Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-01-29 @ 8:57 PM
Study NCT ID:
NCT03121950
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
2017-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Movement and Music Intervention for Individuals With Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020961', 'term': 'Lewy Body Disease'}, {'id': 'D003704', 'term': 'Dementia'}], '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': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009147', 'term': 'Music Therapy'}], 'ancestors': [{'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kegelmeyer.1@osu.edu', 'phone': '614-293-0214', 'title': 'Deb Kegelmeyer', 'organization': 'The Ohio State University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Our study had many limitations including significant barriers to recruitment and retention of participants. Because of this, we changed the design to a pretest-posttest pilot study and included data from a participant at 6 weeks in the manuscript.'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Dance in Dementia', 'description': 'examine if participating in a dance class improves mobility and/or cognition in individuals with dementia.\n\nDance: The primary intervention is a dance class', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Music and Dementia', 'description': 'examine if listening to music improves mobility and/or cognition in individuals with dementia.\n\nmusic: the secondary intervention is listening to live music', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Timed up and go Cognitive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dance in Dementia', 'description': 'examine if participating in a dance class improves mobility and/or cognition in individuals with dementia.\n\nDance: The primary intervention is a dance class'}, {'id': 'OG001', 'title': 'Music and Dementia', 'description': 'examine if listening to music improves mobility and/or cognition in individuals with dementia.\n\nmusic: the secondary intervention is listening to live music'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.49', 'spread': '9.66', 'groupId': 'OG000'}, {'value': '-13.35', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'The change in time to complete the Timed Up and Go - Cognitive (TUG-Cog) is recorded in seconds. The participant is timed with a stop watch while walking 3 meters turning and returning to a chair while performing a concurrent cognitive task. This time is compared to the Timed Up and Go (TUG) and the difference in time indicates the effect cognitive deficits have on motor function. Higher scores, indicating more time, means worse outcomes.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Score on the Montreal Cognitive Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dance in Dementia', 'description': 'examine if participating in a dance class improves mobility and/or cognition in individuals with dementia.'}, {'id': 'OG001', 'title': 'Music and Dementia', 'description': 'examine if listening to music improves mobility and/or cognition in individuals with dementia.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'The Montreal Cognitive Assessment (MoCA) is an assessment of overall cognitive status. The range of scores is 0-30, with higher scores indicating better outcomes. Scores 26 or higher indicates normal cognitive function.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Score on the Caregiver Burden Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dance in Dementia', 'description': 'examine if participating in a dance class improves mobility and/or cognition in individuals with dementia.\n\nDance: The primary intervention is a dance class'}, {'id': 'OG001', 'title': 'Music and Dementia', 'description': 'examine if listening to music improves mobility and/or cognition in individuals with dementia.\n\nmusic: the secondary intervention is listening to live music'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.17', 'spread': '8.51', 'groupId': 'OG000'}, {'value': '-7', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'A questionnaire asking caregivers about the impact of caregiving on daily life. Scores range from 0-88, with higher scores indicating worse outcomes or more burden. Scores of 0-20 = little or no burden, 21-40 = mild to moderate burden, 41-60 = moderate to severe burden, and 61-80 = severe burden.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dance in Dementia', 'description': 'examine if participating in a dance class improves mobility and/or cognition in individuals with dementia.'}, {'id': 'FG001', 'title': 'Music and Dementia', 'description': 'examine if listening to music improves mobility and/or cognition in individuals with dementia.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': '1 participant was excluded due to not meeting criteria on minimum score required for participation on the Mini Mental Status Examination'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dance in Dementia', 'description': 'examine if participating in a dance class improves mobility and/or cognition in individuals with dementia.\n\nDance: The primary intervention is a dance class'}, {'id': 'BG001', 'title': 'Music and Dementia', 'description': 'examine if listening to music improves mobility and/or cognition in individuals with dementia.