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

NCT06993545 | Completed

• 1 other identifier: 393/2023
• Study Type: interventional
• Target: 307
• Locations: 1 country
• Sites: 1

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

Conditions

Migraine Disorders; Exercise; Health Education; Audiovisual Aids; Surveys and Questionnaires

Keywords

Migraine disorders; exercise; health education; audiovisual aids; surveys and questionnaires

Outcome Measures

Primary Outcomes (1)

• Change in Headache Impact Test (HIT-6) score from baseline to 6-month follow-up

  The Headache Impact Test (HIT-6) is a validated questionnaire used to assess the impact of headaches on a person's ability to function in daily life. It includes six questions covering domains such as pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. Each item is scored on a scale, and the total score ranges from 36 to 78, with higher scores indicating greater impact of headaches. In this study, HIT-6 was used as the primary outcome measure to evaluate the effect of the video-based educational intervention on migraine-related disability. Scores were collected at baseline and again six months later, three months after the intervention period ended, to assess any changes in the perceived impact of migraine on participants' lives.

  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 (4)

• Change in physical activity indices from baseline to 6-month follow-up in the intervention group

  Assessed at baseline (T0) and 6-month follow-up (T6), corresponding to three months after the intervention period.

• Change in monthly migraine frequency from baseline to 6-month follow-up in the intervention group

  Assessed at baseline and at 6-month follow-up (T6), i.e., three months post-intervention.

• Change in monthly frequency of acute medication use from baseline to 6-month follow-up in the intervention group

  Reported monthly and compared between baseline and 6-month follow-up, which occurred three months after the intervention.

• Patient Global Impression of Change (PGIC) score at 6-month follow-up in the intervention group

  Assessed only at the 6-month follow-up (T6), three months after completion of the intervention.

Study Arms (2)

Control group

NO INTERVENTION

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.

Intervention group

EXPERIMENTAL

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.

Behavioral: Video-based educational program on physical activity for migraine management

Interventions

Video-based educational program on physical activity for migraine management 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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade do Porto: lead

Study Sites (1)

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

Porto, Porto District, 4200-319, Portugal

Location

MeSH Terms

Conditions

Migraine Disorders; Motor Activity; Health Education

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 29, 2025
• Study Start: April 22, 2024
• Primary Completion: October 21, 2024
• Study Completion: October 21, 2024
• Last Updated: June 11, 2025

Record last verified: 2025-05

Locations

PT (1)