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The Effect of Exercise on Migraine Attacks in Chronic Migraine

Primary Purpose

Migraine, Chronic Migraine

Status

Recruiting

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Combined exercise

Aerobic exercise

About this trial

This is an interventional supportive care trial for Migraine focused on measuring Headache, Exercise

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ege University Sport Medicine ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Combined exercise group

Aerobic exercise group

Control group

Arm Description

Aerobic plus resistance exercise intervention

Only aerobic exercise intervention

Outcomes

Primary Outcome Measures

Change in the number of days with migraine (in migraine frequency)

Defined as the number of days with a migraine headache in a month

Secondary Outcome Measures

Intensity of headache

A categorical, four level rating scale will be used to rate each headache as absent, mild, moderate, or severe

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

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

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

Aerobic capacity measurement

Astrand submaximal bicycle ergometer test will be used to measure aerobic capacity.

Acute treatment utilization

Change the frequency of use of acute headache medications(which not effect of migraine frequency) during the trial

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

Full Information

NCT ID

NCT05568004

First Posted

September 27, 2022

Last Updated

June 23, 2023

Sponsor

Ege University

1. Study Identification

Unique Protocol Identification Number

NCT05568004

Brief Title

The Effect of Exercise on Migraine Attacks in Chronic Migraine

Official Title

The Effect of Exercise on Migraine Attack Frequency in Chronic Migraine

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 28, 2022 (Actual)

Primary Completion Date

March 2024 (Anticipated)

Study Completion Date

May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Migraine, Chronic Migraine

Keywords

Headache, Exercise

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Combined exercise group

Arm Type

Experimental

Arm Description

Aerobic plus resistance exercise intervention

Arm Title

Aerobic exercise group

Arm Type

Experimental

Arm Description

Only aerobic exercise intervention

Arm Title

Control group

Arm Type

No Intervention

Intervention Type

Behavioral

Intervention Name(s)

Combined exercise

Intervention Description

aerobic plus resistance exercise

Intervention Type

Behavioral

Intervention Name(s)

Aerobic exercise

Intervention Description

Only aerobic exercise

Primary Outcome Measure Information:

Title

Change in the number of days with migraine (in migraine frequency)

Description

Defined as the number of days with a migraine headache in a month

Time Frame

Baseline and Week 12 and Week 20

Secondary Outcome Measure Information:

Title

Intensity of headache

Description

A categorical, four level rating scale will be used to rate each headache as absent, mild, moderate, or severe

Time Frame

Baseline and Week 12 and Week 20

Title

Responder rate

Description

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

Time Frame

Week 12 and 20

Title

Depression and anxiety

Description

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

Time Frame

Baseline and Week 12 and Week 20

Title

Migraine specific quality of life

Description

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

Time Frame

Baseline and Week 12 and Week 20

Title

Aerobic capacity measurement

Description

Astrand submaximal bicycle ergometer test will be used to measure aerobic capacity.

Time Frame

Baseline and Week 12 and Week 20

Title

Acute treatment utilization

Description

Change the frequency of use of acute headache medications(which not effect of migraine frequency) during the trial

Time Frame

Baseline and Week 12 and Week 20

Title

Change in physical activity level

Description

Time Frame

Baseline and Week 12 and Week 20

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yunus Emre Meydanal

Phone

+905068046512

yemremeydanal@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yunus Emre Meydanal

Organizational Affiliation

Ege University Sport Medicine Clinic

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Seckin Senısık

Organizational Affiliation

Ege University Sport Medicine Clinic

Official's Role

Study Director

Facility Information:

Facility Name

Ege University Sport Medicine Clinic

City

İzmir

State/Province

Bornova

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yunus Emre Meydanal

Phone

905068046512

yemremeydanal@gmail.com

First Name & Middle Initial & Last Name & Degree

Seckin Senısık

First Name & Middle Initial & Last Name & Degree

Hadiye Sirin

12. IPD Sharing Statement

Plan to Share IPD

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The Effect of Exercise on Migraine Attacks in Chronic Migraine

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