Aerobic Exercise and Its Impact on Sensory, Musculoskeletal, and Psychosocial Aspects in Migraine
Recruiting · NCT06716489 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Sao Paulo
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 it is running
1 location listed.
- Ribeirão Preto Medical School - University of São Paulo (FMRP-USP) - Ribeirão Preto, São Paulo, Brazil