Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2025-12-31 @ 6:44 AM
Study NCT ID:
NCT01768832
Status:
COMPLETED
Last Update Posted:
2018-11-19
First Post:
2013-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Exercise and Parkinson's: Comparing Interventions and Exploring Neural Mechanisms
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005080', 'term': 'Exercise Test'}, {'id': 'D051784', 'term': 'Aryl Hydrocarbon Receptor Nuclear Translocator'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D029543', 'term': 'Nucleocytoplasmic Transport Proteins'}, {'id': 'D026901', 'term': 'Membrane Transport Proteins'}, {'id': 'D002352', 'term': 'Carrier Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D051793', 'term': 'Hypoxia-Inducible Factor 1'}, {'id': 'D051792', 'term': 'Basic Helix-Loop-Helix Transcription Factors'}, {'id': 'D004268', 'term': 'DNA-Binding Proteins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D014157', 'term': 'Transcription Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'earhartg@wustl.edu', 'phone': '314-286-1407', 'title': 'Dr. Gammon M. Earhart', 'organization': 'Washington University in St. Louis'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Through study completion, an average of 6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Treadmill', 'description': 'Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.\n\nTreadmill', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Tango', 'description': 'Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.\n\nTango', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Stretching', 'description': 'Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.\n\nStretching', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Walking Velocity at Baseline and 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treadmill', 'description': 'Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.\n\nTreadmill'}, {'id': 'OG001', 'title': 'Tango', 'description': 'Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.\n\nTango'}, {'id': 'OG002', 'title': 'Stretching', 'description': 'Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.\n\nStretching'}], 'classes': [{'title': 'Baseline Forward Walking Velocity', 'categories': [{'measurements': [{'value': '103.28', 'spread': '4.67', 'groupId': 'OG000'}, {'value': '104.53', 'spread': '3.92', 'groupId': 'OG001'}, {'value': '111.21', 'spread': '3.81', 'groupId': 'OG002'}]}]}, {'title': 'Forward Walking Velocity at 3 months', 'categories': [{'measurements': [{'value': '109.57', 'spread': '4.65', 'groupId': 'OG000'}, {'value': '103.36', 'spread': '4.21', 'groupId': 'OG001'}, {'value': '110.52', 'spread': '5.02', 'groupId': 'OG002'}]}]}, {'title': 'Baseline Backward Walking Velocity', 'categories': [{'measurements': [{'value': '63.45', 'spread': '4.22', 'groupId': 'OG000'}, {'value': '60.80', 'spread': '3.70', 'groupId': 'OG001'}, {'value': '65.17', 'spread': '4.60', 'groupId': 'OG002'}]}]}, {'title': 'Backward Walking Velocity at 3 months', 'categories': [{'measurements': [{'value': '64.89', 'spread': '3.72', 'groupId': 'OG000'}, {'value': '71.87', 'spread': '4.83', 'groupId': 'OG001'}, {'value': '75.17', 'spread': '6.69', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 and 3 months', 'description': 'Walking velocity during forward and backward walking as determined by a computerized mat.', 'unitOfMeasure': 'cm/sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Blood Oxygen Level Dependent Signal at Baseline to 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treadmill', 'description': 'Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.\n\nTreadmill'}, {'id': 'OG001', 'title': 'Tango', 'description': 'Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.\n\nTango'}, {'id': 'OG002', 'title': 'Stretching', 'description': 'Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.\n\nStretching'}], 'classes': [{'title': 'Bold Signal at Baseline in Primary Motor Cortex', 'categories': [{'measurements': [{'value': '.110', 'spread': '.165', 'groupId': 'OG000'}, {'value': '.043', 'spread': '.255', 'groupId': 'OG001'}, {'value': '.095', 'spread': '.307', 'groupId': 'OG002'}]}]}, {'title': 'Bold Signal at 3 months in Primary Motor Cortex', 'categories': [{'measurements': [{'value': '.126', 'spread': '.246', 'groupId': 'OG000'}, {'value': '.111', 'spread': '.242', 'groupId': 'OG001'}, {'value': '.117', 'spread': '.159', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 and 3 months', 'description': 'Measure of the ratio of oxygenated to deoxygenated blood in areas of the brain at a specific time. Used as an indirect assessment of brain activity and connections. Higher values indicate more brain activity in the brain areas of interest.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to issues with data quality related to head movement while in the MRI scanner, we had a limited numbers of participants in each group with usable MRI data.'