Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-01-08 @ 9:42 AM
Study NCT ID:
NCT03384602
Status:
COMPLETED
Last Update Posted:
2024-08-09
First Post:
2017-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MOVE for Your MIND
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two intervention groups: Active I = Dalcroze Eurhythmic Program Active II: simple home exercise program Control group: no change in daily activities, no intervention'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 195}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-07', 'studyFirstSubmitDate': '2017-10-16', 'studyFirstSubmitQcDate': '2017-12-19', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Structural brain changes', 'timeFrame': '12 months', 'description': 'Assessed by voxel based volumetry with a Siemens Avanto 1.5 T (Siemens Erlangen, Germany) deploying the classical dementia protocol (T2\\_tse\\_tra\\_512, T2\\_tirm\\_tra\\_dark-fl\\_5mm, T2\\_fl2d\\_tra\\_T2, T2\\_tse\\_cor\\_3mm, BC\\_t1\\_mpr\\_tra\\_iso\\_2, Ep2d\\_diff\\_tra). No contrast agents will be used.'}, {'measure': 'Daily physical activity', 'timeFrame': '12 months', 'description': "assessed with the Nurse's Health Study physical activity questionnaire excerpt."}, {'measure': 'Effect of life-time physical activity', 'timeFrame': 'Baseline', 'description': 'Retrospective Physical Activity Survey modified after Kriska et al. (1988)'}, {'measure': 'TNF-alpha', 'timeFrame': '12 months', 'description': 'Blood sample assessment: TNF-alpha'}, {'measure': 'VEGF', 'timeFrame': '12 months', 'description': 'Blood sample assessment: VEGF'}, {'measure': 'BDNF', 'timeFrame': '12 months', 'description': 'Blood sample assessment: BDNF'}, {'measure': 'Sr IL-6', 'timeFrame': '12 months', 'description': 'Blood sample assessment: Sr IL-6'}, {'measure': '25-hydroxyvitamin D', 'timeFrame': '12 months', 'description': 'Blood sample assessment: 25-hydroxyvitamin D'}, {'measure': 'Hearing', 'timeFrame': '12 months', 'description': 'Pure-tone testing in both ears'}, {'measure': 'Effect of life-time cognitive activities', 'timeFrame': '12 months', 'description': 'Cognitive Activities Questionnaire (CAQ)'}], 'primaryOutcomes': [{'measure': 'Change in cognitive function', 'timeFrame': '12 months', 'description': 'assessed with the CERAD-plus test'}, {'measure': 'Rate of falls', 'timeFrame': '12 months', 'description': 'The circumstances and injuries associated with the fall will be ascertained with a questionnaire.'}], 'secondaryOutcomes': [{'measure': 'Proportion of seniors with any falls and injurious falls', 'timeFrame': '12 months', 'description': 'Participants will record incident falls in the study diary.'}, {'measure': 'Rate of injurious falls', 'timeFrame': '12 months', 'description': 'The number of falls that resulted in any injury will be examined and categorized according to severity of the injury.'}, {'measure': 'Cognitive function: verbal fluency test', 'timeFrame': '12 months', 'description': 'The verbal fluency test (animal naming) is part of the CERAD test battery (change over 12 months will be evaluated)'}, {'measure': 'Cognitive function: Boston Naming test', 'timeFrame': '12 months', 'description': 'The Boston Naming test (15 items) is part of the CERAD test battery (change over 12 months will be evaluated)'}, {'measure': 'Cognitive function: Mini Mental State Exam', 'timeFrame': '12 months', 'description': 'The Mini Mental State Exam is part of the CERAD test battery (change over 12 months will be evaluated)'}, {'measure': 'Cognitive function: Word List Learning', 'timeFrame': '12 months', 'description': 'Word List Learning is part of the CERAD test battery (change over 12 months will be evaluated)'}, {'measure': 'Cognitive function: Word List Recall', 'timeFrame': '12 months', 'description': 'Word List Recall is part of the CERAD test battery (change over 12 months will be evaluated)'}, {'measure': 'Cognitive function: Word List Recognition', 'timeFrame': '12 months', 'description': 'Word List Recognition (10 original words, 10 foils) is part of the CERAD-plus test battery (change over 12 months will be evaluated)'}, {'measure': 'Cognitive function: Constructional Praxis', 'timeFrame': '12 months', 'description': 'Constructional Praxis is part of the CERAD test battery (change over 12 months will be evaluated)'}, {'measure': 'Cognitive function: Constructional Praxis Recall', 'timeFrame': '12 months', 'description': 'Constructional Praxis Recall is part of the CERAD test battery (change over 12 months will be evaluated)'}, {'measure': 'Cognitive function: Trial Making Test A', 'timeFrame': '12 months', 'description': 'The Trial Making Test A is part of the CERAD-Plus test battery (change over 12 months will be evaluated)'}, {'measure': 'Cognitive function: Trial Making Test B', 'timeFrame': '12 months', 'description': 'The Trial Making Test B is part of the CERAD-Plus test battery (change over 12 months will be evaluated)'}, {'measure': 'Cognitive function: Phonematic Fluency Test', 'timeFrame': '12 months', 'description': 'The Phonematic Fluency test (S-words) is part of the CERAD-Plus test battery (change over 12 months will be evaluated)'}, {'measure': 'Incident MCI', 'timeFrame': '12 months', 'description': 'Based on the results from the CERAD-plus test battery'}, {'measure': 'Functional decline: gait speed', 'timeFrame': '12 months', 'description': 'Gait speed will be measured with a stop watch over a distance of 4 meters.'