Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-25 @ 7:08 PM
Study NCT ID:
NCT05410704
Status:
UNKNOWN
Last Update Posted:
2022-06-08
First Post:
2022-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Pelvic Floor Muscle Training and Diaphragmatic Breathing Exercise on Body Posture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-05', 'studyFirstSubmitDate': '2022-05-28', 'studyFirstSubmitQcDate': '2022-06-05', 'lastUpdatePostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of Quality of Life', 'timeFrame': 'baseline', 'description': '36-Item Short Form Survey (SF-36). On the scale, higher scores mean a better outcome. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.'}, {'measure': 'Assessment of Body Posture', 'timeFrame': 'baseline', 'description': 'New York Posture Rating Chart. On the scale, each body segment was scored 5 (correct posture), 3 (slight deviation), or 1 (pronounced deviation). The scores of the body alignment segments are summed, allowing a range of overall score between 13 and 65. Higher scores mean a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Assessment of Physical Activity Level', 'timeFrame': 'baseline', 'description': 'International Physical Activity Questionnaire-short form (IPAQ-SF) The questionnaire records the activity of four intensity levels: 1) vigorous-intensity activity such as aerobics, 2) moderate-intensity activity such as leisure cycling, 3) walking, and 4) sitting.'}, {'measure': 'Assessment of Pelvic Floor Muscle Function', 'timeFrame': 'baseline', 'description': 'Pelvic Floor Impact Questionnaire (PFIQ). The PFIQ 7 has 7 questions and each question has 3 separate responses. The response to each item of satisfaction, impact and worry was rated from 3 (quite a bit) to 0 (not at all) for the PFIQ-7. The mean value for all the answered items within the corresponding scale (possible value 0-3) was estimated, then multiplied by (100/3) to obtain the scale score, range 0-100. We added the scores from the 3 scales together to obtain the PFIQ 7 summary score (range 0-300).For the scale, a higher score indicates worse health status.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Telerehabilitation', 'Body Posture', 'Pelvic Floor Muscle Training', 'Diaphragmatic Breathing', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'This study; It will be done in order to show evidence of the effects of pelvic floor muscle training and diaphragmatic breathing exercise via telerehabilitation on body posture and quality of life in healthy individuals. International Physical Activity Quastionnaire Short Form (IPAQ), Pelvic Floor Impact Quastionnaire Short Form (PFIQ-7), 36-Item Short Form Survey(SF-36) and New York Posture Rating Chart will be applied.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index between 18-25\n* Being a woman over the age of 18\n\nExclusion Criteria:\n\n* obstructive or restrictive lung disease\n* diagnosed with urinary incontinence or pelvic organ prolapse\n* pelvic pain\n* history of pelvic surgery\n* Any history of spinal, thoracic or abdominal surgery\n* To smoke\n* cardiac, neurological and rheumatological disease\n* Congenital deformity or previous history of surgery in the spine and thorax\n* endocrine and metabolic disease\n* psychiatric disorders\n* cardiological disorders\n* malignancy\n* Doing regular physical activity or sports for the last 3 months'}, 'identificationModule': {'nctId': 'NCT05410704', 'briefTitle': 'Effects of Pelvic Floor Muscle Training and Diaphragmatic Breathing Exercise on Body Posture', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi'}, 'officialTitle': 'Effects of Pelvic Floor Muscle Training and Diaphragmatic Breathing Exercise Via Telerehabilitation on Body Posture and Quality of Life Outcomes', 'orgStudyIdInfo': {'id': 'postureandlife'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Group', 'description': 'Pelvic floor muscle exercises and diaphragmatic breathing exercises will be performed 3 times a week for 12 weeks. New York Posture Rating Scale and SF-36 will be applied before and after the study. International Physical Activity Questionnaire and Pelvic Floor Impact Questionnaire will be applied before the study.', 'interventionNames': ['Other: exercises']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'No intervention. New York Posture Rating Scale and SF-36 will be applied before and after the study. International Physical Activity Questionnaire and Pelvic Floor Impact Questionnaire will be applied before the study.'}], 'interventions': [{'name': 'exercises', 'type': 'OTHER', 'description': 'Pelvic floor muscle exercises and diaphragmatic breathing exercise', 'armGroupLabels': ['Study Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Tülay SEVİM', 'role': 'CONTACT', 'email': 'tulayulkusevim@gmail.com'}], 'facility': 'Tülay Ülkü SEVİM', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Tülay Sevim', 'role': 'CONTACT', 'email': 'tulayulkusevim@gmail.com', 'phone': '+905349787081'}], 'overallOfficials': [{'name': 'Meltem VURAL', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Saglik Bilimleri Universitesi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}