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Aerobic Endurance Training vs. Relaxation Training in Patients With Migraine (ARMIG)

Primary Purpose

Migraine

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Relaxation Training
Aerobic endurance Training
Sponsored by
Universität Duisburg-Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Department of Neurology, University of Duisburg-Essen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Relaxation training

Aerobic endurance training

Arm Description

Patients participate in a relaxation training program under expert guidance at least three times a week over 12 weeks.

Patients participate in a moderate aerobic endurance training program under expert guidance three times a week over 12 weeks.

Outcomes

Primary Outcome Measures

Reduction of headache days in the last 4 weeks of the 12-week training compared to baseline (4 weeks before start of the training).

Secondary Outcome Measures

Number of headache days 12 weeks after finishing the training (follow up).
Consumption of analgetic agents/triptans
Increase in aerobic capability
Impact on burden of disease
Psychological Impact of Training

Full Information

First Posted
August 1, 2011
Last Updated
December 2, 2014
Sponsor
Universität Duisburg-Essen
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1. Study Identification

Unique Protocol Identification Number
NCT01407861
Brief Title
Aerobic Endurance Training vs. Relaxation Training in Patients With Migraine
Acronym
ARMIG
Official Title
Aerobic Endurance Training Versus Relaxation Training in Migraine Prophylaxis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität Duisburg-Essen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Relaxation training
Arm Type
Active Comparator
Arm Description
Patients participate in a relaxation training program under expert guidance at least three times a week over 12 weeks.
Arm Title
Aerobic endurance training
Arm Type
Active Comparator
Arm Description
Patients participate in a moderate aerobic endurance training program under expert guidance three times a week over 12 weeks.
Intervention Type
Other
Intervention Name(s)
Relaxation Training
Intervention Description
Patients participate in a relaxation training program under expert guidance at least three times a week over 12 weeks.
Intervention Type
Other
Intervention Name(s)
Aerobic endurance Training
Intervention Description
Patients participate in a moderate aerobic endurance training program under expert guidance three times a week over 12 weeks.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Number of headache days 12 weeks after finishing the training (follow up).
Time Frame
20 weeks
Title
Consumption of analgetic agents/triptans
Time Frame
20 weeks
Title
Increase in aerobic capability
Time Frame
12 weeks
Title
Impact on burden of disease
Time Frame
20 weeks
Title
Psychological Impact of Training
Time Frame
20

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charly Gaul, MD
Organizational Affiliation
Department of Neurology, University of Duisburg-Essen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, University of Duisburg-Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
22540391
Citation
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.
Results Reference
derived

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Aerobic Endurance Training vs. Relaxation Training in Patients With Migraine

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