Respiratory ComplicationsNCT06814951
Acute Effect of the Thoraco-abdominal Rebalance Method Postoperative Cardiac Surgery
A study testing TAR Method and Conventional physiotherapy in people with Respiratory Complications and Diaphragmatic Excursion, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Respiratory Complications, Diaphragmatic Excursion, Pulmonary Spirometry
- What is being tested?
- TAR Method and Conventional physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2024to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals over 35 years of age who undergo coronary artery bypass graft surgery with prescribed physiotherapy treatment will be included in the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Intituto de Cardiologia do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90620-001
Bruna Eibel, +55(051)9970001110, brunaeibel@gmail.com
Karolini R Branco, +55(051)995075412, karolinireis@hotmail.com
About this study
Official title: Acute Effect of the Thoraco-abdominal Rebalance Method on Diaphragmatic Function, Respiratory Discomfort, Pulmonary Complications and Hemodynamic Variables in Postoperative Cardiac Surgery Patients: Randomized Clinical Trial
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.
Read more
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
Read the detailed description
To compare the effect of conventional physiotherapy techniques with the management of thoracoabdominal rebalancing in postoperative patients after myocardial revascularization surgery, carefully evaluating these effects through diaphragm ultrasound and pulmonary spirometry, in addition to variables such as vital signs and respiratory distress scales and pulmonary complications after cardiac surgery. This is a randomized trial in which patients undergoing myocardial revascularization surgery at the Cardiology Institute of Rio Grande do Sul will participate.
Individuals over 35 years of age who underwent myocardial revascularization surgery with prescribed physiotherapy treatment will be included in the study. Patients who were intubated and/or remained on mechanical ventilation for more than twelve hours or who required non-invasive mechanical ventilation before or during the collection period will be excluded.
The study was submitted to the Research Ethics Committee of the Cardiology Institute of Porto Alegre (CEP-ICFUC). All study participants will receive clear explanations about the research, and those who voluntarily agree to participate in the study will sign the informed consent form in two copies, one of which will be made available to the participant and the other to the researchers. Participants will not be paid, nor will they receive any assistance during or after the end of the research (466/12).
The benefits of this research will be in improved conduct that prevents or reduces complications and/or respiratory discomfort, as well as speeding up the patient's recovery, aiming for faster hospital discharge. Patients selected for the control group (conventional physiotherapy) will be exposed to respiratory physiotherapy techniques such as vibrocompression, passive manual expiratory therapy, acceleration of expiratory flow, fractional inspiration in times, diaphragmatic breathing and aspiration when necessary, and patients selected for group intervention will undergo thoracoabdominal rebalancing management such as abdominal supports and/or in the ileocostal space, inspiratory assistance, release of the shoulder girdle, thoracic swing, release of the pectoralis major and deltoid muscles together with aspiration if necessary.
The research presents minimal risks for the participants, which are related to the measurement of hemodynamic variables through the monitor, in addition to the pulmonary spirometry test and diaphragmatic analysis through ultrasound, and/or application of conventional physiotherapy techniques such as vibrocompression, acceleration of expiratory flow, passive manual expiratory therapy that may suggest some discomfort or pain when touching the chest in a sensation of pressure and vibration. Patients undergoing thoracoabdominal rebalancing treatment are expected to have lower scores on the pulmonary complications scale, Downes and Raphaelly respiratory distress scale and, consequently, better diaphragmatic excursion, as well as improvements in other variables.
- Being tested
- TAR Method, Conventional physiotherapy
- Keywords
- Physiotherapy, Ultrasonography, Cardiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAR MethodProcedure or surgery
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.
Conventional physiotherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: TAR Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic excursion
Increase in measures
Measured: 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
Measured: Immediately before the intervention and within 30 minutes after the intervention
Pulmonary spirometry
Increase in measurements: CVF (L)
Measured: Immediately before the intervention and within 30 minutes after the intervention
Secondary outcomes (5)
Respiratory rate
Breathing intervals per minute
Measured: Immediately before the intervention and within 30 minutes after the intervention
Peripheral oxygen saturation
SpO2
Measured: Immediately before the intervention and within 30 minutes after the intervention
Mean arterial pressure
mmHg
Measured: Immediately before the intervention and within 30 minutes after the intervention
Lung auscultation assessment
Wheezing, rhonchi or stridor
Measured: Immediately before the intervention and within 30 minutes after the intervention
Heart rate
Beats per minute
Measured: Immediately before the intervention and within 30 minutes after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start1 Sep 2024
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Respiratory ComplicationsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Instituto de Cardiologia do Rio Grande do Sul, Principal investigator, Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre, Brasil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814951
- Sponsor's protocol ID
- 6075/23
- Status last verified
- Mar 2026
- First submitted
- 4 Feb 2025
- Last updated
- 27 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
SANTANA, Pauliane Vieira et al. Ultrassonografia diafragmática: uma revisão de seus aspectos metodológicos e usos clínicos. Jornal Brasileiro de Pneumologia, v. 46, 2020.
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.
PubMed 12495408OLIVEIRA, 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
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.
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.
