Aerobic Exercise and Neck Exercises in Pediatric Migraine Treatment

Sponsor

Gaziosmanpasa Research and Education Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06068751

Collaborator

(none)

Enrollment

Location

Arms

3.3

Anticipated Duration (Months)

18.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Migraine in Children	Other: Aerobic Exercise Other: Neck Exercises	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 22, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Aerobic Exercise 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 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.

Arm

Intervention/Treatment

Active Comparator: Aerobic Exercise

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

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.

Outcome Measures

Primary Outcome Measures

Migraine Attack Frequency [Baseline, first and third month follow-ups]
The frequency of migraine attacks in patients will be evaluated in days/month.
Migraine Attack Duration [Baseline, first and third month follow-ups]
The duration of attacks in patients will be recorded in hours.
Migraine Attack Severity [Baseline, first and third month follow-ups]
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.
Neck Pain Severity [Baseline, first and third month follow-ups]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gaziosmanpaşa Research and Training Hospital	Istanbul		Turkey

Sponsors and Collaborators

Gaziosmanpasa Research and Education Hospital

Investigators

Study Director: Orhan Coskun, MD, Gaziosmanpaşa Research and Training Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rabia Likos Akpınar, MD in ER, Principal Investigator, Gaziosmanpasa Research and Education Hospital

ClinicalTrials.gov Identifier:

NCT06068751

Other Study ID Numbers:

First Posted:

Oct 5, 2023

Last Update Posted:

Oct 5, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Migraine Disorders

Study Results

No Results Posted as of Oct 5, 2023