}, {'measure': 'Functional decline: timed up and go test', 'timeFrame': '12 months', 'description': 'Assessed with the standard timed up and go test protocol'}, {'measure': 'Functional decline: repeated sit-to-stand test', 'timeFrame': '12 months', 'description': 'Assessed with the repeated sit-to-stand test protocol'}, {'measure': 'Functional decline: grip strength', 'timeFrame': '12 months', 'description': 'Assessed using a Martin Vigorimeter'}, {'measure': 'Functional decline: short physical performance battery', 'timeFrame': '12 months', 'description': 'Assessed using the short physical performance battery'}, {'measure': 'Change in gait variability under single task condition', 'timeFrame': '12 months', 'description': 'Assessed with a GAITRite® gait analysis system (Platinum CIR Systems, PA, USA) and/or Gait Up gait analysis system (Gait UP SA, Lausanne, Switzerland)'}, {'measure': 'Change in gait variability under dual task condition', 'timeFrame': '12 months', 'description': 'Assessed with a GAITRite® gait analysis system (Platinum CIR Systems, PA, USA) and/or Gait Up gait analysis system (Gait UP SA, Lausanne, Switzerland)'}, {'measure': 'Quality of life: EuroQuol', 'timeFrame': '12 months', 'description': 'Assessed using the German Version of EuroQuol EQ5D-3L questionnaire according to the Austrian reference scale'}, {'measure': 'Quality of life: RAND 36-Item Short Form Survey', 'timeFrame': '12 months', 'description': 'Assessed using the RAND 36-Item Short Form Survey (SF-36)'}, {'measure': 'Mental Health: Geriatric Depression Scale', 'timeFrame': '12 months', 'description': 'Assessed with the short form of the Geriatric Depression Scale (GDS)'}, {'measure': 'Changes in IGF-1', 'timeFrame': '12 months', 'description': 'Blood marker analyses: IGF-1'}, {'measure': 'Changes in biomarkers of inflammation: hr-CRP', 'timeFrame': '12 months', 'description': 'Blood marker analyses: hr-CRP'}, {'measure': 'Changes in biomarkers of inflammation: IL-6', 'timeFrame': '12 months', 'description': 'Blood marker analyses: IL-6'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['subjective cognitive decline', 'falls prevention', 'cognitive function', 'dalcroze eurhythmics', 'home exercise program', 'seniors'], 'conditions': ['Cognitive Decline', 'Fall']}, 'descriptionModule': {'briefSummary': 'Among the most promising interventions targeting both cognitive and functional decline, is Exercise. However, evidence regarding exercise interventions among seniors with cognitive impairment are inconclusive, likely due to challenges of recruitment and adherence. Alternatively, seniors with subjective cognitive decline (SCD), who are not yet meeting objective criteria of cognitive impairment, but have been shown to have twice the conversion rate to dementia compared with healthy seniors, are more likely to be motivated to participate and adhere to exercise interventions. Thus, exercise interventions in seniors with SCD may provide a window of opportunity for early prevention of dementia and falls.\n\nThe investigators aim to test the effect of a group exercise (multi-task Jaques-Dalcroze Eurhythmics) and a simple home strength exercise program on change of cognitive function and the rate of falling among seniors with SCD.', 'detailedDescription': 'In Europe and in Switzerland, the number of seniors age 70 and older is predicted to increase from 25% to 40% by 2030, as is the number of seniors with cognitive impairments, physical frailty and resulting consequences, such as falls and loss of autonomy. One out of three seniors age 65 and one out of two seniors age 80 experience at least one fall per year. Prevalence of dementia increases with age and more than doubles a seniors\' risk of falling.\n\nAmong the most promising interventions targeting both cognitive and functional decline, is Exercise. However, evidence regarding exercise interventions among seniors with cognitive impairment are inconclusive, likely due to challenges of recruitment and adherence. Alternatively, seniors with subjective cognitive decline (SCD), who are not yet meeting objective criteria of cognitive impairment, but have been shown to have twice the conversion rate to dementia compared with healthy seniors, are more likely to be motivated to participate and adhere to exercise interventions. Thus, exercise interventions in seniors with SCD may provide a window of opportunity for early prevention of dementia and falls.\n\nThe investigators aim to test the effect of a group exercise (multi-task Jaques-Dalcroze Eurhythmics) and a simple home strength exercise program on change of cognitive function and the rate of falling among seniors with SCD.