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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of the Thoraco-abdominal Rebalance Method on Diaphragmatic Function, Respiratory Discomfort, Pulmonary Complications and Hemodynamic Variables in Postoperative Cardiac Surgery Patients: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06814951
- Acronym / sponsor ID
- 6075/23
- Keywords
- Physiotherapy, Ultrasonography, Cardiology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 7 Feb 2025 (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.
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
Detailed description
To compare the effect of conventional physiotherapy techniques with the management of thoracoabdominal rebalancing in postoperative patients after myocardial revascularization surgery, carefully evaluating these effects through diaphragm ultrasound and pulmonary spirometry, in addition to variables such as vital signs and respiratory distress scales and pulmonary complications after cardiac surgery. This is a randomized trial in which patients undergoing myocardial revascularization surgery at the Cardiology Institute of Rio Grande do Sul will participate.
Individuals over 35 years of age who underwent myocardial revascularization surgery with prescribed physiotherapy treatment will be included in the study. Patients who were intubated and/or remained on mechanical ventilation for more than twelve hours or who required non-invasive mechanical ventilation before or during the collection period will be excluded.
The study was submitted to the Research Ethics Committee of the Cardiology Institute of Porto Alegre (CEP-ICFUC). All study participants will receive clear explanations about the research, and those who voluntarily agree to participate in the study will sign the informed consent form in two copies, one of which will be made available to the participant and the other to the researchers. Participants will not be paid, nor will they receive any assistance during or after the end of the research (466/12).
The benefits of this research will be in improved conduct that prevents or reduces complications and/or respiratory discomfort, as well as speeding up the patient's recovery, aiming for faster hospital discharge. Patients selected for the control group (conventional physiotherapy) will be exposed to respiratory physiotherapy techniques such as vibrocompression, passive manual expiratory therapy, acceleration of expiratory flow, fractional inspiration in times, diaphragmatic breathing and aspiration when necessary, and patients selected for group intervention will undergo thoracoabdominal rebalancing management such as abdominal supports and/or in the ileocostal space, inspiratory assistance, release of the shoulder girdle, thoracic swing, release of the pectoralis major and deltoid muscles together with aspiration if necessary.
The research presents minimal risks for the participants, which are related to the measurement of hemodynamic variables through the monitor, in addition to the pulmonary spirometry test and diaphragmatic analysis through ultrasound, and/or application of conventional physiotherapy techniques such as vibrocompression, acceleration of expiratory flow, passive manual expiratory therapy that may suggest some discomfort or pain when touching the chest in a sensation of pressure and vibration. Patients undergoing thoracoabdominal rebalancing treatment are expected to have lower scores on the pulmonary complications scale, Downes and Raphaelly respiratory distress scale and, consequently, better diaphragmatic excursion, as well as improvements in other variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Conventional physiotherapy | Active comparator | Procedure: Conventional physiotherapyPatients 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. |
| TAR Method | Active comparator | Procedure: TAR MethodPatients 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. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals over 35 years of age who undergo coronary artery bypass graft surgery with prescribed physiotherapy treatment will be included in the study.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| TAR MethodPatients 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. | Procedure or surgery | TAR Method |
| Conventional physiotherapyPatients 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 or surgery | Conventional physiotherapy |
Primary outcome
Diaphragmatic excursion
Time frame: Immediately before the intervention and within 30 minutes after the intervention
Increase in measures
Change in the Downes and Raphaelly respiratory distress scale
Time frame: Immediately before the intervention and within 30 minutes after the intervention
Points 0-10, where 0 is best and 10 is worst
Pulmonary spirometry
Time frame: Immediately before the intervention and within 30 minutes after the intervention
Increase in measurements: CVF (L)
5 secondary outcomes
Respiratory rate
Time frame: Immediately before the intervention and within 30 minutes after the intervention
Peripheral oxygen saturation
Time frame: Immediately before the intervention and within 30 minutes after the intervention
Mean arterial pressure
Time frame: Immediately before the intervention and within 30 minutes after the intervention
Lung auscultation assessment
Time frame: Immediately before the intervention and within 30 minutes after the intervention
Heart rate
Time frame: Immediately before the intervention and within 30 minutes after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- BackgroundSANTANA, Pauliane Vieira et al. Ultrassonografia diafragmática: uma revisão de seus aspectos metodológicos e usos clínicos. Jornal Brasileiro de Pneumologia, v. 46, 2020.
- Background: PubMed 12495408Hulzebos 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.
- BackgroundOLIVEIRA, 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
- BackgroundSOARES, 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.
- BackgroundSANTANA, 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.
- Background1. 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.
- Individual participant dataSharing planned: No
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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.
Instituto de Cardiologia do Rio Grande do Sul principal investigator
Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre, Brasil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAR Method and Conventional physiotherapy in people with Respiratory Complications and Diaphragmatic Excursion, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 27 Apr 2026. 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karolini R Branco (+55(051)995075412, karolinireis@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragmatic excursion (time frame: Immediately before the intervention and within 30 minutes after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06814951, which also lists 6 linked publications.
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 27 Apr 2026.