Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:47 PM
Study NCT ID:
NCT01639469
Status:
COMPLETED
Last Update Posted:
2017-06-23
First Post:
2012-07-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Telemedicine Intervention to Improve Physical Function
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 were collected over 1 year participation period.', 'eventGroups': [{'id': 'EG000', 'title': 'Structured Exercise', 'description': 'Structured exercise instruction by smartphone\n\nStructured exercise: Structured exercise includes stretching, strengthening, and balance exercises.', 'otherNumAtRisk': 89, 'deathsNumAtRisk': 89, 'otherNumAffected': 0, 'seriousNumAtRisk': 89, 'deathsNumAffected': 4, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Lifestyle Exercise', 'description': 'Lifestyle exercise program taught via smartphone\n\nLifestyle exercise: Subjects will be taught lifestyle exercises and advised about mobility strategies', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 0, 'seriousNumAtRisk': 80, 'deathsNumAffected': 2, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Falls During the 1-year Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Structured Exercise', 'description': 'Structured exercise instruction by smartphone\n\nStructured exercise: Structured exercise includes stretching, strengthening, and balance exercises.'}, {'id': 'OG001', 'title': 'Lifestyle Exercise', 'description': 'Lifestyle exercise program taught via smartphone\n\nLifestyle exercise: Subjects will be taught lifestyle exercises and advised about mobility strategies'}], 'classes': [{'categories': [{'measurements': [{'value': '1026', 'groupId': 'OG000'}, {'value': '1861', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.39', 'ciLowerLimit': '0.22', 'ciUpperLimit': '0.68', 'groupDescription': 'Testing to see if there is a significant difference in fall rates over 12months between the two groups.', 'statisticalMethod': 'Negative Binomial Regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'up to 1 year', 'description': 'Total number of falls over the 1-year follow-up; self-reported falls collected on a weekly basis and totaled over the follow-up period.', 'unitOfMeasure': 'Total count of falls', 'reportingStatus': 'POSTED', 'populationDescription': '2 participants not analyzed were excluded due to "early loss to follow-up" and had no fall data collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Structured Exercise', 'description': 'Structured exercise instruction by smartphone\n\nStructured exercise: Structured exercise includes stretching, strengthening, and balance exercises.'}, {'id': 'FG001', 'title': 'Lifestyle Exercise', 'description': 'Lifestyle exercise program taught via smartphone\n\nLifestyle exercise: Subjects will be taught lifestyle exercises and advised about mobility strategies'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '77'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Structured Exercise', 'description': 'Structured exercise instruction by smartphone\n\nStructured exercise: Structured exercise includes stretching, strengthening, and balance exercises.'}, {'id': 'BG001', 'title': 'Lifestyle Exercise', 'description': 'Lifestyle exercise program taught via smartphone\n\nLifestyle exercise: Subjects will be taught lifestyle exercises and advised about mobility strategies'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '71.5', 'spread': '9.4', 'groupId': 'BG000'}, {'value': '72.7', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '72.1', 'spread': '9.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 169}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-22', 'studyFirstSubmitDate': '2012-07-10', 'resultsFirstSubmitDate': '2017-04-04', 'studyFirstSubmitQcDate': '2012-07-11', 'lastUpdatePostDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-22', 'studyFirstPostDateStruct': {'date': '2012-07-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Falls During the 1-year Follow-up', 'timeFrame': 'up to 1 year', 'description': 'Total number of falls over the 1-year follow-up; self-reported falls collected on a weekly basis and totaled over the follow-up period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parkinson Disease', 'Quality of Life', 'Exercise Therapy'], 'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "This project is investigating whether a one-year in-home exercise program will reduce the rate of falls and improve strength and quality of life in patients with Parkinson's disease.", 'detailedDescription': "Background/Rationale:\n\nParkinson's disease (PD) is the second most common neurodegenerative disease, affecting over one million Americans. The cardinal clinical manifestations of PD are motoric, which limit functional mobility leading to difficulty working, caring for family members, managing a household, and overall decreased independence and quality of life (QOL). A wealth of growing data indicates tremendous benefits of exercise for patients with PD. Not only have exercise programs been shown to improve motor function and reduce the risk of falls, but also improve overall QOL and possibly the very course of disease pathology. However, programs that involve supervision in the home of people with PD are expensive to roll out widely, and programs that involve people with PD traveling to a central site not only result in non-compliance over time because of difficulty getting to the site, but also rule out the involvement of a large number of people with PD who simply live too far from larger centers where such programs are typically established.\n\nObjective:\n\nThe investigators hypothesize that a one-year in-home exercise program, centered around remote, real-time instruction and supervision, will reduce the rate of falls and improve strength and QOL in patients with PD.\n\nMethods:\n\nThe proposed study is a randomized controlled trial of a structured exercise program, evaluating effects on fall rate, physical functioning, and QOL. Community-dwelling people with PD will be randomized either to a group who receives structured and remote exercise instruction and supervision in real-time or a group who is taught a lifestyle exercise program. Subjects will be male and female Veterans with a physician diagnosis of idiopathic, typical PD, with at least 2 of 3 cardinal signs of PD, and response to dopaminergic medication. The interventions will last one year."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Physician diagnosis of idiopathic, typical Parkinson's disease (PD)\n* At least 2 of 3 cardinal signs of PD\n* Response to dopaminergic medication\n\nExclusion Criteria:\n\n* Angina pectoris\n* History of myocardial infarction within 6 months\n* History of ventricular dysrhythmia requiring current therapy"}, 'identificationModule': {'nctId': 'NCT01639469', 'briefTitle': 'Telemedicine Intervention to Improve Physical Function', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'A Telemedicine Intervention to Improve Physical Function in Patients With PD', 'orgStudyIdInfo': {'id': 'IIR 11-342'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Structured exercise', 'description': 'Structured exercise instruction by smartphone', 'interventionNames': ['Behavioral: Structured exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'lifestyle exercise', 'description': 'Lifestyle exercise program taught via smartphone', 'interventionNames': ['Behavioral: Lifestyle exercise']}], 'interventions': [{'name': 'Structured exercise', 'type': 'BEHAVIORAL', 'description': 'Structured exercise includes stretching, strengthening, and balance exercises.', 'armGroupLabels': ['Structured exercise']}, {'name': 'Lifestyle exercise', 'type': 'BEHAVIORAL', 'description': 'Subjects will be taught lifestyle exercises and advised about mobility strategies', 'armGroupLabels': ['lifestyle exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02130', '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 W 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'}}}}