Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-25 @ 5:31 PM
Study NCT ID:
NCT05568004
Status:
COMPLETED
Last Update Posted:
2025-03-10
First Post:
2022-09-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Effect of Different Exercise Types on Migraine Frequency in Individuals With Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D006261', 'term': 'Headache'}, {'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': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'yemremeydanal@gmail.com', 'phone': '905068046512', 'title': 'Dr. Yunus Emre Meydanal', 'organization': 'Ege University Faculty of Medicine Sport Medicine Department'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Low sample size Performing exercises without supervision Not having a group that does only resistance exercise Participants continue their current preventive medications without changing the dose during the intervention.'}}, 'adverseEventsModule': {'timeFrame': '20 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Combined Exercise Group', 'description': 'Aerobic plus resistance exercise intervention\n\nCombined exercise: aerobic plus resistance exercise For 12 weeks participants did aerobic exercise 3 times a week. One session took 45 minutes During this time patients did five different resistance exercise with elastic bands three times a week. Participants started resistance exercises with 2 sets of 8 repetitions, with a gradual increase until 3 sets of 12 repetitions were reached at the end of the first month.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Aerobic Exercise Group', 'description': 'Only aerobic exercise intervention\n\nAerobic exercise: Only aerobic exercise For 12 weeks participants did aerobic exercise 3 times a week. One session took 45 minutes', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Control Group', 'description': 'no intervention', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in the Number of Days With Migraine (in Migraine Frequency)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Exercise Group', 'description': 'Aerobic plus resistance exercise intervention\n\nCombined exercise: aerobic plus resistance exercise For 12 weeks participants did aerobic exercise 3 times a week. One session took 45 minutes During this time patients did five different resistance exercise with elastic bands three times a week. Participants started resistance exercises with 2 sets of 8 repetitions, with a gradual increase until 3 sets of 12 repetitions were reached at the end of the first month.'}, {'id': 'OG001', 'title': 'Aerobic Exercise Group', 'description': 'Only aerobic exercise intervention\n\nAerobic exercise: Only aerobic exercise For 12 weeks participants did aerobic exercise 3 times a week. One session took 45 minutes'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'no intervention'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '9.9', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '12.4', 'spread': '4.5', 'groupId': 'OG001'}, {'value': '11.8', 'spread': '3.4', 'groupId': 'OG002'}]}]}, {'title': 'End of 12 weeks(Post intervention)', 'categories': [{'measurements': [{'value': '6.3', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '8', 'spread': '4.5', 'groupId': 'OG001'}, {'value': '10.6', 'spread': '2.3', 'groupId': 'OG002'}]}]}, {'title': 'End of 8 weeks (follow up)', 'categories': [{'measurements': [{'value': '6.5', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '4.1', 'groupId': 'OG001'}, {'value': '10.6', 'spread': '3.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000'], 'pValueComment': 'A p-value of \\< 0.05 was considered statistically significant for all analyses.Two-tailed testing was used in nature of hypothesis testing.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'p value for change over time within the group, Friedman 2-way ANOVA test was applied.', 'otherAnalysisDescription': "Statistical analysis was conducted by a researcher using the Statistical Package for Social Sciences (SPSS) version 26.0. The Shapiro-Wilk test and histograms evaluated the data for normal distribution, and the Levene test confirmed homogeneous variances between groups (p \\> 0.05). Continuous data following a normal distribution are presented as mean ± standard deviation (SD). The independent samples t test or Mann-Whitney U test was used to compare independent continuous data between groups, while the chi-square or Fisher's exact test was used to compare categorical data. Friedman two-way ANOVA was used to analyze dependent variables, while the two-way mixed ANOVA was used to examine the changes between groups over time. Before the two-way mixed ANOVA, boxplot evaluation confirmed no outliers. Mauchly's sphericity test showed that the assumption of sphericity for two-way interaction was met. Tukey's correction was used for pairwise subgroup comparisons."}, {'pValue': '0.001', 'groupIds': ['OG001'], 'groupDescription': 'A p-value of \\< 0.05 was considered statistically significant for all analyses.Two-tailed testing was used in nature of hypothesis testing.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'p value for change over time within the group, Friedman 2-way ANOVA test was applied.'}, {'pValue': '0.166', 'groupIds': ['OG002'], 'pValueComment': 'A p-value of \\< 0.05 was considered statistically significant for all analyses.Two-tailed testing was used in nature of hypothesis testing.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'p value for change over time within the group, Friedman 2-way ANOVA test was applied.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12 and Week 20', 'description': 'Defined as the number of days with a migraine headache in a month', 'unitOfMeasure': 'days/month', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants who were assigned to the arm'}, {'type': 'SECONDARY', 'title': 'Average Intensity of Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}, {'units': 'headaches', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Exercise Group', 'description': 'Aerobic plus resistance exercise intervention\n\nCombined exercise: aerobic plus resistance exercise For 12 weeks participants did aerobic exercise 3 times a week. One session took 45 minutes During this time patients did five different resistance exercise with elastic bands three times a week. Participants started resistance exercises with 2 sets of 8 repetitions, with a gradual increase until 3 sets of 12 repetitions were reached at the end of the first month.'}, {'id': 'OG001', 'title': 'Aerobic Exercise Group', 'description': 'Only aerobic exercise intervention\n\nAerobic exercise: Only aerobic exercise For 12 weeks participants did aerobic exercise 3 times a week. One session took 45 minutes'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'no intervention'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '7.4', 'spread': '0.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 12(Post intervention)', 'categories': [{'measurements': [{'value': '6.3', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '1', 'groupId': 'OG001'}, {'value': '7', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 20(follow up)', 'categories': [{'measurements': [{'value': '6.6', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '7.1', 'spread': '0.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.074', 'groupIds': ['OG000'], 'pValueComment': 'A p-value of \\< 0.05 was considered statistically significant for all analyses.Two-tailed testing was used in nature of hypothesis testing.', 'groupDescription': 'Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'p value for change over time within the group, Friedman 2-way ANOVA test was applied.'}, {'pValue': '0.074', 'groupIds': ['OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'p value for change over time within the group, Friedman 2-way ANOVA test was applied.', 'nonInferiorityComment': 'A p-value of \\< 0.05 was considered statistically significant for all analyses.Two-tailed testing was used in nature of hypothesis testing.'}, {'pValue': '0.311', 'groupIds': ['OG002'], 'pValueComment': 'A p-value of \\< 0.05 was considered statistically significant for all analyses.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'p value for change over time within the group, Friedman 2-way ANOVA test was applied.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12 and Week 20', 'description': 'A categorical, 11 points visual analogue scale will be used to rate each headache between 0-10. Higher scores mean higher severity headache', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'headaches', 'denomUnitsSelected': 'headaches', 'populationDescription': 'all participants who were assigned to the arm'}, {'type': 'SECONDARY', 'title': 'Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Exercise Group', 'description': 'Aerobic plus resistance exercise intervention\n\nCombined exercise: aerobic plus resistance exercise For 12 weeks participants did aerobic exercise 3 times a week. One session took 45 minutes During this time patients did five different resistance exercise with elastic bands three times a week. Participants started resistance exercises with 2 sets of 8 repetitions, with a gradual increase until 3 sets of 12 repetitions were reached at the end of the first month.'}, {'id': 'OG001', 'title': 'Aerobic Exercise Group', 'description': 'Only aerobic exercise intervention\n\nAerobic exercise: Only aerobic exercise For 12 weeks participants did aerobic exercise 3 times a week. One session took 45 minutes'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'no intervention'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '10.3', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '3.9', 'groupId': 'OG001'}, {'value': '6.3', 'spread': '3.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 (post intervention)', 'categories': [{'measurements': [{'value': '8.5', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '6', 'spread': '2.6', 'groupId': 'OG001'}, {'value': '6.3', 'spread': '3.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 20 (follow up)', 'categories': [{'measurements': [{'value': '8.3', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '2.4', 'groupId': 'OG001'}, {'value': '5.8', 'spread': '3.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.018', 'groupIds': ['OG000'], 'pValueComment': 'A p-value of \\< 0.05 was considered statistically significant for all analyses.', 'groupDescription': 'Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "\\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied."}, {'pValue': '0.152', 'groupIds': ['OG001'], 'pValueComment': 'A p-value of \\< 0.05 was considered statistically significant for all analyses.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "\\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied."}, {'pValue': '0.438', 'groupIds': ['OG002'], 'pValueComment': 'A p-value of \\< 0.05 was considered statistically significant for all analyses.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "\\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied"}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12 and Week 20', 'description': 'Hospital Anxiety and Depression Scale (HADS) will be used. Score could score between 0 and 21 for either anxiety or depression subscale . Higher points are associated with worse anxiety or depression', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants who were assigned to the arm'}, {'type': 'SECONDARY', 'title': 'Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Exercise Group', 'description': 'Aerobic plus resistance exercise intervention\n\nCombined exercise: aerobic plus resistance exercise For 12 weeks participants did aerobic exercise 3 times a week. One session took 45 minutes During this time patients did five different resistance exercise with elastic bands three times a week. Participants started resistance exercises with 2 sets of 8 repetitions, with a gradual increase until 3 sets of 12 repetitions were reached at the end of the first month.'}, {'id': 'OG001', 'title': 'Aerobic Exercise Group', 'description': 'Only aerobic exercise intervention\n\nAerobic exercise: Only aerobic exercise For 12 weeks participants did aerobic exercise 3 times a week. One session took 45 minutes'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'no intervention'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '3.1', 'groupId': 'OG001'}, {'value': '5.4', 'spread': '2.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 (post intervention)', 'categories': [{'measurements': [{'value': '5.6', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '2.9', 'groupId': 'OG001'}, {'value': '4.9', 'spread': '2.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 20 (follow up)', 'categories': [{'measurements': [{'value': '5.5', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '3.3', 'groupId': 'OG001'}, {'value': '5.3', 'spread': '1.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.135', 'groupIds': ['OG000'], 'pValueComment': 'A p-value of \\< 0.05 was considered statistically significant for all analyses.', 'groupDescription': 'Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "\\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied"}, {'pValue': '0.203', 'groupIds': ['OG001'], 'pValueComment': 'A p-value of \\< 0.05 was considered statistically significant for all analyses.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "\\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied"}, {'pValue': '0.593', 'groupIds': ['OG002'], 'pValueComment': 'A p-value of \\< 0.05 was considered statistically significant for all analyses.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "\\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied"}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12 and Week 20', 'description': 'Hospital Anxiety and Depression Scale (HADS) will be used. Score could score between 0 and 21 for either anxiety or depression subscales . Higher points are associated with worse anxiety or depression', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants who were assigned to the arm'}, {'type': 'SECONDARY', 'title': 'Migraine Specific Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Exercise Group', 'description': 'Aerobic plus resistance exercise intervention\n\nCombined exercise: aerobic plus resistance exercise For 12 weeks participants did aerobic exercise 3 times a week. One session took 45 minutes During this time patients did five different resistance exercise with elastic bands three times a week. Participants started resistance exercises with 2 sets of 8 repetitions, with a gradual increase until 3 sets of 12 repetitions were reached at the end of the first month.'