Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2026-01-02 @ 2:09 AM
Study NCT ID:
NCT05530850
Status:
COMPLETED
Last Update Posted:
2025-09-02
First Post:
2022-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Holistic Corrective Exercise Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2022-09-02', 'studyFirstSubmitQcDate': '2022-09-02', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of Life by using SRS-22', 'timeFrame': '12 weeks', 'description': 'Scoliosis Research Society-22 Questionnaire (SRS-22)'}], 'primaryOutcomes': [{'measure': 'The Kyphosis angle by using flexible ruler', 'timeFrame': '12 weeks', 'description': 'Flexible ruler'}], 'secondaryOutcomes': [{'measure': 'Balance assesment by using the romberg index', 'timeFrame': '12 weeks', 'description': 'the Romberg index, Pedobarography'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kyphosis Thoracic']}, 'descriptionModule': {'briefSummary': 'This study was planned to investigate the effect of holistic approach corrective exercise program on the degree of kyphosis, balance and quality of life in kyphotic adolescents. A holistic approach corrective exercise program including corrective exercises and postural perception training was applied to one group. Thoracic region focused exercise program was applied to the other group. The programs of the exercise groups were applied three days a week, for 12 weeks. The kyphosis angle of all individuals participating in the study was evaluated using the flexible ruler, the Romberg index measured with balance pedobarography, and the quality of life using the Scoliosis Research Society-22 Questionnaire (SRS-22). In our study, a decrease in the degree of kyphosis was detected in the holistic approach corrective exercise and thoracic region-focused exercise group after 12 weeks of exercise training (p\\<0.001), while no change was observed in the control group (p\\>0.05). Balance improved after exercise training in the holistic corrective exercise group (p=0.006). The quality of life increased in the holistic approach corrective exercise and thoracic region focused exercise groups after the training (p\\<0.001). The use of postural perception training together with corrective exercise programs in applications for thoracic kyphosis reveals a holistic approach and may increase the effect of the intervention.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male individual between the ages of 10-18,\n* Kyphosis degree ≥50°,\n\nExclusion Criteria:\n\n* Rrigid thoracic kyphosis\n* Scoliosis with a Cobb angle \\>10°\n* Congenital spine problem,\n* Shoulder, pelvis and other spinal injuries'}, 'identificationModule': {'nctId': 'NCT05530850', 'briefTitle': 'The Effect of Holistic Corrective Exercise Program', 'organization': {'class': 'OTHER', 'fullName': 'Gaziantep Islam Science and Technology University'}, 'officialTitle': 'The Effect of Holistic Corrective Exercise Program on Kyphosis Degree, Balance and Quality of Life in Kyphotic Adolescent', 'orgStudyIdInfo': {'id': 'HKU-GE-KYPHOSİS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Holistic Corrective Exercise Program', 'description': 'A holistic approach corrective exercise program including corrective exercises and postural perception training', 'interventionNames': ['Behavioral: Holistic Corrective Exercise Program']}, {'type': 'EXPERIMENTAL', 'label': 'Thoracic exercise program', 'description': 'Thoracic region focused exercise program', 'interventionNames': ['Other: Thoracic exercise program']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'Individuals in the control group were asked to continue their activities of daily living.'}], 'interventions': [{'name': 'Holistic Corrective Exercise Program', 'type': 'BEHAVIORAL', 'description': 'A holistic approach corrective exercise program including corrective exercises and postural perception training,', 'armGroupLabels': ['Holistic Corrective Exercise Program']}, {'name': 'Thoracic exercise program', 'type': 'OTHER', 'description': 'Thoracic region focused exercise program', 'armGroupLabels': ['Thoracic exercise program']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Şehitkamil', 'state': 'Gazi̇antep', 'country': 'Turkey (Türkiye)', 'facility': 'Hasan Kalyoncu Üniversitesi', 'geoPoint': {'lat': 37.07962, 'lon': 37.38003}}], 'overallOfficials': [{'name': 'GÖNÜL ELPEZE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HKU'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gaziantep Islam Science and Technology University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor Of Philosophy', 'investigatorFullName': 'Gönül Elpeze', 'investigatorAffiliation': 'Hasan Kalyoncu University'}}}}