Migraine DisordersPA-MIGNCT06993545
Educational Video Program to Promote Physical Activity and Reduce Migraine Frequency in Adults With Migraine
A study testing Video-based educational program on physical activity for migraine management in people with Migraine Disorders and Exercise, run by Universidade do Porto at 1 site in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine Disorders, Exercise, Health Education
- What is being tested?
- Video-based educational program on physical activity for migraine management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 307 participants
- Where
- 1 sitePortugal
- Study dates
- 22 Apr 2024to 21 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Unidade Local de Saúde de São João, E.P.E.
Porto, Porto District, 4200-319
About this study
Official title: Impact of Promoting Physical Exercise on Migraine - a Video-based Randomized Clinical Trial
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?
Read more
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
- Being tested
- Video-based educational program on physical activity for migraine management
- Keywords
- Migraine disorders, exercise, health education, audiovisual aids, surveys and questionnaires
- Medical subject headings
- Migraine Disorders, Motor Activity, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-based educational program on physical activity for migraine managementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Video-based educational program on physical activity for migraine management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Three physical activity indices (PAI) were used to evaluate changes in participants' activity levels: job-related PAI, housework, house maintenance, and caring for family-related PAI, and recreation, sport, and leisure time-related PAI. These indices are derived from validated self-report questionnaires and reflect both the intensity and frequency of physical activity in different contexts. This outcome aimed to assess whether the video-based educational intervention led to meaningful behavioral changes regarding physical activity. Measurements were taken at baseline and again at 6-month follow-up, corresponding to three months after the completion of the video series.
Measured: 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
Migraine frequency was measured as the number of self-reported migraine days per month. This secondary outcome aimed to evaluate whether the educational video program contributed to a reduction in the frequency of migraine attacks. Participants recorded their migraine occurrences in headache diaries, and data were collected at baseline and at the 6-month follow-up to compare the frequency before and after the intervention.
Measured: 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
This outcome measures how often participants used acute medication (e.g., analgesics or triptans) to treat migraine attacks each month. The goal was to determine whether the video-based educational program reduced the need for acute migraine medication. Participants kept monthly medication logs, and frequency data were collected at baseline and again at the 6-month follow-up to evaluate the impact of the intervention.
Measured: 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
At the 6-month follow-up, participants' perceived overall change in their migraine condition was assessed using an adapted version of the Patient Global Impression of Change (PGIC) scale. This version was translated and culturally adapted to Portuguese and asked participants to rate how their condition had changed since the beginning of the study. Response options ranged from "no changes (or worsening of the condition)" to "much better." The PGIC is a validated, subjective measure commonly used in chronic condition trials to evaluate patients' impressions of treatment effectiveness. This outcome aimed to capture participants' global self-assessment of improvement or deterioration after the educational video intervention.
Measured: Assessed only at the 6-month follow-up (T6), three months after completion of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start22 Apr 2024
- Primary completion21 Oct 2024
- Study completion21 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993545
- Sponsor's protocol ID
- 393/2023
- Acronym
- PA-MIG
- Status last verified
- May 2025
- First submitted
- 19 May 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Promoting Physical Exercise on Migraine - a Video-based Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06993545
- Acronym / sponsor ID
- PA-MIG / 393/2023
- Conditions
- Migraine Disorders, Exercise, Health Education, Audiovisual Aids, Surveys and Questionnaires
- Keywords
- Migraine disorders, exercise, health education, audiovisual aids, surveys and questionnaires
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 21 Oct 2024 (actual)
- Study completion
- 21 Oct 2024 (actual)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Video-based educational program on physical activity for migraine managementThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-based educational program on physical activity for migraine managementThe 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. | Behavioural | Intervention group |
Primary outcome
Change in Headache Impact Test (HIT-6) score from baseline to 6-month follow-up
Time frame: 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.
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.
4 secondary outcomes
Change in physical activity indices from baseline to 6-month follow-up in the intervention group
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Assessed only at the 6-month follow-up (T6), three months after completion of the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-based educational program on physical activity for migraine management in people with Migraine Disorders and Exercise, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Headache Impact Test (HIT-6) score from baseline to 6-month follow-up (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.