[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571149":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":67,"collaborators":25,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":25,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":25,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":100,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"University of Sao Paulo","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Supervised Aerobic Exercise plus Pain Neuroscience Education","EXPERIMENTAL","Participants allocated to this group will receive a supervised aerobic exercise program combined with pain neuroscience education. At the beginning of the intervention, participants will attend a single structured pain neuroscience education session (approximately 60 minutes), delivered by a trained physiotherapist, aiming to explain migraine mechanisms, central sensitization, the role of safe movement, and realistic expectations regarding symptom fluctuations. Following the educational session, participants will perform supervised aerobic exercise on a treadmill three times per week for 16 weeks. Exercise intensity will be individually prescribed based on cardiovascular assessment, targeting 60-70% of heart rate reserve. Each session will include a warm-up period, aerobic training phase, recovery, and stretching. Adherence will be monitored through attendance records, and participants attending at least 75% of the supervised sessions will be considered adherent.",[13],"Behavioral: Supervised Aerobic Exercise plus Pain Neuroscience Education",{"label":15,"type":16,"description":17,"interventionNames":18},"Active Control: Physical Activity Recommendations","ACTIVE_COMPARATOR","Participants allocated to the active control group will receive general recommendations to increase physical activity levels during the 16-week study period. On the allocation day, participants will be instructed to either achieve a daily goal of 10,000 steps or complete at least 150 minutes of physical activity per week, according to their preference. No supervised exercise sessions, structured education, or motivational strategies will be provided. Participants will be asked to record daily physical activity using a paper diary and free step-counting applications. Monthly contacts will be made solely to verify participant well-being and monitor adherence, without providing additional guidance or encouragement. Participants will be advised to interrupt physical activity in case of adverse symptoms and to avoid exercise during migraine attacks.",[19],"Behavioral: Physical Activity Recommendations",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","This intervention consists of a supervised aerobic exercise program combined with a single session of pain neuroscience education. Aerobic exercise will be performed on a treadmill three times per week for 16 weeks, with intensity individually prescribed based on heart rate reserve. Pain neuroscience education will be delivered in one structured session at the beginning of the intervention, focusing on migraine mechanisms, central sensitization, and the benefits of safe movement.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Physical Activity Recommendations","Participants will receive general recommendations to increase physical activity levels, consisting of either achieving 10,000 steps per day or completing at least 150 minutes of physical activity per week for 16 weeks. No supervision, structured education, or motivational strategies will be provided.",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Amanda Rodrigues, PhD student","CONTACT","55 16 33150737","amanda_rodrigues@usp.br",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Débora Bevilaqua Grossi, PhD","55 16 33155515","deborabg@fmrp.usp.br",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Ribeirão Preto Medical School - University of São Paulo (FMRP-USP)","RECRUITING","Ribeirão Preto","São Paulo","14049-900","Brazil","BR",{"type":50,"coordinates":51},"Point",[52,53],-47.81028,-21.1775,{"lat":53,"lon":52},[56,59,61,62,65],{"name":57,"role":33,"phone":58,"phoneExt":25,"email":35},"Amanda Rodrigues","+55 16 3315-0737",{"name":32,"role":60,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"name":37,"role":60,"phone":25,"phoneExt":25,"email":25},{"name":63,"role":64,"phone":25,"phoneExt":25,"email":25},"Hugo Celso Dutra de Souza, PhD","SUB_INVESTIGATOR",{"name":66,"role":64,"phone":25,"phoneExt":25,"email":25},"Fabiola Dach, PhD",{"type":60,"investigatorFullName":57,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PhD student","100571149","aerobic-exercise-and-its-impact-on-sensory-musculoskeletal-and-psychosocial-aspects-in-migraine-100571149",false,"NCT06716489","Aerobic Exercise and Its Impact on Sensory, Musculoskeletal, and Psychosocial Aspects in Migraine","Influence of Aerobic Exercise on Sensory Perception, Musculoskeletal and Psychosocial Alterations in Patients With Migraine","Inclusion Criteria:\n\n* Women aged between 18 and 48 years.\n* Diagnosed with migraine by an experienced neurologist specialized in headaches, following the criteria of the International Classification of Headache Disorders (ICHD).\n* Frequency of headache between 3 and 8 days per month, to ensure adherence to the treatment.\n\nExclusion Criteria:\n\n* Presence of any other type of concurrent headache.\n* Medical conditions affecting sensitivity and autonomic modulation, such as peripheral neuropathies, autonomic disorders, severe neurological diseases, and others.\n* Conditions that prevent physical activity, such as severe musculoskeletal injuries, cardiovascular diseases, or related conditions.\n* Premature ovarian failure.\n* Regular physical exercise in the past year.\n* Body Mass Index (BMI) above 30.0.\n* Smokers or individuals using drugs that interfere with sensitivity and cardiac modulation (e.g., beta-blockers).\n* Abuse of abortive medications.","FEMALE","18 Years","48 Years",{"count":80,"type":81},100,"ESTIMATED","INTERVENTIONAL",[84],"NA","Migraine is a neurological disorder associated with high levels of disability and changes in sensory processing, musculoskeletal function, and psychosocial factors. Aerobic exercise is a low-cost, non-pharmacological strategy that has shown potential benefits for migraine management, but its effects on sensory perception and musculoskeletal function are not yet fully understood.\n\nThis randomized controlled trial will investigate the effects of a supervised aerobic exercise program combined with pain neuroscience education compared with an active control condition in women aged 18 to 48 years diagnosed with migraine. Participants will be randomly allocated to either an intervention group, which will perform supervised aerobic exercise three times per week for 16 weeks and receive one session of pain neuroscience education, or a control group, which will receive recommendations for unsupervised physical activity at home.\n\nOutcomes related to migraine-related disability, self-reported symptoms, sensory sensitivity, and musculoskeletal function will be assessed at baseline and after the intervention period. Questionnaires will also be collected at a 6-month follow-up. The results of this study may contribute to the development of accessible and low-risk non-pharmacological treatment strategies for people with migraine.",[87,88,89,90,91,92,93,94,95,96,97,98,99],"Migraine","Migraine Disease","Migraine Disorder","Migraine Disorders, Brain","Headache","Headache (Migraine)","Headache Disorders","Headache Disorders, Primary","Aerobic Exercise","Pain Management","Sensory Disorders","Psychosocial Factors","Quality of Life",[101,102,103,104,105,106,107,108,109,110,111,98,112,113,114,115,116,117,118,119,120],"migraine","aerobic exercise","sensory perception","exercise","headache","disability","musculoeskeletal alterations","quality of life","neck pain","cervical pain","Sensory Thresholds","Physical Fitness","Exercise Intervention","Central Sensitization","Physical Therapy","Migraine Management","Non-pharmacological Treatment","Clinical Trial","Headache Relief","sensitization","2026-04-27",{"date":123,"type":124},"2026-04-28","ACTUAL",{"date":126,"type":124},"2026-03-03",{"date":128,"type":81},"2028-11-30",{"name":5,"class":6},1]