The Effect of Exercise on Migraine Attacks in Chronic Migraine

Migraine Clinical Trial

Official title:

The Effect of Exercise on Migraine Attack Frequency in Chronic Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05568004
• Other study ID #: 22-9T/12
• Status: Completed
• Phase: N/A
• Start date: November 28, 2022
• Est. completion date: May 10, 2024

Study information

• Verified date: May 2024
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 10, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• A diagnosis of chronic migraine confirmed by a specialist neurologist according to ICHD-3B

• 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

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine
• Migraine Disorders

Intervention

Behavioral:
• Combined exercise
aerobic plus resistance exercise
• Aerobic exercise
Only aerobic exercise

Locations

Country	Name	City	State
Turkey	Ege University Sport Medicine Clinic	Izmir	Bornova

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

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* Note: There are 53 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the number of days with migraine (in migraine frequency)	Defined as the number of days with a migraine headache in a month	Baseline and Week 12 and Week 20
Secondary	Intensity of headache	A categorical, four level rating scale will be used to rate each headache as absent, mild, moderate, or severe	Baseline and Week 12 and Week 20
Secondary	Responder rate	The responder rate is calculated as a percent reduction from baseline in the number of migraine days or number of moderate or severe headache days in each treatment period	Week 12 and 20
Secondary	Depression and anxiety	Hospital Anxiety and Depression Scale (HADS) will be used. Score could score between 0 and 21 for either anxiety or depression . Higher points are associated with worse anxiety or depression	Baseline and Week 12 and Week 20
Secondary	Migraine specific quality of life	Migraine Disability Assessment (MIDAS) questionnaire will be used . There is no upper limit on scoring. More than 21 points show severe disability. Higher points mean more disability	Baseline and Week 12 and Week 20
Secondary	Aerobic capacity measurement	Astrand submaximal bicycle ergometer test will be used to measure aerobic capacity.	Baseline and Week 12 and Week 20
Secondary	Acute treatment utilization	Change the frequency of use of acute headache medications(which not effect of migraine frequency) during the trial	Baseline and Week 12 and Week 20
Secondary	Change in physical activity level	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