Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2025-12-29 @ 8:05 AM
Study NCT ID:
NCT07196761
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-29
First Post:
2025-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Whole-body Vibration on Postmenopausal Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-20', 'studyFirstSubmitDate': '2025-09-20', 'studyFirstSubmitQcDate': '2025-09-20', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Assessment of Constipation Symptom (PAC - SYM)', 'timeFrame': '6 weeks', 'description': "It is a reliable and valid tool to measure the patient's perspective constipation symptoms in terms of frequency and severity. It is a 12- item that is divided into three symptom subscales: abdominal (four items); rectal (three items); and stool (five items). Items are scored on 5-point Like scales, with scores ranging from 0 to 4 (0 = 'symptom absent', 1 = 'mild', 2 = 'moderate', 3 = 'severe' and 4 = 'very severe'). A mean total score in the range of 0-4 is generated by dividing the total score by the number of questions completed; the lower the total score, the lower the symptom burden."}], 'secondaryOutcomes': [{'measure': 'Patient Assessment of Constipation quality of life (PAC - QOL)', 'timeFrame': '6 weeks', 'description': 'The PAC-QOL questionnaire is used to evaluate the quality of life of patients having constipation. It is a brief but comprehensive tool which evaluates constipation through daily individual health assessment and functioning. This questionnaire consists of 28 self-reported items which subcategorized into 4 items on physical discomfort. 8 items on psychosocial discomfort, 5 items on treatment satisfaction, and finally 11 items on worries and discomfort. The overall score ranges from 0 -16. The higher the score, the higher the quality of life.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Constipation']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to investigate the effect of whole-body vibration on postmenopausal constipation', 'detailedDescription': "Constipation is common in menopause with prevalence ranging from 4% to 29% in various parts of the world. The incidence of constipation among postmenopausal women has been reported to be 37.3%. It can affect the physical, mental and social well-being of women; it reduces individual productivity and creates a significant burden on society and disrupting women's quality of life.\n\nPostmenopausal constipation needs to be treated as it can cause serious problems as hemorrhoids, anal fissures, pelvic organ prolapse and severe pain during defecation.\n\nLaxatives can prevent constipation but its overuse may lead to dependency and decreased bowel function . Also, it may cause some side effects as rectal bleeding, bloody stools, severe cramps or pain, weakness or unusual tiredness, unexplained changes in bowel patterns, severe diarrhea, weakness or unusual tiredness.\n\nWhole body vibration strengthens smooth muscles through oscillation, which causes muscles to rapidly contract and relax. This has been shown to significantly improve the condition of those with chronic functional constipation.\n\nWhole body vibration can aid in minimizing the build up of toxins because it increases blood flow and prevent accumulation of wastes in the colon. Also, it improves gut microbiota that aid in digestion due to increased intestinal permeability.\n\nFew studies have investigated the effect of whole body vibration specifically on postmenopausal woman. So, this study will be conducted to investigate the effect of the whole body vibration on functional constipation in postmenopausal women to provide an insight for the benefits of such intervention in the management of postmenopausal constipation."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '50 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fifty postmenopausal women are clinically diagnosed as having functional constipation after menopause (at least one year after stoppage of last menstrual cycle)\n* Their age will be ranged from 50 to 60 years old.\n* Their body mass index will not exceed 30 kg/m2.\n* They will not receive any medical treatment.\n* All of them should have at least two criteria of Rome III diagnostic criteria of constipation.\n\nExclusion Criteria:\n\n* Irritable bowel syndrome or anal fissures.\n* Genital organ prolapse as rectocele.\n* Any neurological diseases, spinal diseases or spinal deformities.\n* History of bowel surgery.'}, 'identificationModule': {'nctId': 'NCT07196761', 'briefTitle': 'Effect of Whole-body Vibration on Postmenopausal Constipation', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Whole-body Vibration on Postmenopausal Constipation', 'orgStudyIdInfo': {'id': 'P.T.REC/012/005907'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bowel care advice group', 'description': 'The participants will receive general bowel care advice only for 6 weeks.', 'interventionNames': ['Other: Bowel care advice']}, {'type': 'EXPERIMENTAL', 'label': 'Whole body vibration and bowl care advice group', 'description': 'The participants will be subjected to whole-body vibration therapy for 25-minute/session , 3 times per week for 6 weeks in addition to general bowel care advice.', 'interventionNames': ['Other: Bowel care advice', 'Device: Whole-body vibration']}], 'interventions': [{'name': 'Bowel care advice', 'type': 'OTHER', 'description': 'It includes: - Encourage adequate fiber intake (20 to 35 grams) each day.\n\n* Avoid caffeine - containing foods and beverages\n* Drink at least 1.5 to 2 liters of water/day\n* Proper defecation position such as, sitting with knees higher than hips (use a foot stool or other flat, stable object if necessary) , lean forward and put elbows on knees, relax and bulge out the stomach and straighten the spine', 'armGroupLabels': ['Bowel care advice group', 'Whole body vibration and bowl care advice group']}, {'name': 'Whole-body vibration', 'type': 'DEVICE', 'description': 'Crazy fit massager (made in China ) with platform surface size (65 cm X 35 cm ) base height 20 cm, heavy-duty motor wattage: 200 - 500 watts, will be used to provide whole body vibration for the participants in the experimental group, for 25 minutes, 3 times per week for 6 weeks.', 'armGroupLabels': ['Whole body vibration and bowl care advice group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Nouran Mohamed Sabry', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'centralContacts': [{'name': 'Nouran Sabry, Master', 'role': 'CONTACT', 'email': 'Nourantemo@yahoo.com', 'phone': '01277482959'}, {'name': 'Mohamed Abo Eleinien, Professor', 'role': 'CONTACT', 'email': 'Drfawzygyna61@gmail.com', 'phone': '01001414404'}], 'overallOfficials': [{'name': 'Azza Kassab, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Nouran Mohamed Sabry', 'investigatorAffiliation': 'Cairo University'}}}}