Aerobic Exercise and Neck Exercises in Pediatric Migraine Treatment

NCT06068751 | Unknown

• 1 other identifier: 139
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Aerobic Exercise

ACTIVE COMPARATOR

Aerobic Exercise

Other: Aerobic Exercise

Neck Exercises

ACTIVE COMPARATOR

Neck Exercises

Other: Neck Exercises

Interventions

Aerobic Exercise 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.

Aerobic Exercise

Neck Exercises 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.

Neck Exercises

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Gaziosmanpaşa Research and Training Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Orhan Coskun, MD

  Gaziosmanpaşa Research and Training Hospital

  STUDY DIRECTOR

Central Study Contacts

Rabia Likos, MD

CONTACT

+902129453000; rabialikos@gmail.com

Orhan Coskun, MD

CONTACT

+902129453000

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD in ER, Principal Investigator

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: October 5, 2023
• Study Start: September 22, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

TU (1)