Cardiac InfarctNCT06247358
Frailty, Physical Capacity and Lung Function in Postoperative Cardiac Surgery Patients
An observational study of Cardiac Infarct and Cardiac Valve Disease, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The goal of this observational and prospective study is to investigate changes in physical performance, lung function, and respiratory and peripheral muscle strength in patients during the postoperative period following coronary artery bypass grafting (CABG) and valve replacement surgery.. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Infarct, Cardiac Valve Disease, Fragility
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- 16 Feb 2024to 16 Jun 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients in the preoperative period of elective coronary artery bypass grafting and valve replacement surgery
Who may be able to join
- Age ≥ 18 years
- Both genders
- Elective coronary artery bypass grafting surgery
- Elective Heart valve surgery
- Absence of cognitive or peripheral motor impairment that prevents the performance of functional tests in the preoperative period.
Who cannot join
- Surgeries performed via lateral thoracotomy or minithoracotomy
- Reoperation for any reason
- Presence of cognitive or peripheral motor impairment that prevents the performance of functional tests in the postoperative period.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 05403-000
About this study
Official title: Assessment of Frailty, Physical Capacity and Lung Function in Postoperative Cardiac Surgery Patients: an Observational and Prospective Clinical Study
The goal of this observational and prospective study is to investigate changes in physical performance, lung function, and respiratory and peripheral muscle strength in patients during the postoperative period following coronary artery bypass grafting (CABG) and valve replacement surgery..
Read the detailed description
This study aims to investigate the physical changes in patients undergoing myocardial revascularization surgery and valve replacement. It will observe alterations in physical performance, lung function, and muscle strength during the postoperative period. The study, observational and prospective, will include individuals aged ≥18 scheduled for these surgeries, evaluating them preoperatively, post-intensive care unit discharge, and before hospital discharge. Assessments involve tests like the Short Physical Performance Battery, 1-minute sit-to-stand test, Clinical Frailty Scale, manovacuometry, dynamometry, and spirometry to identify frailty and measure muscle and lung function. The study also aims to explore predictive variables for functional loss and mortality during hospitalization.
- Conditions
- Cardiac Infarct, Cardiac Valve Disease, Fragility, Physical Disability
- Keywords
- Cardiac surgery, Short Physical Performance Battery, 1-minute sit-tostand test, Spirometry, muscular strength
- Medical subject headings
- Myocardial Infarction, Heart Valve Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate changes in physical performance measured by Short Physical Performance Battery (SPPB)
Measures: walking speed, standing balance and sit-to-stand performance.
Measured: Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge) and through study completion, an average of 15 days.
To investigate changes in physical performance measured by Six-Minute Walk Test.
Measures: the assessment will take place in a flat 30-meter corridor, marked every 1 meter with non-slip flooring, and the patient will be instructed to walk for six minutes as fast as possible.
Measured: Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge) and through study completion, an average of 15 days.
To investigate changes in physical performance by 1-minute sit-to-stand test (1-MSTST)
Measure: number of 1-MSTST repetitions.
Measured: Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge) and through study completion, an average of 15 days.
To investigate changes in peripheral muscle strength
Measure: hand grip strengh measure (Kgf)
Measured: Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge) and through study completion, an average of 15 days.
To investigate changes in respiratory muscle strength:
Measures: maximal inspiratory and expiratory pressure (cmH2O)
Measured: Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge) and through study completion, an average of 15 days.
To investigate changes in lung function test measure by spirometry:
Measures: FVC (L), FEV1 (L), FEF (L/s) and FEF 25-75 (%)
Measured: Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge) and through study completion, an average of 15 days.
To investigate frailty by Clinical Frailty Scale (CFS)
The minimal value is 1 and the maximal is 9 in which the lowest scores mean worse outcomes.
Measured: Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge) and through study completion, an average of 15 days.
Secondary outcomes (5)
To explore potential preoperative and immediate postoperative risk factors as predictors of functional loss.
Occurrence of comorbidities and clinical variables associated with functional decline
Measured: Baseline (one day before the surgery) during the immediate postoperative period.
To investigate hemodynamic behavior during the Short Physical Performance Battery (SPPB).
Measures: heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure.
Measured: Immediately before and after the SPPB.
To investigate hemodynamic behavior during the 1-minute sit-to-stand test (1-MSTST).
Measures: heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure.
Measured: Immediately before and after the 1-MSTST tests.
To investigate respiratory behavior during the Short Physical Performance Battery (SPPB).
Measures: respiratory rate, Borg dyspnea scale and peripheral oxygen saturation.
Measured: Immediately before and after the SPPB.
To investigate respiratory behavior during 1-minute sit-to-stand test (1-1-MSTST).
Measures: respiratory rate, Borg dyspnea scale and peripheral oxygen saturation.
