Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-02-19 @ 5:16 PM
Study NCT ID:
NCT03972969
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2019-05-31
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Highly Challenging Balance Program to Reduce Fall Rate in PD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'david.sparrow@va.gov', 'phone': '857-364-6407', 'title': 'Dr. David Sparrow', 'organization': 'VA Boston Healthcare System'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events collected over the 6-month participation period', 'eventGroups': [{'id': 'EG000', 'title': 'In-person Exercise Group', 'description': 'facility-based structured exercise program\n\nFacility-based structured exercise: Structured exercise program in a facility with instruction and encouragement', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'deathsNumAffected': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Remote Exercise Group', 'description': 'home-based structured exercise program\n\nHome-based structured exercise: Structured exercise program in the home with instruction and encouragement', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 0, 'seriousNumAtRisk': 58, 'deathsNumAffected': 2, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Control Group', 'description': 'health education\n\nHealth education: Provision of general information about a variety of topics', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 0, 'seriousNumAtRisk': 53, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Falls Over 3 Month Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'In-person Exercise Group', 'description': 'facility-based structured exercise program\n\nFacility-based structured exercise: Structured exercise program in a facility with instruction and encouragement'}, {'id': 'OG001', 'title': 'Remote Exercise Group', 'description': 'home-based structured exercise program\n\nHome-based structured exercise: Structured exercise program in the home with instruction and encouragement'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'health education\n\nHealth education: Provision of general information about a variety of topics'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '3.0', 'groupId': 'OG001'}, {'value': '9.7', 'spread': '48.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Incidence Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '0.05', 'ciUpperLimit': '0.32', 'statisticalMethod': 'negative binomial regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.05', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Incidence Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.25', 'ciLowerLimit': '0.10', 'ciUpperLimit': '0.61', 'statisticalMethod': 'negative binomial regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.52', 'ciLowerLimit': '0.19', 'ciUpperLimit': '1.38', 'statisticalMethod': 'negative binomial regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 3 months', 'description': 'Total number of falls from baseline to the 3-month follow-up. Falls are defined as unexpected events in which the participants come to rest on the ground, floor, or lower level.', 'unitOfMeasure': 'number of falls', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Falls Over 6 Month Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'In-person Exercise Group', 'description': 'facility-based structured exercise program\n\nFacility-based structured exercise: Structured exercise program in a facility with instruction and encouragement'}, {'id': 'OG001', 'title': 'Remote Exercise Group', 'description': 'home-based structured exercise program\n\nHome-based structured exercise: Structured exercise program in the home with instruction and encouragement'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'health education\n\nHealth education: Provision of general information about a variety of topics'}], 'classes': [{'categories': [{'measurements': [{'value': '2.08', 'spread': '3.46', 'groupId': 'OG000'}, {'value': '3.02', 'spread': '6.32', 'groupId': 'OG001'}, {'value': '11.36', 'spread': '49.55', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Incidence Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '0.07', 'ciUpperLimit': '0.33', 'statisticalMethod': 'negative binomial regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.05', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Incidence Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.26', 'ciLowerLimit': '0.11', 'ciUpperLimit': '0.58', 'statisticalMethod': 'negative binomial regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.58', 'ciLowerLimit': '0.25', 'ciUpperLimit': '1.38', 'statisticalMethod': 'negative binomial regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months', 'description': 'Total number of falls from baseline to the 6-month follow-up. Falls are defined as unexpected events in which the participants come to rest on the ground, floor, or lower level.', 'unitOfMeasure': 'number of falls', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'In-person Exercise Group', 'description': 'facility-based structured exercise program\n\nFacility-based structured exercise: Structured exercise program in a facility with instruction and encouragement'}, {'id': 'FG001', 'title': 'Remote Exercise Group', 'description': 'home-based structured exercise program\n\nHome-based structured exercise: Structured exercise program in the home with instruction and encouragement'}, {'id': 'FG002', 'title': 'Control Group', 'description': 'health education\n\nHealth education: Provision of general information about a variety of topics'}], 'periods': [{'title': '3-month Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': '6-month Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '54'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '162', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'In-person Exercise Group', 'description': 'facility-based structured exercise program\n\nFacility-based structured exercise: Structured exercise program in a facility with instruction and encouragement'}, {'id': 'BG001', 'title': 'Remote Exercise Group', 'description': 'home-based structured exercise program\n\nHome-based structured exercise: Structured exercise program in the home with instruction and encouragement'}, {'id': 'BG002', 'title': 'Control Group', 'description': 'health education\n\nHealth education: Provision of general information about a variety of topics'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.5', 'spread': '7.0', 'groupId': 'BG000'}, {'value': '76.2', 'spread': '7.2', 'groupId': 'BG001'}, {'value': '73.2', 'spread': '7.7', 'groupId': 'BG002'}, {'value': '74.4', 'spread': '7.