Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT05435456
Status:
COMPLETED
Last Update Posted:
2022-06-28
First Post:
2022-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Exercise on Post-Covid Symptoms
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': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'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': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-26', 'studyFirstSubmitDate': '2022-06-26', 'studyFirstSubmitQcDate': '2022-06-26', 'lastUpdatePostDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'McGill Pain Scale short form (SFMPQ)', 'timeFrame': 'at the enrollment and after the study', 'description': 'It gives an information about the sensation, severity and effect of pain'}, {'measure': 'Short-Form 36 (SF-36)', 'timeFrame': 'at the enrollment and after the study', 'description': 'It asses general quality of life with 8 parameters'}, {'measure': 'Pittsburg Sleep Quality Index', 'timeFrame': 'at the enrollment and after the study', 'description': 'It asses sleep quality with 19 questions that each question scored between 0-3.'}, {'measure': 'Beck Anxiety Scale', 'timeFrame': 'at the enrollment and after the study', 'description': 'It asses anxiety levels with subjective and somatic factors'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '32644129', 'type': 'BACKGROUND', 'citation': 'Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.'}, {'pmid': '32379667', 'type': 'RESULT', 'citation': 'Liu K, Chen Y, Wu D, Lin R, Wang Z, Pan L. Effects of progressive muscle relaxation on anxiety and sleep quality in patients with COVID-19. Complement Ther Clin Pract. 2020 May;39:101132. doi: 10.1016/j.ctcp.2020.101132. Epub 2020 Mar 6.'}]}, 'descriptionModule': {'briefSummary': 'The study aimed to investigate the effects of strengthening and relaxation exercises on pain, anxiety, and sleep quality. 76 post-covid patients were randomized into experimental and control groups. Experimental group patients performed strengthening and relaxation exercises 3 times a week for 8 weeks. Control group patients did not perform any program. All participants were assessed with McGill Pain Scale short form (SFMPQ), short-form 36 (SF-36), Pittsburgh sleep quality index (PSQI) before and after the study.', 'detailedDescription': 'After COVID-19, musculoskeletal pain, anxiety, and sleep problems can continue. The study aimed to investigate the effects of strengthening and relaxation exercises on pain, anxiety, and sleep quality. The study was performed at Gaziosmanpaşa Education and Research Hospital with 76 post-covid patients that were randomized into experimental and control groups. Experimental group patients performed strengthening and relaxation exercises 3 times a week for 8 weeks. Control group patients did not perform any program. All participants were assessed with McGill Pain Scale short form (SFMPQ), short-form 36 (SF-36), and Pittsburgh sleep quality index (PSQI) before and after the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* to be between the ages of 18-65\n* to be diagnosed with Covid-19 in the last 3 months\n* to have a negative PCR test, or to have completed the 14-day isolation period\n\nExclusion Criteria:\n\n* have undergone surgery in the last 6 months\n* have severe mental retardation that would prevent communication'}, 'identificationModule': {'nctId': 'NCT05435456', 'briefTitle': 'Effect of Exercise on Post-Covid Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Halic University'}, 'officialTitle': 'Effect of Strengthening and Relaxation Exercises on Musculoskeletal Pain, Anxiety, and Sleep Quality on Post-covid Symptoms', 'orgStudyIdInfo': {'id': 'ssaka7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Performed strengthening and relaxation exercises 3 times a week for 8 weeks.', 'interventionNames': ['Other: Exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'There is no intervention'}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'Strengthening and Relaxation Exercises', 'armGroupLabels': ['Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Gaziosmanpaşa Education and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Seda Saka, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Haliç University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Halic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Seda Saka', 'investigatorFullName': 'Seda Saka', 'investigatorAffiliation': 'Halic University'}}}}