Evaluation of an Aerobic Exercise Program in Migraine Management

Not Applicable

Terminated

• Conditions: Migraine
• Interventions: Other: Aerobic exercise

• Registration Number: NCT01857557
• Lead Sponsor: University of Calgary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-05-15
• Study First Submitted QC: 2013-05-17
• Study First Posted: 2013-05-20
• Primary Completion: 2020-08-06
• Study Completion: 2020-08-06
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-04
• Last Update Posted: 2020-11-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aerobic Exercise	Aerobic exercise	Fitness program for migraine patients in addition to usual headache care.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

South Health Campus; 🇨🇦 Calgary, Alberta, Canada