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Evaluation of an Aerobic Exercise Program in Migraine Management

This study is currently recruiting participants.
Verified August 2016 by Farnaz Amoozegar, University of Calgary
Sponsor:
ClinicalTrials.gov Identifier:
NCT01857557
First Posted: May 20, 2013
Last Update Posted: August 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Farnaz Amoozegar, University of Calgary
  Purpose
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.

Condition Intervention
Migraine Other: Aerobic exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of an Aerobic Exercise Program in Migraine Management

Resource links provided by NLM:


Further study details as provided by Farnaz Amoozegar, University of Calgary:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • Adherence to fitness program in the intervention group [ Time Frame: At 6 months after randomization ]

Estimated Enrollment: 80
Study Start Date: August 2012
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 58 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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. -
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857557


Contacts
Contact: Dr Farnaz Amoozegar, MD,FRCPC 403-956-2462 farnaz.amoozegar@albertahealthservices.ca
Contact: Dr Werner Becker, MD,FRCPC 403-944-4240 wbecker@ucalgary.ca

Locations
Canada, Alberta
South Health Campus Recruiting
Calgary, Alberta, Canada, T3M 1M4
Contact: Dr Farnaz Amoozegar, MD,FRCPC    403-956-2462    farnaz.amoozegar@albertahealthservices.ca   
Contact: Dr Werner Becker, MD,FRCPC    403-944-4240    wbecker@ucalgary.ca   
Principal Investigator: Dr Farnaz Amoozegar, MD,FRCPC         
Sub-Investigator: Dr Werner Becker, MD, FRCPC         
Sub-Investigator: Dr Jeptha Davenport         
Sub-Investigator: Dr Prin Chitsantikul         
Sponsors and Collaborators
University of Calgary
Investigators
Principal Investigator: Dr Farnaz Amoozegar, MD, FRCPC South Health Campus, Calgary, Alberta, Canada
  More Information

Responsible Party: Farnaz Amoozegar, Dr Farnaz Amoozegar, University of Calgary
ClinicalTrials.gov Identifier: NCT01857557     History of Changes
Other Study ID Numbers: 24702
First Submitted: May 15, 2013
First Posted: May 20, 2013
Last Update Posted: August 18, 2016
Last Verified: August 2016

Keywords provided by Farnaz Amoozegar, University of Calgary:
Exercise
Fitness program

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases