The Effect of Different Exercise Types on Migraine Frequency in Individuals With Migraine

February 17, 2025 updated by: Yunus Emre Meydanal, Ege University

The Effect of Different Exercise Types on Migraine Frequency in Individuals With Migraine :Randomized Controlled Study

The purpose of this study is to evaluate and compare the effect of different exercise types and combinations on migraine attacks in patients with migraine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Bornova
      • İzmir, Bornova, Turkey
        • Ege University Sport Medicine Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • A diagnosis of migraine confirmed by a specialist neurologist according to International Classification of Headache Disorders, 3rd version(ICHD-3)
  • Diagnosed as chronic migraine at the time of initial diagnosis (may have turned into episodic migraine under preventive treatment)
  • At least 5 migraine attack/month in baseline diary
  • No obstacle to exercise in the evaluation made with physical examination and ECG
  • Diagnosed with migraine for at least 12 months
  • Between the ages of 18-50

Exclusion Criteria:

  • Exercising regularly in the last 6 months
  • Presence of concomitant internal and neurological diseases
  • Anti-psychotic drug use
  • Drug, alcohol addiction
  • Pregnancy, breastfeeding
  • Patients who cannot reach the targeted exercise level

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: Combined exercise group
Aerobic plus resistance exercise intervention
Behavioral: Combined exercise
aerobic plus resistance exercise
Experimental: Aerobic exercise group
Only aerobic exercise intervention
Behavioral: Aerobic exercise
Only aerobic exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Number of Days With Migraine (in Migraine Frequency)
Time Frame: Baseline and Week 12 and Week 20
Defined as the number of days with a migraine headache in a month
Baseline and Week 12 and Week 20

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Intensity of Headache
Time Frame: Baseline and Week 12 and Week 20
A categorical, 11 points visual analogue scale will be used to rate each headache between 0-10. Higher scores mean higher severity headache
Baseline and Week 12 and Week 20
Anxiety
Time Frame: Baseline and Week 12 and Week 20
Hospital Anxiety and Depression Scale (HADS) will be used. Score could score between 0 and 21 for either anxiety or depression subscale . Higher points are associated with worse anxiety or depression
Baseline and Week 12 and Week 20
Depression
Time Frame: Baseline and Week 12 and Week 20
Hospital Anxiety and Depression Scale (HADS) will be used. Score could score between 0 and 21 for either anxiety or depression subscales . Higher points are associated with worse anxiety or depression
Baseline and Week 12 and Week 20
Migraine Specific Quality of Life
Time Frame: Baseline and Week 12 and Week 20
Migraine Disability Assessment (MIDAS) questionnaire will be used . There is no upper or lower limit on scoring. More than 21 points show severe disability. Higher points mean more disability.MIDAS Grade/ MIDAS Score: Little or No Disability 0-5 , Mild Disability 6-10 , Moderate Disability 11-20 , Severe Disability 21+
Baseline and Week 12 and Week 20
Aerobic Capacity Measurement V02 Max
Time Frame: Baseline and Week 12 and Week 20
Astrand submaximal bicycle ergometer test will be used to measure aerobic capacity.
Baseline and Week 12 and Week 20
Change in Physical Activity Level
Time Frame: Baseline and Week 12 and Week 20
The International Physical Activity Questionnaires (IPAQ) short form will be used. Scoring is not classical numerical type. For activity type and duration are important for scoring. Higher points means more physical activity
Baseline and Week 12 and Week 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Investigators

  • Principal Investigator: Yunus Emre Meydanal, Ege University Sport Medicine Clinic
  • Study Director: Seckin Senısık, Ege University Sport Medicine Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2022

Primary Completion (Actual)

March 1, 2024

Study Completion (Actual)

May 10, 2024

Study Registration Dates

First Submitted

September 27, 2022

First Submitted That Met QC Criteria

September 30, 2022

First Posted (Actual)

October 5, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 17, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-9T/12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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