MOVE for Your MIND
- Conditions
- Cognitive DeclineFall
- Interventions
- Other: home exercise strength programOther: Dalcroze Eurhythmics Program
- Registration Number
- NCT03384602
- Lead Sponsor
- University of Zurich
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 195
- Age 70+, living in the community
- Meet the criterion for SCD defined by a score of ≥25 points on the MAC-Q questionnaire
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description home exercise strength program home exercise strength program simple strength training program to perform individually at home Dalcroze Eurhythmics program Dalcroze Eurhythmics Program music-based multi-task exercise intervention
- Primary Outcome Measures
Name Time Method Change in cognitive function 12 months assessed with the CERAD-plus test
Rate of falls 12 months The circumstances and injuries associated with the fall will be ascertained with a questionnaire.
- Secondary Outcome Measures
Name Time Method Proportion of seniors with any falls and injurious falls 12 months Participants will record incident falls in the study diary.
Cognitive function: Mini Mental State Exam 12 months The Mini Mental State Exam is part of the CERAD test battery (change over 12 months will be evaluated)
Cognitive function: verbal fluency test 12 months The verbal fluency test (animal naming) is part of the CERAD test battery (change over 12 months will be evaluated)
Cognitive function: Word List Recognition 12 months Word 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 falls 12 months The number of falls that resulted in any injury will be examined and categorized according to severity of the injury.
Cognitive function: Boston Naming test 12 months The Boston Naming test (15 items) is part of the CERAD test battery (change over 12 months will be evaluated)
Cognitive function: Phonematic Fluency Test 12 months The Phonematic Fluency test (S-words) is part of the CERAD-Plus test battery (change over 12 months will be evaluated)
Incident MCI 12 months Based on the results from the CERAD-plus test battery
Cognitive function: Constructional Praxis Recall 12 months Constructional Praxis Recall is part of the CERAD test battery (change over 12 months will be evaluated)
Functional decline: repeated sit-to-stand test 12 months Assessed with the repeated sit-to-stand test protocol
Change in gait variability under single task condition 12 months Assessed 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: RAND 36-Item Short Form Survey 12 months Assessed using the RAND 36-Item Short Form Survey (SF-36)
Changes in biomarkers of inflammation: hr-CRP 12 months Blood marker analyses: hr-CRP
Cognitive function: Trial Making Test A 12 months The Trial Making Test A is part of the CERAD-Plus test battery (change over 12 months will be evaluated)
Functional decline: gait speed 12 months Gait speed will be measured with a stop watch over a distance of 4 meters.
Cognitive function: Trial Making Test B 12 months The Trial Making Test B is part of the CERAD-Plus test battery (change over 12 months will be evaluated)
Cognitive function: Word List Learning 12 months Word List Learning is part of the CERAD test battery (change over 12 months will be evaluated)
Cognitive function: Word List Recall 12 months Word List Recall is part of the CERAD test battery (change over 12 months will be evaluated)
Functional decline: timed up and go test 12 months Assessed with the standard timed up and go test protocol
Quality of life: EuroQuol 12 months Assessed using the German Version of EuroQuol EQ5D-3L questionnaire according to the Austrian reference scale
Changes in biomarkers of inflammation: IL-6 12 months Blood marker analyses: IL-6
Cognitive function: Constructional Praxis 12 months Constructional Praxis is part of the CERAD test battery (change over 12 months will be evaluated)
Functional decline: short physical performance battery 12 months Assessed using the short physical performance battery
Change in gait variability under dual task condition 12 months Assessed with a GAITRite® gait analysis system (Platinum CIR Systems, PA, USA) and/or Gait Up gait analysis system (Gait UP SA, Lausanne, Switzerland)
Changes in IGF-1 12 months Blood marker analyses: IGF-1
Functional decline: grip strength 12 months Assessed using a Martin Vigorimeter
Mental Health: Geriatric Depression Scale 12 months Assessed with the short form of the Geriatric Depression Scale (GDS)
Trial Locations
- Locations (1)
Centre on Aging and Mobility, University of Zurich
🇨🇭Zürich, Switzerland