Aerobic exercise to improve sensory, muscle, and psychosocial symptoms in women with migraine
Influence of Aerobic Exercise on Sensory Perception, Musculoskeletal and Psychosocial Alterations in Patients With Migraine
This trial will test whether supervised aerobic exercise plus one pain neuroscience education session helps women aged 18–48 with migraine reduce disability and improve sensory, musculoskeletal, and psychosocial symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 48 Years |
| Sex | Female |
| Sponsor | University of Sao Paulo Academic / other |
| Locations | 1 site (Ribeirão Preto, São Paulo) |
| Trial ID | NCT06716489 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will enroll 100 women aged 18–48 with a neurologist-confirmed diagnosis of migraine and randomize them 1:1 to an intervention or control group. The intervention group will perform supervised aerobic exercise three times per week for 16 weeks with intensity prescribed from cardiovascular testing and receive one session of pain neuroscience education, while the control group will receive recommendations for unsupervised physical activity to do at home. Outcomes measured at baseline and after 16 weeks include migraine-related disability, self-reported symptoms, sensory and musculoskeletal assessments, and psychosocial measures, with a six-month follow-up using self-report only. The trial is conducted at Ribeirão Preto Medical School, University of São Paulo, focusing on a low-cost, non-pharmacological management approach for migraine.
Who should consider this trial
Good fit: Women aged 18–48 with a neurologist-confirmed migraine diagnosis who have 3–8 headache days per month, are not regular exercisers, have BMI ≤30, and have no medical contraindications to exercise.
Not a fit: Those unlikely to benefit include people with other concurrent headache types, fewer than 3 or more than 8 headache days per month, smokers, BMI >30, regular exercisers, users of medications that affect sensitivity or cardiac modulation, or those with conditions preventing physical activity.
Why it matters
Potential benefit: If successful, this approach could offer a low-cost, non-drug option that reduces migraine-related disability and improves sensory, musculoskeletal function and quality of life.
How similar studies have performed: Prior trials have shown aerobic exercise can reduce migraine frequency and disability, but combining supervised aerobic training with pain neuroscience education to target sensory and musculoskeletal outcomes is less tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ribeirão Preto, São Paulo
- Ribeirão Preto Medical School - University of São Paulo (FMRP-USP) — Ribeirão Preto, São Paulo, Brazil (Recruiting)
Study contacts
- Study coordinator: Amanda Rodrigues, PhD student
- Email: amanda_rodrigues@usp.br
- Phone: 55 16 33150737
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.