Aerobic exercise to improve sensory, muscle, and psychosocial symptoms in women with migraine

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing telehealth cognitive behavioral therapy for youth with migraines

  This study is testing whether online therapy for kids and teens with migraines works better when combined with medication or on its own.

  Recruiting at 15 sites Children's Hospital Medical Center, Cincinnati · Birmingham, Alabama and 14 other locations · NCT05889624

• HEADS Registry: Headache, Ear, Auditory, Dizziness, and Sinus</n> Registry

  This registry tests whether collecting online symptom reports from adults in the U.S. with sinus, vestibular, ear, or headache symptoms can help improve diagnosis and treatment.

  Recruiting Association of Migraine Disorders · North Kingstown, Rhode Island · NCT07754266

• Evaluating a lifestyle intervention for chronic migraine management

  This study is testing a new lifestyle program to see if it can help people with chronic migraines feel better compared to a control group.

  Recruiting Mayo Clinic · Phoenix, Arizona · NCT05415020

• OCT in Neurological Practice: Use of Retinal Layers to Help Diagnose and Follow Neurological Diseases

  This study tests whether optical coherence tomography (OCT) of the retina can help in diagnosing and tracking multiple sclerosis, Alzheimer's, Parkinson's, migraines, and other headaches compared with healthy people.

  Recruiting IRCCS San Raffaele · Milan, Milano · NCT07720765

• Gepants for Acute Migraine in the Emergency Department

  This study tests whether rimegepant or zavegepant given in the ED can relieve an acute migraine for adults.

  Recruiting Phase 1 University of South Florida · Tampa, Florida · NCT07667621

• Pain and moderate exercise in midlife former athletes, masters athletes, and nonathletes

  This trial tests if moderate-intensity strength versus aerobic exercise changes pain before and after workouts in adults aged 35–65 who are former competitive athletes, current master's athletes, or nonathletes.

  Recruiting Marquette University · Milwaukee, Wisconsin · NCT07502742

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.