NCT06716489 Aerobic Exercise and Its Impact on Sensory, Musculoskeletal, and Psychosocial Aspects in Migraine
| NCT ID | NCT06716489 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Sao Paulo |
| Condition | Migraine |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-03-03 |
| Primary Completion | 2028-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2026-03-03 with a primary completion date of 2028-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06716489 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 48 Years, studying Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06716489 currently recruiting?
Yes, NCT06716489 is actively recruiting participants. Contact the research team at amanda_rodrigues@usp.br for enrollment information.
Where is the NCT06716489 trial being conducted?
This trial is being conducted at Ribeirão Preto, Brazil.
Who is sponsoring the NCT06716489 clinical trial?
NCT06716489 is sponsored by University of Sao Paulo. The trial plans to enroll 100 participants.
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