Aerobic Exercise and Its Impact on Sensory, Musculoskeletal, and Psychosocial Aspects in Migraine
Influence of Aerobic Exercise on Sensory Perception, Musculoskeletal and Psychosocial Alterations in Patients With Migraine
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2024
CompletedFirst Posted
Study publicly available on registry
December 4, 2024
CompletedStudy Start
First participant enrolled
March 3, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2028
April 28, 2026
April 1, 2026
2.7 years
November 25, 2024
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Headache-related disability
Headache-related disability will be assessed using the Headache Impact Test-6 (HIT-6), a validated questionnaire that evaluates the impact of headache on daily functioning. The total score ranges from 36 to 78, with higher scores indicating greater headache-related disability.
16 weeks (measured before and after the 16-week intervention period).
Secondary Outcomes (3)
Pressure pain threshold
16 weeks (measured before and after the 16-week intervention period).
Self-efficacy
16 weeks (measured before and after the 16-week intervention period).
Cervical range of motion
16 weeks (measured before and after the 16-week intervention period).
Other Outcomes (2)
Exploratory clinical, psychosocial, sensory, and musculoskeletal outcomes
16 weeks (measured before and after the 16-week intervention period).
Credibility/Expectancy Questionnaire
Baseline (after randomization and before the start of the intervention).
Study Arms (2)
Supervised Aerobic Exercise plus Pain Neuroscience Education
EXPERIMENTALParticipants 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 Control: Physical Activity Recommendations
ACTIVE COMPARATORParticipants 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.
Interventions
This intervention consists of a supervised aerobic exercise program combined with a single session of pain neuroscience education. Aerobic exercise will be performed on a treadmill three times per week for 16 weeks, with intensity individually prescribed based on heart rate reserve. Pain neuroscience education will be delivered in one structured session at the beginning of the intervention, focusing on migraine mechanisms, central sensitization, and the benefits of safe movement.
Participants will receive general recommendations to increase physical activity levels, consisting of either achieving 10,000 steps per day or completing at least 150 minutes of physical activity per week for 16 weeks. No supervision, structured education, or motivational strategies will be provided.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ribeirão Preto Medical School - University of São Paulo (FMRP-USP)
Ribeirão Preto, São Paulo, 14049-900, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD student
Study Record Dates
First Submitted
November 25, 2024
First Posted
December 4, 2024
Study Start
March 3, 2026
Primary Completion (Estimated)
November 1, 2028
Study Completion (Estimated)
November 30, 2028
Last Updated
April 28, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Start Date: December 1, 2028 (the date after study completion). End Date: November 30, 2033 (five years after study completion).
- Access Criteria
- 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.
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.