Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-03-15 @ 6:13 AM
Study NCT ID:
NCT04562857
Status:
COMPLETED
Last Update Posted:
2021-01-27
First Post:
2020-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Exercise Training in Patients With Atrial Fibrillation and Sleep Apnea: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012892', 'term': 'Sleep Deprivation'}], 'ancestors': [{'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-01', 'size': 56275, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-09-19T08:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-25', 'studyFirstSubmitDate': '2020-09-08', 'studyFirstSubmitQcDate': '2020-09-19', 'lastUpdatePostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep quality scores (0 is best, 3 is worst)', 'timeFrame': '10 weeks', 'description': 'data about sleep from Pittsburgh sleep quality index questionnaire'}, {'measure': 'sleep latency (in min)', 'timeFrame': '10 weeks', 'description': 'time spent in bed before falling asleep (from the actigraph)'}, {'measure': 'Total sleep time (in hours)', 'timeFrame': '10 weeks', 'description': 'Total time actually slept (from the actigraph)'}, {'measure': 'Sleep fragmentation index (in %) (the more means worse)', 'timeFrame': '10 weeks', 'description': 'Index of the level of the sleep continuity (from the actigraph)'}, {'measure': 'cutpoints', 'timeFrame': '10 weeks', 'description': 'numbers displayed on the actigraph to give a picture about activity level'}], 'secondaryOutcomes': [{'measure': 'six minute walking distance (in meters)', 'timeFrame': '10 weeks', 'description': 'represent aerobic capacity (distance walked in 6 min)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep Deprivation']}, 'descriptionModule': {'briefSummary': 'Background: There are still many gaps in research concerning the effect of different physical training modalities on sleep deprivation in the population with different types of sleep apnea. Aims: The purpose of this study was to examine the effect of moderate-intensity interval training (MITT) on patients with different types of sleep apnea.', 'detailedDescription': 'Methods: 15 Participants aged 45-65 years were randomized into two groups: obstructive sleep apnea group (OSA), and central sleep apnea group (CSA). The training lasted ten consecutive weeks with 30 uninterrupted sessions. The actigraph together with the Pittsburg sleep quality index (PSQI) was used in sleep quality assessment. The actigraph (Actiwatch Minimitter Company, Incorporated (INC) - Sunriver, OR, USA) was placed on the non-dominant wrist and activities were monitored continuously while being recorded at one-minute intervals. The participants kept the device for a period of 96 hours, filled PSQI, and did 6MWT before the first and last training sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who have AF confirmed by ECG\n2. Their ages range from 45 and 65 years of age\n3. Medically stable patients.\n4. Current complaint of poor Sleep quality (SQ) (score \\> 5 of the SQ scale)\n5. Patients who have OSA or CSA confirmed by polysomnography\n\nExclusion Criteria:\n\n* Any patient was known to have any unstable medical condition;or with any known musculoskeletal or neurological conditions that might interfere with the execution or the assessment of the exercise, was excluded from the study.'}, 'identificationModule': {'nctId': 'NCT04562857', 'briefTitle': 'Effects of Exercise Training in Patients With Atrial Fibrillation and Sleep Apnea: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effects of Exercise Training in Patients With Atrial Fibrillation and Sleep Apnea: A Pilot Study', 'orgStudyIdInfo': {'id': 'AF and sleep apnea'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'obstructive sleep apnea', 'description': 'interval exercises (intervention) on bicycle for patients with AF and OSA for 10 weeks, 3 times/week for duration of 30-45 min/ session.', 'interventionNames': ['Behavioral: Moderate intensity interval training (MITT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Central sleep apnea', 'description': 'interval exercises (intervention) on bicycle for patients with AF and CSA for 10 weeks, 3 times/week for duration of 30-45 min/ session.', 'interventionNames': ['Behavioral: Moderate intensity interval training (MITT)']}], 'interventions': [{'name': 'Moderate intensity interval training (MITT)', 'type': 'BEHAVIORAL', 'description': 'interval exercises (intervention) on bicycle for patients with AF and OSA or AF with CSA for 10 weeks, 3 times/week for duration of 30-45 min/ session.', 'armGroupLabels': ['Central sleep apnea', 'obstructive sleep apnea']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11262', 'city': 'Giza', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'National heart institute'}], 'overallOfficials': [{'name': 'Hady Balabel', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'after 1 month for12 months', 'ipdSharing': 'YES', 'description': 'After approval can be shared', 'accessCriteria': 'will upload it to the journal of publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Swinburne University of Technology', 'class': 'OTHER'}, {'name': 'National Heart Institute, Egypt', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of physical therapy for cardiopulmonary disorders, Faculty of Physical therapy', 'investigatorFullName': 'Hady Atef Labib', 'investigatorAffiliation': 'Cairo University'}}}}