Functional Disturbance Following Cardiac SurgeryNCT01513642
Respiratory Physiotherapy After Cardiac Surgery
A study testing Breath Stacking in people with Functional Disturbance Following Cardiac Surgery, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial summary
Although incentive spirometry is commonly used to avoid pulmonary complications in cardiac surgery patients, the breath-stacking technique has been proposed as an alternative to increase pulmonary volumes in the post-operative period. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Functional Disturbance Following Cardiac Surgery
- What is being tested?
- Breath Stacking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2009to Dec 2011
- Phase
- Interventional
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients submitted to myocardial revascularization surgery
Who cannot join
- cognitive impairment or incoordination to perform IS
- face mask intolerance during BS
- level of consciousness incompatible to perform IS
- hemodynamic complications [arrhythmia, intraoperative myocardial infarction, major blood loss (defined as a loss of ≥20% of total blood volume), mean arterial pressure <70 mmHg and reduce cardiac output requiring the use of an intra-aortic balloon pump or vasoactive drugs)
- intubation for more than 72 h after admission to the Intensive Care Unit
- the need for reintubation.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal Bonsucesso Hospital
Rio de Janeiro, Rio de Janeiro, 21041030
About this study
Official title: Inspiratory Volume and Muscle Recruitment During Breath-stacking and Incentive Spirometry Techniques in Postoperative Cardiac Patients
Although incentive spirometry is commonly used to avoid pulmonary complications in cardiac surgery patients, the breath-stacking technique has been proposed as an alternative to increase pulmonary volumes in the post-operative period.
Objective: To compare inspiratory volume and electromyographic activity of respiratory muscles during breath stacking technique and incentive spirometry in patients undergoing cardiac surgery.
Read the detailed description
The purpose of the present study are:
- to evaluate and compare the inspiratory volume during the course of Breath Stacking and Incentive Spirometry techniques in patients submitted to myocardial revascularization surgery.
- to compare the electromyographic activity of the scalene, sternocleidomastoid (SCM) and diaphragm muscles during both techniques.
- Being tested
- Breath Stacking
- Keywords
- physiotherapy, cardiac surgery, breath Stacking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath StackingBehavioural
Also called respiratory exercises
To perform the BS maneuver, a silicone mask containing a one-way valve was attached to the patient's face. Once the mask was adjusted to allow only inspiration (the expiratory branch remained occluded), the patient was asked to make successive inspiratory efforts during 20 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Incentive spirometry | Other | Not described Receives: Behavioral: Breath Stacking |
| Breath Stacking | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory volume and muscle recruitment during breath-stacking and incentive spirometry techniques in postoperative cardiac patients
Measured: Within 2 days after cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startMar 2009
- Primary completionFeb 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Disturbance Following Cardiac 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juliana Flávia de Oliveira, Universidade Federal do Rio de Janeiro
- Investigators
- Cristina Dias, PhD, Study director, Centro Universitário Augusto Motta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513642
- Sponsor's protocol ID
- oliveira1
- Status last verified
- Jan 2012
- First submitted
- 16 Jan 2012
- Last updated
- 20 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Volume and Muscle Recruitment During Breath-stacking and Incentive Spirometry Techniques in Postoperative Cardiac Patients
- ClinicalTrials.gov ID
- NCT01513642
- Acronym / sponsor ID
- oliveira1
- Keywords
- physiotherapy, cardiac surgery, breath Stacking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 20 Jan 2012 (estimated)
- 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.
Although incentive spirometry is commonly used to avoid pulmonary complications in cardiac surgery patients, the breath-stacking technique has been proposed as an alternative to increase pulmonary volumes in the post-operative period.
Objective: To compare inspiratory volume and electromyographic activity of respiratory muscles during breath stacking technique and incentive spirometry in patients undergoing cardiac surgery.
Detailed description
The purpose of the present study are:
- to evaluate and compare the inspiratory volume during the course of Breath Stacking and Incentive Spirometry techniques in patients submitted to myocardial revascularization surgery.
- to compare the electromyographic activity of the scalene, sternocleidomastoid (SCM) and diaphragm muscles during both techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incentive spirometry | Other | Behavioral: Breath Stacking |
| Breath Stacking | No intervention | – |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients submitted to myocardial revascularization surgery
Key exclusion criteria (6 listed)
- cognitive impairment or incoordination to perform IS
- face mask intolerance during BS
- level of consciousness incompatible to perform IS
- hemodynamic complications [arrhythmia, intraoperative myocardial infarction, major blood loss (defined as a loss of ≥20% of total blood volume), mean arterial pressure <70 mmHg and reduce cardiac output requiring the use of an intra-aortic balloon pump or vasoactive drugs)
- intubation for more than 72 h after admission to the Intensive Care Unit
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 |
|---|---|---|
| Breath StackingAlso: respiratory exercisesTo perform the BS maneuver, a silicone mask containing a one-way valve was attached to the patient's face. Once the mask was adjusted to allow only inspiration (the expiratory branch remained occluded), the patient was asked to make successive inspiratory efforts during 20 seconds. | Behavioural | Incentive spirometry |
Primary outcome
Inspiratory volume and muscle recruitment during breath-stacking and incentive spirometry techniques in postoperative cardiac patients
Time frame: Within 2 days after cardiac surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2012.
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.
Cristina Dias, PhD study director
Centro Universitário Augusto Motta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breath Stacking in people with Functional Disturbance Following Cardiac Surgery, run by Universidade Federal do Rio de Janeiro 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 6 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: finished, as of the sponsor's last update on 20 Jan 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inspiratory volume and muscle recruitment during breath-stacking and incentive spirometry techniques in postoperative cardiac patients (time frame: Within 2 days after cardiac surgery). 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 20 Jan 2012; AzTrials last refreshed its copy on 30 Oct 2026.