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

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

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: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Rafael M Ianotti, PT; Phone Number: +55 11 26615319; Email: rafael.ianotti@hc.fm.usp.br

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 05403-000
      • Recruiting
      • Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
      • Sub-Investigator: Kelly CO Abud, PT, PhD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To investigate changes in physical performance measured by Short Physical Performance Battery (SPPB)	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)	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	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:	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:	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)	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To explore potential preoperative and immediate postoperative risk factors as predictors of functional loss.	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).	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).	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).	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).	Measures: respiratory rate, Borg dyspnea scale and peripheral oxygen saturation.	Immediately before and after the 1-MSTST tests.

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Rafael M Ianotti, PT, Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2024
• Primary Completion (Estimated): November 10, 2024
• Study Completion (Estimated): October 10, 2025

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Cardiac surgery; Spirometry; muscular strength; Short Physical Performance Battery; 1-minute sit-tostand test
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Myocardial Infarction; Frailty; Heart Valve Diseases
• Other Study ID 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