Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2026-03-05 @ 12:30 AM
Study NCT ID:
NCT04921059
Status:
COMPLETED
Last Update Posted:
2025-02-10
First Post:
2021-05-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Investigation of Heart Rate Recovery Responses to Repeated Active Stand Protocols
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004244', 'term': 'Dizziness'}], 'ancestors': [{'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-06', 'studyFirstSubmitDate': '2021-05-31', 'studyFirstSubmitQcDate': '2021-06-04', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Baseline Heart Rate', 'timeFrame': '60 seconds prior to standing assessment', 'description': 'R-R interval is recorded by portable ECG throughout assessment'}, {'measure': 'Maximum heart rate', 'timeFrame': 'Within 3 minutes of standing assessment', 'description': 'R-R interval is recorded by portable ECG throughout assessment'}, {'measure': 'Minimum heart rate', 'timeFrame': 'Within 3 minutes of standing assessment', 'description': 'R-R interval is recorded by portable ECG throughout assessment'}], 'secondaryOutcomes': [{'measure': 'Demographic data', 'timeFrame': 'Day 1', 'description': 'gender, age, relevant past medical history'}, {'measure': 'Height', 'timeFrame': 'Day 1', 'description': 'Centimeters'}, {'measure': 'Weight', 'timeFrame': 'Day 1', 'description': 'Kilograms'}, {'measure': 'Body Mass Index', 'timeFrame': 'Day 1', 'description': 'Kg/m\\^2'}, {'measure': 'Body Fat Percentage', 'timeFrame': 'Day 1', 'description': 'Percentage'}, {'measure': 'Blood Pressure', 'timeFrame': 'At baseline', 'description': 'Blood Pressure'}, {'measure': 'Vascular Stiffness', 'timeFrame': 'Day 1', 'description': 'Pulse Wave Analysis conducted using the Mobil-O-Graph 24-hour Pulse Wave Analysis (PWA) system.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart rate response', 'Active Stand'], 'conditions': ['Heart Rate Response', 'Orthostasis']}, 'descriptionModule': {'briefSummary': "Study background:\n\nImpaired heart rate recovery following active stand is associated with morbidity and mortality. Evidence for the repeatability of this measure is limited. This study seeks to determine the repeatability of the active stand procedure in eliciting heart rate recovery in healthy adults of all ages.\n\nResearch aims:\n\nThe aims of this study are to determine the repeatability of heart rate recovery in response to the active stand procedure among different age groups.\n\nStudy design:\n\nThis will be a repeatability study with between group comparison.\n\nStudy setting:\n\nThis study will take place in the Clinical Research Facility in St James's Hospital.\n\nParticipants:\n\nParticipants will be recruited from the staff and student population of Trinity College Dublin and St James's Hospital, from the Trinity Retirement Association and from the community in the St. James's Hospital catchment area. Participants will be healthy adults (over 18 years old). They will be invited to participate via an email and poster campaign. Participation will be fully voluntary. Participants who meet inclusion criteria will be selected. Informed, explicit voluntary consent will be obtained from each participant.\n\nData collection and processing:\n\nData collection and processing will be carried out by the Research Physiotherapist. A clinical visit for the participant will be arranged at a time most convenient for them. Participants will conduct the active stand assessment on three occasions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Healthy adults aged 18+ from the staff and students of Trinity College Dublin and St James's Hospital, from the Trinity Retirement Association and from the community in the SJH catchment area.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults aged ≥18 (considering 18 is the age of legal consent).\n* Fluent in English.\n* Free of intellectual disability or cognitive impairment that would impair or impede the ability to give informed, explicit consent.\n* Free of all exclusion criteria below.\n\nExclusion Criteria:\n\n* Unstable or un-managed cardiac/respiratory/metabolic conditions (i.e. condition must be diagnosed and being managed as per medical input to be classified as stable and managed).\n* Neuro- musculoskeletal disorders.\n* Acute musculoskeletal injury or impairment (including acute pain).\n* Malignancy.\n* Mental illness.\n* Chronic infectious disease (Hep C/ HIV/ AIDS).\n* Acute systemic infection or illness.\n* Taking medication that affects cardiovascular function.\n* Exclusion for any other reason deemed appropriate by the research team.'}, 'identificationModule': {'nctId': 'NCT04921059', 'briefTitle': 'An Investigation of Heart Rate Recovery Responses to Repeated Active Stand Protocols', 'organization': {'class': 'OTHER', 'fullName': "St. James's Hospital, Ireland"}, 'officialTitle': 'An Investigation of Heart Rate Recovery Responses to Repeated Active Stand Protocols', 'orgStudyIdInfo': {'id': 'AS repeatability'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Active Stand', 'type': 'DIAGNOSTIC_TEST', 'description': 'The participant is asked to lie down for 10 mins without moving or speaking. A heart rate monitor is attached while the participant is lying down. They are then asked to stand up as quickly as possible and to remain standing unassisted for 3 minutes. The participant will be asked to describe any symptoms at 1 and 3 minutes after standing. Blood pressure and heart rate will be monitored constantly throughout the test.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dublin', 'country': 'Ireland', 'facility': "Clinical Research Facility, St James's Hospital", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}], 'overallOfficials': [{'name': 'John Gormley, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Dublin, Trinity College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual patient data will not be shared with outside parties.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Caitríona Quinn', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Physiotherapist', 'investigatorFullName': 'Caitríona Quinn', 'investigatorAffiliation': "St. James's Hospital, Ireland"}}}}