Clinical trial NCT03384602: MOVE for Your MIND
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Decline
Fall
Keywords: subjective cognitive decline
falls prevention
cognitive function
dalcroze eurhythmics
home exercise program
seniors
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation, Switzerland
name: University Hospital, Toulouse, France
name: Waid City Hospital, Zurich, Switzerland
name: Felix Platter Hospital, Basel, Switzerland
name: JungDiagnostics, Hamburg, Germany
name: Ferrari Data Solution
name: Vontobel Foundation, Switzerland
name: Age Stiftung, Zurich, Switzerland
name: Gemeinnützige Stiftung EMPIRIS, Alzheimer Fund, Zurich Switzerland
name: Stiftung für Demenzforschung in Basel, Switzerland
First posted: 2017-12-27
Enrollment: 195
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in cognitive function
timeFrame: 12 months
measure: Rate of falls
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of seniors with any falls and injurious falls
timeFrame: 12 months
measure: Rate of injurious falls
timeFrame: 12 months
measure: Cognitive function: verbal fluency test
timeFrame: 12 months
measure: Cognitive function: Boston Naming test
timeFrame: 12 months
measure: Cognitive function: Mini Mental State Exam
timeFrame: 12 months
measure: Cognitive function: Word List Learning
timeFrame: 12 months
measure: Cognitive function: Word List Recall
timeFrame: 12 months
measure: Cognitive function: Word List Recognition
timeFrame: 12 months
measure: Cognitive function: Constructional Praxis
timeFrame: 12 months
measure: Cognitive function: Constructional Praxis Recall
timeFrame: 12 months
measure: Cognitive function: Trial Making Test A
timeFrame: 12 months
measure: Cognitive function: Trial Making Test B
timeFrame: 12 months
measure: Cognitive function: Phonematic Fluency Test
timeFrame: 12 months
measure: Incident MCI
timeFrame: 12 months
measure: Functional decline: gait speed
timeFrame: 12 months
measure: Functional decline: timed up and go test
timeFrame: 12 months
measure: Functional decline: repeated sit-to-stand test
timeFrame: 12 months
measure: Functional decline: grip strength
timeFrame: 12 months
measure: Functional decline: short physical performance battery
timeFrame: 12 months
measure: Change in gait variability under single task condition
timeFrame: 12 months
measure: Change in gait variability under dual task condition
timeFrame: 12 months
measure: Quality of life: EuroQuol
timeFrame: 12 months
measure: Quality of life: RAND 36-Item Short Form Survey
timeFrame: 12 months
measure: Mental Health: Geriatric Depression Scale
timeFrame: 12 months
measure: Changes in IGF-1
timeFrame: 12 months
measure: Changes in biomarkers of inflammation: hr-CRP
timeFrame: 12 months
measure: Changes in biomarkers of inflammation: IL-6
timeFrame: 12 months
Other outcomes:
measure: Structural brain changes
timeFrame: 12 months
measure: Daily physical activity
timeFrame: 12 months
measure: Effect of life-time physical activity
timeFrame: Baseline
measure: TNF-alpha
timeFrame: 12 months
measure: VEGF
timeFrame: 12 months
measure: BDNF
timeFrame: 12 months
measure: Sr IL-6
timeFrame: 12 months
measure: 25-hydroxyvitamin D
timeFrame: 12 months
measure: Hearing
timeFrame: 12 months
measure: Effect of life-time cognitive activities
timeFrame: 12 months
Locations:
city: Zürich
country: Switzerland
facility: Centre on Aging and Mobility, University of Zurich
Study officials:
affiliation: University of Zurich
name: Heike A Bischoff, Prof. Dr. med., DrPH
role: PRINCIPAL_INVESTIGATOR
References: