Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT00961805
Status:
COMPLETED
Last Update Posted:
2009-08-25
First Post:
2009-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Dance on Patients With Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'deiasalvador1@yahoo.com.br', 'phone': '551155764239', 'title': 'Andreia S Baptista, PT', 'organization': 'Federal University of Sao Paulo'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Visual Analog Scale for Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).'}, {'id': 'OG001', 'title': 'Dance Group', 'description': 'The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '75', 'spread': '13', 'groupId': 'OG000'}, {'value': '75', 'spread': '17', 'groupId': 'OG001'}]}]}, {'title': 'After 16 weeks', 'categories': [{'measurements': [{'value': '75', 'spread': '14', 'groupId': 'OG000'}, {'value': '46', 'spread': '20', 'groupId': 'OG001'}]}]}, {'title': 'After 32 weeks', 'categories': [{'measurements': [{'value': '73', 'spread': '17', 'groupId': 'OG000'}, {'value': '47', 'spread': '26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Differences in the behavior of the groups over time.', 'groupDescription': 'Sample size was calculated by visual analogue scale for pain (alpha error of 5%, beta error of 20% and standard deviation of 2). The sample was determined to contain 30 patients in each group. Ten additional patients were added to compensate possible losses.\n\nAnalysis was intention to treat using the LOCF technique.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline, after 16 weeks and after 32 weeks', 'description': 'score between 0 and 100 where 0 is no pain and 100 in unbearable pain', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Function - 6 Minute Walk Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).'}, {'id': 'OG001', 'title': 'Dance Group', 'description': 'The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '332', 'spread': '66.7', 'groupId': 'OG000'}, {'value': '372.8', 'spread': '80.2', 'groupId': 'OG001'}]}]}, {'title': 'after 16 weeks', 'categories': [{'measurements': [{'value': '344.3', 'spread': '72.7', 'groupId': 'OG000'}, {'value': '443.5', 'spread': '78.3', 'groupId': 'OG001'}]}]}, {'title': 'after 32 weeks', 'categories': [{'measurements': [{'value': '343', 'spread': '77.9', 'groupId': 'OG000'}, {'value': '431', 'spread': '88.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Differences in the behavior of the groups over time.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline, after 16 weeks and after 32 weeks', 'description': 'meters traveled on a 20-meter course over a six-minute period', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life - Fibromyalgia Impact Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).'}, {'id': 'OG001', 'title': 'Dance Group', 'description': 'The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.34', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '5.89', 'spread': '1.39', 'groupId': 'OG001'}]}]}, {'title': 'After 16 weeks', 'categories': [{'measurements': [{'value': '6.61', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '4.69', 'spread': '1.73', 'groupId': 'OG001'}]}]}, {'title': 'After 32 weeks', 'categories': [{'measurements': [{'value': '5.9', 'spread': '1.86', 'groupId': 'OG000'}, {'value': '4.26', 'spread': '1.81', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.003', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Differences in the behavior of the groups over time.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline, after 16 weeks and after 32 weeks', 'description': 'score between 0 from 10 with 0 indicating no impairment and 10 indicating maximum impairment', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life - SF-36 -Functional Capacity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).'}, {'id': 'OG001', 'title': 'Dance Group', 'description': 'The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '32.6', 'spread': '18.9', 'groupId': 'OG000'}, {'value': '44.9', 'spread': '18.9', 'groupId': 'OG001'}]}]}, {'title': 'After 16 weeks', 'categories': [{'measurements': [{'value': '33.1', 'spread': '18.6', 'groupId': 'OG000'}, {'value': '52.9', 'spread': '21.1', 'groupId': 'OG001'}]}]}, {'title': 'After 32 weeks', 'categories': [{'measurements': [{'value': '39.1', 'spread': '22', 'groupId': 'OG000'}, {'value': '56.3', 'spread': '19.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.146', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Differences in the behavior of the groups over time.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline, after 16 weeks and after 32 weeks', 'description': 'score between 0 from 100, with higher scores denoting better quality of life', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life - SF-36 - Physical Limitation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).'}, {'id': 'OG001', 'title': 'Dance Group', 'description': 'The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '8.8', 'spread': '17.9', 'groupId': 'OG000'}, {'value': '24.7', 'spread': '32.2', 'groupId': 'OG001'}]}]}, {'title': 'After 16 weeks', 'categories': [{'measurements': [{'value': '10.4', 'spread': '21.6', 'groupId': 'OG000'}, {'value': '40.5', 'spread': '30.6', 'groupId': 'OG001'}]}]}, {'title': 'After 32 weeks', 'categories': [{'measurements': [{'value': '13.8', 'spread': '26.5', 'groupId': 'OG000'}, {'value': '36.5', 'spread': '13.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.131', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Differences in the behavior of the groups over time.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline, after 16 weeks and after 32 weeks', 'description': 'score between 0 from 100, with higher scores denoting better quality of life', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life - Sf-36 - Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).'}, {'id': 'OG001', 'title': 'Dance Group', 'description': 'The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '25.7', 'spread': '13.4', 'groupId': 'OG000'}, {'value': '29.6', 'spread': '17.5', 'groupId': 'OG001'}]}]}, {'title': 'After 16 weeks', 'categories': [{'measurements': [{'value': '25.1', 'spread': '14.2', 'groupId': 'OG000'}, {'value': '44.7', 'spread': '20.7', 'groupId': 'OG001'}]}]}, {'title': 'After 32 weeks', 'categories': [{'measurements': [{'value': '29.1', 'spread': '21.1', 'groupId': 'OG000'}, {'value': '46', 'spread': '19.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Differences in the behavior of the groups over time.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline, after 16 weeks and after 32 weeks', 'description': 'score between 0 from 100, with higher scores denoting better quality of life', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life - Sf-36 - General Health State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).'}, {'id': 'OG001', 'title': 'Dance Group', 'description': 'The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '38', 'spread': '16.5', 'groupId': 'OG000'}, {'value': '46', 'spread': '21.7', 'groupId': 'OG001'}]}]}, {'title': 'After 16 weeks', 'categories': [{'measurements': [{'value': '38.1', 'spread': '18.3', 'groupId': 'OG000'}, {'value': '45', 'spread': '21.3', 'groupId': 'OG001'}]}]}, {'title': 'After 32 weeks', 'categories': [{'measurements': [{'value': '41.5', 'spread': '21.4', 'groupId': 'OG000'}, {'value': '44.9', 'spread': '15.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.580', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Differences in the behavior of the groups over time.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline, after 16 weeks and after 32 weeks', 'description': 'score between 0 from 100, with higher scores denoting better quality of life', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life - SF-36 - Vitality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).'}, {'id': 'OG001', 'title': 'Dance Group', 'description': 'The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '29', 'spread': '18.2', 'groupId': 'OG000'}, {'value': '41.3', 'spread': '18.8', 'groupId': 'OG001'}]}]}, {'title': 'After 16 weeks', 'categories': [{'measurements': [{'value': '30.7', 'spread': '18.1', 'groupId': 'OG000'}, {'value': '50', 'spread': '22.8', 'groupId': 'OG001'}]}]}, {'title': 'After 32 weeks', 'categories': [{'measurements': [{'value': '37.1', 'spread': '21.8', 'groupId': 'OG000'}, {'value': '47.6', 'spread': '24.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.082', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Differences in the behavior of the groups over time.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline, after 16 weeks and after 32 weeks', 'description': 'score between 0 from 100, with higher scores denoting better quality of life', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life - SF-36 - Social Aspects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).'}, {'id': 'OG001', 'title': 'Dance Group', 'description': 'The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '47.6', 'spread': '23.1', 'groupId': 'OG000'}, {'value': '52.6', 'spread': '27.7', 'groupId': 'OG001'}]}]}, {'title': 'After 16 weeks', 'categories': [{'measurements': [{'value': '47.6', 'spread': '24.5', 'groupId': 'OG000'}, {'value': '64.1', 'spread': '28', 'groupId': 'OG001'}]}]}, {'title': 'After 32 weeks', 'categories': [{'measurements': [{'value': '51.3', 'spread': '25.5', 'groupId': 'OG000'}, {'value': '57.2', 'spread': '27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.055', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Differences in the behavior of the groups over time.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline, after 16 weeks and after 32 weeks', 'description': 'score between 0 from 100, with higher scores denoting better quality of life', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life - SF-36 - Emotional Aspects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).'}, {'id': 'OG001', 'title': 'Dance Group', 'description': 'The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '21.2', 'spread': '33.1', 'groupId': 'OG000'}, {'value': '34.2', 'spread': '36.9', 'groupId': 'OG001'}]}]}, {'title': 'After 16 weeks', 'categories': [{'measurements': [{'value': '17.5', 'spread': '26.1', 'groupId': 'OG000'}, {'value': '55', 'spread': '33.6', 'groupId': 'OG001'}]}]}, {'title': 'After 32 weeks', 'categories': [{'measurements': [{'value': '31.5', 'spread': '38.7', 'groupId': 'OG000'}, {'value': '51.9', 'spread': '39.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Differences in the behavior of the groups over time.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline, after 16 weeks and after 32 weeks', 'description': 'score between 0 from 100, with higher scores denoting better quality of life', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life - SF-36 - Mental Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).'}, {'id': 'OG001', 'title': 'Dance Group', 'description': 'The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '43.4', 'spread': '24', 'groupId': 'OG000'}, {'value': '46', 'spread': '19.9', 'groupId': 'OG001'}]}]}, {'title': 'After 16 weeks', 'categories': [{'measurements': [{'value': '44.5', 'spread': '26.6', 'groupId': 'OG000'}, {'value': '54.2', 'spread': '20.7', 'groupId': 'OG001'}]}]}, {'title': 'After 32 weeks', 'categories': [{'measurements': [{'value': '46.2', 'spread': '22.6', 'groupId': 'OG000'}, {'value': '52.3', 'spread': '20.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.021', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Differences in the behavior of the groups over time.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline, after 16 weeks and after 32 weeks', 'description': 'score between 0 from 100, with higher scores denoting better quality of life', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Depression - Beck Inventory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).'}, {'id': 'OG001', 'title': 'Dance Group', 'description': 'The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '21.2', 'spread': '13', 'groupId': 'OG000'}, {'value': '23.9', 'spread': '14.7', 'groupId': 'OG001'}]}]}, {'title': 'After 16 weeks', 'categories': [{'measurements': [{'value': '23.5', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '20.2', 'spread': '13.2', 'groupId': 'OG001'}]}]}, {'title': 'After 32 weeks', 'categories': [{'measurements': [{'value': '23.5', 'spread': '13.7', 'groupId': 'OG000'}, {'value': '23.1', 'spread': '15.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.136', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Differences in the behavior of the groups over time.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, after 16 weeks and after 32 weeks', 'description': 'score between 0 from 63, with higher score indicating greater depression', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self-image - Body Dysmorphic Disorder Examination Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).'}, {'id': 'OG001', 'title': 'Dance Group', 'description': 'The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '48.8', 'spread': '34.2', 'groupId': 'OG000'}, {'value': '42.8', 'spread': '32.6', 'groupId': 'OG001'}]}]}, {'title': 'After 16 weeks', 'categories': [{'measurements': [{'value': '50.5', 'spread': '29.4', 'groupId': 'OG000'}, {'value': '33.6', 'spread': '25.9', 'groupId': 'OG001'}]}]}, {'title': 'After 32 weeks', 'categories': [{'measurements': [{'value': '46.9', 'spread': '31.8', 'groupId': 'OG000'}, {'value': '41.1', 'spread': '24.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Differences in the behavior of the groups over time.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, after 16 weeks and after 32 weeks', 'description': 'scored between 0 from 168, with higher scores indicating greater level of dissatisfaction with self-image', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Group', 'description': 'The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).'}, {'id': 'FG001', 'title': 'Dance Group', 'description': 'The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The recruitment of patients started in August 2007 and finished in April 2008. The recruitment was made in Sao Paulo Hospital division of Rheumatology'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group Control', 'description': 'The waiting list'}, {'id': 'BG001', 'title': 'Dance Group', 'description': 'The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.1', 'spread': '11.5', 'groupId': 'BG000'}, {'value': '49.5', 'spread': '10.9', 'groupId': 'BG001'}, {'value': '49.3', 'spread': '11.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-19', 'studyFirstSubmitDate': '2009-04-30', 'resultsFirstSubmitDate': '2009-04-30', 'studyFirstSubmitQcDate': '2009-08-18', 'lastUpdatePostDateStruct': {'date': '2009-08-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-08-18', 'studyFirstPostDateStruct': {'date': '2009-08-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale for Pain', 'timeFrame': 'baseline, after 16 weeks and after 32 weeks', 'description': 'score between 0 and 100 where 0 is no pain and 100 in unbearable pain'}], 'secondaryOutcomes': [{'measure': 'Function - 6 Minute Walk Test', 'timeFrame': 'baseline, after 16 weeks and after 32 weeks', 'description': 'meters traveled on a 20-meter course over a six-minute period'}, {'measure': 'Quality of Life - Fibromyalgia Impact Questionnaire', 'timeFrame': 'baseline, after 16 weeks and after 32 weeks', 'description': 'score between 0 from 10 with 0 indicating no impairment and 10 indicating maximum impairment'}, {'measure': 'Quality of Life - SF-36 -Functional Capacity', 'timeFrame': 'baseline, after 16 weeks and after 32 weeks', 'description': 'score between 0 from 100, with higher scores denoting better quality of life'}, {'measure': 'Quality of Life - SF-36 - Physical Limitation', 'timeFrame': 'baseline, after 16 weeks and after 32 weeks', 'description': 'score between 0 from 100, with higher scores denoting better quality of life'}, {'measure': 'Quality of Life - Sf-36 - Pain', 'timeFrame': 'baseline, after 16 weeks and after 32 weeks', 'description': 'score between 0 from 100, with higher scores denoting better quality of life'}, {'measure': 'Quality of Life - Sf-36 - General Health State', 'timeFrame': 'baseline, after 16 weeks and after 32 weeks', 'description': 'score between 0 from 100, with higher scores denoting better quality of life'}, {'measure': 'Quality of Life - SF-36 - Vitality', 'timeFrame': 'baseline, after 16 weeks and after 32 weeks', 'description': 'score between 0 from 100, with higher scores denoting better quality of life'}, {'measure': 'Quality of Life - SF-36 - Social Aspects', 'timeFrame': 'baseline, after 16 weeks and after 32 weeks', 'description': 'score between 0 from 100, with higher scores denoting better quality of life'}, {'measure': 'Quality of Life - SF-36 - Emotional Aspects', 'timeFrame': 'baseline, after 16 weeks and after 32 weeks', 'description': 'score between 0 from 100, with higher scores denoting better quality of life'}, {'measure': 'Quality of Life - SF-36 - Mental Health', 'timeFrame': 'baseline, after 16 weeks and after 32 weeks', 'description': 'score between 0 from 100, with higher scores denoting better quality of life'}, {'measure': 'Depression - Beck Inventory', 'timeFrame': 'Baseline, after 16 weeks and after 32 weeks', 'description': 'score between 0 from 63, with higher score indicating greater depression'}, {'measure': 'Self-image - Body Dysmorphic Disorder Examination Questionnaire', 'timeFrame': 'Baseline, after 16 weeks and after 32 weeks', 'description': 'scored between 0 from 168, with higher scores indicating greater level of dissatisfaction with self-image'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fibromyalgia', 'Treatment', 'Dance', 'Randomized controlled study', 'Exercise'], 'conditions': ['Fibromyalgia']}, 'referencesModule': {'references': [{'pmid': '23020850', 'type': 'DERIVED', 'citation': 'Baptista AS, Villela AL, Jones A, Natour J. Effectiveness of dance in patients with fibromyalgia: a randomized, single-blind, controlled study. Clin Exp Rheumatol. 2012 Nov-Dec;30(6 Suppl 74):18-23. Epub 2012 Dec 14.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to assess the effectiveness of belly dance as a treatment for pain and improving the quality of life of patients with fibromyalgia.\n\nEighty female patients with fibromyalgia between 18 to 65 years were randomly allocated to a dance group (n=40) and control group (n=40). Patients in the dance group underwent 16 weeks of belly dance twice a week, while the patients in the control group remained on a waiting list. Patients were evaluated with regard to pain (Visual Analogue Scale), function (6 minute walk test), quality of life (Fibromyalgia Impact Questionnaire and SF-36), depression (Beck Inventory), anxiety (State-Trait Anxiety Inventory) and self-image (Body Dysmorphic Disorder Examination) questionnaire. Evaluations were carried out at baseline, after 16 weeks and after 32 weeks.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* classification of fibromyalgia based on the criteria of the American College of Rheumatology\n* female gender\n* aged between 18 and 65 years\n\nExclusion Criteria:\n\n* not having altered treatment in previous three years\n* having signed a term of informed consent\n* patients with other rheumatic diseases, painful osteoarticular conditions, uncontrolled cardiopulmonary disease, diseases of the lower limbs or uncontrolled diabetes were excluded'}, 'identificationModule': {'nctId': 'NCT00961805', 'briefTitle': 'Effectiveness of Dance on Patients With Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Effectiveness of Dance on Patients With Fibromyalgia', 'orgStudyIdInfo': {'id': '1044/06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dance Group', 'description': 'Belly dance', 'interventionNames': ['Behavioral: Dance']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Waiting list', 'interventionNames': ['Other: Control Group']}], 'interventions': [{'name': 'Dance', 'type': 'BEHAVIORAL', 'description': 'Belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.', 'armGroupLabels': ['Dance Group']}, {'name': 'Control Group', 'type': 'OTHER', 'description': 'The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04023-090', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Federal University of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Andreia S Baptista, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of São Paulo'}, {'name': 'Jamil Natour, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Federal University of São Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Andreia Salvador Baptista', 'oldOrganization': 'Federal Unversity of Sao Paulo'}}}}