Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 11:46 PM
Study NCT ID:
NCT06783894
Status:
RECRUITING
Last Update Posted:
2025-01-20
First Post:
2025-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Elliptical Physical Activity and Sexual Dysfunction in Males With Irritable Bowel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D007172', 'term': 'Erectile Dysfunction'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, '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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-06-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-15', 'studyFirstSubmitDate': '2025-01-15', 'studyFirstSubmitQcDate': '2025-01-15', 'lastUpdatePostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'international index of erectile fucntion', 'timeFrame': 'it will be assessed after 12 weeks', 'description': 'it is questionnaire that contains five questions assessing erectile functions'}], 'secondaryOutcomes': [{'measure': 'Irritable Bowel Syndrome Severity Scoring System', 'timeFrame': 'it will be assessed after 12 weeks', 'description': 'it is a questionnaire that assesses the severity symptoms related to irritable bowel syndrome'}, {'measure': 'Irritable Bowel Syndrome Quality of Life Questionnaire', 'timeFrame': 'it will be assessed after 12 weeks', 'description': 'it is a questionnaire that assesses the quality of life in patients irritable bowel syndrome'}, {'measure': 'State Anxiety Inventory', 'timeFrame': 'it will be assessed after 12 weeks', 'description': 'it is a questionnaire that assesses the long standing anxiety'}, {'measure': 'Beck depression inventory', 'timeFrame': 'it will be assessed after 12 weeks', 'description': 'it is a questionnaire that assesses depression symptoms'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Irritable Bowel Syndrome', 'Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': 'psychological disturbances resulting from irritable bowel syndrome causes sexual dysfunction in men such as weak erection of penis. The different exercise forms are important in improving symptoms of this syndrome and exercise also may improve sexual dysfunction in men', 'detailedDescription': 'Forty irritable bowel syndrome men with sexual dysfunction ( weak erection of penis or erectile dysfunction) will divided into Group I or Group II . The group will contain twenty subjects. Group I will perform ellpitical physical activity (40 minutes on elliptical trainer three times weekly. the duration of physical activity will be 12 weeks. Group II will not perform any physical activity.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'genderBased': True, 'genderDescription': 'based on self-representation of gender identity.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men with irritable bowel syndrome\n* men with erectile dysfunction\n* married men\n\nExclusion Criteria:\n\n* obese men\n* chest/renal disease men\n* cardiac/metabolic disease men\n* systemic disease men'}, 'identificationModule': {'nctId': 'NCT06783894', 'briefTitle': 'Elliptical Physical Activity and Sexual Dysfunction in Males With Irritable Bowel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Elliptical Physical Activity and Sexual Dysfunction in Males With Irritable Bowel Syndrome', 'orgStudyIdInfo': {'id': 'IRB00014233-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group I', 'description': 'twenty irritable bowel syndrome men with sexual dysfunction ( weak erection of penis or erectile dysfunction) will perform ellpitical physical activity (40 minutes on elliptical trainer three times weekly. the duration of physical activity will be 12 weeks.', 'interventionNames': ['Behavioral: exercise (elliptical training)']}, {'type': 'NO_INTERVENTION', 'label': 'Group II', 'description': 'twenty irritable bowel syndrome men with sexual dysfunction (weak erection of penis or erectile dysfunction) will perform no type of activity (wait list group).'}], 'interventions': [{'name': 'exercise (elliptical training)', 'type': 'BEHAVIORAL', 'description': 'twenty irritable bowel syndrome men with sexual dysfunction ( weak erection of penis or erectile dysfunction) will perform ellpitical physical activity (40 minutes on elliptical trainer three times weekly. the duration of physical activity will be 12 weeks.', 'armGroupLabels': ['group I']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dokki', 'state': 'Giza Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ali Ismail, lecturer', 'role': 'CONTACT', 'email': 'ali.mohamed@pt.cu.edu.eg', 'phone': '+201005154209'}, {'name': 'Ali MA Ismail, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'faculty of physical therapy Cairo university', 'geoPoint': {'lat': 30.03823, 'lon': 31.2113}}], 'centralContacts': [{'name': 'Ali MA Isamil, Lecturer', 'role': 'CONTACT', 'email': 'ali.mohamed@pt.cu.edu.eg', 'phone': '0201005154209'}], 'overallOfficials': [{'name': 'Ali MA Ismail', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics, Faculty of Physical Therapy', 'investigatorFullName': 'Ali Mohamed Ali ismail', 'investigatorAffiliation': 'Cairo University'}}}}