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Evaluation of an Aerobic Exercise Program in Migraine Management

Primary Purpose

Migraine

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Aerobic exercise
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Exercise, Fitness program

Eligibility Criteria

18 Years - 58 Years (Adult)All SexesAccepts Healthy Volunteers

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. -

Sites / Locations

  • South Health Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Aerobic Exercise

Control Group

Arm Description

Fitness program for migraine patients in addition to usual headache care.

Patients receiving usual headache care but no exercise program

Outcomes

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

Secondary Outcome Measures

Show Improvement in measures of quality of life,disability,depression,anxiety,and aerobic fitness
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

Full Information

First Posted
May 15, 2013
Last Updated
November 4, 2020
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT01857557
Brief Title
Evaluation of an Aerobic Exercise Program in Migraine Management
Official Title
Evaluation of an Aerobic Exercise Program in Migraine Management
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
Challenges with participant recruitment as a result of COVID-19 pandemic
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 6, 2020 (Actual)
Study Completion Date
August 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Exercise, Fitness program

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic Exercise
Arm Type
Experimental
Arm Description
Fitness program for migraine patients in addition to usual headache care.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients receiving usual headache care but no exercise program
Intervention Type
Other
Intervention Name(s)
Aerobic exercise
Intervention Description
Patients receiving exercise program in addition to usual headache care
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Show Improvement in measures of quality of life,disability,depression,anxiety,and aerobic fitness
Description
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
Time Frame
Baseline, 3 ,6 months post randomization
Other Pre-specified Outcome Measures:
Title
Adherence to fitness program in the intervention group
Time Frame
At 6 months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
58 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients must meet diagnostic criteria for migraine without aura, migraine with aura or chronic migraine. Patients must be 18-50 years of age. Individuals motivated to exercise and complete the study. - Exclusion Criteria: Patient has a headache on more than 25 days a month Patient is a medication over-user by International Headache Society (IHS) criteria Patient currently has a fitness program with regular aerobic exercise for 30 minutes three times a week or more. Known cardiovascular disease which contraindicates the exercise program Inability to complete the outcome measure questionnaires. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Farnaz Amoozegar, MD, FRCPC
Organizational Affiliation
South Health Campus, Calgary, Alberta, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Health Campus
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3M 1M4
Country
Canada

12. IPD Sharing Statement

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Evaluation of an Aerobic Exercise Program in Migraine Management

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