Clinical trial NCT06247358: Frailty, Physical Capacity and Lung Function in Postoperative Cardiac Surgery Patients
Official title: Assessment of Frailty, Physical Capacity and Lung Function in Postoperative Cardiac Surgery Patients: an Observational and Prospective Clinical Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Infarct
Cardiac Valve Disease
Fragility
Physical Disability
Keywords: Cardiac surgery
Short Physical Performance Battery
1-minute sit-tostand test
Spirometry
muscular strength
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in the preoperative period of elective coronary artery bypass grafting and valve replacement surgery

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To investigate changes in physical performance measured by Short Physical Performance Battery (SPPB)
timeFrame: 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: To investigate changes in physical performance measured by Six-Minute Walk Test.
timeFrame: 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: To investigate changes in physical performance by 1-minute sit-to-stand test (1-MSTST)
timeFrame: 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: To investigate changes in peripheral muscle strength
timeFrame: 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: To investigate changes in respiratory muscle strength:
timeFrame: 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: To investigate changes in lung function test measure by spirometry:
timeFrame: 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: To investigate frailty by Clinical Frailty Scale (CFS)
timeFrame: 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 outcomes:
measure: To explore potential preoperative and immediate postoperative risk factors as predictors of functional loss.
timeFrame: Baseline (one day before the surgery) during the immediate postoperative period.
measure: To investigate hemodynamic behavior during the Short Physical Performance Battery (SPPB).
timeFrame: Immediately before and after the SPPB.
measure: To investigate hemodynamic behavior during the 1-minute sit-to-stand test (1-MSTST).
timeFrame: Immediately before and after the 1-MSTST tests.
measure: To investigate respiratory behavior during the Short Physical Performance Battery (SPPB).
timeFrame: Immediately before and after the SPPB.
measure: To investigate respiratory behavior during 1-minute sit-to-stand test (1-1-MSTST).
timeFrame: Immediately before and after the 1-MSTST tests.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
state: SP
Study officials:
affiliation: Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
name: Rafael M Ianotti, PT
role: PRINCIPAL_INVESTIGATOR
References: