Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT06068751
Status:
UNKNOWN
Last Update Posted:
2023-10-05
First Post:
2023-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Aerobic Exercise and Neck Exercises in Pediatric Migraine Treatment
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-28', 'studyFirstSubmitDate': '2023-09-22', 'studyFirstSubmitQcDate': '2023-09-28', 'lastUpdatePostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Migraine Attack Frequency', 'timeFrame': 'Baseline, first and third month follow-ups', 'description': 'The frequency of migraine attacks in patients will be evaluated in days/month.'}, {'measure': 'Migraine Attack Duration', 'timeFrame': 'Baseline, first and third month follow-ups', 'description': 'The duration of attacks in patients will be recorded in hours.'}, {'measure': 'Migraine Attack Severity', 'timeFrame': 'Baseline, first and third month follow-ups', 'description': 'The severity of migraine attacks will be assessed using a visual analog scale, and a score between 0 and 10 will be assigned. A high score indicates more severe attack.'}, {'measure': 'Neck Pain Severity', 'timeFrame': 'Baseline, first and third month follow-ups', 'description': 'The severity of neck pain will be assessed using a visual analog scale, and a score between 0 and 10 will be assigned. A high score indicates severe pain.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Migraine in Children']}, 'descriptionModule': {'briefSummary': 'This randomized controlled single-blind trial will include 60 pediatric migraine patients. Participants will be divided into two groups: one performing aerobic exercise, and the other conducting neck exercises. Assessments include attack frequency, severity, duration, and neck pain over three months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Pediatric Migraneurs, as per International Classification of Headache Disorders-3 guidelines\n\nExclusion Criteria:\n\n* individuals with any other concomitant headaches\n* those showing findings beyond nonspecific hyperintense areas on cranial Magnetic Resonance Imaging\n* patients with systemic diseases other than migraine, such as fibromyalgia\n* individuals who had experienced treatment changes or required treatment changes within the last month\n* limited mental capacity or psychological illnesses that could hinder their participation in surveys and exercises\n* a history of increased attack frequency or severity with previous physical activity program involvement, or a history of trauma to the neck or face\n* individuals with a history of a herniated disc in the cervical region or symptoms of cervical radiculopathy'}, 'identificationModule': {'nctId': 'NCT06068751', 'briefTitle': 'Aerobic Exercise and Neck Exercises in Pediatric Migraine Treatment', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Gaziosmanpasa Research and Education Hospital'}, 'officialTitle': 'The Effectiveness of Aerobic Exercise and Neck Exercises in Pediatric Migraine Treatment: A Randomized Controlled Single-Blind Study', 'orgStudyIdInfo': {'id': '139'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Aerobic Exercise', 'description': 'Aerobic Exercise', 'interventionNames': ['Other: Aerobic Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Neck Exercises', 'description': 'Neck Exercises', 'interventionNames': ['Other: Neck Exercises']}], 'interventions': [{'name': 'Aerobic Exercise', 'type': 'OTHER', 'description': 'The initial group will receive instructions to increase their moderate to high-intensity physical activity frequency to at least 60 minutes per day (in episodes exceeding 10 minutes) by 50%, with a minimum of three days per week. They will be encouraged to engage in enjoyable and age-appropriate activities, including jogging, brisk walking, swimming, dancing, cycling, as well as sports like basketball, football, and tennis.', 'armGroupLabels': ['Aerobic Exercise']}, {'name': 'Neck Exercises', 'type': 'OTHER', 'description': 'The second group, focused on neck exercises, will receive guidance from an experienced physiotherapist and their families. The physiotherapist will demonstrate a series of stretching and isometric strengthening exercises for specific muscle groups: upper trapezius, levator scapula, sternocleidomastoid, cervical flexors, and extensors, which have been associated with migraines in prior studies. Each patient will perform 3 sets of 10-15 repetitions for both stretching and isometric strengthening exercises per muscle group, with a 1-minute break between sets. Patients will be advised to maintain a gentle stretch during stretching exercises, avoiding excessive force to prevent discomfort. Static stretching and isometric strengthening exercises will involve holding each position for 5-10 seconds. In the initial week, a reduced set of 5 repetitions will be allowed for adaptation. Throughout the intervention, participants will follow this exercise regimen for 3 days weekly.', 'armGroupLabels': ['Neck Exercises']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Rabia Likos, MD', 'role': 'CONTACT'}], 'facility': 'Gaziosmanpaşa Research and Training Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Rabia Likos, MD', 'role': 'CONTACT', 'email': 'rabialikos@gmail.com', 'phone': '+902129453000'}, {'name': 'Orhan Coskun, MD', 'role': 'CONTACT', 'phone': '+902129453000'}], 'overallOfficials': [{'name': 'Orhan Coskun, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gaziosmanpaşa Research and Training Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gaziosmanpasa Research and Education Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD in ER, Principal Investigator', 'investigatorFullName': 'Rabia Likos Akpınar', 'investigatorAffiliation': 'Gaziosmanpasa Research and Education Hospital'}}}}