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MOVE for Your MIND

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03384602
Enrollment
195
Registered
2017-12-27
Start date
2017-12-14
Completion date
2022-11-02
Last updated
2024-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Decline, Fall

Keywords

subjective cognitive decline, falls prevention, cognitive function, dalcroze eurhythmics, home exercise program, seniors

Brief summary

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. The 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.

Detailed description

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. 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. The 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. The 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.

Interventions

OTHERDalcroze Eurhythmics Program

music-based multi-task exercise in group setting

OTHERhome exercise strength program

simple strength exercise program to perform individually at home

Sponsors

Swiss National Science Foundation, Switzerland
CollaboratorUNKNOWN
University Hospital, Toulouse, France
CollaboratorUNKNOWN
Waid City Hospital, Zurich, Switzerland
CollaboratorUNKNOWN
Felix Platter Hospital, Basel, Switzerland
CollaboratorUNKNOWN
JungDiagnostics, Hamburg, Germany
CollaboratorUNKNOWN
Ferrari Data Solution
CollaboratorOTHER
Vontobel Foundation, Switzerland
CollaboratorUNKNOWN
Age Stiftung, Zurich, Switzerland
CollaboratorUNKNOWN
Gemeinnützige Stiftung EMPIRIS, Alzheimer Fund, Zurich Switzerland
CollaboratorUNKNOWN
Stiftung für Demenzforschung in Basel, Switzerland
CollaboratorUNKNOWN
University of Zurich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

Two intervention groups: Active I = Dalcroze Eurhythmic Program Active II: simple home exercise program Control group: no change in daily activities, no intervention

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age 70+, living in the community * Meet the criterion for SCD defined by a score of ≥25 points on the MAC-Q questionnaire

Exclusion criteria

* Signs of mild cognitive impairment (MCI), MoCA score ≤24 * Score of ≥5 on the short form of the Geriatric Depression Scale (15items) * Inability to walk or to come to the study entre * 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) * 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 * Active cancer or current cancer treatment * Inability to read and/or speak German necessary to understand the instructions

Design outcomes

Primary

MeasureTime frameDescription
Change in cognitive function12 monthsassessed with the CERAD-plus test
Rate of falls12 monthsThe circumstances and injuries associated with the fall will be ascertained with a questionnaire.

Secondary

MeasureTime frameDescription
Cognitive function: Constructional Praxis Recall12 monthsConstructional Praxis Recall is part of the CERAD test battery (change over 12 months will be evaluated)
Functional decline: grip strength12 monthsAssessed using a Martin Vigorimeter
Functional decline: short physical performance battery12 monthsAssessed using the short physical performance battery
Change in gait variability under single task condition12 monthsAssessed with a GAITRite® gait analysis system (Platinum CIR Systems, PA, USA) and/or Gait Up gait analysis system (Gait UP SA, Lausanne, Switzerland)
Change in gait variability under dual task condition12 monthsAssessed with a GAITRite® gait analysis system (Platinum CIR Systems, PA, USA) and/or Gait Up gait analysis system (Gait UP SA, Lausanne, Switzerland)
Quality of life: EuroQuol12 monthsAssessed using the German Version of EuroQuol EQ5D-3L questionnaire according to the Austrian reference scale
Quality of life: RAND 36-Item Short Form Survey12 monthsAssessed using the RAND 36-Item Short Form Survey (SF-36)
Mental Health: Geriatric Depression Scale12 monthsAssessed with the short form of the Geriatric Depression Scale (GDS)
Changes in IGF-112 monthsBlood marker analyses: IGF-1
Changes in biomarkers of inflammation: hr-CRP12 monthsBlood marker analyses: hr-CRP
Changes in biomarkers of inflammation: IL-612 monthsBlood marker analyses: IL-6
Cognitive function: Constructional Praxis12 monthsConstructional Praxis is part of the CERAD test battery (change over 12 months will be evaluated)
Cognitive function: Word List Recall12 monthsWord List Recall is part of the CERAD test battery (change over 12 months will be evaluated)
Proportion of seniors with any falls and injurious falls12 monthsParticipants will record incident falls in the study diary.
Cognitive function: Word List Recognition12 monthsWord List Recognition (10 original words, 10 foils) is part of the CERAD-plus test battery (change over 12 months will be evaluated)
Rate of injurious falls12 monthsThe number of falls that resulted in any injury will be examined and categorized according to severity of the injury.
Cognitive function: verbal fluency test12 monthsThe verbal fluency test (animal naming) is part of the CERAD test battery (change over 12 months will be evaluated)
Cognitive function: Boston Naming test12 monthsThe Boston Naming test (15 items) is part of the CERAD test battery (change over 12 months will be evaluated)
Cognitive function: Mini Mental State Exam12 monthsThe Mini Mental State Exam is part of the CERAD test battery (change over 12 months will be evaluated)
Cognitive function: Word List Learning12 monthsWord List Learning is part of the CERAD test battery (change over 12 months will be evaluated)
Cognitive function: Trial Making Test A12 monthsThe Trial Making Test A is part of the CERAD-Plus test battery (change over 12 months will be evaluated)
Cognitive function: Trial Making Test B12 monthsThe Trial Making Test B is part of the CERAD-Plus test battery (change over 12 months will be evaluated)
Cognitive function: Phonematic Fluency Test12 monthsThe Phonematic Fluency test (S-words) is part of the CERAD-Plus test battery (change over 12 months will be evaluated)
Incident MCI12 monthsBased on the results from the CERAD-plus test battery
Functional decline: gait speed12 monthsGait speed will be measured with a stop watch over a distance of 4 meters.
Functional decline: timed up and go test12 monthsAssessed with the standard timed up and go test protocol
Functional decline: repeated sit-to-stand test12 monthsAssessed with the repeated sit-to-stand test protocol

Other

MeasureTime frameDescription
Effect of life-time physical activityBaselineRetrospective Physical Activity Survey modified after Kriska et al. (1988)
TNF-alpha12 monthsBlood sample assessment: TNF-alpha
VEGF12 monthsBlood sample assessment: VEGF
BDNF12 monthsBlood sample assessment: BDNF
Sr IL-612 monthsBlood sample assessment: Sr IL-6
25-hydroxyvitamin D12 monthsBlood sample assessment: 25-hydroxyvitamin D
Hearing12 monthsPure-tone testing in both ears
Effect of life-time cognitive activities12 monthsCognitive Activities Questionnaire (CAQ)
Structural brain changes12 monthsAssessed 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.
Daily physical activity12 monthsassessed with the Nurse's Health Study physical activity questionnaire excerpt.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026