Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
Study NCT ID:
NCT06392620
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Telerehabilitation in Ankylosing Spondylitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-07-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-26', 'studyFirstSubmitDate': '2024-04-26', 'studyFirstSubmitQcDate': '2024-04-26', 'lastUpdatePostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spinal mobility', 'timeFrame': '10 minutes', 'description': 'Spinal mobility will be assessed and scored with BASMI. According to the index, there are five measurements: lateral lumbar flexion, tragus-wall distance, lumbar flexion (Modified Schober), maximal intermalleolar distance and cervical rotation.'}], 'secondaryOutcomes': [{'measure': 'Disease activity', 'timeFrame': '1 minute', 'description': 'Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) consisting of 6 questions will be used to assess disease activity.'}, {'measure': 'Function', 'timeFrame': '2 minutes', 'description': 'BASFI will be used to assess function. The index includes 10 questions about activities of daily living. A 10 cm VAS will be used for each question'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ankylosing Spondilitis,', 'Exercise', 'YouTube'], 'conditions': ['Ankylosing Spondylitis']}, 'referencesModule': {'references': [{'pmid': '40715923', 'type': 'DERIVED', 'citation': 'Yentur SB, Boyrazli IS, Elbasti MS, Koca SS. Effects of telerehabilitation and YouTube platform-based exercise videos in patients with axial spondyloarthritis: a randomized controlled study. Clin Rheumatol. 2025 Sep;44(9):3561-3571. doi: 10.1007/s10067-025-07591-w. Epub 2025 Jul 25.'}]}, 'descriptionModule': {'briefSummary': 'Ankylosing Spondylitis (AS) is an inflammatory rheumatic disease primarily affecting the spine and sacroiliac joint. xercise is one of the most important nonpharmacologic treatment modalities in AS. Stretching, strengthening, aerobic, posture, balance and moltimodal exercise methods are the most commonly used treatment methods. The study will include 44 patients diagnosed with AS aged 18-65 years. Patients will be divided into two randomized controlled groups with 22 patients in each group. Group 1 will receive a personalized exercise program including stretching, strengthening, respiratory, aerobic and posture exercises via video conferencing. Group 2 will be recommended a video on the YouTube platform and will be asked to perform the exercises by following the content of these videos. Spinal mobility will be assessed with Bath Ankylosing Spondylitis Metrology Index, disease activity with Bath Ankylosing Spondylitis Disease Activity Index, function with Bath Ankylosing Spondylitis Function Index, quality of life with Ankylosing Spondylitis Quality of Life Scale and posture with PostureScreeen mobile application.', 'detailedDescription': 'Ankylosing Spondylitis (AS) is an inflammatory rheumatic disease primarily affecting the spine and sacroiliac joint. It usually begins in the second decade of life and is more common in men than women. The benefits of exercise and physical activity in health and disease are well recognized. Exercise is one of the most important nonpharmacologic treatment modalities in AS. Stretching, strengthening, aerobic, posture, balance and moltimodal exercise methods are the most commonly used treatment modalities. However, the application of these exercise methods to patients with AS in the form of a home exercise program is advantageous due to its low cost and the ease with which patients can start exercising. The study will include 44 patients diagnosed with AS aged 18-65 years. Patients will be divided into two randomized controlled groups with 22 patients in each group. Group 1 will receive a personalized exercise program including stretching, strengthening, respiratory, aerobic and posture exercises via video conferencing. Group 2 will be recommended a video on the YouTube platform and will be asked to perform the exercises by following the content of these videos. Patients in Group 2 will be followed up by regular communication with the patients and by asking the patient to create an attendance chart. Patients in both groups will receive the treatment 3 days a week for 8 weeks. Evaluation methods will be applied at the beginning and at the end of the treatment. Spinal mobility will be assessed with Bath Ankylosing Spondylitis Metrology Index, disease activity with Bath Ankylosing Spondylitis Disease Activity Index, function with Bath Ankylosing Spondylitis Function Index, quality of life with Ankylosing Spondylitis Quality of Life Scale and posture with PostureScreeen mobile application.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65 years old\n* Patients whose medical treatment has not changed in the last three months\n* Patients with a diagnosis of AS will be included.\n\nExclusion Criteria:\n\n* Patients who are pregnant\n* Patients with a diagnosis of malignancy\n* Patients with other concomitant systemic inflammatory rheumatic diseases\n* Patients with neurological, orthopedic or congenital problems that prevent physical activity\n* Patients with regular exercise habits will be excluded from the study'}, 'identificationModule': {'nctId': 'NCT06392620', 'briefTitle': 'Telerehabilitation in Ankylosing Spondylitis', 'organization': {'class': 'OTHER', 'fullName': 'Firat University'}, 'officialTitle': 'Effects of Telerehabilitation in Patients With Ankylosing Spondylitis', 'orgStudyIdInfo': {'id': '2024/03-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'An individually planned exercise program including stretching, strengthening, respiratory, aerobic and posture exercises will be applied via video conference method.', 'interventionNames': ['Other: Study Group']}, {'type': 'EXPERIMENTAL', 'label': 'Control group', 'description': 'It will be recommended a video on YouTube platform and will be asked to do the exercises by following the content of these videos', 'interventionNames': ['Other: Study Group']}], 'interventions': [{'name': 'Study Group', 'type': 'OTHER', 'description': 'n individually planned exercise program including stretching, strengthening, respiratory, aerobic and posture exercises will be applied via video conference method', 'armGroupLabels': ['Control group', 'Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23100', 'city': 'Elâzığ', 'state': 'Elâzığ', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Songul Baglan Yentur', 'role': 'CONTACT', 'email': 'songulbaglan23@hotmail.com', 'phone': '04242370000'}], 'facility': 'Songul Baglan Yentur', 'geoPoint': {'lat': 38.67431, 'lon': 39.22321}}], 'centralContacts': [{'name': 'Songul Baglan Yentur', 'role': 'CONTACT', 'email': 'songulbaglan23@hotmail.com', 'phone': '+90 424 2370000'}], 'overallOfficials': [{'name': 'Songul Baglan Yentur', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Firat University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Firat University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Firat University', 'investigatorFullName': 'Songül Bağlan Yentür', 'investigatorAffiliation': 'Firat University'}}}}