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

Physical Disability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06247358
• Other study ID #: CAAEE: 73168923.7.0000.0068
• Status: Recruiting
• Start date: February 16, 2024
• Est. completion date: October 10, 2025

Study information

• Verified date: March 2024
• Source: University of Sao Paulo General Hospital
• Contact: Rafael M Ianotti, PT
• Phone: +55 11 26615319
• Email: rafael.ianotti[@]hc.fm.usp.br
• Is FDA regulated: No
• Study type: Observational

Clinical 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..

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 10, 2025
• Est. primary completion date: November 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Infarct
• Cardiac Valve Disease
• Fragility
• Frailty
• Heart Valve Diseases
• Myocardial Infarction
• Physical Disability

Locations

Country	Name	City	State
Brazil	Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.	Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge) and through study completion, an average of 15 days.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.