}, {'id': 'OG001', 'title': 'Aerobic Exercise Group', 'description': 'Only aerobic exercise intervention\n\nAerobic exercise: Only aerobic exercise For 12 weeks participants did aerobic exercise 3 times a week. One session took 45 minutes'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'no intervention'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '49', 'spread': '17.8', 'groupId': 'OG000'}, {'value': '46.8', 'spread': '37', 'groupId': 'OG001'}, {'value': '42.8', 'spread': '23.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 (post intervention)', 'categories': [{'measurements': [{'value': '32.1', 'spread': '14.8', 'groupId': 'OG000'}, {'value': '30.6', 'spread': '25.2', 'groupId': 'OG001'}, {'value': '39.5', 'spread': '19.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 20 (follow up)', 'categories': [{'measurements': [{'value': '35.1', 'spread': '15.4', 'groupId': 'OG000'}, {'value': '32.4', 'spread': '26.4', 'groupId': 'OG001'}, {'value': '40', 'spread': '19.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000'], 'pValueComment': 'A p-value of \\< 0.05 was considered statistically significant for all analyses.', 'groupDescription': 'Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "\\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied."}, {'pValue': '0.021', 'groupIds': ['OG001'], 'pValueComment': 'A p-value of \\< 0.05 was considered statistically significant for all analyses.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "\\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied."}, {'pValue': '0.081', 'groupIds': ['OG002'], 'pValueComment': 'A p-value of \\< 0.05 was considered statistically significant for all analyses.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "\\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied."}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12 and Week 20', 'description': 'Migraine Disability Assessment (MIDAS) questionnaire will be used . There is no upper or lower limit on scoring. More than 21 points show severe disability. Higher points mean more disability.MIDAS Grade/ MIDAS Score: Little or No Disability 0-5 , Mild Disability 6-10 , Moderate Disability 11-20 , Severe Disability 21+', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants who were assigned to the arm'}, {'type': 'SECONDARY', 'title': 'Aerobic Capacity Measurement V02 Max', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Exercise Group', 'description': 'Aerobic plus resistance exercise intervention\n\nCombined exercise: aerobic plus resistance exercise For 12 weeks participants did aerobic exercise 3 times a week. One session took 45 minutes During this time patients did five different resistance exercise with elastic bands three times a week. Participants started resistance exercises with 2 sets of 8 repetitions, with a gradual increase until 3 sets of 12 repetitions were reached at the end of the first month.'}, {'id': 'OG001', 'title': 'Aerobic Exercise Group', 'description': 'Only aerobic exercise intervention\n\nAerobic exercise: Only aerobic exercise For 12 weeks participants did aerobic exercise 3 times a week. One session took 45 minutes'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'no intervention'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '30.1', 'spread': '3', 'groupId': 'OG000'}, {'value': '29.5', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '28', 'spread': '1.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 (post intervention)', 'categories': [{'measurements': [{'value': '33.4', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '32.5', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '28.1', 'spread': '1.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 20 (follow up)', 'categories': [{'measurements': [{'value': '32.1', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '31.1', 'spread': '2', 'groupId': 'OG001'}, {'value': '28.1', 'spread': '1.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'A p-value of \\< 0.05 was considered statistically significant for all analyses.', 'groupDescription': 'Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "\\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied."}, {'pValue': '<0.001', 'groupIds': ['OG001'], 'pValueComment': 'A p-value of \\< 0.05 was considered statistically significant for all analyses.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "\\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied."}, {'pValue': '0.747', 'groupIds': ['OG002'], 'pValueComment': 'A p-value of \\< 0.05 was considered statistically significant for all analyses.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "\\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied."