Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT05172102
Status:
COMPLETED
Last Update Posted:
2023-04-04
First Post:
2021-12-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quality of Life and Lung Function on Post Covid-19 Patient
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001945', 'term': 'Breathing Exercises'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-02', 'studyFirstSubmitDate': '2021-12-25', 'studyFirstSubmitQcDate': '2021-12-25', 'lastUpdatePostDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health-related quality of life, Medical Outcomes Study short-form (SF-36)', 'timeFrame': 'at baseline', 'description': 'assessed using the Short Form-36 (SF-36). The SF-36 scale had 8 dimensions, and each dimension was converted into a percentage score.'}, {'measure': 'Health-related quality of life, Medical Outcomes Study short-form (SF-36)', 'timeFrame': 'after 6 weeks', 'description': 'assessed using the Short Form-36 (SF-36). The SF-36 scale had 8 dimensions, and each dimension was converted into a percentage score.'}, {'measure': 'Respiratory function measurement', 'timeFrame': 'at baseline', 'description': 'assessed by a spirometer. The following parameters related to respiratory function will be measured: (1) forced expiratory volume in 1 second (FEV1); (2) forced vital capacity (FVC).'}, {'measure': 'Respiratory function measurement', 'timeFrame': 'after 6 weeks', 'description': 'assessed by a spirometer. The following parameters related to respiratory function will be measured: (1) forced expiratory volume in 1 second (FEV1); (2) forced vital capacity (FVC).'}], 'secondaryOutcomes': [{'measure': 'Chest expansion measurement', 'timeFrame': 'at baseline', 'description': 'measured with a tape measure at 2 different levels of the rib cage. Measurements will be taken at the maximal inspiration and expiration'}, {'measure': 'Chest expansion measurement', 'timeFrame': 'after 6 weeks', 'description': 'measured with a tape measure at 2 different levels of the rib cage. Measurements will be taken at the maximal inspiration and expiration'}, {'measure': 'Exercise endurance measurement', 'timeFrame': 'at baseline', 'description': 'measured by the 6-min walk test (6MWT), is the distance one walks within 6 min'}, {'measure': 'Exercise endurance measurement', 'timeFrame': 'after 6 weeks', 'description': 'measured by the 6-min walk test (6MWT), is the distance one walks within 6 min'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '32379637', 'type': 'RESULT', 'citation': 'Liu K, Zhang W, Yang Y, Zhang J, Li Y, Chen Y. Respiratory rehabilitation in elderly patients with COVID-19: A randomized controlled study. Complement Ther Clin Pract. 2020 May;39:101166. doi: 10.1016/j.ctcp.2020.101166. Epub 2020 Apr 1.'}, {'pmid': '30154127', 'type': 'RESULT', 'citation': 'Mendes LP, Moraes KS, Hoffman M, Vieira DS, Ribeiro-Samora GA, Lage SM, Britto RR, Parreira VF. Effects of Diaphragmatic Breathing With and Without Pursed-Lips Breathing in Subjects With COPD. Respir Care. 2019 Feb;64(2):136-144. doi: 10.4187/respcare.06319. Epub 2018 Aug 28.'}, {'pmid': '31499605', 'type': 'RESULT', 'citation': 'Ubolnuar N, Tantisuwat A, Thaveeratitham P, Lertmaharit S, Kruapanich C, Mathiyakom W. Effects of Breathing Exercises in Patients With Chronic Obstructive Pulmonary Disease: Systematic Review and Meta-Analysis. Ann Rehabil Med. 2019 Aug;43(4):509-523. doi: 10.5535/arm.2019.43.4.509. Epub 2019 Aug 31.'}]}, 'descriptionModule': {'briefSummary': 'Gaining a greater understanding of how the breathing exercise combined with aerobic and strengthening exercises will affects lung function and quality of life in post covid-19 persons', 'detailedDescription': 'this will improve exercise prescription guidelines relevant to this post covid-19. Therefore, the purpose of this work was determining the effect of breathing exercise combined with aerobic and strengthening exercises in improve chest expansion, lung function and quality of life in post covid-19 persons.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female. Age from 20 to 30 years old. - Body mass index (BMI) 19 to 24 kg/m2.- Non-smoker- Recovered from COVID-19 over the past 12 months. - They are experiencing mild to moderate symptoms without any complications. -\n* Able to use online communication programs.\n\nExclusion Criteria:\n\n* \\- Anyone who does regular physical exercise.\n* history of acute illness, asthma, pulmonary fibrosis, hypertension, diabetes disease.\n* hypoxemia in rest.'}, 'identificationModule': {'nctId': 'NCT05172102', 'acronym': 'Covid-19', 'briefTitle': 'Quality of Life and Lung Function on Post Covid-19 Patient', 'organization': {'class': 'OTHER', 'fullName': 'Qassim University'}, 'officialTitle': 'Effect of Breathing Exercise on Chest Expansion, Quality of Life and Lung Function on Post Covid-19 Patient: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'H-04-Q-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study group', 'description': 'Will receive diaphragmatic breathing with pursed lips as (breathing exercise), They will instruct to perform 3 different conditions will be registered: (1) 6 min of quiet breathing (3 sets of 2 min each), defined as spontaneous breathing pattern; (2) 6 min of diaphragmatic breathing (3 sets of 2 min each); and (3) 6 min of diaphragmatic breathing plus pursed-lips breathing (3 sets of 2 min each).\n\nFor aerobic exercises: Will include the following exercises: walking, cycling, running and intermittent running. The exercises will perform for 18-60 minutes for 1-2 sets per week.\n\nFor resistance exercises: Will include the following 8 exercises: shoulder press, biceps curl, triceps curl, bench press, leg squats, leg press, leg curl and toe raise. The exercises will perform for 60 minutes for 2-3 sets per week.', 'interventionNames': ['Other: breathing exercise, Aerobic exercises']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'not receiving any exercises'}], 'interventions': [{'name': 'breathing exercise, Aerobic exercises', 'type': 'OTHER', 'otherNames': ['resistance exercises'], 'description': '6 min of quiet breathing (3 sets of 2 min each), 6 min of diaphragmatic breathing (3 sets of 2 min each), 6 min of diaphragmatic breathing plus pursed-lips breathing (3 sets of 2 min each).', 'armGroupLabels': ['study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Buraidah', 'state': 'Al-Qassim Region', 'country': 'Saudi Arabia', 'facility': 'College of medical rehabilitation', 'geoPoint': {'lat': 26.32599, 'lon': 43.97497}}], 'overallOfficials': [{'name': 'Sahar Mahmoud, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Qassim University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '6 months after publication', 'ipdSharing': 'YES', 'description': 'The data sets generated during and/or analyzed during the current study is available from the corresponding author on reasonable request.', 'accessCriteria': 'relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qassim University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Assistant Professor of physical therapy, College of Medical Rehabilitation, Qassim University, Saudi Arabia, Qassim, Buraidah. Consultant Physical Therapist', 'investigatorFullName': 'Maged Basha', 'investigatorAffiliation': 'Qassim University'}}}}