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

Recruiting

• Conditions: Cardiac Infarct; Cardiac Valve Disease; Physical Disability; Fragility

• Registration Number: NCT06247358
• Lead Sponsor: University of Sao Paulo General Hospital

Brief 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..

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 Timeline

• Study First Submitted: 2023-12-19
• Study First Submitted QC: 2024-01-30
• Study First Posted: 2024-02-07
• Study Start: 2024-02-16
• Status Verified: 2024-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-28
• Primary Completion: 2025-09-10
• Study Completion: 2026-10-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To investigate changes in physical performance measured by Six-Minute Walk Test.	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 peripheral muscle strength	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 physical performance measured by Short Physical Performance Battery (SPPB)	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 by 1-minute sit-to-stand test (1-MSTST)	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 respiratory muscle strength:	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:	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)	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 Outcome Measures

Name	Time	Method
To investigate hemodynamic behavior during the Short Physical Performance Battery (SPPB).	Immediately before and after the SPPB.	Measures: heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure.
To investigate respiratory behavior during 1-minute sit-to-stand test (1-1-MSTST).	Immediately before and after the 1-MSTST tests.	Measures: respiratory rate, Borg dyspnea scale and peripheral oxygen saturation.
To explore potential preoperative and immediate postoperative risk factors as predictors of functional loss.	Baseline (one day before the surgery) during the immediate postoperative period.	Occurrence of comorbidities and clinical variables associated with functional decline
To investigate hemodynamic behavior during the 1-minute sit-to-stand test (1-MSTST).	Immediately before and after the 1-MSTST tests.	Measures: heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure.
To investigate respiratory behavior during the Short Physical Performance Battery (SPPB).	Immediately before and after the SPPB.	Measures: respiratory rate, Borg dyspnea scale and peripheral oxygen saturation.

Trial Locations

Locations (1)

Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo; 🇧🇷 São Paulo, SP, Brazil