Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2025-12-28 @ 10:00 PM
Study NCT ID:
NCT01407861
Status:
COMPLETED
Last Update Posted:
2014-12-03
First Post:
2011-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aerobic Endurance Training vs. Relaxation Training in Patients With Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012064', 'term': 'Relaxation Therapy'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-02', 'studyFirstSubmitDate': '2011-08-01', 'studyFirstSubmitQcDate': '2011-08-01', 'lastUpdatePostDateStruct': {'date': '2014-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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).', 'timeFrame': '16 weeks'}], 'secondaryOutcomes': [{'measure': 'Number of headache days 12 weeks after finishing the training (follow up).', 'timeFrame': '20 weeks'}, {'measure': 'Consumption of analgetic agents/triptans', 'timeFrame': '20 weeks'}, {'measure': 'Increase in aerobic capability', 'timeFrame': '12 weeks'}, {'measure': 'Impact on burden of disease', 'timeFrame': '20 weeks'}, {'measure': 'Psychological Impact of Training', 'timeFrame': '20'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Migraine']}, 'referencesModule': {'references': [{'pmid': '22540391', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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\\].\n* Patients have a clinical diagnosis of migraine with or without aura according to IHS criteria at least one year prior to enrollment.\n* 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\n* Patients that report at least three headache days per month\n\nExclusion Criteria:\n\n* Diseases or disabilities that disqualify to perform either aerobic endurance training or relaxation training\n* Language difficulties that disable to fill out questionnaires\n* Pregnancy\n* Additional diagnosis of secondary headache according to the IHS criteria"}, 'identificationModule': {'nctId': 'NCT01407861', 'acronym': 'ARMIG', 'briefTitle': 'Aerobic Endurance Training vs. Relaxation Training in Patients With Migraine', 'organization': {'class': 'OTHER', 'fullName': 'Universität Duisburg-Essen'}, 'officialTitle': 'Aerobic Endurance Training Versus Relaxation Training in Migraine Prophylaxis', 'orgStudyIdInfo': {'id': 'Aerobic-Relax-Migraine'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Relaxation training', 'description': 'Patients participate in a relaxation training program under expert guidance at least three times a week over 12 weeks.', 'interventionNames': ['Other: Relaxation Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aerobic endurance training', 'description': 'Patients participate in a moderate aerobic endurance training program under expert guidance three times a week over 12 weeks.', 'interventionNames': ['Other: Aerobic endurance Training']}], 'interventions': [{'name': 'Relaxation Training', 'type': 'OTHER', 'description': 'Patients participate in a relaxation training program under expert guidance at least three times a week over 12 weeks.', 'armGroupLabels': ['Relaxation training']}, {'name': 'Aerobic endurance Training', 'type': 'OTHER', 'description': 'Patients participate in a moderate aerobic endurance training program under expert guidance three times a week over 12 weeks.', 'armGroupLabels': ['Aerobic endurance training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'Department of Neurology, University of Duisburg-Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}], 'overallOfficials': [{'name': 'Charly Gaul, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurology, University of Duisburg-Essen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universität Duisburg-Essen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. of Neurology', 'investigatorFullName': 'Hans-Christoph Diener', 'investigatorAffiliation': 'Universität Duisburg-Essen'}}}}