\n\nmusic: the secondary intervention is listening to live music'}, {'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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '83.76', 'spread': '7.55', 'groupId': 'BG000'}, {'value': '74', 'spread': '11.36', 'groupId': 'BG001'}, {'value': '82.3', 'spread': '8.62', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', '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': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-09-08', 'size': 288081, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_001.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2020-08-20T15:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be placed in one of two groups. One group will participate 2 times a week in a dance class. The other group will listen to live music once a week.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2017-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-11', 'studyFirstSubmitDate': '2017-04-10', 'resultsFirstSubmitDate': '2018-02-26', 'studyFirstSubmitQcDate': '2017-04-17', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-21', 'studyFirstPostDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Score on the Caregiver Burden Scale', 'timeFrame': '12 weeks', 'description': 'A questionnaire asking caregivers about the impact of caregiving on daily life. Scores range from 0-88, with higher scores indicating worse outcomes or more burden. Scores of 0-20 = little or no burden, 21-40 = mild to moderate burden, 41-60 = moderate to severe burden, and 61-80 = severe burden.'}], 'primaryOutcomes': [{'measure': 'Timed up and go Cognitive', 'timeFrame': '12 weeks', 'description': 'The change in time to complete the Timed Up and Go - Cognitive (TUG-Cog) is recorded in seconds. The participant is timed with a stop watch while walking 3 meters turning and returning to a chair while performing a concurrent cognitive task. This time is compared to the Timed Up and Go (TUG) and the difference in time indicates the effect cognitive deficits have on motor function. Higher scores, indicating more time, means worse outcomes.'}], 'secondaryOutcomes': [{'measure': 'Change in Score on the Montreal Cognitive Assessment', 'timeFrame': '12 weeks', 'description': 'The Montreal Cognitive Assessment (MoCA) is an assessment of overall cognitive status. The range of scores is 0-30, with higher scores indicating better outcomes. Scores 26 or higher indicates normal cognitive function.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dementia'], 'conditions': ['Dementia With Lewy Bodies', 'Dementia']}, 'descriptionModule': {'briefSummary': 'The goal of the study is to learn about how possible benefits of movement and music for individuals with dementia. Individuals with dementia will participate in a dance class. The study includes assessments of walking, balance and cognition.', 'detailedDescription': "Dementia impacts 5%-7% of individuals \\>60 years old. It impacts the person's ability to perform work, care for him/herself and ultimately leads to physical disability. There is a high caregiver burden associated with dementia and many individuals require care in a long-term care facility. There is some emerging evidence that music based interventions may have a protective effect on the brain in those with dementia. There is also evidence that doing activities that engage the brain through music are beneficial. This study seeks to investigate the potential benefits of a music based intervention for individuals with dementia. The study aims to recruit individuals with a diagnosis of dementia. Once enrolled participants will undergo assessment of walking, balance and cognition and then be asked to participate either in a dance class or to listen to live music. After 6 weeks and again at the end of the study (after 12 weeks) participants will undergo assessments of walking, balance and cognition."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of dementia\n* Mini-Mental State Examination score \\> 9\n* Age \\> 60 years\n* Able to follow simple instructions\n\nExclusion Criteria:\n\n* Unable to walk 10 feet unassisted\n* Presence of orthopedic disorder that impacts walking\n* Presence of other neurologic diagnosis that impacts cognitive or motor function such as stroke, Parkinson disease or traumatic brain injury'}, 'identificationModule': {'nctId': 'NCT03121950', 'briefTitle': 'Movement and Music Intervention for Individuals With Dementia', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Movement and Music Intervention for Individuals With Dementia', 'orgStudyIdInfo': {'id': '2016H0211'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dance in dementia', 'description': 'examine if participating in a dance class improves mobility and/or cognition in individuals with dementia.', 'interventionNames': ['Other: Dance']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Music and dementia', 'description': 'examine if listening to music improves mobility and/or cognition in individuals with dementia.', 'interventionNames': ['Other: Music']}], 'interventions': [{'name': 'Dance', 'type': 'OTHER', 'description': 'The primary intervention is a dance class', 'armGroupLabels': ['Dance in dementia']}, {'name': 'Music', 'type': 'OTHER', 'description': 'the secondary intervention is listening to live music', 'armGroupLabels': ['Music and dementia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Deb Kegelmeyer, DPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Clinical', 'investigatorFullName': 'Deb Kegelmeyer', 'investigatorAffiliation': 'Ohio State University'}}}}