Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-25 @ 7:17 PM
Study NCT ID:
NCT05739032
Status:
COMPLETED
Last Update Posted:
2024-01-16
First Post:
2023-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exercise Training Six-Months After Discharge in Post-COVID-19 Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-11', 'studyFirstSubmitDate': '2023-02-21', 'studyFirstSubmitQcDate': '2023-02-21', 'lastUpdatePostDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Six Minute Walk Test Distance', 'timeFrame': 'six minute'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['post-COVID-19', 'Lung function', 'Fatigue', 'Aerobic exercise', 'Strength training'], 'conditions': ['COVID-19 Pneumonia']}, 'descriptionModule': {'briefSummary': 'The goal of this study investigate the effects of 12-week exercise training on pulmonary function, symptoms, functional capacity, and quality of life (QoL) in patients with severe COVID 6 months after intensive care discharge. The main question it aims to answer are:\n\n1-Does exercise training given in post-COVID-19 syndrome have an effect on pulmonary function, symptoms, functional capacity, muscle strength and quality of life?\n\n25 severe post-COVID patients (35 M) were in exercise group (EG) (age=52.9±11 years, 18M), and 25 (age=53.6±11.9 years, 17M) were in the control group (CG). EG received aerobic exercise (30-min walking) and upper and lower extremity strength training for 12 weeks for 3 days/week. CG continued only routine follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COVID-19 pneumonia patients were followed up for at least 24 h in the ICU. Those post-COVID six months who could cooperate with the tests and volunteered to participate were included.\n\nExclusion Criteria:\n\n* Individuals with pulmonary, orthopedic, neurological, vestibular, and psychological problems diagnosed before COVID-19 infection; myocarditis developed after COVID-19 infection; and those pregnant and those having any other acute diseases (such as infection and trauma) that would prevent performing the tests and/or interfering with the test results were excluded.'}, 'identificationModule': {'nctId': 'NCT05739032', 'briefTitle': 'Exercise Training Six-Months After Discharge in Post-COVID-19 Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Nuh Naci Yazgan University'}, 'officialTitle': 'Exercise Training Six-Months After Discharge in Post-COVID-19 Syndrome: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'NNYUSİRAYDER1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise group', 'description': 'Exercise group received aerobic exercise (30-min walking) and upper and lower extremity strength training for 12 weeks for 3 days/week.', 'interventionNames': ['Other: Aerobic exercise and strength training']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Control group continued only routine follow-up.'}], 'interventions': [{'name': 'Aerobic exercise and strength training', 'type': 'OTHER', 'description': 'Aerobic Exercise Training: The individuals in the study group were given aerobic exercise training at 70-80% of the 6MWT average speed. Patients performed exercise three days per week (twice under the supervision of a physiotherapist and once at home) for 30 minutes a day.\n\nStrength Training: Lower and upper extremity strengthening training was performed three days a week, 3x10-12 repetitions per day, with the help of a resistance band suitable for muscle strength. Hip flexion, hip abduction, knee flexion, and knee extension exercises for the lower extremity, and shoulder flexion, shoulder extension, shoulder abduction, shoulder elevation, external rotation, horizontal shoulder abduction, and scapular adduction exercises for the upper extremity were performed.', 'armGroupLabels': ['Exercise group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kayseri', 'country': 'Turkey (Türkiye)', 'facility': 'Nuh Naci Yazgan University', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'two years', 'ipdSharing': 'YES', 'description': 'send via mail'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ukbe Sirayder', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ukbe Sirayder', 'investigatorAffiliation': 'Nuh Naci Yazgan University'}}}}