Evaluation of an Aerobic Exercise Program in Migraine Management

NCT01857557 | Terminated

• 1 other identifier: 24702
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Keywords

Exercise; Fitness program

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Baseline, 3 ,6 months post randomization

Other Outcomes (1)

• Adherence to fitness program in the intervention group

  At 6 months after randomization

Study Arms (2)

Aerobic Exercise

EXPERIMENTAL

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

Other: Aerobic exercise

Control Group

NO INTERVENTION

Patients receiving usual headache care but no exercise program

Interventions

Aerobic exercise OTHER

Patients receiving exercise program in addition to usual headache care

Aerobic Exercise

Eligibility Criteria

• Age: 18 Years - 58 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

South Health Campus

Calgary, Alberta, T3M 1M4, Canada

Location

MeSH Terms

Conditions

Migraine Disorders; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Dr Farnaz Amoozegar, MD, FRCPC

  South Health Campus, Calgary, Alberta, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Farnaz Amoozegar

Study Record Dates

• First Submitted: May 15, 2013
• First Posted: May 20, 2013
• Study Start: August 1, 2012
• Primary Completion: August 6, 2020
• Study Completion: August 6, 2020
• Last Updated: November 6, 2020

Record last verified: 2020-11

Locations

CA (1)