Migraine in ChildrenNCT06068751
Aerobic Exercise and Neck Exercises in Pediatric Migraine Treatment
A study testing Aerobic Exercise and Neck Exercises in people with Migraine in Children, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Migraine in Children
- What is being tested?
- Aerobic Exercise and Neck Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Sep 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric Migraneurs, as per International Classification of Headache Disorders-3 guidelines
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Orhan Coskun, MD contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziosmanpaşa Research and Training Hospital
Istanbul
Rabia Likos, MD
About this study
Official title: 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.
- Conditions
- Migraine in Children
- Being tested
- Aerobic Exercise, Neck Exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseOther
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 ExercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise | Active comparator | Aerobic Exercise Receives: Other: Aerobic Exercise |
| Neck Exercises | Active comparator | Neck Exercises Receives: Other: Neck Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine Attack Frequency
The frequency of migraine attacks in patients will be evaluated in days/month.
Measured: Baseline, first and third month follow-ups
Migraine Attack Duration
The duration of attacks in patients will be recorded in hours.
Measured: 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.
Measured: 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.
Measured: Baseline, first and third month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start22 Sep 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rabia Likos Akpınar, Gaziosmanpasa Research and Education Hospital
- Investigators
- Orhan Coskun, MD, Study director, Gaziosmanpaşa Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068751
- Sponsor's protocol ID
- 139
- Status last verified
- Sep 2023
- First submitted
- 22 Sep 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Aerobic Exercise and Neck Exercises in Pediatric Migraine Treatment: A Randomized Controlled Single-Blind Study
- ClinicalTrials.gov ID
- NCT06068751
- Acronym / sponsor ID
- 139
- Conditions
- Migraine in Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise | Active comparator | Other: Aerobic ExerciseAerobic Exercise |
| Neck Exercises | Active comparator | Other: Neck ExercisesNeck Exercises |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric Migraneurs, as per International Classification of Headache Disorders-3 guidelines
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseThe 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. | Other | Aerobic Exercise |
| Neck ExercisesThe 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. | Other | Neck Exercises |
Primary outcome
Migraine Attack Frequency
Time frame: Baseline, first and third month follow-ups
The frequency of migraine attacks in patients will be evaluated in days/month.
Migraine Attack Duration
Time frame: Baseline, first and third month follow-ups
The duration of attacks in patients will be recorded in hours.
Migraine Attack Severity
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orhan Coskun, MD contact
Orhan Coskun, MD study director
Gaziosmanpaşa Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise and Neck Exercises in people with Migraine in Children, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rabia Likos, MD (+902129453000, rabialikos@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migraine Attack Frequency (time frame: Baseline, first and third month follow-ups). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.