Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2026-01-04 @ 8:46 AM
Study NCT ID:
NCT03264612
Status:
COMPLETED
Last Update Posted:
2017-08-29
First Post:
2017-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Swimming on Premenstrual Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011293', 'term': 'Premenstrual Syndrome'}], 'ancestors': [{'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D013550', 'term': 'Swimming'}], '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': 'D008124', 'term': 'Locomotion'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-08-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-25', 'studyFirstSubmitDate': '2017-08-25', 'studyFirstSubmitQcDate': '2017-08-25', 'lastUpdatePostDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Premenstrual distress questionnaire', 'timeFrame': '3 months after start of swimming', 'description': '47 manifestations on a 6 point scale separately for the premenstrual, menstrual and intermenstrual phases of her latest and worst menstrual cycle. Daily Symptoms Report was filled at the start and at end of the study (before and after performing swimming exercise)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Premenstrual Syndrome']}, 'referencesModule': {'references': [{'pmid': '29350276', 'type': 'DERIVED', 'citation': 'Maged AM, Abbassy AH, Sakr HRS, Elsawah H, Wagih H, Ogila AI, Kotb A. Effect of swimming exercise on premenstrual syndrome. Arch Gynecol Obstet. 2018 Apr;297(4):951-959. doi: 10.1007/s00404-018-4664-1. Epub 2018 Jan 19.'}]}, 'descriptionModule': {'briefSummary': 'Each female sets her experience of 47 manifestations on a 6 point scale separately for the premenstrual, menstrual and intermenstrual phases of her latest and worst menstrual cycle. Daily Symptoms Report was filled at the start and at end of the study (before and after performing swimming exercise) Females in group I were instructed to engage into swimming exercise 30 minutes daily, 3 times weekly for 3 months. Exercise was ceased on the first 3 days of menstrual cycle then resumed afterwards.\n\nThe exercise included three stages: warming up, swimming and cooling down.', 'detailedDescription': 'Each female sets her experience of 47 manifestations on a 6 point scale separately for the premenstrual, menstrual and intermenstrual phases of her latest and worst menstrual cycle. Daily Symptoms Report was filled at the start and at end of the study (before and after performing swimming exercise) Females in group I were instructed to engage into swimming exercise 30 minutes daily, 3 times weekly for 3 months. Exercise was ceased on the first 3 days of menstrual cycle then resumed afterwards.\n\nThe exercise included three stages: warming up, swimming and cooling down. Warming up phase involved 5 minutes of breathing, circulatory and stretching exercises. Breathing diaphragmatic and costal exercise was performed. Diaphragmatic breathing exercise was performed at a convenient position with full relaxation, then she inspires deeply through the nose, ballooning her abdomen then expires through the mouth with a sigh and slowly and that was repeated 3-5 times.\n\nCostal breathing exercise was done also at the woman favorable position then she inspires deeply through the nose, opens out her ribs then expires through the mouth with a sigh and slowly and that was repeated 3-5 times..\n\nCirculatory foot and ankle exercises were done by instructing the woman to point her toes up and down, doing isometric calf muscle contractions and knee flexion and extension.\n\nStretching exercise of neck flexors, extensors, latissimus dorsi, Deltoid dorsal fibers, triceps, pectoralis major, supraspinatus, wrist , lumbar extensors, abdominal, lumbar flexors, lumbar rotators, hamstrings, adductor, gluteal, gastrocnemius, hip flexors, tensor fascia latae and quadriceps muscles were performed during warming up phase.\n\nThe second phase of treatment was swimming for 20 minutes starting with 5 minutes walking inside the pool around its edges, then forth and back swimming without reaching fatigue level for 15 minutes.\n\nThe last phase was cooling down phase which was the same exercises of the warming up phase for 5 minutes'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. virgins.\n2. Their age ranged from 18 to 25 years old\n3. Their body mass index (BMI) ranged from 18 to 25 kg/m2.\n4. They were clinically and medically stable during the study\n5. Have regular menstrual cycle of 23 to 35 days duration\n\nExclusion Criteria:\n\n1. cardiopulmonary or orthopaedic problems\n2. women taking any hormonal drugs or drugs that affect hormones as antidepressnats during the preceding 3 months before participation in the study\n3. any abnormality in ovulation or those with pelvic inflammatory diseases (PID).\n4. Women with endocrine abnormality as thyroid, pituitary or ovarian disorders'}, 'identificationModule': {'nctId': 'NCT03264612', 'briefTitle': 'Effect of Swimming on Premenstrual Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Aeropbic Exercise as Swimming on Premenstrual Syndrome', 'orgStudyIdInfo': {'id': '10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Swimming group', 'description': 'Females in group I were instructed to engage into swimming exercise 30 minutes daily, 3 times weekly for 3 months. Exercise was ceased on the first 3 days of menstrual cycle then resumed afterwards.\n\nThe exercise included three stages: warming up, swimming and cooling down.', 'interventionNames': ['Behavioral: Aerobic exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Non swimming group', 'description': 'no intervention'}], 'interventions': [{'name': 'Aerobic exercise', 'type': 'BEHAVIORAL', 'otherNames': ['Swimming'], 'description': 'Females in group I were instructed to engage into swimming exercise 30 minutes daily, 3 times weekly for 3 months. Exercise was ceased on the first 3 days of menstrual cycle then resumed afterwards.\n\nThe exercise included three stages: warming up, swimming and cooling down.', 'armGroupLabels': ['Swimming group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12151', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr Alainy medical school', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ahmed Maged, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'kasr Alainy medical school'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ahmed Maged', 'investigatorAffiliation': 'Cairo University'}}}}