Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined exercise group | Experimental | Aerobic plus resistance exercise intervention |
|
| Aerobic exercise group | Experimental | Only aerobic exercise intervention |
|
| Control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined exercise | Behavioral | aerobic plus resistance exercise |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Number of Days With Migraine (in Migraine Frequency) | Defined as the number of days with a migraine headache in a month | Baseline and Week 12 and Week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and Week 12 and Week 20 |
| Anxiety |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yunus Emre Meydanal | Ege University Sport Medicine Clinic | Principal Investigator |
| Seckin Senısık | Ege University Sport Medicine Clinic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ege University Sport Medicine Clinic | Izmir | Bornova | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29368949 | Background | 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. | |
| 27733282 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Of 32 enrolled participants , 24 participants filled out baseline headache diaries regularly and were randomized to groups
Participants who applied to Ege University Hospital Neurology Department of Headache policlinic were recruited based on neurology physician up to International Headache Disorder Classification 3rd version (ICHD-3). Participants were enrolled to study between November 2022- January 2024.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Combined Exercise Group | Aerobic plus resistance exercise intervention Combined exercise: aerobic plus resistance exercise For 12 weeks participants did aerobic exercise 3 times a week. One session took 45 minutes During this time patients did five different resistance exercise with elastic bands three times a week. Participants started resistance exercises with 2 sets of 8 repetitions, with a gradual increase until 3 sets of 12 repetitions were reached at the end of the first month. |
| FG001 | Aerobic Exercise Group | Only aerobic exercise intervention Aerobic exercise: Only aerobic exercise For 12 weeks participants did aerobic exercise 3 times a week. One session took 45 minutes |
| FG002 | Control Group | no intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Combined Exercise Group | Aerobic plus resistance exercise intervention Combined exercise: aerobic plus resistance exercise For 12 weeks participants did aerobic exercise 3 times a week. One session took 45 minutes During this time patients did five different resistance exercise with elastic bands three times a week. Participants started resistance exercises with 2 sets of 8 repetitions, with a gradual increase until 3 sets of 12 repetitions were reached at the end of the first month. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in the Number of Days With Migraine (in Migraine Frequency) | Defined as the number of days with a migraine headache in a month | all participants who were assigned to the arm | Posted | Mean | Standard Deviation | days/month | Baseline and Week 12 and Week 20 |
|
20 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Combined Exercise Group | Aerobic plus resistance exercise intervention Combined exercise: aerobic plus resistance exercise For 12 weeks participants did aerobic exercise 3 times a week. One session took 45 minutes During this time patients did five different resistance exercise with elastic bands three times a week. Participants started resistance exercises with 2 sets of 8 repetitions, with a gradual increase until 3 sets of 12 repetitions were reached at the end of the first month. |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yunus Emre Meydanal | Ege University Faculty of Medicine Sport Medicine Department | 905068046512 | yemremeydanal@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 15, 2025 | Feb 17, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 16, 2024 | Jan 16, 2025 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Aerobic exercise |
| Behavioral |
Only aerobic exercise |
|
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
| 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 | 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+ | Baseline and Week 12 and Week 20 |
