Aerobic Exercise and Neck Exercises in Pediatric Migraine Treatment

Migraine in Children Clinical Trial

Official title:

The Effectiveness of Aerobic Exercise and Neck Exercises in Pediatric Migraine Treatment: A Randomized Controlled Single-Blind Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06068751
• Other study ID #: 139
• Status: Recruiting
• Phase: N/A
• Start date: September 22, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2023
• Source: Gaziosmanpasa Research and Education Hospital
• Contact: Rabia Likos, MD
• Phone: +902129453000
• Email: rabialikos[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine in Children

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Gaziosmanpasa Research and Training Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Gaziosmanpasa Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Migraine Attack Frequency	The frequency of migraine attacks in patients will be evaluated in days/month.	Baseline, first and third month follow-ups
Primary	Migraine Attack Duration	The duration of attacks in patients will be recorded in hours.	Baseline, first and third month follow-ups
Primary	Migraine Attack Severity	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.	Baseline, first and third month follow-ups
Primary	Neck Pain Severity	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.	Baseline, first and third month follow-ups