MigraineNCT05568004

The Effect of Different Exercise Types on Migraine Frequency in Individuals With Migraine

A study testing Combined exercise and Aerobic exercise in people with Migraine and Chronic Migraine, run by Ege University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate and compare the effect of different exercise types and combinations on migraine attacks in patients with migraine. Read more about this study

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Migraine, Chronic Migraine
What is being tested?: Combined exercise and Aerobic exercise
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 28 Nov 2022to 10 May 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

A diagnosis of migraine confirmed by a specialist neurologist according to International Classification of Headache Disorders, 3rd version(ICHD-3)
Diagnosed as chronic migraine at the time of initial diagnosis (may have turned into episodic migraine under preventive treatment)
At least 5 migraine attack/month in baseline diary
No obstacle to exercise in the evaluation made with physical examination and ECG
Diagnosed with migraine for at least 12 months
Between the ages of 18-50

Who cannot join

Exercising regularly in the last 6 months
Presence of concomitant internal and neurological diseases
Anti-psychotic drug use
Drug, alcohol addiction
Pregnancy, breastfeeding
Patients who cannot reach the targeted exercise level

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Ege University Sport Medicine Clinic
Izmir, Bornova

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Different Exercise Types on Migraine Frequency in Individuals With Migraine :Randomized Controlled Study

The purpose of this study is to evaluate and compare the effect of different exercise types and combinations on migraine attacks in patients with migraine.

Conditions: Migraine, Chronic Migraine
Being tested: Combined exercise, Aerobic exercise
Keywords: Headache, Exercise, Resistance exercises, Aerobic exercise
Medical subject headings: Migraine Disorders, Headache, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Combined exerciseBehavioural
aerobic plus resistance exercise
Aerobic exerciseBehavioural
Only aerobic exercise

Study groups in NCT05568004
Study group	Role	What they receive
Combined exercise group	Experimental	Aerobic plus resistance exercise intervention Receives: Behavioral: Combined exercise
Aerobic exercise group	Experimental	Only aerobic exercise intervention Receives: Behavioral: Aerobic exercise
Control group	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the Number of Days With Migraine (in Migraine Frequency)
Defined as the number of days with a migraine headache in a month
Measured: Baseline and Week 12 and Week 20

Secondary outcomes (6)

Average Intensity of Headache
A categorical, 11 points visual analogue scale will be used to rate each headache between 0-10. Higher scores mean higher severity headache
Measured: Baseline and Week 12 and Week 20
Anxiety
Hospital Anxiety and Depression Scale (HADS) will be used. Score could score between 0 and 21 for either anxiety or depression subscale . Higher points are associated with worse anxiety or depression
Measured: Baseline and Week 12 and Week 20
Depression
Hospital Anxiety and Depression Scale (HADS) will be used. Score could score between 0 and 21 for either anxiety or depression subscales . Higher points are associated with worse anxiety or depression
Measured: Baseline and Week 12 and Week 20
Migraine Specific Quality of Life
Migraine Disability Assessment (MIDAS) questionnaire will be used . There is no upper or lower limit on scoring. More than 21 points show severe disability. Higher points mean more disability.MIDAS Grade/ MIDAS Score: Little or No Disability 0-5 , Mild Disability 6-10 , Moderate Disability 11-20 , Severe Disability 21+
Measured: Baseline and Week 12 and Week 20
Aerobic Capacity Measurement V02 Max
Astrand submaximal bicycle ergometer test will be used to measure aerobic capacity.
Measured: Baseline and Week 12 and Week 20
Change in Physical Activity Level
The International Physical Activity Questionnaires (IPAQ) short form will be used. Scoring is not classical numerical type. For activity type and duration are important for scoring. Higher points means more physical activity
Measured: Baseline and Week 12 and Week 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Nov 202210 May 2024