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '160', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity', 'categories': [{'title': 'White Non-Hispanic', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '160', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-16', 'size': 212060, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-02-27T11:52', 'hasProtocol': True}, {'date': '2022-04-11', 'size': 298808, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-06-06T13:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-28', 'studyFirstSubmitDate': '2019-05-31', 'resultsFirstSubmitDate': '2024-02-28', 'studyFirstSubmitQcDate': '2019-05-31', 'lastUpdatePostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-28', 'studyFirstPostDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Falls Over 3 Month Period', 'timeFrame': 'Baseline to 3 months', 'description': 'Total number of falls from baseline to the 3-month follow-up. Falls are defined as unexpected events in which the participants come to rest on the ground, floor, or lower level.'}], 'secondaryOutcomes': [{'measure': 'Number of Falls Over 6 Month Period', 'timeFrame': 'Baseline to 6 months', 'description': 'Total number of falls from baseline to the 6-month follow-up. Falls are defined as unexpected events in which the participants come to rest on the ground, floor, or lower level.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Parkinson's disease", 'Exercise therapy', 'Accidental falls'], 'conditions': ["Parkinson's Disease"]}, 'referencesModule': {'references': [{'pmid': '38588457', 'type': 'DERIVED', 'citation': "Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3."}, {'pmid': '36602886', 'type': 'DERIVED', 'citation': "Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2."}]}, 'descriptionModule': {'briefSummary': "This study will test the hypothesis that two highly challenging exercise programs, one based at the VA medical center and the other conducted remotely, will both significantly reduce overall fall rates in patients with Parkinson's disease.", 'detailedDescription': "Background/Rationale. Parkinson's disease (PD) is the second most common neurodegenerative disease, affecting over one million Americans. The cardinal clinical manifestations of PD include resting tremor, rigidity, bradykinesia, and postural instability/gait disturbance. In addition, people with PD fall frequently, with 60% falling annually and two-thirds of these falling recurrently. Identifying interventions that successfully improve postural control and reduce fall rate is critical to reduce disability, improve quality of life, and potentially increase survival in patients with PD. Recent randomized, controlled trials (RCT) have examined the effects of exercise and physical therapy interventions on reducing falls in patients with PD; however, with mixed results.\n\nObjectives. There is a limited availability of effective treatment options to reduce falls in PD. In this context, some studies suggest that highly challenging exercise approaches may lead to better outcomes. The investigators propose investigating the effects of two theoretically driven, progressive, highly challenging exercise programs: 1) a structured exercise program at the VA and 2) a structured exercise program at home. There will also be a control group in which health education is provided.\n\nMethods. The investigators propose to conduct an RCT evaluating effects on fall rate. A total of 162 VA patients with mild-to-moderate PD will be randomly assigned to one of the three 3-month interventions: in-person exercise at the VA, remotely-delivered exercise, or health education. Outcomes will be compared between each intervention group and the control group. Fall rates will be compared between groups with the use of negative binomial regression models."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physician diagnosis of idiopathic PD\n* At least 2 of the 3 cardinal signs of PD (resting tremor, rigidity, bradykinesia)\n* Response to dopaminergic medication\n\nExclusion Criteria:\n\n* Angina pectoris\n* History of myocardial infarction (MI) within 6 months\n* History of ventricular dysrhythmia requiring current therapy'}, 'identificationModule': {'nctId': 'NCT03972969', 'briefTitle': 'Highly Challenging Balance Program to Reduce Fall Rate in PD', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Highly Challenging Balance Program to Reduce Fall Rate in PD', 'orgStudyIdInfo': {'id': 'E3055-R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'In-person exercise group', 'description': 'facility-based structured exercise program', 'interventionNames': ['Behavioral: Facility-based structured exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Remote exercise group', 'description': 'home-based structured exercise program', 'interventionNames': ['Behavioral: Home-based structured exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'health education', 'interventionNames': ['Behavioral: Health education']}], 'interventions': [{'name': 'Facility-based structured exercise', 'type': 'BEHAVIORAL', 'description': 'Structured exercise program in a facility with instruction and encouragement', 'armGroupLabels': ['In-person exercise group']}, {'name': 'Home-based structured exercise', 'type': 'BEHAVIORAL', 'description': 'Structured exercise program in the home with instruction and encouragement', 'armGroupLabels': ['Remote exercise group']}, {'name': 'Health education', 'type': 'BEHAVIORAL', 'description': 'Provision of general information about a variety of topics', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02130-4817', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'David Sparrow, DSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}