Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2026-01-01 @ 8:44 PM
Study NCT ID:
NCT04618835
Status:
UNKNOWN
Last Update Posted:
2021-02-24
First Post:
2020-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Activity a Vital Sign? 40 Steps to Safety Test for Patients With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-11-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-23', 'studyFirstSubmitDate': '2020-10-31', 'studyFirstSubmitQcDate': '2020-11-05', 'lastUpdatePostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in decision to discharge', 'timeFrame': '24 hours', 'description': '1. No change\n2. Further investigations\n3. Hospital admission\n\na) No change b) Further investigations c) Hospital admission'}, {'measure': 'Hospital', 'timeFrame': '30 days', 'description': 'Admission to hospital within 30 days of the test'}, {'measure': 'Death', 'timeFrame': '30 days', 'description': 'Death within 30 days of the test'}], 'secondaryOutcomes': [{'measure': 'Feasibility of the 40-steps test', 'timeFrame': '12 months', 'description': 'Proportion of sites and patients able to undertake the test'}, {'measure': 'Change in heart rate', 'timeFrame': 'Within 2 minutes of completion of the test', 'description': 'Change in heart rate compared to value measured before expercise'}, {'measure': 'Change in oxygen saturations', 'timeFrame': 'Within 2 minutes of completion of the test', 'description': 'Change in heart rate compared to value measured before exercise'}, {'measure': 'Change in respiratory rate', 'timeFrame': 'Within 2 minutes of completion of the test', 'description': 'Change in respiratory rate compared to value measured before exercise'}, {'measure': 'Change in breathlessness', 'timeFrame': 'Within 2 minutes of completion of the test', 'description': 'Change in breathlessness compared to value measured before exercise'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise tolerance test', 'Vital signs', 'Readmission', 'Mortality'], 'conditions': ['Covid19', 'Medical Emergencies']}, 'descriptionModule': {'briefSummary': 'Exertional desaturation is a feature of COVID-19. The study will measure vital signs of patients discharge by practitioners in primary care, secondary care or by paramedic practitioners. Patients will then undertake a 40-steps on the spot walk followed by measurements of heart rate and oxygen saturations for up to two minutes. Association of desaturation with 30 days hospital admission and mortality will be reported.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All alert and mobile acutely ill patients with mild symptoms and little or no vital sign derangement being considered for discharge to independent care', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients are being considered for discharge to independent care\n* Participant is willing and able to give informed consent for participation in the study.\n* Patient with independent, stable, gait\n* Patient is alert, attentive, coherent, and calm\n* Male or Female, aged 18 years or above.\n\nExclusion Criteria:\n\n* Minor injuries\n* Elective surgery patients\n* Post-operative patients at discharge\n* Requires supplemental oxygen\n* Shortness of breath at rest (i.e. Borg or Numerical Rating Scale \\>=2)\n* Unstable angina\n* Patients on long-term-oxygen therapy\n* Pregnancy as stated by patient\n* Oxygen saturations \\< 95% on room air\n* Resting heart rate \\> 100 bpm\n* Resting respiratory rate \\> 25 bpm\n* ECG with signs of acute ischemia in patients where an ECG has been requested by the treating clinician\n* National Early Warning Score of 5 or more\n* Nursing home residents, or those being transferred to a nursing home or similar care facility'}, 'identificationModule': {'nctId': 'NCT04618835', 'briefTitle': 'Physical Activity a Vital Sign? 40 Steps to Safety Test for Patients With COVID-19', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Betsi Cadwaladr University Health Board'}, 'officialTitle': 'Exertional Desaturation as a Marker of Risk - Validation Study for the 40-steps-test; A Multi-centre Prospective Observational Cohort Study', 'orgStudyIdInfo': {'id': '283998'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Emergency presentations', 'description': 'Patients discharged after a presentation to practitioners in the community, primary and secondary care.', 'interventionNames': ['Diagnostic Test: 40-Steps-test']}], 'interventions': [{'name': '40-Steps-test', 'type': 'DIAGNOSTIC_TEST', 'description': '40 steps performed on the spot', 'armGroupLabels': ['Emergency presentations']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LL57 2PW', 'city': 'Menai Bridge', 'state': 'Gwynedd', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Christian Subbe', 'role': 'CONTACT', 'email': 'csubbe@hotmail.com', 'phone': '07771922890'}, {'name': 'Laura Langshaw', 'role': 'CONTACT', 'email': 'laura.longshaw@wales.nhs.uk', 'phone': '+441248384384'}], 'facility': 'Ysbyty Gwynedd', 'geoPoint': {'lat': 53.22775, 'lon': -4.16926}}], 'centralContacts': [{'name': 'Christian Subbe, DM', 'role': 'CONTACT', 'email': 'csubbe@hotmail.com', 'phone': '+447771922890'}, {'name': 'Laura Langshaw', 'role': 'CONTACT', 'email': 'laura.longshaw@wales.nhs.uk', 'phone': '+441248384384'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Betsi Cadwaladr University Health Board', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Oxford Brookes University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Physician', 'investigatorFullName': 'Dr Christian P Subbe', 'investigatorAffiliation': 'Betsi Cadwaladr University Health Board'}}}}