Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2026-02-18 @ 3:30 AM
Study NCT ID:
NCT06752993
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-31
First Post:
2024-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Expiratory Muscle Strength Training in Adolescent Idiopathic Scoliosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012600', 'term': 'Scoliosis'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-07-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-20', 'studyFirstSubmitDate': '2024-12-06', 'studyFirstSubmitQcDate': '2024-12-20', 'lastUpdatePostDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cobb Angle', 'timeFrame': '6 Weeks', 'description': "This is the gold standard method used to assess the lateral curvature of the spine. In this method, participants' anteroposterior radiographic images will be captured while they are in a standing position. The angle between a line drawn parallel to the upper edge of the highest vertebra involved in the scoliosis curve and a line drawn parallel to the lower edge of the lowest vertebra involved will be measured on the radiographic image. These measurements will be performed by an experienced orthopedic physician"}], 'secondaryOutcomes': [{'measure': 'Respiratory Muscle Strength', 'timeFrame': '6 Weeks', 'description': "The measurement of maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP), which are voluntarily assessed to evaluate the participants' respiratory muscle strength, will be conducted using an electronic and portable mouth pressure measurement device (Micro Medical MicroRM, UK) in accordance with ATS/ERS criteria."}, {'measure': 'McGill Endurance Test', 'timeFrame': '6 Weeks', 'description': "The participants' core stabilization will be assessed using the McGill Endurance Test."}, {'measure': "'6 Minute Pegboard and Ring' Test", 'timeFrame': '6 Weeks', 'description': "To assess the functional exercise capacity of the participants, the 'Pegboard and Ring' test will be performed for the upper extremities."}, {'measure': 'Scoliosis Research Society 22 Patient Questionnaire', 'timeFrame': '6 Weeks', 'description': "The participants' quality of life will be assessed using the scoliosis research society 22 patient questionnaire. This questionnaire consists of 22 items and each item is scored between 0-5 point. While, the maximum score that obtained from the questionnaire is 110 point, the minimum score is 0 point. An increase scores on this questionnaire mean that quality of life has improved."}, {'measure': 'Quick Disabilities of the Arm, Shoulder and Hand Questionnaire', 'timeFrame': '6 Weeks', 'description': "The functional impairments of the upper extremities in the participants' activities of daily living will be assessed using the quick disabilities of the arm, shoulder, and hand questionnaire. This questionnaire consists of 11 items and each item is scored between 1-5 point. While, the maximum score that obtained from the questionnaire is 55 point, the minimum score is 11 point. An increase scores on this questionnaire mean that upper extremities in the participants' activities of daily living have worsened."}, {'measure': 'The Stabilizer Pressure Biofeedback Unit', 'timeFrame': '6 Weeks', 'description': 'To assess the deep core muscle stabilization of the participants, the stabilizer pressure biofeedback unit will be performed.'}, {'measure': '6 Minute Walk Test', 'timeFrame': '6 Weeks', 'description': "To evaluate functional exercise capacity of the participants, the '6-Minute Walk test will be conducted for the lower extremities"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adolescent idiopathic scoliosis', 'Expiratory muscle strength training', 'Cobb angle', 'Core stability', 'Functional exercise capacity', 'Respiratory muscle stregth'], 'conditions': ['Adolescent Idiopathic Scoliosis (AIS)', 'Scoliosis; Adolescence']}, 'descriptionModule': {'briefSummary': 'Adolescent idiopathic scoliosis result in deterioration of core muscles and respiratory system. Core muscles provide trunk stabilization as well as responsible for respiratory system. Especially tr. abdominis, rectus abdominis, external oblic and internal oblic muscle, which are core muscles, highly active during forced expiration while diaphragm muscle also active during inspiration. Thus, expiratory muscle strength training has effect not only respiratory muscle strength but also trunk stabilization. While, effects of expiratory muscle strength training in adolesecent idiopathic scoliosis is a topic that needs to be investigated, this topic has not been investigated until today. Hence, this current study aimed to investigate the effects of expiratory muscle strength training on cobb angle, respiratory muscle strength, core stabilization, functional exercise capacity and quality