\n\nThe MOVE for your MIND trial will be a single center, single-blinded randomized controlled clinical trial among 195 senior men and women and a 12 month follow-up. Participants will be community-dwelling seniors, age 70+ who meet the criteria for SCD without evidence for objective cognitive impairment. The 3 treatment arms are: (1) Jaques-Dalcroze Eurhythmics group exercise (1x60min/week), (2) simple home exercise strength program (3x30min/week), (3) control group without exercise intervention. All participants will receive a monthly "Healthy Nutrition" lecture. The hypothesis is that both exercise groups are superior to control. Under these assumptions, and a sample size of 195 seniors, the investigators will have \\>90% power for change in cognitive function and \\>80% power for the difference in the rate of falls. Clinical visits will be at baseline, 6 months, and 12 months. Therapeutic interventions for seniors with early subjective signs of cognitive decline that are effective, affordable, and well-tolerated in the prevention of both, cognitive and physical function decline, are urgently needed and will have an outstanding impact on public health as a whole. To the investigator\'s knowledge, this is the first exercise trial to target seniors with SCD and with the change in cognitive function and the rate of falls as the primary endpoints. Providing an evidence-base for a group- and a home-based exercise will give a choice to patients. Further, the mechanistic biomarker study for brain and muscle health among seniors with SCD will support the findings at the cellular level and whole-brain MRI imaging will support them at a structural level.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 70+, living in the community\n* Meet the criterion for SCD defined by a score of ≥25 points on the MAC-Q questionnaire\n\nExclusion Criteria:\n\n* Signs of mild cognitive impairment (MCI), MoCA score ≤24\n* Score of ≥5 on the short form of the Geriatric Depression Scale (15items)\n* Inability to walk or to come to the study entre\n* Severe gait impairment or diseases with a risk of recurrent falling (e.g. Parkinson's disease/syndrome, Hemiplegia after stroke, symptomatic stenosis of the spinal canal, polyneuropathy, epilepsy, recurring vertigo, recurring syncope, heavy alcohol consumption)\n* Currently engaged in regular (once a week or more) strength training instructed by a professional teacher and including the explicit aim to improve muscle strength, or regular (once a week or more) Dalcroze eurhythmics classes\n* Active cancer or current cancer treatment\n* Inability to read and/or speak German necessary to understand the instructions"}, 'identificationModule': {'nctId': 'NCT03384602', 'briefTitle': 'MOVE for Your MIND', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Prevention of Cognitive Decline and Falls With Dalcroze Eurhythmics and a Simple Home Exercise Strength Program for Seniors With Subjective Cognitive Decline (SCD) - MOVE for Your MIND', 'orgStudyIdInfo': {'id': '2017-01288'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dalcroze Eurhythmics program', 'description': 'music-based multi-task exercise intervention', 'interventionNames': ['Other: Dalcroze Eurhythmics Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'home exercise strength program', 'description': 'simple strength training program to perform individually at home', 'interventionNames': ['Other: home exercise strength program']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'no change in the daily activities, no exercise intervention'}], 'interventions': [{'name': 'Dalcroze Eurhythmics Program', 'type': 'OTHER', 'description': 'music-based multi-task exercise in group setting', 'armGroupLabels': ['Dalcroze Eurhythmics program']}, {'name': 'home exercise strength program', 'type': 'OTHER', 'description': 'simple strength exercise program to perform individually at home', 'armGroupLabels': ['home exercise strength program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8037', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Centre on Aging and Mobility, University of Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Heike A Bischoff, Prof. Dr. med., DrPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Swiss National Science Foundation, Switzerland', 'class': 'UNKNOWN'}, {'name': 'University Hospital, Toulouse, France', 'class': 'UNKNOWN'}, {'name': 'Waid City Hospital, Zurich, Switzerland', 'class': 'UNKNOWN'}, {'name': 'Felix Platter Hospital, Basel, Switzerland', 'class': 'UNKNOWN'}, {'name': 'JungDiagnostics, Hamburg, Germany', 'class': 'UNKNOWN'}, {'name': 'Ferrari Data Solution', 'class': 'OTHER'}, {'name': 'Vontobel Foundation, Switzerland', 'class': 'UNKNOWN'}, {'name': 'Age Stiftung, Zurich, Switzerland', 'class': 'UNKNOWN'}, {'name': 'Gemeinnützige Stiftung EMPIRIS, Alzheimer Fund, Zurich Switzerland', 'class': 'UNKNOWN'}, {'name': 'Stiftung für Demenzforschung in Basel, Switzerland', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}