Evaluation of an Aerobic Exercise Program in Migraine Management

November 4, 2020 updated by: Farnaz Amoozegar, University of Calgary
This trial assesses the impact of a supervised aerobic exercise program by a kinesiologist in patients with migraine. Patients can be assigned to one of two groups 1)The exercise group or 2)non-exercise group. This is a important area to study because there is currently limited information regarding exercise and its impact on migraine frequency and severity. In many cases, migraine patients are disabled by their headaches and sometimes will not have a significant response to medications. As a result, it is important to study other non-pharmacological interventions. In this study, the investigators hope to show the benefits of exercise by a reduction in number of headache days per month as well as by improvement in quality of life, disability,depression,anxiety,and aerobic fitness.This study will not interfere with the usual treatment patients receive at our headache clinic and patients can remain on medications deemed necessary.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3M 1M4
        • South Health Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 58 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients must meet diagnostic criteria for migraine without aura, migraine with aura or chronic migraine.
  2. Patients must be 18-50 years of age.

  3. Individuals motivated to exercise and complete the study.

    -

Exclusion Criteria:

  1. Patient has a headache on more than 25 days a month
  2. Patient is a medication over-user by International Headache Society (IHS) criteria
  3. Patient currently has a fitness program with regular aerobic exercise for 30 minutes three times a week or more.
  4. Known cardiovascular disease which contraindicates the exercise program
  5. Inability to complete the outcome measure questionnaires. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aerobic Exercise
Fitness program for migraine patients in addition to usual headache care.
Other: Aerobic exercise
Patients receiving exercise program in addition to usual headache care
No Intervention: Control Group
Patients receiving usual headache care but no exercise program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Days with headache per month (based on headache diaries),comparing the change from baseline to month 3 and 6 post-randomization in the control versus the intervention group. Migraine Specific Quality of Life Questionnaire scores
Time Frame: At baseline,3, 6 months
At baseline,3, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Show Improvement in measures of quality of life,disability,depression,anxiety,and aerobic fitness
Time Frame: Baseline, 3 ,6 months post randomization
Headache Impact Test (HIT-6 )score, Migraine Disability Assessment scores, Patient Health Questionnaire(PHQ-9 )scores,Generalized Anxiety Disorder (GAD-7) scores, Average headache intensity, Body Mass Index, Aerobic fitness
Baseline, 3 ,6 months post randomization

Other Outcome Measures

Outcome Measure
Time Frame
Adherence to fitness program in the intervention group
Time Frame: At 6 months after randomization
At 6 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Investigators

  • Principal Investigator: Dr Farnaz Amoozegar, MD, FRCPC, South Health Campus, Calgary, Alberta, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

August 6, 2020

Study Completion (Actual)

August 6, 2020

Study Registration Dates

First Submitted

May 15, 2013

First Submitted That Met QC Criteria

May 17, 2013

First Posted (Estimate)

May 20, 2013

Study Record Updates

Last Update Posted (Actual)

November 6, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24702

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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