Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-01-06 @ 9:24 AM
Study NCT ID:
NCT03853668
Status:
COMPLETED
Last Update Posted:
2019-02-26
First Post:
2019-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Quality Response to Resisted Training After Coronary Artery Bypass Grafting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012892', 'term': 'Sleep Deprivation'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], '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'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D000072038', 'term': 'Cardiac Rehabilitation'}], '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': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-21', 'studyFirstSubmitDate': '2019-02-15', 'studyFirstSubmitQcDate': '2019-02-21', 'lastUpdatePostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sleep quality to be assessed by Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'up to 12 months', 'description': '1.The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval.'}, {'measure': 'sleep fragmentation index to be assessed by actigraphy', 'timeFrame': 'up to 12 months', 'description': '2.Actigraphy is a valid tool to assist in determining sleep patterns in normal, healthy adult populations, normal infants and children, and patients suspected of certain sleep disorders.'}], 'secondaryOutcomes': [{'measure': 'Functional aerobic capacity to be assessed by 6 minute walk test (6MWT)', 'timeFrame': '6 months', 'description': 'The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sleep quality', 'aerobic and resisted exercises', 'CABG'], 'conditions': ['Sleep Deprivation']}, 'descriptionModule': {'briefSummary': 'Background:There are still many gaps in research concerning the effect of different physical training modalities on sleep quality in the population underwent coronary artery bypass graft surgeries(CABG).Purpose:The present study was conducted to compare the quality of sleep in subjects who underwent CABG, were submitted to two types of training (i.e, aerobic exercise alone or combined aerobic and resistance training', 'detailedDescription': 'OBJECTIVE/BACKGROUND:\n\nThere are still many gaps in research concerning the effect of different physical training modalities on sleep quality in the cardiac population. Thus, the objective of the present study was to compare the quality of sleep in subjects who underwent coronary artery bypass surgery submitted to two types of training (ie, aerobic exercise alone or combined aerobic and resistance training).\n\nPATIENTS/METHODS:\n\n80 Participants aged 45-65 years were randomized to two groups: aerobic group (AG), combined aerobic and resistance group (ARG). Training lasted ten consecutive weeks with 30 uninterrupted sessions. 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 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 underwent CABG surgery since 6-8 weeks\n2. Their ages ranges from 40 and 80 years of age\n3. Medically stable patients.\n4. patients did CABG-only treatment (not combined with valve replacement surgery)\n5. Current complaint of poor Sleep quality (SQ) (score \\> 5 of the SQ scale)\n6. Body mass index ≤ 35 kg/m2 (no obstructive sleep apnea)\n\nExclusion Criteria:\n\n1. Any patient is known to have any unstable medical condition\n2. History of chronic insomnia for at least one year before surgery\n3. Indication of receiving treatments for depression and anxiety\n4. Musculoskeletal or neurological conditions that might interfere with the execution or the assessment of the exercise.'}, 'identificationModule': {'nctId': 'NCT03853668', 'acronym': 'exercises', 'briefTitle': 'Sleep Quality Response to Resisted Training After Coronary Artery Bypass Grafting', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Sleep Quality Response to Resisted Training After Coronary Artery Bypass Grafting', 'orgStudyIdInfo': {'id': 'Sleep and exercise'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'aerobic exercise group', 'description': 'aerobic exercises (intervention) on treadmill for 10 weeks, 3 times/week for duration of 30-45 min/session.\n\nExercise intensity is 50-65%of maximal heart rate (MHR)', 'interventionNames': ['Behavioral: exercise']}, {'type': 'EXPERIMENTAL', 'label': 'aerobic and resisted exercise', 'description': 'combined resisted and aerobic exercises (intervention) for 10 weeks (circuit weight training and treadmill training respectively) 2 times/week for a duration of 30-45 min/session Exercise intensity is 50-65%of maximal heart rate (MHR) for aerobic part and 50% of 1 repetition maximum (1RM) for resistance part.', 'interventionNames': ['Behavioral: exercise']}], 'interventions': [{'name': 'exercise', 'type': 'BEHAVIORAL', 'otherNames': ['cardiac rehabilitation'], 'description': 'control group (n=40) did aerobic exercises on treadmill for 10 weeks experimental group (n=40) did combined aerobic and resisted exercises for 10 weeks', 'armGroupLabels': ['aerobic and resisted exercise', 'aerobic exercise group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11262', 'city': 'Giza', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'National heart institute'}], 'overallOfficials': [{'name': 'Hady Atef, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant lecturer of physical therapy,Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of physical therapy', 'investigatorFullName': 'Hady Atef Labib', 'investigatorAffiliation': 'Cairo University'}}}}