}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12 and Week 20', 'description': 'Astrand submaximal bicycle ergometer test will be used to measure aerobic capacity.', 'unitOfMeasure': 'mililiter/kilogram/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants who were assigned to the arm'}, {'type': 'SECONDARY', 'title': 'Change in Physical Activity Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Exercise Group', 'description': 'Aerobic plus resistance exercise intervention\n\nCombined exercise: aerobic plus resistance exercise For 12 weeks participants did aerobic exercise 3 times a week. One session took 45 minutes During this time patients did five different resistance exercise with elastic bands three times a week. Participants started resistance exercises with 2 sets of 8 repetitions, with a gradual increase until 3 sets of 12 repetitions were reached at the end of the first month.'}, {'id': 'OG001', 'title': 'Aerobic Exercise Group', 'description': 'Only aerobic exercise intervention\n\nAerobic exercise: Only aerobic exercise For 12 weeks participants did aerobic exercise 3 times a week. One session took 45 minutes'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'no intervention'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '565.1', 'spread': '328.9', 'groupId': 'OG000'}, {'value': '585.1', 'spread': '427.9', 'groupId': 'OG001'}, {'value': '415.1', 'spread': '272.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 (post intervention)', 'categories': [{'measurements': [{'value': '1338.4', 'spread': '156.3', 'groupId': 'OG000'}, {'value': '1542.4', 'spread': '379.9', 'groupId': 'OG001'}, {'value': '660.8', 'spread': '514.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 20 (follow up)', 'categories': [{'measurements': [{'value': '854.8', 'spread': '301.7', 'groupId': 'OG000'}, {'value': '867', 'spread': '438.5', 'groupId': 'OG001'}, {'value': '552.1', 'spread': '359.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000'], 'pValueComment': 'A p-value of \\< 0.05 was considered statistically significant for all analyses.', 'groupDescription': 'Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "\\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied."}, {'pValue': '<0.001', 'groupIds': ['OG001'], 'pValueComment': 'A p-value of \\< 0.05 was considered statistically significant for all analyses.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "p-value for changes over time within the group; Friedman's two-way ANOVA test was applied."}, {'pValue': '0.05', 'groupIds': ['OG002'], 'pValueComment': 'A p-value of \\< 0.05 was considered statistically significant for all analyses.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "p-value for changes over time within the group; Friedman's two-way ANOVA test was applied."}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12 and Week 20', 'description': 'The International Physical Activity Questionnaires (IPAQ) short form will be used. Scoring is not classical numerical type. For activity type and duration are important for scoring. Higher points means more physical activity', 'unitOfMeasure': 'metabolic equivalent /week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants who were assigned to the arm'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Combined Exercise Group', 'description': 'Aerobic plus resistance exercise intervention\n\nCombined exercise: aerobic plus resistance exercise For 12 weeks participants did aerobic exercise 3 times a week. One session took 45 minutes During this time patients did five different resistance exercise with elastic bands three times a week. Participants started resistance exercises with 2 sets of 8 repetitions, with a gradual increase until 3 sets of 12 repetitions were reached at the end of the first month.'}, {'id': 'FG001', 'title': 'Aerobic Exercise Group', 'description': 'Only aerobic exercise intervention\n\nAerobic exercise: Only aerobic exercise For 12 weeks participants did aerobic exercise 3 times a week. One session took 45 minutes'}, {'id': 'FG002', 'title': 'Control Group', 'description': 'no intervention'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants who applied to Ege University Hospital Neurology Department of Headache policlinic were recruited based on neurology physician up to International Headache Disorder Classification 3rd version (ICHD-3). Participants were enrolled to study between November 2022- January 2024.', 'preAssignmentDetails': 'Of 32 enrolled participants , 24 participants filled out baseline headache diaries regularly and were randomized to groups'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Combined Exercise Group', 'description': 'Aerobic plus resistance exercise intervention\n\nCombined exercise: aerobic plus resistance exercise For 12 weeks participants did aerobic exercise 3 times a week. One session took 45 minutes During this time patients did five different resistance exercise with elastic bands three times a week. Participants started resistance exercises with 2 sets of 8 repetitions, with a gradual increase until 3 sets of 12 repetitions were reached at the end of the first month.'