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The Effect of Exercise on Migraine Attacks in Chronic Migraine

Sponsor
Ege University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05568004
Collaborator
(none)
90
Enrollment
1
Location
3
Arms
11.1
Anticipated Duration (Months)
8.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Combined exercise
  • Behavioral: Aerobic exercise
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Exercise on Migraine Attack Frequency in Chronic Migraine
Actual Study Start Date :
Nov 28, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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
No Intervention: Control group

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Intensity of headache [Baseline and Week 12 and Week 20]

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

  2. Responder rate [Week 12 and 20]

    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

  3. Depression and 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 . Higher points are associated with worse anxiety or depression

  4. Migraine specific quality of life [Baseline and Week 12 and Week 20]

    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

  5. Aerobic capacity measurement [Baseline and Week 12 and Week 20]

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

  6. Acute treatment utilization [Baseline and Week 12 and Week 20]

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

  7. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ege University Sport Medicine Clinic İzmir Bornova Turkey

Sponsors and Collaborators

  • Ege University

Investigators

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

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Yunus Emre Meydanal, Resident physician of Sport Medicine Department, Ege University
ClinicalTrials.gov Identifier:
NCT05568004
Other Study ID Numbers:
  • 22-9T/12
First Posted:
Oct 5, 2022
Last Update Posted:
Jan 27, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yunus Emre Meydanal, Resident physician of Sport Medicine Department, Ege University
Headache
Exercise
Additional relevant MeSH terms:
Migraine Disorders

Study Results

No Results Posted as of Jan 27, 2023