First posted5 Oct 2022
Study start28 Nov 2022
Primary completion1 Mar 2024
Study completion10 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (54)Papers the sponsor has linked to this study.
Other trials for MigraineStudies of the same condition, open and under way.
More trials run by Ege UniversityThe sponsor's other registered studies.
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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Care provider, Investigator, Outcomes assessor
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05568004
Sponsor's protocol ID: 22-9T/12
Status last verified: Feb 2025
First submitted: 27 Sep 2022
Last updated: 10 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
PubMed 29368949
GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1545-1602. doi: 10.1016/S0140-6736(16)31678-6.
PubMed 27733282
GBD 2015 Neurological Disorders Collaborator Group. Global, regional, and national burden of neurological disorders during 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Neurol. 2017 Nov;16(11):877-897. doi: 10.1016/S1474-4422(17)30299-5. Epub 2017 Sep 17.
PubMed 28931491
Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF; AMPP Advisory Group. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007 Jan 30;68(5):343-9. doi: 10.1212/01.wnl.0000252808.97649.21.
PubMed 17261680
Ertas M, Baykan B, Orhan EK, Zarifoglu M, Karli N, Saip S, Onal AE, Siva A. One-year prevalence and the impact of migraine and tension-type headache in Turkey: a nationwide home-based study in adults. J Headache Pain. 2012 Mar;13(2):147-57. doi: 10.1007/s10194-011-0414-5. Epub 2012 Jan 14.
PubMed 22246025
Calhoun AH, Ford S, Millen C, Finkel AG, Truong Y, Nie Y. The prevalence of neck pain in migraine. Headache. 2010 Sep;50(8):1273-7. doi: 10.1111/j.1526-4610.2009.01608.x. Epub 2010 Jan 18.
PubMed 20100298
Lipton RB, Silberstein SD. Episodic and chronic migraine headache: breaking down barriers to optimal treatment and prevention. Headache. 2015 Mar;55 Suppl 2:103-22; quiz 123-6. doi: 10.1111/head.12505_2.
PubMed 25662743
Smitherman TA, Burch R, Sheikh H, Loder E. The prevalence, impact, and treatment of migraine and severe headaches in the United States: a review of statistics from national surveillance studies. Headache. 2013 Mar;53(3):427-36. doi: 10.1111/head.12074. Epub 2013 Mar 7.
PubMed 23470015
Buse DC, Manack AN, Fanning KM, Serrano D, Reed ML, Turkel CC, Lipton RB. Chronic migraine prevalence, disability, and sociodemographic factors: results from the American Migraine Prevalence and Prevention Study. Headache. 2012 Nov-Dec;52(10):1456-70. doi: 10.1111/j.1526-4610.2012.02223.x. Epub 2012 Jul 25.
PubMed 22830411
Stewart WF, Ricci JA, Chee E, Morganstein D, Lipton R. Lost productive time and cost due to common pain conditions in the US workforce. JAMA. 2003 Nov 12;290(18):2443-54. doi: 10.1001/jama.290.18.2443.
PubMed 14612481
Blumenfeld AM, Varon SF, Wilcox TK, Buse DC, Kawata AK, Manack A, Goadsby PJ, Lipton RB. Disability, HRQoL and resource use among chronic and episodic migraineurs: results from the International Burden of Migraine Study (IBMS). Cephalalgia. 2011 Feb;31(3):301-15. doi: 10.1177/0333102410381145. Epub 2010 Sep 2.
PubMed 20813784
Lipton RB, Stewart WF, Sawyer J, Edmeads JG. Clinical utility of an instrument assessing migraine disability: the Migraine Disability Assessment (MIDAS) questionnaire. Headache. 2001 Oct;41(9):854-61.
PubMed 11703471
Lipton RB, Bigal ME, Stewart WF. Clinical trials of acute treatments for migraine including multiple attack studies of pain, disability, and health-related quality of life. Neurology. 2005 Dec 29;65(12 Suppl 4):S50-8. doi: 10.1212/wnl.65.12_suppl_4.s50.
PubMed 16385104
Buse DC, Manack A, Serrano D, Turkel C, Lipton RB. Sociodemographic and comorbidity profiles of chronic migraine and episodic migraine sufferers. J Neurol Neurosurg Psychiatry. 2010 Apr;81(4):428-32. doi: 10.1136/jnnp.2009.192492. Epub 2010 Feb 17.
PubMed 20164501
Bigal ME, Serrano D, Reed M, Lipton RB. Chronic migraine in the population: burden, diagnosis, and satisfaction with treatment. Neurology. 2008 Aug 19;71(8):559-66. doi: 10.1212/01.wnl.0000323925.29520.e7.
PubMed 18711108

