MigraineARMIGNCT01407861
Aerobic Endurance Training vs. Relaxation Training in Patients With Migraine
A study testing Relaxation Training and Aerobic endurance Training in people with Migraine, run by Universität Duisburg-Essen at 1 site in Germany.
Trial summary
This is a single centre, open label, prospective, randomized study on the prophylactic effect of moderate aerobic endurance training versus relaxation training in patients with migraine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Relaxation Training and Aerobic endurance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2011to Nov 2014
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient's signature on the informed consent document [each patient should be given ample time to read (or have read to them) the consent form, ask any questions they may have regarding the trial and have a clear understanding of the trial and the procedures involved prior to the signing of the consent form].
- Patients have a clinical diagnosis of migraine with or without aura according to IHS criteria at least one year prior to enrollment.
- Patients have a clinical diagnosis of migraine with or without aura and in addition a clinical diagnosis of tension type headache according to IHS criteria, if patients are able to differentiate between the two headache diagnoses and if migraine is more frequent in these patients
- Patients that report at least three headache days per month
Who cannot join
- Diseases or disabilities that disqualify to perform either aerobic endurance training or relaxation training
- Language difficulties that disable to fill out questionnaires
- Pregnancy
- Additional diagnosis of secondary headache according to the IHS criteria
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Neurology, University of Duisburg-Essen
Essen, 45147
About this study
Official title: Aerobic Endurance Training Versus Relaxation Training in Migraine Prophylaxis
This is a single centre, open label, prospective, randomized study on the prophylactic effect of moderate aerobic endurance training versus relaxation training in patients with migraine.
- Conditions
- Migraine
- Being tested
- Relaxation Training, Aerobic endurance Training
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation TrainingOther
Patients participate in a relaxation training program under expert guidance at least three times a week over 12 weeks.
Aerobic endurance TrainingOther
Patients participate in a moderate aerobic endurance training program under expert guidance three times a week over 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Relaxation training | Active comparator | Patients participate in a relaxation training program under expert guidance at least three times a week over 12 weeks. Receives: Other: Relaxation Training |
| Aerobic endurance training | Active comparator | Patients participate in a moderate aerobic endurance training program under expert guidance three times a week over 12 weeks. Receives: Other: Aerobic endurance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of headache days in the last 4 weeks of the 12-week training compared to baseline (4 weeks before start of the training).
Measured: 16 weeks
Secondary outcomes (5)
Number of headache days 12 weeks after finishing the training (follow up).
Measured: 20 weeks
Consumption of analgetic agents/triptans
Measured: 20 weeks
Increase in aerobic capability
Measured: 12 weeks
Impact on burden of disease
Measured: 20 weeks
Psychological Impact of Training
Measured: 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hans-Christoph Diener, Universität Duisburg-Essen
- Investigators
- Charly Gaul, MD, Principal investigator, Department of Neurology, University of Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407861
- Sponsor's protocol ID
- Aerobic-Relax-Migraine
- Acronym
- ARMIG
- Status last verified
- Dec 2014
- First submitted
- 1 Aug 2011
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Totzeck A, Unverzagt S, Bak M, Augst P, Diener HC, Gaul C. Aerobic endurance training versus relaxation training in patients with migraine (ARMIG): study protocol for a randomized controlled trial. Trials. 2012 Apr 27;13:46. doi: 10.1186/1745-6215-13-46.
PubMed 22540391
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Endurance Training Versus Relaxation Training in Migraine Prophylaxis
- ClinicalTrials.gov ID
- NCT01407861
- Acronym / sponsor ID
- ARMIG / Aerobic-Relax-Migraine
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 2 Aug 2011 (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 is a single centre, open label, prospective, randomized study on the prophylactic effect of moderate aerobic endurance training versus relaxation training in patients with migraine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relaxation training | Active comparator | Other: Relaxation TrainingPatients participate in a relaxation training program under expert guidance at least three times a week over 12 weeks. |
| Aerobic endurance training | Active comparator | Other: Aerobic endurance TrainingPatients participate in a moderate aerobic endurance training program under expert guidance three times a week over 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient's signature on the informed consent document [each patient should be given ample time to read (or have read to them) the consent form, ask any questions they may have regarding the trial and have a clear understanding of the trial and the procedures involved prior to the signing of the consent form].
- Patients have a clinical diagnosis of migraine with or without aura according to IHS criteria at least one year prior to enrollment.
- Patients have a clinical diagnosis of migraine with or without aura and in addition a clinical diagnosis of tension type headache according to IHS criteria, if patients are able to differentiate between the two headache diagnoses and if migraine is more frequent in these patients
- Patients that report at least three headache days per month
Key exclusion criteria (4 listed)
- Diseases or disabilities that disqualify to perform either aerobic endurance training or relaxation training
- Language difficulties that disable to fill out questionnaires
- Pregnancy
- Additional diagnosis of secondary headache according to the IHS criteria
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 |
|---|---|---|
| Relaxation TrainingPatients participate in a relaxation training program under expert guidance at least three times a week over 12 weeks. | Other | Relaxation training |
| Aerobic endurance TrainingPatients participate in a moderate aerobic endurance training program under expert guidance three times a week over 12 weeks. | Other | Aerobic endurance training |
Primary outcome
Reduction of headache days in the last 4 weeks of the 12-week training compared to baseline (4 weeks before start of the training).
Time frame: 16 weeks
5 secondary outcomes
Number of headache days 12 weeks after finishing the training (follow up).
Time frame: 20 weeks
Consumption of analgetic agents/triptans
Time frame: 20 weeks
Increase in aerobic capability
Time frame: 12 weeks
Impact on burden of disease
Time frame: 20 weeks
Psychological Impact of Training
Time frame: 20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
- Derived from this study: PubMed 22540391Totzeck A, Unverzagt S, Bak M, Augst P, Diener HC, Gaul C. Aerobic endurance training versus relaxation training in patients with migraine (ARMIG): study protocol for a randomized controlled trial. Trials. 2012 Apr 27;13:46. doi: 10.1186/1745-6215-13-46.
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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.
Charly Gaul, MD principal investigator
Department of Neurology, University of Duisburg-Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation Training and Aerobic endurance Training in people with Migraine, run by Universität Duisburg-Essen at 1 site in Germany.
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 4 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: finished, as of the sponsor's last update on 3 Dec 2014. 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 Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction of headache days in the last 4 weeks of the 12-week training compared to baseline (4 weeks before start of the training). (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01407861, which also lists 1 linked publication.
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 3 Dec 2014.