Aerobic Exercise and Neck Exercises in Pediatric Migraine Treatment

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

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.

Study Overview

• Status: Recruiting
• Conditions: Migraine in Children
• Intervention / Treatment: Other: Aerobic Exercise; Other: Neck Exercises

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rabia Likos, MD; Phone Number: +902129453000; Email: rabialikos@gmail.com
• Study Contact Backup: Name: Orhan Coskun, MD; Phone Number: +902129453000

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Gaziosmanpasa Research and Training Hospital
    • Contact: Rabia Likos, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aerobic Exercise	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.
Active Comparator: Neck Exercises	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Migraine Attack Frequency	The frequency of migraine attacks in patients will be evaluated in days/month.	Baseline, first and third month follow-ups
Migraine Attack Duration	The duration of attacks in patients will be recorded in hours.	Baseline, first and third month follow-ups
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
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

Collaborators and Investigators

• Sponsor: Gaziosmanpasa Research and Education Hospital
• Investigators: Study Director: Orhan Coskun, MD, Gaziosmanpasa Research and Training Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 5, 2023

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: 139

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No