}, {'id': 'BG001', 'title': 'Aerobic Exercise Group', 'description': 'Only aerobic exercise intervention\n\nAerobic exercise: Only aerobic exercise For 12 weeks participants did aerobic exercise 3 times a week. One session took 45 minutes'}, {'id': 'BG002', 'title': 'Control Group', 'description': 'no intervention'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '39', 'spread': '13', 'groupId': 'BG000'}, {'value': '36', 'spread': '11', 'groupId': 'BG001'}, {'value': '44', 'spread': '5', 'groupId': 'BG002'}, {'value': '39.8', 'spread': '10.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Body weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '74', 'spread': '14', 'groupId': 'BG000'}, {'value': '68', 'spread': '10', 'groupId': 'BG001'}, {'value': '75', 'spread': '12', 'groupId': 'BG002'}, {'value': '71.9', 'spread': '12.12', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '166', 'spread': '10', 'groupId': 'BG000'}, {'value': '163', 'spread': '5', 'groupId': 'BG001'}, {'value': '162', 'spread': '2', 'groupId': 'BG002'}, {'value': '163.5', 'spread': '6.35', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body mass index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '26.60', 'spread': '3.46', 'groupId': 'BG000'}, {'value': '25.50', 'spread': '3.84', 'groupId': 'BG001'}, {'value': '28.45', 'spread': '5.15', 'groupId': 'BG002'}, {'value': '26.85', 'spread': '4.21', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram/square meter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Migraine duration', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '13.2', 'spread': '12.9', 'groupId': 'BG000'}, {'value': '8.5', 'spread': '10', 'groupId': 'BG001'}, {'value': '16.8', 'spread': '7.8', 'groupId': 'BG002'}, {'value': '12.8', 'spread': '10.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of Participants with Migraine Aura', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Number of participants in that group with migraine headache accompanied by aura (determined using participants' baseline diaries)", 'unitOfMeasure': 'Participants'}, {'title': 'Preventive drugs number', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'spread': '1', 'groupId': 'BG000'}, {'value': '1', 'spread': '1', 'groupId': 'BG001'}, {'value': '1', 'spread': '0', 'groupId': 'BG002'}, {'value': '1', 'spread': '0.48', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Numbers indicate the mean number of preventive drug used in the baseline period before the intervention in this group.', 'unitOfMeasure': 'mean number of medication used', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Beta blocker use', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The numbers show how many patients in that group used this type of medication in the baseline period before the intervention', 'unitOfMeasure': 'Participants'}, {'title': 'Serotonin and norepinephrine reuptake inhibitors (SNRIs) use', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The numbers show how many patients in that group used this type of medication in the baseline period before the intervention', 'unitOfMeasure': 'Participants'}, {'title': 'Tricyclic antidepressants (TCAs)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The numbers show how many patients in that group used this type of medication in the baseline period before the intervention', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants using medication for migraine attack treatment(triptan)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'The numbers show how many patients in that group used this type of medication(triptan) in the baseline period before the intervention (In our study, all participants using preventive drugs for migraine were using a single type of medication, triptan.)', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-02-15', 'size': 41588, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-02-17T01:36', 'hasProtocol': True}, {'date': '2024-06-16', 'size': 100365, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-01-16T02:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-17', 'studyFirstSubmitDate': '2022-09-27', 'resultsFirstSubmitDate': '2024-06-13', 'studyFirstSubmitQcDate': '2022-09-30', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-17', 'studyFirstPostDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Number of Days With Migraine (in Migraine Frequency)', 'timeFrame': 'Baseline and Week 12 and Week 20', 'description': 'Defined as the number of days with a migraine headache in a month'}], 'secondaryOutcomes': [{'measure': 'Average Intensity of Headache', 'timeFrame': 'Baseline and Week 12 and Week 20', 'description': 'A categorical, 11 points visual analogue scale will be used to rate each headache between 0-10. Higher