The Effect of a Video-Based Exercise Program on Migraine Symptoms

NCT06871852 | Enrolling By Invitation

• 1 other identifier: 2024-292
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the effects of a video- and brochure-based physiotherapy and exercise program on migraine symptoms, neck disability, cognitive functions, and quality of life in patients with migraine. Hypotheses H1: The video-based physiotherapy and exercise program has an effect on migraine symptoms in patients with migraine. H2: The video-based physiotherapy and exercise program has an effect on neck disability in patients with migraine. H3: The video-based physiotherapy and exercise program has an effect on cognitive functions in patients with migraine. H4: The video-based physiotherapy and exercise program has an effect on quality of life in patients with migraine. H5: The brochure-based physiotherapy and exercise program has an effect on migraine symptoms in patients with migraine. H6: The brochure-based physiotherapy and exercise program has an effect on neck disability in patients with migraine. H7: The brochure-based physiotherapy and exercise program has an effect on cognitive functions in patients with migraine. H8: The brochure-based physiotherapy and exercise program has an effect on quality of life in patients with migraine. Participants diagnosed with migraine who meet the inclusion criteria and voluntarily agree to participate in the study will be randomly assigned to three groups using block randomization. The study will be conducted online. Before the intervention, participants will be asked to complete the Demographic Information Form, Migraine Disability Assessment (MIDAS) Questionnaire, Mig-Scog Questionnaire, Neck Disability Index (NDI), and SF-12 Quality of Life Questionnaire via an online Google Form. Group 1 will receive a video-based physiotherapy and exercise program. Group 2 will receive a brochure-based physiotherapy and exercise program. Group 3 will serve as the control group. Participants in the intervention groups will be instructed to perform the exercises three times per week for 12 weeks, with one session per day, consisting of 10 repetitions for each exercise. At the end of the 12th week, all assessments will be repeated to evaluate the effects of the intervention.

Conditions

Migraine; Exercise

Keywords

migraine; exercise; video-based; telerehabilitation

Outcome Measures

Primary Outcomes (2)

• The Migraine Disability Assessment (MIDAS)

  The Migraine Disability Assessment (MIDAS) questionnaire is a brief, self-administered tool designed to measure headache-related disability over a three-month period. It consists of five items that assess the number of days, in the past 3 months, of activity limitations due to migraine. Higher scores indicate greater disability. The MIDAS questionnaire has been shown to be internally consistent, highly reliable, valid, and correlates with physicians' clinical judgment. Consequently, it is widely used in clinical research as a standard assessment tool.

  baseline - after 3 months

• The Migraine-Specific Cognitive Assessment (Mig-SCog)

  The Migraine-Specific Cognitive Assessment (Mig-SCog) is a self-administered questionnaire developed in 2011 by Gil-Gouveia and colleagues to assess and monitor cognitive symptoms during migraine attacks. The scale consists of nine Likert-type items, each scored from 0 to 2, with a total score ranging from 0 to 18; higher scores indicate a greater frequency of cognitive symptoms. The first three items assess attention, processing speed, and orientation; items four and five evaluate planning and attention; items six and seven pertain to language; and items eight and nine focus on naming. Thus, the Mig-SCog primarily examines executive functions (attention, planning, and orientation) and language (naming and verbal fluency), which are the areas most commonly reported as problematic by patients during migraine attacks. A high Mig-SCog score indicates a high frequency of cognitive symptoms.

  baseline - after 3 months

Secondary Outcomes (3)

• The Neck Disability Index (NDI)

  Baseline- after 3 months

• The Short Form-12 (SF-12)

  baseline - after 3 months

• The Exercise Adherence Rating Scale (EARS)

  baseline - after 3 months

Study Arms (3)

Video-Based Intervention Group

EXPERIMENTAL

Group 1 - video-based physiotherapy and exercise program: Video-Based Intervention Group: Participants in this group will receive videos detailing migraine triggers, precautionary measures, and a physiotherapy and exercise program. Each exercise will be thoroughly explained by a physiotherapist in the videos, enabling participants to perform the exercises correctly by following the verbal and visual instructions. To ensure proper technique, additional video recordings will be provided to address participants' questions upon request.

Other: a video-based physiotherapy and exercise program.

Brochure-Based Intervention Group

EXPERIMENTAL

Brochure-Based Intervention Group: Participants in this group will be provided with brochures that include information on migraine triggers, precautionary measures, and rehabilitation exercises accompanied by visual aids. The exercises will be detailed with written instructions and illustrations.

Other: brochure-based physiotherapy and exercise program.

control group

NO INTERVENTION

No exercise/training will be given to the control group.

Interventions

a video-based physiotherapy and exercise program. OTHER

Video-Based Intervention Group: Participants in this group will receive videos detailing migraine triggers, precautionary measures, and a physiotherapy and exercise program. Each exercise will be thoroughly explained by a physiotherapist in the videos, enabling participants to perform the exercises correctly by following the verbal and visual instructions.

Video-Based Intervention Group

brochure-based physiotherapy and exercise program. OTHER

Brochure-Based Intervention Group: Participants in this group will be provided with brochures that include information on migraine triggers, precautionary measures, and rehabilitation exercises accompanied by visual aids. The exercises will be detailed with written instructions and illustrations. Exercise Program: The exercise program will include self-massage techniques for specific muscle groups, self C1-C2 joint mobilization, cervical region exercises, cognitive exercises, and progressive relaxation exercises for the back and face.

Brochure-Based Intervention Group

Eligibility Criteria

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

You may qualify if:

• Migraine has been diagnosed by a specialist physician
• Between the ages of 18 and 65
• Volunteering to participate in the study
• To be able to answer surveys sent from a smart phone or computer

You may not qualify if:

• Having secondary diseases such as morbid obesity, blood pressure, diabetes
• Any other neurological or psychiatric disorder
• Severe cervical disc herniation or radiculopathy
• Receiving any other treatment for migraine during the study (except medication)

Sponsors & Collaborators

• Bandırma Onyedi Eylül University: lead

Study Sites (1)

Bandirma Onyedi Eylul University

Bandırma, Balıkesir, 10200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Migraine Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: randomized controlled study (3 group)

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: March 12, 2025
• Study Start: February 20, 2025
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)