Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 10:05 PM
Study NCT ID:
NCT04913558
Status:
UNKNOWN
Last Update Posted:
2021-07-27
First Post:
2021-05-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Aerobic Exercise on Stress and Fatigue of Lactating Employed Women
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'}], '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': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-26', 'studyFirstSubmitDate': '2021-05-29', 'studyFirstSubmitQcDate': '2021-05-29', 'lastUpdatePostDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stress assessment', 'timeFrame': 'Baseline and 6 weeks post-intervention', 'description': 'Change from baseline of stress at 6 weeks. Assessment of stress through using perceived stress scale 10 will be performed before and after intervention'}, {'measure': 'Fatigue assessment', 'timeFrame': 'Baseline and 6 weeks post-intervention', 'description': 'Change from baseline of stress at 6 weeks. Assessment of fatigue through using fatigue assessment scale will be performed before and after intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress', 'Fatigue']}, 'descriptionModule': {'briefSummary': 'The study aims to determine the effect of aerobic exercise on stress and fatigue of employed lactating women.', 'detailedDescription': 'The study aims to determine the effect of aerobic exercise on stress and fatigue of employed lactating women. This study will be carried out on Sixty lactating mothers working in the medical field who have returned to work after maternity leave and suffering from stress and fatigue.\n\nThe subjects will be divided randomly into two groups equal in number, the Aerobic exercise group ( group A) and the Control group ( group B).\n\nGroup A will consist of thirty employed lactating women suffering from stress and fatigue. These women will perform aerobic exercise for 30 minutes for each session, 5 times per week, for 6 weeks in the form of treadmill training (60- 70% of HR max) and do some modifications of their routine by following lifestyle modification advice given to them during the 6 weeks of the program period.\n\nControl group (group B):\n\nThis group will consist of thirty employed lactating women suffering from stress and fatigue. This group will receive the same lifestyle modification advice that will be given to group (A) during the six weeks of the program period.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '25 Years', 'genderBased': True, 'genderDescription': 'lactating mothers working in the medical field who have returned to work after maternity leave and suffering from stress and fatigue.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All participants are lactating mothers.\n* Working in the medical field 4 to 6 hours per day, 4 to 5 days per week.\n* Returned to work after 4 months of maternity leave.\n* Suffering stress and fatigue considering the perceived stress questionnaire and the fatigue assessment scale.\n* Their babies' ages will be ranged from 6 to 8 months old.\n* Having at least one year of work experience before giving birth.\n* Their age will be ranged from 25 to 35 years.\n* They haven't exercised more than twice per week during the previous 3 months.\n\nExclusion Criteria:\n\n* Any neurological, cardiovascular disorders, or metabolic disease\n* Physical impairments that prevent following the program.\n* Women who are planning to stop breastfeeding in the next 4 months.\n* Women with regular medications.\n* Mothers of formula feeding babies.\n* women who are smoking will be excluded from this study."}, 'identificationModule': {'nctId': 'NCT04913558', 'briefTitle': 'Effect of Aerobic Exercise on Stress and Fatigue of Lactating Employed Women', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Aerobic Exercise on Stress and Fatigue of Lactating Employed Women', 'orgStudyIdInfo': {'id': 'Sarazaher_Msc'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional Treatment Arm', 'description': 'This group will consist of thirty employed lactating women suffering from stress and fatigue. This group will receive the same lifestyle modification advice that will be given to the aerobic exercise group during the six weeks of the program period.', 'interventionNames': ['Other: Traditional Treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Aerobic exercise group', 'description': 'This group will consist of thirty employed lactating women suffering from stress and fatigue. These women will perform aerobic exercise for 30 minutes for each session, 5 times per week, for 6 weeks in the form of treadmill training (60- 70% of HR max) and do some modifications of their routine by following lifestyle modification advice given to them during the 6 weeks of the program period.', 'interventionNames': ['Other: Aerobic exercise', 'Other: Traditional Treatment']}], 'interventions': [{'name': 'Aerobic exercise', 'type': 'OTHER', 'description': 'The exercise will be performed by using the treadmill as the following:\n\n\\- The first stage (warming up): It consists of 5 minutes warming up with the treadmill speed set at 1.0 mile per hour.\n\n\\- The second stage (active stage): It consists of 20 minutes with the treadmill speed set at 3.0 miles per hour.\n\n\\- Third stage (cooling down): It consists of 5 minutes of cooling down with the treadmill speed set at 1.0 miles per hour.', 'armGroupLabels': ['Aerobic exercise group']}, {'name': 'Traditional Treatment', 'type': 'OTHER', 'description': '1. General advice for reducing fatigue and stress\n2. Fluid and diet advice\n3. Carrying the Baby\n4. While Breastfeeding in a sitting position\n5. Selecting Clothing', 'armGroupLabels': ['Aerobic exercise group', 'Traditional Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12611', 'city': 'Dokki', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Sara Zaher', 'role': 'CONTACT', 'email': 'sara.elsayed.zaher@gmail.com', 'phone': '+201127222726'}], 'facility': 'Cairo University', 'geoPoint': {'lat': 30.03823, 'lon': 31.2113}}], 'centralContacts': [{'name': 'Sara Zaher', 'role': 'CONTACT', 'email': 'sara.elsayed.zaher@gmail.com', 'phone': '+201127222726'}], 'overallOfficials': [{'name': 'Sara Zahrer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sara Elsayed Basyouny Zaher', 'investigatorAffiliation': 'Cairo University'}}}}