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

Not Applicable

Completed

• Conditions: Migraine; Chronic Migraine
• Interventions: Behavioral: Aerobic exercise; Behavioral: Combined exercise

• Registration Number: NCT05568004
• Lead Sponsor: Ege University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-27
• Study First Submitted QC: 2022-09-30
• Study First Posted: 2022-10-05
• Study Start: 2022-11-28
• Primary Completion: 2024-03-01
• Study Completion: 2024-05-10
• Results First Submitted: 2024-06-13
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-17
• Last Update Submitted: 2025-02-17
• Results First Posted: 2025-03-10
• Last Update Posted: 2025-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aerobic exercise group	Aerobic exercise	Only aerobic exercise intervention
Combined exercise group	Combined exercise	Aerobic plus resistance exercise intervention

Primary Outcome Measures

Name	Time	Method
Change in the Number of Days With Migraine (in Migraine Frequency)	Baseline and Week 12 and Week 20	Defined as the number of days with a migraine headache in a month

Secondary Outcome Measures

Name	Time	Method
Average Intensity of Headache	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
Anxiety	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
Depression	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
Migraine Specific Quality of Life	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+
Aerobic Capacity Measurement V02 Max	Baseline and Week 12 and Week 20	Astrand submaximal bicycle ergometer test will be used to measure aerobic capacity.
Change in Physical Activity Level	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

Trial Locations

Locations (1)

Ege University Sport Medicine Clinic; 🇹🇷 İzmir, Bornova, Turkey