}, {'type': 'SECONDARY', 'title': 'Mini Balance Evaluation Systems Test (Mini-BESTest) at Baseline and 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treadmill', 'description': 'Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.\n\nTreadmill'}, {'id': 'OG001', 'title': 'Tango', 'description': 'Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.\n\nTango'}, {'id': 'OG002', 'title': 'Stretching', 'description': 'Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.\n\nStretching'}], 'classes': [{'title': 'MiniBEST at baseline', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '15.5', 'upperLimit': '21.5'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '21'}, {'value': '20', 'groupId': 'OG002', 'lowerLimit': '18', 'upperLimit': '22'}]}]}, {'title': 'MiniBESTest at 3 months', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '23'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '22.5'}, {'value': '21', 'groupId': 'OG002', 'lowerLimit': '18.25', 'upperLimit': '22.75'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0 and 3 months', 'description': 'The Mini Balance Evaluation Systems Test (Mini-BESTest) is a clinical assessment of balance ability. Score range from 0 to 28 with higher scores indicating better balance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'PDQ-39 Scores at Baseline and 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treadmill', 'description': 'Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.\n\nTreadmill'}, {'id': 'OG001', 'title': 'Tango', 'description': 'Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.\n\nTango'}, {'id': 'OG002', 'title': 'Stretching', 'description': 'Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.\n\nStretching'}], 'classes': [{'title': 'PDQ-39 at baseline', 'categories': [{'measurements': [{'value': '19.22', 'spread': '2.71', 'groupId': 'OG000'}, {'value': '18.33', 'spread': '1.89', 'groupId': 'OG001'}, {'value': '16.30', 'spread': '1.86', 'groupId': 'OG002'}]}]}, {'title': 'PDQ-39 at 3 months', 'categories': [{'measurements': [{'value': '17.86', 'spread': '2.41', 'groupId': 'OG000'}, {'value': '18.80', 'spread': '1.85', 'groupId': 'OG001'}, {'value': '16.39', 'spread': '2.35', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 and 3 months', 'description': 'The Parkinson Disease Quality of Life Questionnaire is a 39-item tool rating quality of life with higher scores indicating better quality of life. Scores range from 0 to 195.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at Baseline to 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treadmill', 'description': 'Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.\n\nTreadmill'}, {'id': 'OG001', 'title': 'Tango', 'description': 'Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.\n\nTango'}, {'id': 'OG002', 'title': 'Stretching', 'description': 'Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.\n\nStretching'}], 'classes': [{'title': 'MDS-UPDRS-III at baseline', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '41.5'}, {'value': '37', 'groupId': 'OG001', 'lowerLimit': '29.5', 'upperLimit': '41.5'}, {'value': '38', 'groupId': 'OG002', 'lowerLimit': '33.25', 'upperLimit': '44.5'}]}]}, {'title': 'MDS-UPDRS-III at 3 months', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '39'}, {'value': '33', 'groupId': 'OG001', 'lowerLimit': '27.5', 'upperLimit': '41.5'}, {'value': '33', 'groupId': 'OG002', 'lowerLimit': '27.25', 'upperLimit': '38'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0 and 3 months', 'description': 'The Movement Disorder Society Unified Parkinson Disease Rating Scale - Subscale III is a standardized rating of motor symptom severity in Parkinson disease. Scores range from 0 to 132 with higher scores being worse, i.e. higher scores indicate more severe disease.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mini Balance Evaluation Systems Test (Mini-BESTest) at 3 and 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treadmill', 'description': 'Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.\n\nTreadmill'}, {'id': 'OG001', 'title': 'Tango', 'description': 'Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.\n\nTango'}, {'id': 'OG002', 'title': 'Stretching', 'description': 'Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.\n\nStretching'}], 'classes': [{'title': 'MiniBESTest at 3 months', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '23'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '23'}, {'value': '21', 'groupId': 'OG002', 'lowerLimit': '18.5', 'upperLimit': '23'}]}]}, {'title': 'MiniBESTest at 6 months', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '22'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '22'}, {'value': '20', 'groupId': 'OG002', 'lowerLimit': '18', 'upperLimit': '21'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 and 6 months', 'description': 'The Mini Balance Evaluation Systems Test (Mini-BESTest) is a clinical assessment of balance ability. Score range from 0 to 28 with higher scores indicating better balance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at 3 Months and 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treadmill', 'description': 'Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.\n\nTreadmill'}, {'id': 'OG001', 'title': 'Tango', 'description': 'Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.\n\nTango'}, {'id': 'OG002', 'title': 'Stretching', 'description': 'Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.\n\nStretching'}], 'classes': [{'title': 'MDS-UPDRS-III at 3 months', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '38'}, {'value': '32', 'groupId': 'OG001', 'lowerLimit': '27', 'upperLimit': '39.25'}, {'value': '33', 'groupId': 'OG002', 'lowerLimit': '27', 'upperLimit': '38.5'}]}]}, {'title': 'MDS-UPDRS-III at 6 months', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '27', 'upperLimit': '40'}, {'value': '35', 'groupId': 'OG001', 'lowerLimit': '28.75', 'upperLimit': '41.25'}, {'value': '38', 'groupId': 'OG002', 'lowerLimit': '28.5', 'upperLimit': '44'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 and 6 months', 'description': 'The Movement Disorder Society Unified Parkinson Disease Rating Scale - Subscale III is a standardized rating of motor symptom severity in Parkinson disease. Scores range from 0 to 132 with higher scores being worse, i.e. higher scores indicate more severe disease.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis included only participants who completed the study visit at the six month time point.'}, {'type': 'SECONDARY', 'title': 'PDQ-39 Scores at 3 Months and 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treadmill', 'description': 'Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.\n\nTreadmill'}, {'id': 'OG001', 'title': 'Tango', 'description': 'Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.\n\nTango'}, {'id': 'OG002', 'title': 'Stretching', 'description': 'Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.\n\nStretching'}], 'classes': [{'title': 'PDQ-39 at 3 months', 'categories': [{'measurements': [{'value': '17.86', 'spread': '2.41', 'groupId': 'OG000'}, {'value': '18.80', 'spread': '1.85', 'groupId': 'OG001'}, {'value': '16.39', 'spread': '2.35', 'groupId': 'OG002'}]}]}, {'title': 'PDQ-39 at 6 months', 'categories': [{'measurements': [{'value': '12.66', 'spread': '2.41', 'groupId': 'OG000'}, {'value': '19.20', 'spread': '1.75', 'groupId': 'OG001'}, {'value': '9.33', 'spread': '1.40', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 and 6 months', 'description': 'The Parkinson Disease Quality of Life Questionnaire is a 39-item tool rating quality of life with higher scores indicating better quality of life. Scores range from 0 to 195.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Walking Velocity at 3 Months and 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treadmill', 'description': 'Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.\n\nTreadmill'}, {'id': 'OG001', 'title': 'Tango', 'description': 'Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.\n\nTango'}, {'id': 'OG002', 'title': 'Stretching', 'description': 'Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.\n\nStretching'}], 'classes': [{'title': 'Forward Walking Velocity at 3 months', 'categories': [{'measurements': [{'value': '116.7', 'groupId': 'OG000', 'lowerLimit': '10.7', 'upperLimit': '128.5'}, {'value': '109.7', 'groupId': 'OG001', 'lowerLimit': '93.73', 'upperLimit': '123.5'}, {'value': '111.6', 'groupId': 'OG002', 'lowerLimit': '101.4', 'upperLimit': '125.5'}]}]}, {'title': 'Forward Walking Velocity at 6 months', 'categories': [{'measurements': [{'value': '113.9', 'groupId': 'OG000', 'lowerLimit': '102', 'upperLimit': '125.7'}, {'value': '108.4', 'groupId': 'OG001', 'lowerLimit': '89.33', 'upperLimit': '124.9'}, {'value': '117', 'groupId': 'OG002', 'lowerLimit': '104.6', 'upperLimit': '126'}]}]}, {'title': 'Backward Walking Velocity at 3 months', 'categories': [{'measurements': [{'value': '78.8', 'groupId': 'OG000', 'lowerLimit': '60.3', 'upperLimit': '95.1'}, {'value': '67.8', 'groupId': 'OG001', 'lowerLimit': '54.05', 'upperLimit': '79.4'}, {'value': '73.4', 'groupId': 'OG002', 'lowerLimit': '55.05', 'upperLimit': '87.95'}]}]}, {'title': 'Backward Walking Velocity at 6 months', 'categories': [{'measurements': [{'value': '74.2', 'groupId': 'OG000', 'lowerLimit': '60.4', 'upperLimit': '95.8'}, {'value': '70.3', 'groupId': 'OG001', 'lowerLimit': '44.93', 'upperLimit': '81.43'}, {'value': '68.2', 'groupId': 'OG002', 'lowerLimit': '55.05', 'upperLimit': '89.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 and 6 months', 'description': 'Walking velocity during forward and backward walking as determined by a computerized mat.', 'unitOfMeasure': 'cm/sec', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis included only those participants who completed the 6 month visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treadmill', 'description': 'Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.\n\nTreadmill'}, {'id': 'FG001', 'title': 'Tango', 'description': 'Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.\n\nTango'}, {'id': 'FG002', 'title': 'Stretching', 'description': 'Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.\n\nStretching'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '96', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Treadmill', 'description': 'Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.\n\nTreadmill'}, {'id': 'BG001', 'title': 'Tango', 'description': 'Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.\n\nTango'}, {'id': 'BG002', 'title': 'Stretching', 'description': 'Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.\n\nStretching'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.52', 'spread': '9.54', 'groupId': 'BG000'}, {'value': '66.73', 'spread': '9.52', 'groupId': 'BG001'}, {'value': '66.18', 'spread': '7.30', 'groupId': 'BG002'}, {'value': '67.16', 'spread': '8.94', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '95', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Disease Duration', 'classes': [{'categories': [{'measurements': [{'value': '5.59', 'spread': '3.81', 'groupId': 'BG000'}, {'value': '6.10', 'spread': '4.82', 'groupId': 'BG001'}, {'value': '4.40', 'spread': '5.04', 'groupId': 'BG002'}, {'value': '5.47', 'spread': '4.59', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "Years since being diagnosed with Parkinson's disease", 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'We analyzed baseline data only from those participants who completed at least the first 3 months of the 6 months study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-12-01', 'size': 798236, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-09-13T19:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-14', 'studyFirstSubmitDate': '2013-01-08', 'resultsFirstSubmitDate': '2018-08-17', 'studyFirstSubmitQcDate': '2013-01-11', 'lastUpdatePostDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-14', 'studyFirstPostDateStruct': {'date': '2013-01-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Walking Velocity at Baseline and 3 Months', 'timeFrame': '0 and 3 months', 'description': 'Walking velocity during forward and backward walking as determined by a computerized mat.'}], 'secondaryOutcomes': [{'measure': 'Blood Oxygen Level Dependent Signal at Baseline to 3 Months', 'timeFrame': '0 and 3 months', 'description': 'Measure of the ratio of oxygenated to deoxygenated blood in areas of the brain at a specific time. Used as an indirect assessment of brain activity and connections. Higher values indicate more brain activity in the brain areas of interest.'}, {'measure': 'Mini Balance Evaluation Systems Test (Mini-BESTest) at Baseline and 3 Months', 'timeFrame': '0 and 3 months', 'description': 'The Mini Balance Evaluation Systems Test (Mini-BESTest) is a clinical assessment of balance ability. Score range from 0 to 28 with higher scores indicating better balance.'}, {'measure': 'PDQ-39 Scores at Baseline and 3 Months', 'timeFrame': '0 and 3 months', 'description': 'The Parkinson Disease Quality of Life Questionnaire is a 39-item tool rating quality of life with higher scores indicating better quality of life. Scores range from 0 to 195.'}, {'measure': 'Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at Baseline to 3 Months', 'timeFrame': '0 and 3 months', 'description': 'The Movement Disorder Society Unified Parkinson Disease Rating Scale - Subscale III is a standardized rating of motor symptom severity in Parkinson disease. Scores range from 0 to 132 with higher scores being worse, i.e. higher scores indicate more severe disease.'}, {'measure': 'Mini Balance Evaluation Systems Test (Mini-BESTest) at 3 and 6 Months', 'timeFrame': '3 and 6 months', 'description': 'The Mini Balance Evaluation Systems Test (Mini-BESTest) is a clinical assessment of balance ability. Score range from 0 to 28 with higher scores indicating better balance.'}, {'measure': 'Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at 3 Months and 6 Months', 'timeFrame': '3 and 6 months', 'description': 'The Movement Disorder Society Unified Parkinson Disease Rating Scale - Subscale III is a standardized rating of motor symptom severity in Parkinson disease. Scores range from 0 to 132 with higher scores being worse, i.e. higher scores indicate more severe disease.'}, {'measure': 'PDQ-39 Scores at 3 Months and 6 Months', 'timeFrame': '3 and 6 months', 'description': 'The Parkinson Disease Quality of Life Questionnaire is a 39-item tool rating quality of life with higher scores indicating better quality of life. Scores range from 0 to 195.'}, {'measure': 'Walking Velocity at 3 Months and 6 Months', 'timeFrame': '3 and 6 months', 'description': 'Walking velocity during forward and backward walking as determined by a computerized mat.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Parkinson disease', 'walking', 'fMRI', 'exercise', 'dance', 'treadmill'], 'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '30531383', 'type': 'DERIVED', 'citation': 'Rawson KS, McNeely ME, Duncan RP, Pickett KA, Perlmutter JS, Earhart GM. Exercise and Parkinson Disease: Comparing Tango, Treadmill, and Stretching. J Neurol Phys Ther. 2019 Jan;43(1):26-32. doi: 10.1097/NPT.0000000000000245.'}, {'pmid': '25652002', 'type': 'DERIVED', 'citation': 'Earhart GM, Duncan RP, Huang JL, Perlmutter JS, Pickett KA. Comparing interventions and exploring neural mechanisms of exercise in Parkinson disease: a study protocol for a randomized controlled trial. BMC Neurol. 2015 Feb 5;15:9. doi: 10.1186/s12883-015-0261-0.'}]}, 'descriptionModule': {'briefSummary': 'Parkinson disease (PD) is characterized by substantial disability and reduced quality of life, both of which can be attributed in large part to difficulties with walking. Evidence suggests that exercise may be an important addition to traditional treatments, particularly with respect to addressing walking problems. In particular, dance and treadmill training have been individually shown to improve walking performance and quality of life. At present it is not clear whether dance or treadmill training have similar effects or if one is superior to the other. Furthermore, our understanding of the means by which these exercise interventions convey benefits is extremely limited. This study aims to address these knowledge gaps by directly comparing dance, treadmill training and stretching (control group). The primary area of interest is the effects on gait, with secondary measures of disease severity, balance, and quality of life. The investigators will determine not only the effects of the interventions on walking performance, but will also investigate the effects of the interventions on connections between different parts of the brain and on brain function during imagined walking tasks using functional magnetic resonance imaging (fMRI). Participants will be randomly assigned to dance, treadmill training, or a stretching/flexibility control group. Participants will be assessed over a period of 6 months at 3 different time points. The investigators hypothesize that both dance and treadmill training will lead to improvements in forward walking, but that dance will result in greater improvements in backward walking compared to treadmill training. Furthermore, the investigators hypothesize that the tango and treadmill interventions will have different effects of brain function and brain connections. The investigators expect dance to enhance the activity and connections of particular brain regions and treadmill training to enhance activity and connections of different brain regions. The investigators do not expect changes in brain activity or connections in the control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. diagnosis of Parkinson disease\n2. at least grade 3/5 strength and normal joint ranges of motion in both legs,\n3. vision corrected to 20/40 or better,\n4. able to walk independently for 10 feet with or without an assistive device, 5) normal gross somatosensory function in the feet (2-point discrimination, vibration, joint kinesthesia, and light touch),\n\n6\\) no history of vestibular disease, 7) no evidence of dementia\n\nExclusion Criteria:\n\n1. medical condition for which exercise is contraindicated,\n2. evidence of abnormality other than PD-related changes on brain imaging,\n3. history or evidence of neurological deficit other than PD that could interfere, such as previous stroke or muscle disease,\n4. history or evidence of orthopedic or muscular problem,\n5. failed to pass magnetic resonance imaging screening procedure'}, 'identificationModule': {'nctId': 'NCT01768832', 'briefTitle': "Exercise and Parkinson's: Comparing Interventions and Exploring Neural Mechanisms", 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': "Exercise and Parkinson's: Comparing Interventions and Exploring Neural Mechanisms", 'orgStudyIdInfo': {'id': '1R01NS077959-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01NS077959-01A1', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treadmill', 'description': 'Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.', 'interventionNames': ['Behavioral: Treadmill']}, {'type': 'EXPERIMENTAL', 'label': 'Tango', 'description': 'Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.', 'interventionNames': ['Behavioral: Tango']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stretching', 'description': 'Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.', 'interventionNames': ['Behavioral: Stretching']}], 'interventions': [{'name': 'Treadmill', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Treadmill']}, {'name': 'Tango', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Tango']}, {'name': 'Stretching', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Stretching']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63108', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Gammon M Earhart, PhD, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}