| Aerobic Capacity Measurement V02 Max | Astrand submaximal bicycle ergometer test will be used to measure aerobic capacity. | 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 | Baseline and Week 12 and Week 20 |
| 28931491 | Background | 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. |
| 17261680 | Background | 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. |
| 22246025 | Background | 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. |
| 20100298 | Background | 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. |
| 25662743 | Background | 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. |
| 23470015 | Background | 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. |
| 22830411 | Background | 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. |
| 14612481 | Background | 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. |
| 20813784 | Background | 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. |
| 11703471 | Background | 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. |
| 16385104 | Background | 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. |
| 20164501 | Background | 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. |
| 18711108 | Background | 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. |
| 22644168 | Background | Giannini G, Cevoli S, Sambati L, Cortelli P. Migraine: risk factor and comorbidity. Neurol Sci. 2012 May;33 Suppl 1:S37-41. doi: 10.1007/s10072-012-1029-6. |
| 20042889 | Background | Stewart WF, Wood GC, Manack A, Varon SF, Buse DC, Lipton RB. Employment and work impact of chronic migraine and episodic migraine. J Occup Environ Med. 2010 Jan;52(1):8-14. doi: 10.1097/JOM.0b013e3181c1dc56. |
| 20865469 | Background | Negro A, D'Alonzo L, Martelletti P. Chronic migraine: comorbidities, risk factors, and rehabilitation. Intern Emerg Med. 2010 Oct;5 Suppl 1:S13-9. doi: 10.1007/s11739-010-0457-7. |
| 21188255 | Background | Wang SJ, Chen PK, Fuh JL. Comorbidities of migraine. Front Neurol. 2010 Aug 23;1:16. doi: 10.3389/fneur.2010.00016. eCollection 2010. |
| 21210177 | Background | Antonaci F, Nappi G, Galli F, Manzoni GC, Calabresi P, Costa A. Migraine and psychiatric comorbidity: a review of clinical findings. J Headache Pain. 2011 Apr;12(2):115-25. doi: 10.1007/s10194-010-0282-4. Epub 2011 Jan 6. |
| 9793713 | Background | Breslau N. Psychiatric comorbidity in migraine. Cephalalgia. 1998 Aug;18 Suppl 22:56-8; discussion 58-61. doi: 10.1177/0333102498018s2210. No abstract available. |
| 23007859 | Background | Ashina S, Serrano D, Lipton RB, Maizels M, Manack AN, Turkel CC, Reed ML, Buse DC. Depression and risk of transformation of episodic to chronic migraine. J Headache Pain. 2012 Nov;13(8):615-24. doi: 10.1007/s10194-012-0479-9. Epub 2012 Sep 25. |
| 15327811 | Background | McWilliams LA, Goodwin RD, Cox BJ. Depression and anxiety associated with three pain conditions: results from a nationally representative sample. Pain. 2004 Sep;111(1-2):77-83. doi: 10.1016/j.pain.2004.06.002. |
| 23331287 | Background | Lucchetti G, Peres MF, Lucchetti AL, Mercante JP, Guendler VZ, Zukerman E. Generalized anxiety disorder, subthreshold anxiety and anxiety symptoms in primary headache. Psychiatry Clin Neurosci. 2013 Jan;67(1):41-9. doi: 10.1111/j.1440-1819.2012.02405.x. |
| 22527034 | Background | Chen YC, Tang CH, Ng K, Wang SJ. Comorbidity profiles of chronic migraine sufferers in a national database in Taiwan. J Headache Pain. 2012 Jun;13(4):311-9. doi: 10.1007/s10194-012-0447-4. Epub 2012 Apr 12. |
| 19187337 | Background | Queiroz LP, Peres MF, Piovesan EJ, Kowacs F, Ciciarelli MC, Souza JA, Zukerman E. A nationwide population-based study of migraine in Brazil. Cephalalgia. 2009 Jun;29(6):642-9. doi: 10.1111/j.1468-2982.2008.01782.x. Epub 2009 Feb 2. |
| 18771495 | Background | Varkey E, Hagen K, Zwart JA, Linde M. Physical activity and headache: results from the Nord-Trondelag Health Study (HUNT). Cephalalgia. 2008 Dec;28(12):1292-7. doi: 10.1111/j.1468-2982.2008.01678.x. Epub 2008 Sep 11. |
| 17376107 | Background | Wober C, Brannath W, Schmidt K, Kapitan M, Rudel E, Wessely P, Wober-Bingol C; PAMINA Study Group. Prospective analysis of factors related to migraine attacks: the PAMINA study. Cephalalgia. 2007 Apr;27(4):304-14. doi: 10.1111/j.1468-2982.2007.01279.x. |