scores mean higher severity headache'}, {'measure': 'Anxiety', 'timeFrame': 'Baseline and Week 12 and Week 20', 'description': 'Hospital Anxiety and Depression Scale (HADS) will be used. Score could score between 0 and 21 for either anxiety or depression subscale . Higher points are associated with worse anxiety or depression'}, {'measure': 'Depression', 'timeFrame': 'Baseline and Week 12 and Week 20', 'description': 'Hospital Anxiety and Depression Scale (HADS) will be used. Score could score between 0 and 21 for either anxiety or depression subscales . Higher points are associated with worse anxiety or depression'}, {'measure': 'Migraine Specific Quality of Life', 'timeFrame': 'Baseline and Week 12 and Week 20', 'description': 'Migraine Disability Assessment (MIDAS) questionnaire will be used . There is no upper or lower limit on scoring. More than 21 points show severe disability. Higher points mean more disability.MIDAS Grade/ MIDAS Score: Little or No Disability 0-5 , Mild Disability 6-10 , Moderate Disability 11-20 , Severe Disability 21+'}, {'measure': 'Aerobic Capacity Measurement V02 Max', 'timeFrame': 'Baseline and Week 12 and Week 20', 'description': 'Astrand submaximal bicycle ergometer test will be used to measure aerobic capacity.'}, {'measure': 'Change in Physical Activity Level', 'timeFrame': 'Baseline and Week 12 and Week 20', 'description': 'The International Physical Activity Questionnaires (IPAQ) short form will be used. Scoring is not classical numerical type. For activity type and duration are important for scoring. Higher points means more physical activity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Headache', 'Exercise', 'Resistance exercises', 'Aerobic exercise'], 'conditions': ['Migraine', 'Chronic Migraine']}, 'referencesModule': {'references': [{'pmid': '29368949', 'type': 'BACKGROUND', 'citation': 'Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.'}, {'pmid': '27733282', 'type': 'BACKGROUND', 'citation': 'GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. 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No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate and compare the effect of different exercise types and combinations on migraine attacks in patients with migraine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A diagnosis of migraine confirmed by a specialist neurologist according to International Classification of Headache Disorders, 3rd version(ICHD-3)\n* Diagnosed as chronic migraine at the time of initial diagnosis (may have turned into episodic migraine under preventive treatment)\n* At least 5 migraine attack/month in baseline diary\n* No obstacle to exercise in the evaluation made with physical examination and ECG\n* Diagnosed with migraine for at least 12 months\n* Between the ages of 18-50\n\nExclusion Criteria:\n\n* Exercising regularly in the last 6 months\n* Presence of concomitant internal and neurological diseases\n* Anti-psychotic drug use\n* Drug, alcohol addiction\n* Pregnancy, breastfeeding\n* Patients who cannot reach the targeted exercise level'}, 'identificationModule': {'nctId': 'NCT05568004', 'briefTitle': 'The Effect of Different Exercise Types on Migraine Frequency in Individuals With Migraine', 'organization': {'class': 'OTHER', 'fullName': 'Ege University'}, 'officialTitle': 'The Effect of Different Exercise Types on Migraine Frequency in Individuals With Migraine :Randomized Controlled Study', 'orgStudyIdInfo': {'id': '22-9T/12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Combined exercise group', 'description': 'Aerobic plus resistance exercise intervention', 'interventionNames': ['Behavioral: Combined exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Aerobic exercise group', 'description': 'Only aerobic exercise intervention', 'interventionNames': ['Behavioral: Aerobic exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control group'}], 'interventions': [{'name': 'Combined exercise', 'type': 'BEHAVIORAL', 'description': 'aerobic plus resistance exercise', 'armGroupLabels': ['Combined exercise group']}, {'name': 'Aerobic exercise', 'type': 'BEHAVIORAL', 'description': 'Only aerobic exercise', 'armGroupLabels': ['Aerobic exercise group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Izmir', 'state': 'Bornova', 'country': 'Turkey (Türkiye)', 'facility': 'Ege University Sport Medicine Clinic', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Yunus Emre Meydanal', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ege University Sport Medicine Clinic'}, {'name': 'Seckin Senısık', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ege University Sport Medicine Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ege University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident physician of Sport Medicine Department', 'investigatorFullName': 'Yunus Emre Meydanal', 'investigatorAffiliation': 'Ege University'}}}}