Educational Video Program to Promote Physical Activity and Reduce Migraine Frequency in Adults With Migraine

NCT ID: NCT06993545

Last Updated: 2025-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

307 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-22

Study Completion Date

2024-10-21

Brief Summary

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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

Detailed Description

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Conditions

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Migraine Disorders Exercise Health Education Audiovisual Aids Surveys and Questionnaires

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Control group

Participants in the control group received usual care provided by their healthcare professionals, with no additional educational materials or interventions related to physical activity. This group did not receive the video-based educational program. Throughout the study, preventive and acute treatments were maintained according to standard clinical practice. Participants completed the same assessments as the intervention group at baseline and follow-up, including questionnaires on migraine impact, frequency, medication use, and physical activity levels.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group

The intervention consisted of a series of seven short, pre-recorded educational videos delivered over a 3-month period. The videos focused on the benefits of regular physical activity for individuals with migraine and included practical strategies to increase daily activity levels. The content was evidence-based, developed with input from healthcare professionals, and tailored to migraine management. Participants received access to one video approximately every two weeks via email or online platform. The videos aimed to improve awareness, motivation, and self-efficacy regarding physical activity without prescribing a specific exercise program. No direct interaction with healthcare providers occurred during the intervention period.

Group Type EXPERIMENTAL

Video-based educational program on physical activity for migraine management

Intervention Type BEHAVIORAL

The intervention consisted of a series of seven short, pre-recorded educational videos delivered over a 3-month period. The videos focused on the benefits of regular physical activity for individuals with migraine and included practical strategies to increase daily activity levels. The content was evidence-based, developed with input from healthcare professionals, and tailored to migraine management. Participants received access to one video approximately every two weeks via email or online platform. The videos aimed to improve awareness, motivation, and self-efficacy regarding physical activity without prescribing a specific exercise program. No direct interaction with healthcare providers occurred during the intervention period.

Interventions

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Video-based educational program on physical activity for migraine management

The intervention consisted of a series of seven short, pre-recorded educational videos delivered over a 3-month period. The videos focused on the benefits of regular physical activity for individuals with migraine and included practical strategies to increase daily activity levels. The content was evidence-based, developed with input from healthcare professionals, and tailored to migraine management. Participants received access to one video approximately every two weeks via email or online platform. The videos aimed to improve awareness, motivation, and self-efficacy regarding physical activity without prescribing a specific exercise program. No direct interaction with healthcare providers occurred during the intervention period.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade do Porto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Unidade Local de Saúde de São João, E.P.E.

Porto, Porto District, Portugal

Site Status

Countries

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Portugal

Other Identifiers

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393/2023

Identifier Type: -

Identifier Source: org_study_id

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