Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-29 @ 1:33 PM
Study NCT ID:
NCT01857557
Status:
TERMINATED
Last Update Posted:
2020-11-06
First Post:
2013-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of an Aerobic Exercise Program in Migraine Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'whyStopped': 'Challenges with participant recruitment as a result of COVID-19 pandemic', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-04', 'studyFirstSubmitDate': '2013-05-15', 'studyFirstSubmitQcDate': '2013-05-17', 'lastUpdatePostDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adherence to fitness program in the intervention group', 'timeFrame': 'At 6 months after randomization'}], 'primaryOutcomes': [{'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', 'timeFrame': 'At baseline,3, 6 months'}], 'secondaryOutcomes': [{'measure': 'Show Improvement in measures of quality of life,disability,depression,anxiety,and aerobic fitness', 'timeFrame': 'Baseline, 3 ,6 months post randomization', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Exercise', 'Fitness program'], 'conditions': ['Migraine']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '58 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients must meet diagnostic criteria for migraine without aura, migraine with aura or chronic migraine.\n2. Patients must be 18-50 years of age.\n3. Individuals motivated to exercise and complete the study.\n\n \\-\n\nExclusion Criteria:\n\n1. Patient has a headache on more than 25 days a month\n2. Patient is a medication over-user by International Headache Society (IHS) criteria\n3. Patient currently has a fitness program with regular aerobic exercise for 30 minutes three times a week or more.\n4. Known cardiovascular disease which contraindicates the exercise program\n5. Inability to complete the outcome measure questionnaires. -'}, 'identificationModule': {'nctId': 'NCT01857557', 'briefTitle': 'Evaluation of an Aerobic Exercise Program in Migraine Management', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Evaluation of an Aerobic Exercise Program in Migraine Management', 'orgStudyIdInfo': {'id': '24702'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aerobic Exercise', 'description': 'Fitness program for migraine patients in addition to usual headache care.', 'interventionNames': ['Other: Aerobic exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Patients receiving usual headache care but no exercise program'}], 'interventions': [{'name': 'Aerobic exercise', 'type': 'OTHER', 'description': 'Patients receiving exercise program in addition to usual headache care', 'armGroupLabels': ['Aerobic Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T3M 1M4', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'South Health Campus', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'overallOfficials': [{'name': 'Dr Farnaz Amoozegar, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'South Health Campus, Calgary, Alberta, Canada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Farnaz Amoozegar', 'investigatorFullName': 'Farnaz Amoozegar', 'investigatorAffiliation': 'University of Calgary'}}}}