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Different Exercise Types on Migraine Frequency in Individuals With Migraine :Randomized Controlled Study
ClinicalTrials.gov ID: NCT05568004
Acronym / sponsor ID: 22-9T/12
Conditions: Migraine, Chronic Migraine
Keywords: Headache, Exercise, Resistance exercises, Aerobic exercise
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Ege UniversityUniversity, hospital or other
Study start: 28 Nov 2022 (actual)
Primary completion: 1 Mar 2024 (actual)
Study completion: 10 May 2024 (actual)
First posted: 5 Oct 2022 (actual)
Results: Posted 10 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate and compare the effect of different exercise types and combinations on migraine attacks in patients with migraine.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Combined exercise group	Experimental	Behavioral: Combined exerciseAerobic plus resistance exercise intervention
Aerobic exercise group	Experimental	Behavioral: Aerobic exerciseOnly aerobic exercise intervention
Control group	No intervention	–

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

A diagnosis of migraine confirmed by a specialist neurologist according to International Classification of Headache Disorders, 3rd version(ICHD-3)
Diagnosed as chronic migraine at the time of initial diagnosis (may have turned into episodic migraine under preventive treatment)
At least 5 migraine attack/month in baseline diary
No obstacle to exercise in the evaluation made with physical examination and ECG
Diagnosed with migraine for at least 12 months

Key exclusion criteria (6 listed)

Exercising regularly in the last 6 months
Presence of concomitant internal and neurological diseases
Anti-psychotic drug use
Drug, alcohol addiction
Pregnancy, breastfeeding

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
Combined exerciseaerobic plus resistance exercise	Behavioural	Combined exercise group
Aerobic exerciseOnly aerobic exercise	Behavioural	Aerobic exercise group

Primary outcome

Change in the Number of Days With Migraine (in Migraine Frequency)
Time frame: Baseline and Week 12 and Week 20
Defined as the number of days with a migraine headache in a month

6 secondary outcomes

Average Intensity of Headache
Time frame: Baseline and Week 12 and Week 20
Anxiety
Time frame: Baseline and Week 12 and Week 20
Depression
Time frame: Baseline and Week 12 and Week 20
Migraine Specific Quality of Life
Time frame: Baseline and Week 12 and Week 20
Aerobic Capacity Measurement V02 Max
Time frame: Baseline and Week 12 and Week 20
Change in Physical Activity Level
Time frame: Baseline and Week 12 and Week 20

Results and safety

Results posted to the registry on 10 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Combined Exercise Group	8	8
Aerobic Exercise Group	8	8
Control Group	8	8

Primary outcome: Change in the Number of Days With Migraine (in Migraine Frequency)

Time frame: Baseline and Week 12 and Week 20. Mean (Standard Deviation). Unit: days/month

Measure	Combined Exercise Group n = 8	Aerobic Exercise Group n = 8	Control Group n = 8
Baseline	9.9 (4.2)	12.4 (4.5)	11.8 (3.4)
End of 12 weeks(Post intervention)	6.3 (3.4)	8 (4.5)	10.6 (2.3)
End of 8 weeks (follow up)	6.5 (3.4)	8.8 (4.1)	10.6 (3.2)

Combined Exercise Group: p = 0.001, ANOVA
Aerobic Exercise Group: p = 0.001, ANOVA
Control Group: p = 0.166, ANOVA

Population analysed: all participants who were assigned to the arm

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 20 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Combined Exercise Group	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Aerobic Exercise Group	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Control Group	0 of 8 (0%)	0 of 8 (0%)	0 of 8

