Aerobic Exercise and Neck Exercises in Pediatric Migraine Treatment

NCT ID: NCT06068751

Last Updated: 2023-10-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-22
• Study Completion Date: 2023-12-31

Brief Summary

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.

Conditions

Migraine in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Aerobic Exercise

Aerobic Exercise

Group Type: ACTIVE_COMPARATOR

Aerobic Exercise

Intervention Type: OTHER

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.

Neck Exercises

Neck Exercises

Group Type: ACTIVE_COMPARATOR

Neck Exercises

Intervention Type: OTHER

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.

Interventions

Aerobic Exercise

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.

Intervention Type: OTHER

Neck Exercises

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Pediatric Migraneurs, as per International Classification of Headache Disorders-3 guidelines

Exclusion Criteria

• individuals with any other concomitant headaches
• those showing findings beyond nonspecific hyperintense areas on cranial Magnetic Resonance Imaging
• patients with systemic diseases other than migraine, such as fibromyalgia
• individuals who had experienced treatment changes or required treatment changes within the last month
• limited mental capacity or psychological illnesses that could hinder their participation in surveys and exercises
• a history of increased attack frequency or severity with previous physical activity program involvement, or a history of trauma to the neck or face
• individuals with a history of a herniated disc in the cervical region or symptoms of cervical radiculopathy

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gaziosmanpasa Research and Education Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Rabia Likos Akpınar

MD in ER, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Orhan Coskun, MD

Role: STUDY_DIRECTOR

Gaziosmanpaşa Research and Training Hospital

Locations

Gaziosmanpaşa Research and Training Hospital

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Rabia Likos, MD

Role: CONTACT

rabialikos@gmail.com

+902129453000

Orhan Coskun, MD

Role: CONTACT

+902129453000

Facility Contacts

Rabia Likos, MD

Role: primary

Other Identifiers

139

Identifier Type: -

Identifier Source: org_study_id