| 14984230 | Background | Koseoglu E, Akboyraz A, Soyuer A, Ersoy AO. Aerobic exercise and plasma beta endorphin levels in patients with migrainous headache without aura. Cephalalgia. 2003 Dec;23(10):972-6. doi: 10.1046/j.1468-2982.2003.00624.x. |
| 18783448 | Background | Varkey E, Cider A, Carlsson J, Linde M. A study to evaluate the feasibility of an aerobic exercise program in patients with migraine. Headache. 2009 Apr;49(4):563-70. doi: 10.1111/j.1526-4610.2008.01231.x. Epub 2008 Sep 9. |
| 21890526 | Background | Varkey E, Cider A, Carlsson J, Linde M. Exercise as migraine prophylaxis: a randomized study using relaxation and topiramate as controls. Cephalalgia. 2011 Oct;31(14):1428-38. doi: 10.1177/0333102411419681. Epub 2011 Sep 2. |
| 21359421 | Background | Domingues RB, Teixeira AL, Domingues SA. Physical practice is associated with less functional disability in medical students with migraine. Arq Neuropsiquiatr. 2011 Feb;69(1):39-43. doi: 10.1590/s0004-282x2011000100009. |
| 29333870 | Background | Kroll LS, Hammarlund CS, Linde M, Gard G, Jensen RH. The effects of aerobic exercise for persons with migraine and co-existing tension-type headache and neck pain. A randomized, controlled, clinical trial. Cephalalgia. 2018 Oct;38(12):1805-1816. doi: 10.1177/0333102417752119. Epub 2018 Jan 15. |
| 29161767 | Background | Hanssen H, Minghetti A, Magon S, Rossmeissl A, Rasenack M, Papadopoulou A, Klenk C, Faude O, Zahner L, Sprenger T, Donath L. Effects of different endurance exercise modalities on migraine days and cerebrovascular health in episodic migraineurs: A randomized controlled trial. Scand J Med Sci Sports. 2018 Mar;28(3):1103-1112. doi: 10.1111/sms.13023. Epub 2018 Jan 8. |
| 21472632 | Background | Darabaneanu S, Overath CH, Rubin D, Luthje S, Sye W, Niederberger U, Gerber WD, Weisser B. Aerobic exercise as a therapy option for migraine: a pilot study. Int J Sports Med. 2011 Jun;32(6):455-60. doi: 10.1055/s-0030-1269928. Epub 2011 Apr 6. |
| 30764753 | Background | Lemmens J, De Pauw J, Van Soom T, Michiels S, Versijpt J, van Breda E, Castien R, De Hertogh W. The effect of aerobic exercise on the number of migraine days, duration and pain intensity in migraine: a systematic literature review and meta-analysis. J Headache Pain. 2019 Feb 14;20(1):16. doi: 10.1186/s10194-019-0961-8. |
| 21694556 | Background | Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb. |
| 26643584 | Background | Irby MB, Bond DS, Lipton RB, Nicklas B, Houle TT, Penzien DB. Aerobic Exercise for Reducing Migraine Burden: Mechanisms, Markers, and Models of Change Processes. Headache. 2016 Feb;56(2):357-69. doi: 10.1111/head.12738. Epub 2015 Dec 8. |
| 23314782 | Background | Misra UK, Kalita J, Tripathi GM, Bhoi SK. Is beta endorphin related to migraine headache and its relief? Cephalalgia. 2013 Apr;33(5):316-22. doi: 10.1177/0333102412473372. Epub 2013 Jan 11. |
| 20188719 | Background | Beavers KM, Brinkley TE, Nicklas BJ. Effect of exercise training on chronic inflammation. Clin Chim Acta. 2010 Jun 3;411(11-12):785-93. doi: 10.1016/j.cca.2010.02.069. Epub 2010 Feb 25. |
| 15388533 | Background | Dietrich A, McDaniel WF. Endocannabinoids and exercise. Br J Sports Med. 2004 Oct;38(5):536-41. doi: 10.1136/bjsm.2004.011718. |
| 17367586 | Background | Hoffman MD, Hoffman DR. Does aerobic exercise improve pain perception and mood? A review of the evidence related to healthy and chronic pain subjects. Curr Pain Headache Rep. 2007 Apr;11(2):93-7. doi: 10.1007/s11916-007-0004-z. |
| 23073072 | Background | Houle TT, Butschek RA, Turner DP, Smitherman TA, Rains JC, Penzien DB. Stress and sleep duration predict headache severity in chronic headache sufferers. Pain. 2012 Dec;153(12):2432-2440. doi: 10.1016/j.pain.2012.08.014. Epub 2012 Oct 13. |
| 17501846 | Background | John PJ, Sharma N, Sharma CM, Kankane A. Effectiveness of yoga therapy in the treatment of migraine without aura: a randomized controlled trial. Headache. 2007 May;47(5):654-61. doi: 10.1111/j.1526-4610.2007.00789.x. |
| 28854396 | Background | Andersen CH, Jensen RH, Dalager T, Zebis MK, Sjogaard G, Andersen LL. Effect of resistance training on headache symptoms in adults: Secondary analysis of a RCT. Musculoskelet Sci Pract. 2017 Dec;32:38-43. doi: 10.1016/j.msksp.2017.08.003. Epub 2017 Aug 14. |
