Intituto de Cardiologia do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90620-001, Brazil

RECRUITING

Related Publications (6)

• SANTANA, Pauliane Vieira et al. Ultrassonografia diafragmática: uma revisão de seus aspectos metodológicos e usos clínicos. Jornal Brasileiro de Pneumologia, v. 46, 2020.

  BACKGROUND

• Hulzebos EH, Van Meeteren NL, De Bie RA, Dagnelie PC, Helders PJ. Prediction of postoperative pulmonary complications on the basis of preoperative risk factors in patients who had undergone coronary artery bypass graft surgery. Phys Ther. 2003 Jan;83(1):8-16.

  PMID: 12495408 BACKGROUND

• OLIVEIRA, Miriana Carvalho; SOBRINHO, Cristina Ortiz; ORSINI, Marco. Comparação entre o método Reequilíbrio Toracoabdominal e a fisioterapia respiratória convencional em recém-nascidos com taquipneia transitória: um ensaio clínico randomizado. Fisioterapia Brasil, v. 18, n. 5, p. 598-607, 2018

  BACKGROUND

• SOARES, Jainy Lima; DE SOUSA, Anderson Moura Bonfim; DA SILVA MEDEIROS, Joelson. Physiotherapy treatment in the pre and postoperative period of cardiac surgery: an integrative review. Revista Ciência & Saberes-Facema, v. 3, n. 3, p. 624-629, 2017.

  BACKGROUND

• SANTANA, Vilma Maria et al. Health Education for Patients in the Perioperative Period of Cardiovascular Surgery: Experience Report. Brazilian Journal of Health Review, v. 4, n. 2, p. 5559-5571, 2021.

  BACKGROUND

• 1. BECCARIA, Lucia Marinilza et al. Postoperative complications in patients undergoing cardiac surgery in a teaching hospital. Archives of Health Sciences, v. 22, n. 3, p. 37-41, 2015.

  BACKGROUND

Study Officials

• Instituto de Cardiologia do Rio Grande do Sul

  Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre, Brasil

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karolini R Branco

CONTACT

+55(051)995075412; karolinireis@hotmail.com

Bruna Eibel

CONTACT

+55(051)997001110; brunaeibel@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The randomization technique for the proposed interventions will be performed using a computer program (www.random.org) containing the coded distribution. The allocation confidentiality will be guaranteed by a randomization list that will be kept in a remote location, which will prevent the researcher from identifying which intervention will be initiated by each patient. The generation of the sequence of numbers will be performed by a blinded researcher, after selecting the patients according to the inclusion criteria. The sequence of numbers to be used for randomization will be kept confidential until the exact moment of the beginning of the study. The randomization of the subjects in the proposed groups will be done in two blocks, in which the program will randomly distribute each new participant to one of the blocks: conventional physiotherapy group and RTA group.

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 7, 2025
• Study Start: September 1, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)