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Completed

NCT Number: NCT05568004

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University Sport Medicine Clinic

Izmir, Bornova, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combined Exercise

Behavioral

aerobic plus resistance exercise

Aerobic Exercise

Behavioral

Only aerobic exercise

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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+

  5. 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.

  6. 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

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 5, 2022
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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