| 22258395 | Background | Sullivan AB, Scheman J, Venesy D, Davin S. The role of exercise and types of exercise in the rehabilitation of chronic pain: specific or nonspecific benefits. Curr Pain Headache Rep. 2012 Apr;16(2):153-61. doi: 10.1007/s11916-012-0245-3. |
| 12220386 | Background | Hagen K, Einarsen C, Zwart JA, Svebak S, Bovim G. The co-occurrence of headache and musculoskeletal symptoms amongst 51 050 adults in Norway. Eur J Neurol. 2002 Sep;9(5):527-33. doi: 10.1046/j.1468-1331.2002.00451.x. |
| 7154893 | Background | Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81. |
| 4721013 | Background | Skinner JS, Hutsler R, Bergsteinova V, Buskirk ER. The validity and reliability of a rating scale of perceived exertion. Med Sci Sports. 1973 Summer;5(2):94-6. No abstract available. |
| 10522637 | Background | Lamb KL, Eston RG, Corns D. Reliability of ratings of perceived exertion during progressive treadmill exercise. Br J Sports Med. 1999 Oct;33(5):336-9. doi: 10.1136/bjsm.33.5.336. |
| 24511345 | Background | Muyor JM. Exercise Intensity and Validity of the Ratings of Perceived Exertion (Borg and OMNI Scales) in an Indoor Cycling Session. J Hum Kinet. 2013 Dec 31;39:93-101. doi: 10.2478/hukin-2013-0072. eCollection 2013 Dec 18. |
| 22210471 | Background | Colado JC, Garcia-Masso X, Triplett TN, Flandez J, Borreani S, Tella V. Concurrent validation of the OMNI-resistance exercise scale of perceived exertion with Thera-band resistance bands. J Strength Cond Res. 2012 Nov;26(11):3018-24. doi: 10.1519/JSC.0b013e318245c0c9. |
| 13211501 | Background | ASTRAND PO, RYHMING I. A nomogram for calculation of aerobic capacity (physical fitness) from pulse rate during sub-maximal work. J Appl Physiol. 1954 Sep;7(2):218-21. doi: 10.1152/jappl.1954.7.2.218. No abstract available. |
| 40391488 | Derived | Meydanal YE, Senisik S, Sirin H. The effect of different exercise types on migraine frequency in individuals with migraine: A pilot study. Headache. 2025 Oct;65(9):1593-1602. doi: 10.1111/head.14951. Epub 2025 May 20. |
| BG001 | Aerobic Exercise Group | Only aerobic exercise intervention Aerobic exercise: Only aerobic exercise For 12 weeks participants did aerobic exercise 3 times a week. One session took 45 minutes |
| BG002 | Control Group | no intervention |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body weight | Mean | Standard Deviation | kilogram |
|
| Height | Mean | Standard Deviation | centimeter |
|
| Body mass index | Mean | Standard Deviation | kilogram/square meter |
|
| Migraine duration | Mean | Standard Deviation | years |
|
| Number of Participants with Migraine Aura | Number of participants in that group with migraine headache accompanied by aura (determined using participants' baseline diaries) | Count of Participants | Participants |
|
| Preventive drugs number | Numbers indicate the mean number of preventive drug used in the baseline period before the intervention in this group. | Mean | Standard Deviation | mean number of medication used |
|
| Beta blocker use | The numbers show how many patients in that group used this type of medication in the baseline period before the intervention | Count of Participants | Participants |
|
| Serotonin and norepinephrine reuptake inhibitors (SNRIs) use | The numbers show how many patients in that group used this type of medication in the baseline period before the intervention | Count of Participants | Participants |
|
| Tricyclic antidepressants (TCAs) | The numbers show how many patients in that group used this type of medication in the baseline period before the intervention | Count of Participants | Participants |
|
| Number of participants using medication for migraine attack treatment(triptan) | The numbers show how many patients in that group used this type of medication(triptan) in the baseline period before the intervention (In our study, all participants using preventive drugs for migraine were using a single type of medication, triptan.) | Number | participants |
|
| Aerobic Exercise Group |
Only aerobic exercise intervention Aerobic exercise: Only aerobic exercise For 12 weeks participants did aerobic exercise 3 times a week. One session took 45 minutes |
| OG002 | Control Group | no intervention |
|
|
|
