Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-30 @ 4:22 AM
Study NCT ID:
NCT04382534
Status:
UNKNOWN
Last Update Posted:
2020-05-11
First Post:
2020-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Cross-sectional and Cohort Study of COVID-19 Patients With Post - Discharge Dysfunction
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': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-07', 'studyFirstSubmitDate': '2020-04-26', 'studyFirstSubmitQcDate': '2020-05-07', 'lastUpdatePostDateStruct': {'date': '2020-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptoms and signs', 'timeFrame': 'Ten days', 'description': 'To take a history and physical examination'}, {'measure': 'Respiratory function', 'timeFrame': 'Ten days', 'description': 'To take a physical examination and mMRC'}, {'measure': 'The body function', 'timeFrame': 'Ten days', 'description': 'To take a MMT, 6-min walking test and Borg Index'}, {'measure': 'ADL', 'timeFrame': 'Ten days', 'description': 'To take a modified Barthel index'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19', 'Respiratory Rehabilitation', 'Cross-sectional Study', 'Cohort Study']}, 'descriptionModule': {'briefSummary': 'Post-discharge rehabilitation regimens for covid-19 patients have not been supported by high-quality evidence-based medical evidence.The first part of this study is a cross-sectional study.The contents of the study were the factors related to the dysfunction of COVID - 19 patients after discharge from the hospital in Wuhan.The second part of this study is a cohort study.To observe the functional changes of COVID-19 patients after discharge in hospital rehabilitation, home rehabilitation and no rehabilitation, in order to propose a more safe and effective rehabilitation program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with COVID-19 after discharge', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with definite diagnosis of COVID-19 normal or severe\n* patients who entered the isolation point \\<3 days after discharge\n* 18-80 years old\n* agree to join the queue\n\nExclusion Criteria:\n\n* body temperature \\>38°C\n* heart rate \\>120 times/min or \\<40 times/min, systolic blood pressure \\<90mmHg or \\>180mmHg, respiratory rate \\>25 times/min in calm state.Or above vital signs fluctuate significantly.\n* continuous oxygen therapy is required.\n* patients with myocarditis, pulmonary hypertension, congestive heart failure, fresh venous thromboembolic diseases, unstable fractures and other inappropriate exercise\n* patients with consciousness disorders, severe sequelae of cerebral infarction, cognitive dysfunction, mental disorders, severe balance disorders, and severe bone and joint diseases, which affect evaluation and treatment\n* other conditions that cannot be cooperated with rehabilitation treatment'}, 'identificationModule': {'nctId': 'NCT04382534', 'briefTitle': 'A Cross-sectional and Cohort Study of COVID-19 Patients With Post - Discharge Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'A Cross-sectional and Cohort Study of COVID-19 Patients With Post - Discharge Dysfunction', 'orgStudyIdInfo': {'id': 'M20200421'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rehabilitation guidance group', 'description': '1 to 2 times of rehabilitation instruction according to the rehabilitation instruction program, either online or in person.According to the rehabilitation instruction, the patient performed self-rehabilitation exercises in the isolation point.'}, {'label': 'Systematic rehabilitation treatment', 'description': 'According to the systematic rehabilitation treatment program, the rehabilitation therapist entered the home for one-to-one rehabilitation treatment, once a day, for a total of 10 days.', 'interventionNames': ['Combination Product: Respiratory rehabilitation']}], 'interventions': [{'name': 'Respiratory rehabilitation', 'type': 'COMBINATION_PRODUCT', 'description': 'Health education and energy saving techniques, chest activity training, local lung dilation techniques, breathing training, airway clearance training, aerobic exercise, resistance training', 'armGroupLabels': ['Systematic rehabilitation treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuanmingfei Zhang, Dr.', 'role': 'CONTACT', 'email': 'zymf@pku.edu.cn', 'phone': '+86 15201469083'}], 'facility': 'Huarunwugang general hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}