Frailty, Physical Capacity and Lung Function in Postoperative Cardiac Surgery Patients

June 18, 2026 updated by: Rafael M. Ianotti, P.T., Ph.D., University of Sao Paulo General Hospital

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..

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil, 05403-000
        • Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients in the preoperative period of elective coronary artery bypass grafting and valve replacement surgery

Description

Inclusion Criteria

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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)
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.
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
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)
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:
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)
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:
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 (%)
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)
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.
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.
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Occurrence of comorbidities and clinical variables associated with functional decline
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.
Measures: heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure.
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.
Measures: heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure.
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.
Measures: respiratory rate, Borg dyspnea scale and peripheral oxygen saturation.
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.
Measures: respiratory rate, Borg dyspnea scale and peripheral oxygen saturation.
Immediately before and after the 1-MSTST tests.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rafael M Ianotti, PT, Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 16, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 16, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 16, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CAAEE: 73168923.7.0000.0068

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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