Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-27 @ 2:25 AM
Study NCT ID:
NCT04368793
Status:
UNKNOWN
Last Update Posted:
2020-07-17
First Post:
2020-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Effects of Internet Assisted Pulmonary Rehabilitation of COVID-2019 Pneumonia Patients After Discharge
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-16', 'studyFirstSubmitDate': '2020-04-23', 'studyFirstSubmitQcDate': '2020-04-29', 'lastUpdatePostDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Six-minute walking distance (6MWD)', 'timeFrame': 'One year', 'description': 'Walking distance within six minutes'}, {'measure': 'Pulmonary function', 'timeFrame': 'One year', 'description': 'Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), etc.'}], 'secondaryOutcomes': [{'measure': 'Respiratory muscle strength', 'timeFrame': 'One year', 'description': 'Maximal inspiratory pressure, maximal expiratory pressure, etc.'}, {'measure': 'Physical fitness assessment', 'timeFrame': 'One year', 'description': 'Two-minute walking test, short physical performance battery, grip strength of both upper limbs, knee extension strength of both lower limbs, etc.'}, {'measure': 'Symptom', 'timeFrame': 'One year', 'description': 'Modified British Medical Research Council (mMRC) dyspnea scale, etc.'}, {'measure': 'Psychological evaluation', 'timeFrame': 'One year', 'description': 'Self-training depression scale (SDS) and self-rating anxiety scale (SAS)'}, {'measure': 'Quality of life', 'timeFrame': 'One year', 'description': '36-item short-form health survey (SF-36), etc.'}, {'measure': 'Physical activity', 'timeFrame': 'One year', 'description': 'International physical activity questionnaire (IPAQ)'}, {'measure': 'Proportion of returning to society', 'timeFrame': 'One year', 'description': 'Proportions of returning to routine work and normal life'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-2019 Pneumonia', 'Pulmonary Rehabilitation']}, 'referencesModule': {'references': [{'pmid': '34260823', 'type': 'DERIVED', 'citation': 'Lei J, Yang L, Wen G, Qumu S, Ren X, Yang T. Pulmonary telerehabilitation and efficacy among discharged COVID-19 patients: Rational and design of a prospective real-world study. Clin Respir J. 2021 Nov;15(11):1158-1167. doi: 10.1111/crj.13422. Epub 2021 Aug 6.'}]}, 'descriptionModule': {'briefSummary': "The noval coronavirus disease 2019 (COVID-19) would cause physical and psychological dysfunctions in infected patients. We expect that an intelligence-based remote pulmonary rehabilitation scheme could improve patients' health status after hospital discharge. The intelligence-based remote pulmonary rehabilitation program is designed in a real-world and prospective manner, aiming to evaluate the efficacy of rehabilitation among 200 patients in the epicenter of China (Wuhan City) according to their varied adherence. An eight-week rehabilitation scheme, including two weeks for physicians and physiotherapists remotely guided training, and six weeks for patient self-management, will be addressed. The primary outcome of current study is six-minute walking distance and lung function, and secondly respiratory muscle strength, physical fitness assessment, symptoms and quality of life, etc. will also be assessed. Recruited patients will be followed up at week 2, 4, 8 after enrollment and at month 1, 3, 6, 12 after the rehabilitation training completed, respectively. The study has been approved by the ethics committee of China-Japan Friendship Hospital and three participating centers in Wuhan City."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All discharged COVID-19 pneumonia patients who have signed the informed consent and met above eligibility criteria will be enrolled in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* patients diagnosed as COVID-19 pneumonia according to the Chinese diagnostic criteria (Trial 7th Edition), aged 20 years or above;\n* patients who did not participate in any other rehabilitation training scheme;\n* patients who did not participate in any other intervention clinical trials;\n* patients who signed the informed consent and were able to adhere to a long-term follow-up for at least one year.\n\nExclusion criteria:\n\n* pregnant women;\n* patients with previous mental disorders or undergoing mental health treatment;\n* patients with previous personality disorder, intelligence disorder, brain injury or brain disease;\n* patients with serious cardiovascular, cerebrovascular, neuromuscular and other systemic diseases or other diseases affecting physical activity;\n* patients with tumors and underwent treatment.\n\nOne will be considered as withdrawal if consent is revoked, lost to follow-up, or unable to take the pulmonary rehabilitation scheme due to severe exacerbation, comorbidities, injury or trauma, etc.'}, 'identificationModule': {'nctId': 'NCT04368793', 'briefTitle': 'Clinical Effects of Internet Assisted Pulmonary Rehabilitation of COVID-2019 Pneumonia Patients After Discharge', 'organization': {'class': 'OTHER', 'fullName': 'China-Japan Friendship Hospital'}, 'officialTitle': 'Intelligence-based Remote Pulmonary Rehabilitation and Efficacy Among Discharged COVID-19 Patients', 'orgStudyIdInfo': {'id': '2020-22-K17'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Discharged COVID-19 patient cohort', 'description': 'All enrolled participants will be given 8 weeks (online 2 weeks + offline 6 weeks) pulmonary rehabilitation intervention, and will be followed up for at least one year, to assess their adherence and efficacy of the rehabilitation program.', 'interventionNames': ['Behavioral: Remote pulmonary rehabilitation']}], 'interventions': [{'name': 'Remote pulmonary rehabilitation', 'type': 'BEHAVIORAL', 'description': 'The pulmonary rehabilitation intervention includes respiratory exercise, barehanded aerobic training, exercise prescription of elastic band impedance training, respiratory muscle strength training, etc.', 'armGroupLabels': ['Discharged COVID-19 patient cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guangyun Guo, Doctor', 'role': 'CONTACT', 'phone': '+86 13886806423'}], 'facility': 'Wuhan Lung Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '430014', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yi Hu, Doctor', 'role': 'CONTACT', 'phone': '+86 13995618974'}], 'facility': 'Wuhan Central Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '430071', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhenshun Cheng, Doctor', 'role': 'CONTACT', 'phone': '+86 13627288300'}], 'facility': 'Zhongnan Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Geyi Wen, Resident', 'role': 'CONTACT', 'email': 'williamwgy@163.com', 'phone': '+86 13263370980'}, {'name': 'Lulu Yang, Resident', 'role': 'CONTACT', 'email': '1277403977@qq.com', 'phone': '+86 18810904716'}], 'overallOfficials': [{'name': 'Ting Yang, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China-Japan Friendship Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wuhan lung Hospital', 'class': 'UNKNOWN'}, {'name': 'Wuhan Central Hospital', 'class': 'OTHER'}, {'name': 'Wuhan University', 'class': 'OTHER'}, {'name': 'Ai You Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Hongtao Niu', 'investigatorAffiliation': 'China-Japan Friendship Hospital'}}}}