| Secondary | 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 | all participants who were assigned to the arm | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 12 and Week 20 | headaches | headaches |
|
|
|
|
| Secondary | 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 | all participants who were assigned to the arm | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 12 and Week 20 |
|
|
|
|
| Secondary | 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 | all participants who were assigned to the arm | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 12 and Week 20 |
|
|
|
|
| Secondary | 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+ | all participants who were assigned to the arm | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 12 and Week 20 |
|
|
|
|
| Secondary | Aerobic Capacity Measurement V02 Max | Astrand submaximal bicycle ergometer test will be used to measure aerobic capacity. | all participants who were assigned to the arm | Posted | Mean | Standard Deviation | mililiter/kilogram/minute | Baseline and Week 12 and Week 20 |
|
|
|
|
| Secondary | 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 | all participants who were assigned to the arm | Posted | Mean | Standard Deviation | metabolic equivalent /week | Baseline and Week 12 and Week 20 |
|
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Aerobic Exercise Group | Only aerobic exercise intervention Aerobic exercise: Only aerobic exercise For 12 weeks participants did aerobic exercise 3 times a week. One session took 45 minutes | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Control Group | no intervention | 0 | 8 | 0 | 8 | 0 | 8 |
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| Male |
|
|
| Week 20(follow up) |
|
| Superiority |
| ANOVA | p value for change over time within the group, Friedman 2-way ANOVA test was applied. | 0.074 | Superiority | A p-value of < 0.05 was considered statistically significant for all analyses.Two-tailed testing was used in nature of hypothesis testing. |
| ANOVA | p value for change over time within the group, Friedman 2-way ANOVA test was applied. | 0.311 | A p-value of < 0.05 was considered statistically significant for all analyses. | Superiority |
|
| Week 20 (follow up) |
|
| ANOVA | *p-value for changes over time within the group; Friedman's two-way ANOVA test was applied. | 0.152 | A p-value of < 0.05 was considered statistically significant for all analyses. | Superiority |
| ANOVA | *p-value for changes over time within the group; Friedman's two-way ANOVA test was applied | 0.438 | A p-value of < 0.05 was considered statistically significant for all analyses. | Superiority |
|
| Week 20 (follow up) |
|
| ANOVA | *p-value for changes over time within the group; Friedman's two-way ANOVA test was applied | 0.203 | A p-value of < 0.05 was considered statistically significant for all analyses. | Superiority |
| ANOVA | *p-value for changes over time within the group; Friedman's two-way ANOVA test was applied | 0.593 | A p-value of < 0.05 was considered statistically significant for all analyses. | Superiority |
|
| Week 20 (follow up) |
|
| ANOVA | *p-value for changes over time within the group; Friedman's two-way ANOVA test was applied. | 0.021 | A p-value of < 0.05 was considered statistically significant for all analyses. | Superiority |
| ANOVA | *p-value for changes over time within the group; Friedman's two-way ANOVA test was applied. | 0.081 | A p-value of < 0.05 was considered statistically significant for all analyses. | Superiority |
|
| Week 20 (follow up) |
|
| ANOVA | *p-value for changes over time within the group; Friedman's two-way ANOVA test was applied. | <0.001 | A p-value of < 0.05 was considered statistically significant for all analyses. | Superiority |
| ANOVA | *p-value for changes over time within the group; Friedman's two-way ANOVA test was applied. | 0.747 | A p-value of < 0.05 was considered statistically significant for all analyses. | Superiority |
|
| Week 20 (follow up) |
|
| ANOVA | p-value for changes over time within the group; Friedman's two-way ANOVA test was applied. | <0.001 | A p-value of < 0.05 was considered statistically significant for all analyses. | Superiority |
| ANOVA | p-value for changes over time within the group; Friedman's two-way ANOVA test was applied. | 0.05 | A p-value of < 0.05 was considered statistically significant for all analyses. | Superiority |