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Influence of Aerobic Exercise on Sensory Perception, Musculoskeletal and Psychosocial Alterations in Patients With Migraine

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 48
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Brazil
Ribeirão Preto Medical School - University of São Paulo (FMRP-USP)
RECRUITING
Ribeirão Preto
Contact Information
Primary
Amanda Rodrigues, PhD student
amanda_rodrigues@usp.br
55 16 33150737
Backup
Débora Bevilaqua Grossi, PhD
deborabg@fmrp.usp.br
55 16 33155515
Time Frame
Start Date: 2026-03-03
Estimated Completion Date: 2028-11-30
Participants
Target number of participants: 100
Treatments
Experimental: Supervised Aerobic Exercise plus Pain Neuroscience Education
Participants allocated to this group will receive a supervised aerobic exercise program combined with pain neuroscience education. At the beginning of the intervention, participants will attend a single structured pain neuroscience education session (approximately 60 minutes), delivered by a trained physiotherapist, aiming to explain migraine mechanisms, central sensitization, the role of safe movement, and realistic expectations regarding symptom fluctuations. Following the educational session, participants will perform supervised aerobic exercise on a treadmill three times per week for 16 weeks. Exercise intensity will be individually prescribed based on cardiovascular assessment, targeting 60-70% of heart rate reserve. Each session will include a warm-up period, aerobic training phase, recovery, and stretching. Adherence will be monitored through attendance records, and participants attending at least 75% of the supervised sessions will be considered adherent.
Active_comparator: Active Control: Physical Activity Recommendations
Participants allocated to the active control group will receive general recommendations to increase physical activity levels during the 16-week study period. On the allocation day, participants will be instructed to either achieve a daily goal of 10,000 steps or complete at least 150 minutes of physical activity per week, according to their preference. No supervised exercise sessions, structured education, or motivational strategies will be provided. Participants will be asked to record daily physical activity using a paper diary and free step-counting applications. Monthly contacts will be made solely to verify participant well-being and monitor adherence, without providing additional guidance or encouragement. Participants will be advised to interrupt physical activity in case of adverse symptoms and to avoid exercise during migraine attacks.
Related Therapeutic Areas
Sponsors
Leads: University of Sao Paulo

This content was sourced from clinicaltrials.gov

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