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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Fall; Cognitive Decline
• Intervention / Treatment: Other: Dalcroze Eurhythmics Program; Other: home exercise strength program

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.

• Study Type: Interventional
• Enrollment (Actual): 195
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland, 8037
    • Centre on Aging and Mobility, University of Zurich, Waid City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dalcroze Eurhythmics program; music-based multi-task exercise intervention	Other: Dalcroze Eurhythmics Program; music-based multi-task exercise in group setting
Active Comparator: home exercise strength program; simple strength training program to perform individually at home	Other: home exercise strength program; simple strength exercise program to perform individually at home
No Intervention: Control group; no change in the daily activities, no exercise intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cognitive function	assessed with the CERAD-plus test	12 months
Rate of falls	The circumstances and injuries associated with the fall will be ascertained with a questionnaire.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of seniors with any falls and injurious falls	Participants will record incident falls in the study diary.	12 months
Rate of injurious falls	The number of falls that resulted in any injury will be examined and categorized according to severity of the injury.	12 months
Cognitive function: verbal fluency test	The verbal fluency test (animal naming) is part of the CERAD test battery (change over 12 months will be evaluated)	12 months
Cognitive function: Boston Naming test	The Boston Naming test (15 items) is part of the CERAD test battery (change over 12 months will be evaluated)	12 months
Cognitive function: Mini Mental State Exam	The Mini Mental State Exam is part of the CERAD test battery (change over 12 months will be evaluated)	12 months
Cognitive function: Word List Learning	Word List Learning is part of the CERAD test battery (change over 12 months will be evaluated)	12 months
Cognitive function: Word List Recall	Word List Recall is part of the CERAD test battery (change over 12 months will be evaluated)	12 months
Cognitive function: Word List Recognition	Word List Recognition (10 original words, 10 foils) is part of the CERAD-plus test battery (change over 12 months will be evaluated)	12 months
Cognitive function: Constructional Praxis	Constructional Praxis is part of the CERAD test battery (change over 12 months will be evaluated)	12 months
Cognitive function: Constructional Praxis Recall	Constructional Praxis Recall is part of the CERAD test battery (change over 12 months will be evaluated)	12 months
Cognitive function: Trial Making Test A	The Trial Making Test A is part of the CERAD-Plus test battery (change over 12 months will be evaluated)	12 months
Cognitive function: Trial Making Test B	The Trial Making Test B is part of the CERAD-Plus test battery (change over 12 months will be evaluated)	12 months
Cognitive function: Phonematic Fluency Test	The Phonematic Fluency test (S-words) is part of the CERAD-Plus test battery (change over 12 months will be evaluated)	12 months
Incident MCI	Based on the results from the CERAD-plus test battery	12 months
Functional decline: gait speed	Gait speed will be measured with a stop watch over a distance of 4 meters.	12 months
Functional decline: timed up and go test	Assessed with the standard timed up and go test protocol	12 months
Functional decline: repeated sit-to-stand test	Assessed with the repeated sit-to-stand test protocol	12 months
Functional decline: grip strength	Assessed using a Martin Vigorimeter	12 months
Functional decline: short physical performance battery	Assessed using the short physical performance battery	12 months
Change in gait variability under single task condition	Assessed with a GAITRite® gait analysis system (Platinum CIR Systems, PA, USA) and/or Gait Up gait analysis system (Gait UP SA, Lausanne, Switzerland)	12 months
Change in gait variability under dual task condition	Assessed with a GAITRite® gait analysis system (Platinum CIR Systems, PA, USA) and/or Gait Up gait analysis system (Gait UP SA, Lausanne, Switzerland)	12 months
Quality of life: EuroQuol	Assessed using the German Version of EuroQuol EQ5D-3L questionnaire according to the Austrian reference scale	12 months
Quality of life: RAND 36-Item Short Form Survey	Assessed using the RAND 36-Item Short Form Survey (SF-36)	12 months
Mental Health: Geriatric Depression Scale	Assessed with the short form of the Geriatric Depression Scale (GDS)	12 months
Changes in IGF-1	Blood marker analyses: IGF-1	12 months
Changes in biomarkers of inflammation: hr-CRP	Blood marker analyses: hr-CRP	12 months
Changes in biomarkers of inflammation: IL-6	Blood marker analyses: IL-6	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Structural brain changes	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.	12 months
Daily physical activity	assessed with the Nurse's Health Study physical activity questionnaire excerpt.	12 months
Effect of life-time physical activity	Retrospective Physical Activity Survey modified after Kriska et al. (1988)	Baseline
TNF-alpha	Blood sample assessment: TNF-alpha	12 months
VEGF	Blood sample assessment: VEGF	12 months
BDNF	Blood sample assessment: BDNF	12 months
Sr IL-6	Blood sample assessment: Sr IL-6	12 months
25-hydroxyvitamin D	Blood sample assessment: 25-hydroxyvitamin D	12 months
Hearing	Pure-tone testing in both ears	12 months
Effect of life-time cognitive activities	Cognitive Activities Questionnaire (CAQ)	12 months

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Ferrari Data Solution; Swiss National Science Foundation, Switzerland; University Hospital, Toulouse, France; Waid City Hospital, Zurich, Switzerland; Felix Platter Hospital, Basel, Switzerland; JungDiagnostics, Hamburg, Germany; Vontobel Foundation, Switzerland; Age Stiftung, Zurich, Switzerland; Gemeinnützige Stiftung EMPIRIS, Alzheimer Fund, Zurich Switzerland; Stiftung für Demenzforschung in Basel, Switzerland
• Investigators: Principal Investigator: Heike A Bischoff, Prof. Dr. med., DrPH, University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2017
• Primary Completion (Actual): November 2, 2021
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: October 16, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (Actual): December 27, 2017

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: cognitive function; seniors; falls prevention; subjective cognitive decline; home exercise program; dalcroze eurhythmics
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 2017-01288

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No