Centre on Aging and Mobility, University of Zurich
Zurich, 8037, Switzerland
NCT Number: NCT03384602
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.
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Notify Me70 year and older
All sexes
Interventional
Not applicable
Zurich, 8037, Switzerland
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
music-based multi-task exercise in group setting
simple strength exercise program to perform individually at home
Time frame: 12 months
assessed with the CERAD-plus test
Time frame: 12 months
The circumstances and injuries associated with the fall will be ascertained with a questionnaire.
Time frame: 12 months
Participants will record incident falls in the study diary.
Time frame: 12 months
The number of falls that resulted in any injury will be examined and categorized according to severity of the injury.
Time frame: 12 months
The verbal fluency test (animal naming) is part of the CERAD test battery (change over 12 months will be evaluated)
Time frame: 12 months
The Boston Naming test (15 items) is part of the CERAD test battery (change over 12 months will be evaluated)
Time frame: 12 months
The Mini Mental State Exam is part of the CERAD test battery (change over 12 months will be evaluated)
Time frame: 12 months
Word List Learning is part of the CERAD test battery (change over 12 months will be evaluated)
Time frame: 12 months
Word List Recall is part of the CERAD test battery (change over 12 months will be evaluated)
Time frame: 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)
Time frame: 12 months
Constructional Praxis is part of the CERAD test battery (change over 12 months will be evaluated)
Time frame: 12 months
Constructional Praxis Recall is part of the CERAD test battery (change over 12 months will be evaluated)
Time frame: 12 months
The Trial Making Test A is part of the CERAD-Plus test battery (change over 12 months will be evaluated)
Time frame: 12 months
The Trial Making Test B is part of the CERAD-Plus test battery (change over 12 months will be evaluated)
Time frame: 12 months
The Phonematic Fluency test (S-words) is part of the CERAD-Plus test battery (change over 12 months will be evaluated)
Time frame: 12 months
Based on the results from the CERAD-plus test battery
Time frame: 12 months
Gait speed will be measured with a stop watch over a distance of 4 meters.
Time frame: 12 months
Assessed with the standard timed up and go test protocol
Time frame: 12 months
Assessed with the repeated sit-to-stand test protocol
Time frame: 12 months
Assessed using a Martin Vigorimeter
Time frame: 12 months
Assessed using the short physical performance battery
Time frame: 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)
Time frame: 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)
Time frame: 12 months
Assessed using the German Version of EuroQuol EQ5D-3L questionnaire according to the Austrian reference scale
Time frame: 12 months
Assessed using the RAND 36-Item Short Form Survey (SF-36)
Time frame: 12 months
Assessed with the short form of the Geriatric Depression Scale (GDS)
Time frame: 12 months
Blood marker analyses: IGF-1
Time frame: 12 months
Blood marker analyses: hr-CRP
Time frame: 12 months
Blood marker analyses: IL-6
Time frame: 12 months
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.
Time frame: 12 months
assessed with the Nurse's Health Study physical activity questionnaire excerpt.
Time frame: Baseline
Retrospective Physical Activity Survey modified after Kriska et al. (1988)
Time frame: 12 months
Blood sample assessment: TNF-alpha
Time frame: 12 months
Blood sample assessment: VEGF
Time frame: 12 months
Blood sample assessment: BDNF
Time frame: 12 months
Blood sample assessment: Sr IL-6
Time frame: 12 months
Blood sample assessment: 25-hydroxyvitamin D
Time frame: 12 months
Pure-tone testing in both ears
Time frame: 12 months
Cognitive Activities Questionnaire (CAQ)
University of Zurich
Other
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
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