Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 4:10 PM
Study NCT ID:
NCT06621160
Status:
COMPLETED
Last Update Posted:
2024-10-01
First Post:
2024-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Spinal Posture and Anthropometric Characteristics of Women with Chronic Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-30', 'studyFirstSubmitDate': '2024-09-25', 'studyFirstSubmitQcDate': '2024-09-30', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anthropometric Characteristics', 'timeFrame': '1 year', 'description': 'The individuals anthropometric characteristics were assessed with triceps, subscapula, suprailiac and calf skinfold thickness, humerus and femur epicondyle diameter, biceps and calf circumference measurements.\n\nTriceps skinfold thickness, subscapula skinfold thickness, suprailiac skinfold thickness, calf skinfold thickness were measured with skinfold caliper; humeral epicondyle diameter, femoral epicondyle diameter were measured with mechanical caliper, biceps circumference, calf circumference were measured with tape measure. Skinfold thickness measurements were performed by the same person. The measurements were taken from the dominant side of the individuals. The measurements were performed on healthy skin and the areas to be measured were marked with a marker. The individuals were asked to relax their muscles while the measurement was performed. The skin in the marked areas was pulled up by pinching between the index finger and thumb, and the skinfold caliper was placed 1 cm below t'}, {'measure': 'Spinal Posture', 'timeFrame': '1 year', 'description': 'The individuals spinal postures were assessed with the Spinal Mouse. Individuals were informed about the device used and the duration of the assessment. Before the measurement, the positions in which the assessment would be made and how to do these positions were explained to the individuals. Then, a trial measurement was made once. The individuals\\' demographic information was entered into the computer software. Individuals were asked to stand symmetrically with their vertebral columns exposed, to take off their shoes and step onto the mat, and to distribute their weight equally on both feet on a flat surface. Spinal processes starting from C7 to S3 were determined by the physiotherapist and marked with a felt-tip pen. For measurements, the Spinal Mouse device was moved from C7 to the S3 spinous process.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Constipation', 'Posture', 'Anthropometric Measurement', 'Physical Activity'], 'conditions': ['Chronic Constipation']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to compare the spinal posture and anthropometric characteristics of women with Chronic Constipation (CC) and healthy women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'women with and without chronic constipation', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria for women with chronic constipation:\n\n * Constipation according to Rome IV criteria between the ages of 18-65\n * Volunteer\n * Literacy\n* Inclusion criteria for healthy women:\n\n * No constipation according to Rome IV criteria between the ages of 18-65\n * Volunteer\n * Literacy\n\nExclusion Criteria:\n\n* Cancer, neurological disease, serious or uncontrolled systemic or metabolic disease\n\n * Being pregnant\n * Having a mental problem that will prevent cooperation\n * Having alarm symptoms over the age of 50\n * Having a diagnosis of secondary constipation\n * Being BMI\\>35\n * Having megacolon/megarectum and inactive (lazy) bowel syndrome\n * Having had colostomy surgery\n * Having a history of recent abdominal surgery\n * Having an open wound or local tumor in the abdominal region\n * Having an abdominal hernia'}, 'identificationModule': {'nctId': 'NCT06621160', 'briefTitle': 'Investigation of Spinal Posture and Anthropometric Characteristics of Women with Chronic Constipation', 'organization': {'class': 'OTHER', 'fullName': 'Ondokuz Mayıs University'}, 'officialTitle': 'Investigation of Spinal Posture and Anthropometric Characteristics of Women with Chronic Constipation', 'orgStudyIdInfo': {'id': '16/2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group', 'description': 'The control group consists of healthy women.', 'interventionNames': ['Other: Observation']}, {'label': 'CC Group', 'description': 'The CC group consists of women with chronic constipation.', 'interventionNames': ['Other: Observation']}], 'interventions': [{'name': 'Observation', 'type': 'OTHER', 'description': 'After the participants\\' physical and sociodemographic characteristics were recorded, they were asked to fill out the Constipation Severity Scale and 7- Day Stool Diary to determine their constipation levels. The individuals\\' anthropometric characteristics were assessed with triceps, subscapula, suprailiac and calf skinfold thickness, humerus and femur epicondyle diameter, biceps and calf circumference measurements, spinal postures were assessed with the Spinal Mouse, and physical activity levels were assessed with the International Physical Activity Questionnaire-Short Form UFAA-KF and pedometer.', 'armGroupLabels': ['CC Group', 'Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Samsun', 'country': 'Turkey (Türkiye)', 'facility': 'Abant İzzet Baysal University', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ondokuz Mayıs University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Deniz Çakır', 'investigatorAffiliation': 'Ondokuz Mayıs University'}}}}