Evaluation of an Aerobic Exercise Program in Migraine Management

Migraine Clinical Trial

Official title:

Evaluation of an Aerobic Exercise Program in Migraine Management

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01857557
• Other study ID #: 24702
• Status: Terminated
• Phase: N/A
• Start date: August 2012
• Est. completion date: August 6, 2020

Study information

• Verified date: November 2020
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: August 6, 2020
• Est. primary completion date: August 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 58 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Other:
• Aerobic exercise
Patients receiving exercise program in addition to usual headache care

Locations

Country	Name	City	State
Canada	South Health Campus	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence to fitness program in the intervention group		At 6 months after randomization
Primary	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		At baseline,3, 6 months
Secondary	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	Baseline, 3 ,6 months post randomization