of life.', 'detailedDescription': 'A convenience of children with adolescent idiopathic scoliosis, 10-19 years, is going to recruited from Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation. Patients will randomly allocate to either a treatment group or control group. The treatments group will receive expiratory muscle strength training at 50% maximal expiratory presssure while, the control group will receive sham expiratory muscle strength training without physiological load. Groups are going to train for a total of 25 breathe/day, 5 days/week, for 6 weeks. Before and after treatment, all of patients progression of scoliosis will be evaluated by calculating cobb angle, respiratory muscle strength using with electronic mouth pressure device, core stability using with Mc-Gill endurance test and the stabilizer biofeedback unit, functional exercise capacity using with six minute walk test (6MWT) and six minute pegboard and ring test (6MPBRT), quality of life using with scoliosis research society -22 questionnare (SRS-22) and daily living activity of upper extremity using with quick-DASH questionnare.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals diagnosed with idiopathic scoliosis,\n* aged between 10 and 19 years,\n* with a Cobb angle ranging from 10 to 45 degrees.\n\nExclusion Criteria:\n\n* Individuals who have undergone spinal surgery,\n* who have received conservative or surgical treatment for scoliosis,\n* individuals with neurological, neuromuscular, systemic, rheumatological, or musculoskeletal disorders, or conditions affecting balance and walking,\n* individuals with a history of cardiac or pulmonary diseases that could affect respiratory function and exercise capacity.'}, 'identificationModule': {'nctId': 'NCT06752993', 'briefTitle': 'Effects of Expiratory Muscle Strength Training in Adolescent Idiopathic Scoliosis', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'Effects of Expiratory Muscle Strength Training on Cobb Angle, Respiratory Muscle Strength, Core Stabilization, Functional Exercise Capacity and Quality of Life in Adolescent Idiopathic Scoliosis', 'orgStudyIdInfo': {'id': '02112001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Expiratory Muscle Strength Training Group', 'description': 'The treatment group will receive expiratory muscle strength training (EMST) at 50% maximal expiratory mouth pressure (PEmax) by using EMST-150 device and training load were adjusted to maintain 50% of the PEmax weekly. The PEmax will measured at supervised sessions each week and 50% of the measured value will determined as the new training work load.', 'interventionNames': ['Device: Expiratory Muscle Strength Training (EMST-150)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Group', 'description': 'The control group will receive expiratory muscle strength training (EMST) without physiological load by using expiratory muscle strength training device.', 'interventionNames': ['Device: Sham Training']}], 'interventions': [{'name': 'Expiratory Muscle Strength Training (EMST-150)', 'type': 'DEVICE', 'description': 'Training is going to perform by using a pressure treshold-loading device (EMST-150, Aspire Products, LLC, Gainesville, FL) used to exhale against a same-pressure load every exhalation for strengthening primarily the core muscles. The device pressure is adjusted according to PEmax and reliability/reproducibility has been demonstrated.', 'armGroupLabels': ['Expiratory Muscle Strength Training Group']}, {'name': 'Sham Training', 'type': 'DEVICE', 'description': 'Training is going to perform by using a pressure treshold-loading device (EMST-150, Aspire Products, LLC, Gainesville, FL) without physiological load. The sham device closely resembled the EMST device, with the only difference being that the pressure release valve was rendered nonfunctional by removing the spring. As a result, it exerted minimal to no physiological load on the targeted muscles.', 'armGroupLabels': ['Sham Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'state': 'Yenimahalle', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Naciye SEVİM', 'role': 'CONTACT', 'email': 'naciye.sevim@gazi.edu.tr', 'phone': '+90 (312) 586 80 00'}, {'name': 'Muserrefe Nur Keles, Phd', 'role': 'CONTACT', 'email': 'muserrefe@gazi.edu.tr'}], 'facility': 'Gazi University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Naciye Sevim', 'role': 'CONTACT', 'email': 'naciye.sevim@gazi.edu.tr', 'phone': '+90 (312) 586 80 00'}, {'name': 'Muserrefe Nur Keles, Phd', 'role': 'CONTACT', 'email': 'muserrefe@gazi.edu.tr'}], 'overallOfficials': [{'name': 'Muserrefe Nur Keles, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Gazi University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Muserrefe Nur Keles', 'investigatorAffiliation': 'Gazi University'}}}}