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Aerobic Exercise and Neck Exercises in Pediatric Migraine Treatment

Primary Purpose

Migraine in Children

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Aerobic Exercise
Neck Exercises
Sponsored by
Gaziosmanpasa Research and Education Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine in Children

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Gaziosmanpaşa Research and Training HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Aerobic Exercise

Neck Exercises

Arm Description

Aerobic Exercise

Neck Exercises

Outcomes

Primary Outcome Measures

Migraine Attack Frequency
The frequency of migraine attacks in patients will be evaluated in days/month.
Migraine Attack Duration
The duration of attacks in patients will be recorded in hours.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 22, 2023
Last Updated
September 28, 2023
Sponsor
Gaziosmanpasa Research and Education Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06068751
Brief Title
Aerobic Exercise and Neck Exercises in Pediatric Migraine Treatment
Official Title
The Effectiveness of Aerobic Exercise and Neck Exercises in Pediatric Migraine Treatment: A Randomized Controlled Single-Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gaziosmanpasa Research and Education Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine in Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aerobic Exercise
Arm Type
Active Comparator
Arm Description
Aerobic Exercise
Arm Title
Neck Exercises
Arm Type
Active Comparator
Arm Description
Neck Exercises
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise
Intervention Description
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
Intervention Name(s)
Neck Exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Migraine Attack Frequency
Description
The frequency of migraine attacks in patients will be evaluated in days/month.
Time Frame
Baseline, first and third month follow-ups
Title
Migraine Attack Duration
Description
The duration of attacks in patients will be recorded in hours.
Time Frame
Baseline, first and third month follow-ups
Title
Migraine Attack Severity
Description
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.
Time Frame
Baseline, first and third month follow-ups
Title
Neck Pain Severity
Description
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.
Time Frame
Baseline, first and third month follow-ups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rabia Likos, MD
Phone
+902129453000
Email
rabialikos@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Orhan Coskun, MD
Phone
+902129453000
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orhan Coskun, MD
Organizational Affiliation
Gaziosmanpaşa Research and Training Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Gaziosmanpaşa Research and Training Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rabia Likos, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Aerobic Exercise and Neck Exercises in Pediatric Migraine Treatment

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