Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 10:08 PM
Study NCT ID:
NCT06247358
Status:
RECRUITING
Last Update Posted:
2025-03-28
First Post:
2023-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Frailty, Physical Capacity and Lung Function in Postoperative Cardiac Surgery Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-10-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2023-12-19', 'studyFirstSubmitQcDate': '2024-01-30', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'description': 'Measures: walking speed, standing balance and sit-to-stand performance.'}, {'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.', 'description': '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.'}, {'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.', 'description': 'Measure: number of 1-MSTST repetitions.'}, {'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.', 'description': 'Measure: hand grip strengh measure (Kgf)'}, {'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.', 'description': 'Measures: maximal inspiratory and expiratory pressure (cmH2O)'}, {'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.', 'description': 'Measures: FVC (L), FEV1 (L), FEF (L/s) and FEF 25-75 (%)'}, {'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.', 'description': 'The minimal value is 1 and the maximal is 9 in which the lowest scores mean worse outcomes.'}], 'secondaryOutcomes': [{'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.', 'description': 'Occurrence of comorbidities and clinical variables associated with functional decline'}, {'measure': 'To investigate hemodynamic behavior during the Short Physical Performance Battery (SPPB).', 'timeFrame': 'Immediately before and after the SPPB.', 'description': 'Measures: heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure.'}, {'measure': 'To investigate hemodynamic behavior during the 1-minute sit-to-stand test (1-MSTST).', 'timeFrame': 'Immediately before and after the 1-MSTST tests.', 'description': 'Measures: heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure.'}, {'measure': 'To investigate respiratory behavior during the Short Physical Performance Battery (SPPB).', 'timeFrame': 'Immediately before and after the SPPB.', 'description': 'Measures: respiratory rate, Borg dyspnea scale and peripheral oxygen saturation.'}, {'measure': 'To investigate respiratory behavior during 1-minute sit-to-stand test (1-1-MSTST).', 'timeFrame': 'Immediately before and after the 1-MSTST tests.', 'description': 'Measures: respiratory rate, Borg dyspnea scale and peripheral oxygen saturation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac surgery', 'Short Physical Performance Battery', '1-minute sit-tostand test', 'Spirometry', 'muscular strength'], 'conditions': ['Cardiac Infarct', 'Cardiac Valve Disease', 'Fragility', 'Physical Disability']}, 'descriptionModule': {'briefSummary': '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..', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in the preoperative period of elective coronary artery bypass grafting and valve replacement surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Age ≥ 18 years\n* Both genders\n* Elective coronary artery bypass grafting surgery\n* Elective Heart valve surgery\n* Absence of cognitive or peripheral motor impairment that prevents the performance of functional tests in the preoperative period.\n\nExclusion Criteria:\n\n* Surgeries performed via lateral thoracotomy or minithoracotomy\n* Reoperation for any reason\n* Presence of cognitive or peripheral motor impairment that prevents the performance of functional tests in the postoperative period.'}, 'identificationModule': {'nctId': 'NCT06247358', 'briefTitle': 'Frailty, Physical Capacity and Lung Function in Postoperative Cardiac Surgery Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Assessment of Frailty, Physical Capacity and Lung Function in Postoperative Cardiac Surgery Patients: an Observational and Prospective Clinical Study', 'orgStudyIdInfo': {'id': 'CAAEE: 73168923.7.0000.0068'}}, 'contactsLocationsModule': {'locations': [{'zip': '05403-000', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Kelly CO Abud, PT, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Rafael M Ianotti, PT', 'role': 'CONTACT', 'email': 'rafael.ianotti@hc.fm.usp.br', 'phone': '+55 11 26615319'}], 'overallOfficials': [{'name': 'Rafael M Ianotti, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Research Coordinator - Physiotherapy Division - Heart Institute (InCor)', 'investigatorFullName': 'Rafael M. Ianotti, PT', 'investigatorAffiliation': 'University of Sao Paulo General Hospital'}}}}