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NCT Number: NCT06247358

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

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..

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Key information

Conditions

Cardiac Infarct Cardiac Valve Disease Cardiovascular Diseases Fragility Heart Diseases Heart Valve Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Physical Disability Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, 05403-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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)

  5. 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)

  6. 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 (%)

  7. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

Assessment of Frailty, Physical Capacity and Lung Function in Postoperative Cardiac Surgery Patients: an Observational and Prospective Clinical Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 7, 2024
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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