MigraineNCT01857557
Evaluation of an Aerobic Exercise Program in Migraine Management
A study testing Aerobic exercise in people with Migraine, run by University of Calgary at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 58 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- Aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2012to 6 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 58 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- -
Who cannot join
- 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. -
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Aerobic exercise
- Keywords
- Exercise, Fitness program
- Medical subject headings
- Migraine Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
Patients receiving exercise program in addition to usual headache care
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise | Experimental | Fitness program for migraine patients in addition to usual headache care. Receives: Other: Aerobic exercise |
| Control Group | No intervention | Patients receiving usual headache care but no exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline,3, 6 months
Secondary outcomes (1)
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
Measured: Baseline, 3 ,6 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startAug 2012
- Primary completion6 Aug 2020
- Study completion6 Aug 2020
Why it stopped: Challenges with participant recruitment as a result of COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farnaz Amoozegar, University of Calgary
- Investigators
- Dr Farnaz Amoozegar, MD, FRCPC, Principal investigator, South Health Campus, Calgary, Alberta, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857557
- Sponsor's protocol ID
- 24702
- Status last verified
- Nov 2020
- First submitted
- 15 May 2013
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Aerobic Exercise Program in Migraine Management
- ClinicalTrials.gov ID
- NCT01857557
- Acronym / sponsor ID
- 24702
- Conditions
- Migraine
- Keywords
- Exercise, Fitness program
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Challenges with participant recruitment as a result of COVID-19 pandemic
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- 6 Aug 2020 (actual)
- Study completion
- 6 Aug 2020 (actual)
- First posted
- 20 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise | Experimental | Other: Aerobic exerciseFitness program for migraine patients in addition to usual headache care. |
| Control Group | No intervention | –Patients receiving usual headache care but no exercise program |
Who may qualify
- Ages
- 18 to 58 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
- -
Key exclusion criteria (5 listed)
- 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. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercisePatients receiving exercise program in addition to usual headache care | Other | Aerobic Exercise |
Primary outcome
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
1 secondary outcome
Show Improvement in measures of quality of life,disability,depression,anxiety,and aerobic fitness
Time frame: Baseline, 3 ,6 months post randomization
Results and safety
The study was stopped early (reason given: Challenges with participant recruitment as a result of COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Farnaz Amoozegar, MD, FRCPC principal investigator
South Health Campus, Calgary, Alberta, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise in people with Migraine, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Challenges with participant recruitment as a result of COVID-19 pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.