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Clinical Trials in Brazil / NCT06716489
Recruiting Not applicable

Aerobic Exercise and Its Impact on Sensory, Musculoskeletal, and Psychosocial Aspects in Migraine

NCT06716489 · tracked via the Priya Life Science Brazil tracker
Phase
Not applicable
Started
2026-03-03
Last updated
2026-04-28

Condition(s) studied

MigraineMigraine DiseaseMigraine DisorderMigraine Disorders, BrainHeadacheHeadache (Migraine)Headache DisordersHeadache Disorders, PrimaryAerobic ExercisePain ManagementSensory DisordersPsychosocial FactorsQuality of Life

Investigational drug(s) / intervention(s)

Supervised Aerobic Exercise plus Pain Neuroscience EducationPhysical Activity Recommendations

Supervised Aerobic Exercise plus Pain Neuroscience Education: 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.

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.

Study summary

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.

This 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.

Outcomes 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
48 Years
Healthy volunteers
No
Inclusion Criteria: * Women aged between 18 and 48 years. * Diagnosed with migraine by an experienced neurologist specialized in headaches, following the criteria of the International Classification of Headache Disorders (ICHD). * Frequency of headache between 3 and 8 days per month, to ensure adherence to the treatment. Exclusion Criteria: * Presence of any other type of concurrent headache. * Medical conditions affecting sensitivity and autonomic modulation, such as peripheral neuropathies, autonomic disorders, severe neurological diseases, and others. * Conditions that prevent physical activity, such as severe musculoskeletal injuries, cardiovascular diseases, or related conditions. * Premature ovarian failure. * Regular physical exercise in the past year. * Body Mass Index (BMI) above 30.0. * Smokers or individuals using drugs that interfere with sensitivity and cardiac modulation (e.g., beta-blockers). * Abuse of abortive medications.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Ribeirão Preto Medical School - University of São Paulo (FMRP-USP) Ribeirão Preto São Paulo Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06716489 on ClinicalTrials.gov ↗ ← All trials in Brazil