Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2025-12-27 @ 9:38 PM
Study NCT ID:
NCT07250295
Status:
COMPLETED
Last Update Posted:
2025-11-26
First Post:
2025-11-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Exercise on Paravertebral Muscle Thickness and Quality of Life in Adolescent Idiopathic Scoliosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D012600', 'term': 'Scoliosis'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, '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': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2025-11-18', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Paravertebral Muscle Thickness in Ultrasonographic Measurements', 'timeFrame': '12 weeks', 'description': 'A standard imaging protocol was employed for the transverse imaging of the thoracic and lumbar multifidus muscles. Pre- and post-exercise measurements were performed by the same physician who was blinded to the exercise program the patient received. This evaluator was a PMR physician with 3 years of experience in the field of ultrasound. For each ultrasound image, the examiner positioned the probe over the spinous process and then moved it laterally and proceeded to image the multifidus and deep thoracic paravertebral muscles on both the convex and concave sides of the apex with the patient positioned prone. Two images were obtained for each segment on each side. The mean of the two trials was employed for the purpose of data analysis.'}, {'measure': 'The Turkish version of the Spinal Appearance Questionnaire (Tr-SGA)', 'timeFrame': '12 weeks', 'description': 'The questionnaire comprises two distinct sections: one pertaining to appearance and the other to expectations. Each section contains a series of questions presented on a 5-point Likert scale.'}], 'secondaryOutcomes': [{'measure': 'The Short Form-36 Health Status Questionnaire (SF-36)', 'timeFrame': '12 weeks', 'description': 'The Short Form-36 Health Status Questionnaire (SF-36) was employed for the purpose of assessing quality of life.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise', 'Muscles', 'Scoliosis', 'Ultrasound'], 'conditions': ['Adolescent Idiopathic Scoliosis']}, 'descriptionModule': {'briefSummary': "The study population comprised patients with AIS who had applied to the outpatient clinic between January and June 2022. The patients were divided into two groups. Treatment group(TG) was instructed in specific scoliosis exercises, while the Control group(CG) was given exercises for the lower extremities. Each patient was included in a 12- week exercise program accompanied by a physiotherapist. The patients' quality of life, and paravertebral muscles were evaluated ultrasonographically before and after treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who had been diagnosed with AIS by means of radiographic and clinical examination of the spine were included in the study.\n\nExclusion Criteria:\n\n* Cases with a history of surgery to the paravertebral region, metabolic bone disease, neuromuscular disease, chromosomal anomaly, serious autoimmune and endocrine disease, congenital scoliosis, skeletal dysplasia, and serious cognitive impairment were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT07250295', 'briefTitle': 'The Effect of Exercise on Paravertebral Muscle Thickness and Quality of Life in Adolescent Idiopathic Scoliosis', 'organization': {'class': 'OTHER', 'fullName': 'Sisli Hamidiye Etfal Training and Research Hospital'}, 'officialTitle': 'The Effect of Exercise on Paravertebral Muscle Thickness and Quality of Life in Adolescent Idiopathic Scoliosis', 'orgStudyIdInfo': {'id': '28.12.2021 / 3388'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment Group', 'description': 'The treatment group (TG) was given exercises for the thoracic and lumbar regions for scoliosis.', 'interventionNames': ['Other: Exercise']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'The control group (CG) was instructed to perform gluteus maximus, hamstring, and quadriceps strengthening exercises.', 'interventionNames': ['Other: Exercise for Lower Extremities']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'Patients were expected to attend treatment under the supervision of a physiotherapist. If they missed a day, they were contacted by phone and advised to do their exercises at home. The number of days they missed did not exceed five. Each set included a 30-second rest period to prevent fatigue. A five-minute warm-up and cool-down period was allotted before and after the exercise session. The exercise program was implemented by a physiotherapist with three years of experience in scoliosis management. Before initiating the intervention, the physiotherapist underwent a structured training session, including practical demonstrations, supervised practice, and detailed exercise protocols.', 'armGroupLabels': ['Treatment Group']}, {'name': 'Exercise for Lower Extremities', 'type': 'OTHER', 'description': 'The control group (CG) was instructed to perform gluteus maximus, hamstring, and quadriceps strengthening exercises.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Hamidiye Etfal Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sisli Hamidiye Etfal Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Roza Jizel Dagdelen MD', 'investigatorAffiliation': 'Sisli Hamidiye Etfal Training and Research Hospital'}}}}