Limitations and caveats (from the sponsor): Low sample size Performing exercises without supervision Not having a group that does only resistance exercise Participants continue their current preventive medications without changing the dose during the intervention.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29368949Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
Background: PubMed 27733282GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1545-1602. doi: 10.1016/S0140-6736(16)31678-6.
Background: PubMed 28931491GBD 2015 Neurological Disorders Collaborator Group. Global, regional, and national burden of neurological disorders during 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Neurol. 2017 Nov;16(11):877-897. doi: 10.1016/S1474-4422(17)30299-5. Epub 2017 Sep 17.
Background: PubMed 17261680Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF; AMPP Advisory Group. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007 Jan 30;68(5):343-9. doi: 10.1212/01.wnl.0000252808.97649.21.
Background: PubMed 22246025Ertas M, Baykan B, Orhan EK, Zarifoglu M, Karli N, Saip S, Onal AE, Siva A. One-year prevalence and the impact of migraine and tension-type headache in Turkey: a nationwide home-based study in adults. J Headache Pain. 2012 Mar;13(2):147-57. doi: 10.1007/s10194-011-0414-5. Epub 2012 Jan 14.
Background: PubMed 20100298Calhoun AH, Ford S, Millen C, Finkel AG, Truong Y, Nie Y. The prevalence of neck pain in migraine. Headache. 2010 Sep;50(8):1273-7. doi: 10.1111/j.1526-4610.2009.01608.x. Epub 2010 Jan 18.
Background: PubMed 25662743Lipton RB, Silberstein SD. Episodic and chronic migraine headache: breaking down barriers to optimal treatment and prevention. Headache. 2015 Mar;55 Suppl 2:103-22; quiz 123-6. doi: 10.1111/head.12505_2.
Background: PubMed 23470015Smitherman TA, Burch R, Sheikh H, Loder E. The prevalence, impact, and treatment of migraine and severe headaches in the United States: a review of statistics from national surveillance studies. Headache. 2013 Mar;53(3):427-36. doi: 10.1111/head.12074. Epub 2013 Mar 7.
Background: PubMed 22830411Buse DC, Manack AN, Fanning KM, Serrano D, Reed ML, Turkel CC, Lipton RB. Chronic migraine prevalence, disability, and sociodemographic factors: results from the American Migraine Prevalence and Prevention Study. Headache. 2012 Nov-Dec;52(10):1456-70. doi: 10.1111/j.1526-4610.2012.02223.x. Epub 2012 Jul 25.
Background: PubMed 14612481Stewart WF, Ricci JA, Chee E, Morganstein D, Lipton R. Lost productive time and cost due to common pain conditions in the US workforce. JAMA. 2003 Nov 12;290(18):2443-54. doi: 10.1001/jama.290.18.2443.
Background: PubMed 20813784Blumenfeld AM, Varon SF, Wilcox TK, Buse DC, Kawata AK, Manack A, Goadsby PJ, Lipton RB. Disability, HRQoL and resource use among chronic and episodic migraineurs: results from the International Burden of Migraine Study (IBMS). Cephalalgia. 2011 Feb;31(3):301-15. doi: 10.1177/0333102410381145. Epub 2010 Sep 2.
Background: PubMed 11703471Lipton RB, Stewart WF, Sawyer J, Edmeads JG. Clinical utility of an instrument assessing migraine disability: the Migraine Disability Assessment (MIDAS) questionnaire. Headache. 2001 Oct;41(9):854-61.
Individual participant dataSharing planned: No

Related trials for Migraine

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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.

Yunus Emre Meydanal principal investigator

Ege University Sport Medicine Clinic

Seckin Senısık study director

Ege University Sport Medicine Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Combined exercise and Aerobic exercise in people with Migraine and Chronic Migraine, run by Ege University 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 10 Mar 2025. 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?

Yes. Results are posted in the registry (first posted 10 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Number of Days With Migraine (in Migraine Frequency) (time frame: Baseline and Week 12 and Week 20). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05568004, which also lists 54 linked publications.

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 10 Mar 2025.