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.

Migraine is a complex neurological disorder characterized by sensory dysfunction, musculoskeletal alterations, and psychosocial impairments, often resulting in substantial disability. Although aerobic exercise and pain neuroscience education are recognized as promising non-pharmacological approaches for migraine management, their combined effects on sensory, musculoskeletal, and self-reported outcomes remain insufficiently explored.

This study is a randomized controlled trial designed to evaluate the effects of a supervised aerobic exercise program combined with pain neuroscience education compared with an active control condition in women with migraine. A total of 100 participants aged 18 to 48 years with a diagnosis of migraine will be randomly allocated in a 1:1 ratio to either an intervention group or a control group.

The intervention group will participate in supervised aerobic exercise sessions performed three times per week for 16 weeks, with exercise intensity individually prescribed based on cardiovascular assessment, and will receive structured pain neuroscience education. The control group will receive recommendations for physical activity to be performed at home without supervision during the same period.

Assessments will be conducted at baseline and immediately after the 16-week intervention period. A follow-up assessment at 6 months will include self-reported outcome measures only. Primary and secondary outcomes include migraine-related disability, self-reported symptoms, quality of life, psychosocial factors, sensory sensitivity, and musculoskeletal function, assessed using validated questionnaires and physical tests.

The findings of this trial are expected to provide evidence regarding the effectiveness of aerobic exercise combined with pain neuroscience education as a low-risk, accessible treatment strategy for individuals with migraine and to improve understanding of the sensory and musculoskeletal mechanisms involved in this condition.

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.

Individual patient data (IPD) will be shared with other interested researchers, as approved by the ethics committee. Sharing will take place via a secure platform, with access restricted to authorized researchers. The data will be anonymized to protect the privacy of the participants. Access to the data will be granted after submission of a research proposal and ethical approval, on the condition that the researchers follow the guidelines for confidentiality and ethical use of the data.

Start Date: December 1, 2028 (the date after study completion). End Date: November 30, 2033 (five years after study completion).

The IPD and supporting information will be made available to qualified researchers, academic institutions, and regulatory agencies conducting related studies or requiring the data for scientific and public health purposes.

What will be accessible:

IPD: The individual participant data (such as demographic details, clinical assessments, outcome measures) collected during the study.

Supporting information:

Study protocol Statistical analysis plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Statistical analysis code

How access is granted:

Access will be granted upon formal request through a dedicated platform (e.g., data sharing platform or institutional repository). Interested parties will need to submit a request detailing their research purpose, data use plan, and any required ethical approvals. Access will be granted under specific conditions that ensure the protection of participant confidentiality and adherence to ethical guidelines for data use.