Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-25 @ 7:06 PM
Study NCT ID:
NCT04206904
Status:
COMPLETED
Last Update Posted:
2020-06-24
First Post:
2019-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence of Frailty in Patients With a Cardiovascular Disease and Correlations With Markers of Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-23', 'studyFirstSubmitDate': '2019-12-17', 'studyFirstSubmitQcDate': '2019-12-19', 'lastUpdatePostDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of (in)dependence via the Katz scale', 'timeFrame': 'At baseline', 'description': 'Evaluation of the level of (in)dependence in activities of daily life via a 4-point scale (1-4)'}, {'measure': 'Nutritional status via the Mini Nutritional Assessment (MNA)', 'timeFrame': 'At baseline', 'description': 'Examination of the nutritional status of the patient via a questionnaire (30 points)'}, {'measure': 'Level of physical activity via the International Physical Activity Questionnaire (IPAQ)', 'timeFrame': 'At baseline', 'description': 'Examination of the level of physical activity of the patient via a questionnaire'}, {'measure': 'Cognitive status via the Mini Mental State Examination (MMSE)', 'timeFrame': 'At baseline', 'description': 'Examination of the cognitive status of the patient via a short screening (30 points)'}, {'measure': 'Psychological status via the Geriatric Depression Scale (GDS-15)', 'timeFrame': 'At baseline', 'description': 'Examination of the presence/absence of a depressive mood via a questionnaire (15 questions/15 points)'}, {'measure': 'Concern about falling via the Falls Efficacy Scale (FES-I)', 'timeFrame': 'At baseline', 'description': 'Examination of the level of concern about falling during social and physical activities via a questionnaire (16 questions/ 64 points)'}, {'measure': 'Weight loss via the evaluation of body weight', 'timeFrame': 'At baseline', 'description': 'Evaluation of involuntary loss of body weight in the previous months'}, {'measure': 'Gait speed via the 4.6 meter walking test', 'timeFrame': 'At baseline', 'description': 'Examination of the walking speed of the patient'}, {'measure': 'Evaluation of handgrip strength', 'timeFrame': 'At baseline', 'description': 'Evaluation of the handgrip strength of the patient via handheld dynamometry'}, {'measure': 'Examination of mobility/balance/muscle strength/risk of falling via the Timed Up and Go Test (TUG)', 'timeFrame': 'At baseline', 'description': 'The Timed Up and Go Test measures the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. By combining this test with a motor or cognitive dual task, the risk of falling of the patient will be examined.'}, {'measure': 'Comorbidities via the record of medication use', 'timeFrame': 'At baseline', 'description': 'Record of cardiac and other medications'}, {'measure': 'Evaluation of lower limb strength', 'timeFrame': 'At baseline', 'description': 'Evaluation of lower limb strength of the patient via Microfet measurements'}, {'measure': 'Evaluation of functional lower limb strength', 'timeFrame': 'At baseline', 'description': 'Evaluation of functional lower limb strength of the patient via the Timed Chair Stand Test'}], 'secondaryOutcomes': [{'measure': 'Correlations between frailty (via the primary frailty outcome measures) and exercise parameters (via the maximal exercise test (CPET)', 'timeFrame': 'At the start of the cardiac rehabilitation program', 'description': 'Evaluation of correlations between frailty characteristics (from the primary outcome measures) and exercise parameters from a maximal exercise test (CPET) (performed at the start of a cardiac rehabilitation program).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['older adults', 'cardiovascular diseases', 'maximal exercise test'], 'conditions': ['Frailty']}, 'descriptionModule': {'briefSummary': 'In the first part of this study the prevalence of frailty in patients with cardiovascular disease will be examined. Frailty is defined as a progressive age-related decline in physiological systems that results in decreased reserves of intrinsic capacity, which confers extreme vulnerability to stressors. Patients (≥65 years, men and women) suffering from heart failure or undergoing a coronary artery bypass grafing (CABG) or percutaneous coronary intervention (PCI) will be included. Based on the phenotype of Fried, frailty will be examined in the physical domain. Moreover, the nutritional, social, psychological and cognitive domain of frailty will be examined. This will result in a total score of 0 (no frailty) to 24 (severe frailty), divided into four categories: no frailty (score 0-6), minor frailty (score 7-12), moderate frailty (score 13-18) or severe frailty (score 18-24).\n\nBesides this frailty protocol, a few other measurements will be completed to collect additional information about the functioning of the patient.\n\nAt discharge from the hospital, some of these patients will start with a cardiac rehabilitation program. To define the exercise intensity of this program, patients will perform a maximal exercise test (CPET). In the second part of this study, correlations will be examined between markers of frailty and markers of exercise from the CPET (e.g. maximal heart rate, maximal oxygen uptake).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men and women with an age of at least 65 years at the start of the study who are admitted to Jessa Hospital Hasselt because of suffering from coronary artery diseases (with planned PCI or CABG surgery) or heart failure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMen and women with an age of at least 65 years at the start of the study; Staying in Jessa Hospital for PCI, CABG or heart failure\n\nExclusion Criteria:\n\nA persistently unstable clinical condition at baseline visit (angina, advanced conduction disturbances, threatening ventricular arrhythmias, acute heart failure, clinical condition requiring interventions such as acute renal failure, Hb \\<9,0 mg/dl, presence of end-stage disease or the lack of informed consent to study participation)'}, 'identificationModule': {'nctId': 'NCT04206904', 'briefTitle': 'Prevalence of Frailty in Patients With a Cardiovascular Disease and Correlations With Markers of Exercise', 'organization': {'class': 'OTHER', 'fullName': 'Hasselt University'}, 'officialTitle': 'Prevalence of Frailty in Patients With a Cardiovascular Disease and Correlations With Markers of Exercise', 'orgStudyIdInfo': {'id': 'FrCR'}}, 'contactsLocationsModule': {'locations': [{'zip': '3500', 'city': 'Hasselt', 'state': 'Limburg', 'country': 'Belgium', 'facility': 'Jessa Hospital Campus Virga Jesse', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasselt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Invesigator', 'investigatorFullName': 'Dominique Hansen', 'investigatorAffiliation': 'Hasselt University'}}}}