Measured: Immediately before and after the 1-MSTST tests.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start16 Feb 2024
- Primary completion16 Jun 2025
- Study completion16 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac InfarctStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael M. Ianotti, P.T., Ph.D., University of Sao Paulo General Hospital
- Investigators
- Rafael M Ianotti, PT, Principal investigator, Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247358
- Sponsor's protocol ID
- CAAEE: 73168923.7.0000.0068
- Status last verified
- Jun 2026
- First submitted
- 19 Dec 2023
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Frailty, Physical Capacity and Lung Function in Postoperative Cardiac Surgery Patients: an Observational and Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT06247358
- Acronym / sponsor ID
- CAAEE: 73168923.7.0000.0068
- Conditions
- Cardiac Infarct, Cardiac Valve Disease, Fragility, Physical Disability
- Keywords
- Cardiac surgery, Short Physical Performance Battery, 1-minute sit-tostand test, Spirometry, muscular strength
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 16 Jun 2025 (actual)
- Study completion
- 16 Jun 2026 (actual)
- First posted
- 7 Feb 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.
The goal of this observational and prospective study is to investigate changes in physical performance, lung function, and respiratory and peripheral muscle strength in patients during the postoperative period following coronary artery bypass grafting (CABG) and valve replacement surgery..
Detailed description
This study aims to investigate the physical changes in patients undergoing myocardial revascularization surgery and valve replacement. It will observe alterations in physical performance, lung function, and muscle strength during the postoperative period. The study, observational and prospective, will include individuals aged ≥18 scheduled for these surgeries, evaluating them preoperatively, post-intensive care unit discharge, and before hospital discharge. Assessments involve tests like the Short Physical Performance Battery, 1-minute sit-to-stand test, Clinical Frailty Scale, manovacuometry, dynamometry, and spirometry to identify frailty and measure muscle and lung function. The study also aims to explore predictive variables for functional loss and mortality during hospitalization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the preoperative period of elective coronary artery bypass grafting and valve replacement surgery
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Both genders
- Elective coronary artery bypass grafting surgery
- Elective Heart valve surgery
- Absence of cognitive or peripheral motor impairment that prevents the performance of functional tests in the preoperative period.
Key exclusion criteria (3 listed)
- Surgeries performed via lateral thoracotomy or minithoracotomy
- Reoperation for any reason
- Presence of cognitive or peripheral motor impairment that prevents the performance of functional tests in the postoperative period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To investigate changes in physical performance measured by Short Physical Performance Battery (SPPB)
Time frame: Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge) and through study completion, an average of 15 days.
Measures: walking speed, standing balance and sit-to-stand performance.
To investigate changes in physical performance measured by Six-Minute Walk Test.
Time frame: Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge) and through study completion, an average of 15 days.
Measures: the assessment will take place in a flat 30-meter corridor, marked every 1 meter with non-slip flooring, and the patient will be instructed to walk for six minutes as fast as possible.
To investigate changes in physical performance by 1-minute sit-to-stand test (1-MSTST)
Time frame: Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge) and through study completion, an average of 15 days.
Measure: number of 1-MSTST repetitions.
To investigate changes in peripheral muscle strength
Time frame: Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge) and through study completion, an average of 15 days.
Measure: hand grip strengh measure (Kgf)
To investigate changes in respiratory muscle strength:
Time frame: Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge) and through study completion, an average of 15 days.
Measures: maximal inspiratory and expiratory pressure (cmH2O)
To investigate changes in lung function test measure by spirometry:
Time frame: Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge) and through study completion, an average of 15 days.
Measures: FVC (L), FEV1 (L), FEF (L/s) and FEF 25-75 (%)
To investigate frailty by Clinical Frailty Scale (CFS)
Time frame: Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge) and through study completion, an average of 15 days.
The minimal value is 1 and the maximal is 9 in which the lowest scores mean worse outcomes.
5 secondary outcomes
To explore potential preoperative and immediate postoperative risk factors as predictors of functional loss.
Time frame: Baseline (one day before the surgery) during the immediate postoperative period.
To investigate hemodynamic behavior during the Short Physical Performance Battery (SPPB).
Time frame: Immediately before and after the SPPB.
To investigate hemodynamic behavior during the 1-minute sit-to-stand test (1-MSTST).
Time frame: Immediately before and after the 1-MSTST tests.
To investigate respiratory behavior during the Short Physical Performance Battery (SPPB).
Time frame: Immediately before and after the SPPB.
To investigate respiratory behavior during 1-minute sit-to-stand test (1-1-MSTST).
Time frame: Immediately before and after the 1-MSTST tests.
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 22 Jun 2026.
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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.
Rafael M Ianotti, PT principal investigator
Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
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 Cardiac Infarct and Cardiac Valve Disease, run by University of Sao Paulo General Hospital 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 5 inclusion and 3 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 22 Jun 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?
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?
To investigate changes in physical performance measured by Short Physical Performance Battery (SPPB) (time frame: Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge) and through study completion, an average of 15 days.). The study lists 7 primary outcomes in all. 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 22 Jun 2026.