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

NCT ID: NCT06247358

Last Updated: 2025-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-16

Study Completion Date

2026-10-10

Brief Summary

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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

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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.

Conditions

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Cardiac Infarct Cardiac Valve Disease Fragility Physical Disability

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rafael M. Ianotti, PT

Clinical Research Coordinator - Physiotherapy Division - Heart Institute (InCor)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rafael M Ianotti, PT

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Rafael M Ianotti, PT

Role: CONTACT

+55 11 26615319

Other Identifiers

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CAAEE: 73168923.7.0000.0068

Identifier Type: -

Identifier Source: org_study_id

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