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Challenges with participant recruitment as a result of COVID-19 pandemic
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerobic Exercise | Experimental | Fitness program for migraine patients in addition to usual headache care. |
|
| Control Group | No Intervention | Patients receiving usual headache care but no exercise program |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic exercise | Other | Patients receiving exercise program in addition to usual headache care |
|
| Measure | Description | 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 | At baseline,3, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to fitness program in the intervention group | At 6 months after randomization |
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.
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Farnaz Amoozegar, MD, FRCPC | South Health Campus, Calgary, Alberta, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Health Campus | Calgary | Alberta | T3M 1M4 | Canada |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| D009422 | Nervous System Diseases |
| D001519 | Behavior |