Clinical trial NCT06993545: Educational Video Program to Promote Physical Activity and Reduce Migraine Frequency in Adults With Migraine
Official title: Impact of Promoting Physical Exercise on Migraine - a Video-based Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine Disorders
Exercise
Health Education
Audiovisual Aids
Surveys and Questionnaires
Keywords: Migraine disorders
exercise
health education
audiovisual aids
surveys and questionnaires
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if an educational video program can help reduce migraine frequency and improve migraine-related outcomes in adults with migraine. The main questions it aims to answer are:

* Does the video-based intervention reduce the number of monthly migraine episodes?
* Does it reduce the use of acute migraine medication?
* Does it increase the physical activity levels?

Researchers will compare participants who watch educational videos about physical activity with participants who receive usual care, to see if the intervention has additional benefits.

Participants will:

* Be randomly assigned to one of two groups: intervention or control
* The intervention group will watch seven short educational videos over a period of 3 months
* All participants will complete questionnaires before and after the intervention period to assess migraine impact, frequency, medication use, and physical activity levels


Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years or older
* Diagnosis of episodic or chronic migraine confirmed by a neurologist, based on the 3rd edition of the International Classification of Headache Disorders (ICHD-3)
* Willing and able to participate in the study

Exclusion Criteria:

* Inability to read or understand the study materials
* Inability or unwillingness to collaborate with study procedures
* Refusal to participate
* Diagnosis of other primary headache disorders (except for medication overuse headache)
* Presence of substance use disorders
* Presence of chronic medical conditions that limit physical activity (e.g., rheumatic diseases, systemic inflammatory conditions, neoplastic diseases)
* Presence of severe psychiatric disorders

Primary outcomes:
measure: Change in Headache Impact Test (HIT-6) score from baseline to 6-month follow-up
timeFrame: HIT-6 scores were collected at baseline (T0) and at 6-month follow-up (T6), corresponding to three months after the completion of the video-based intervention.
Secondary outcomes:
measure: Change in physical activity indices from baseline to 6-month follow-up in the intervention group
timeFrame: Assessed at baseline (T0) and 6-month follow-up (T6), corresponding to three months after the intervention period.
measure: Change in monthly migraine frequency from baseline to 6-month follow-up in the intervention group
timeFrame: Assessed at baseline and at 6-month follow-up (T6), i.e., three months post-intervention.
measure: Change in monthly frequency of acute medication use from baseline to 6-month follow-up in the intervention group
timeFrame: Reported monthly and compared between baseline and 6-month follow-up, which occurred three months after the intervention.
measure: Patient Global Impression of Change (PGIC) score at 6-month follow-up in the intervention group
timeFrame: Assessed only at the 6-month follow-up (T6), three months after completion of the intervention.
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Unidade Local de Saúde de São João, E.P.E.
Study officials:
References: