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MOVE for Your MIND

Primary Purpose

Cognitive Decline, Fall

Status
Active
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Dalcroze Eurhythmics Program
home exercise strength program
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Decline focused on measuring subjective cognitive decline, falls prevention, cognitive function, dalcroze eurhythmics, home exercise program, seniors

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Dalcroze Eurhythmics program

home exercise strength program

Control group

Arm Description

music-based multi-task exercise intervention

simple strength training program to perform individually at home

no change in the daily activities, no exercise intervention

Outcomes

Primary Outcome Measures

Change in cognitive function
assessed with the CERAD-plus test
Rate of falls
The circumstances and injuries associated with the fall will be ascertained with a questionnaire.

Secondary Outcome Measures

Proportion of seniors with any falls and injurious falls
Participants will record incident falls in the study diary.
Rate of injurious falls
The number of falls that resulted in any injury will be examined and categorized according to severity of the injury.
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)
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)
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)
Cognitive function: Word List Learning
Word List Learning is part of the CERAD test battery (change over 12 months will be evaluated)
Cognitive function: Word List Recall
Word List Recall is part of the CERAD test battery (change over 12 months will be evaluated)
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)
Cognitive function: Constructional Praxis
Constructional Praxis is part of the CERAD test battery (change over 12 months will be evaluated)
Cognitive function: Constructional Praxis Recall
Constructional Praxis Recall is part of the CERAD test battery (change over 12 months will be evaluated)
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)
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)
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)
Incident MCI
Based on the results from the CERAD-plus test battery
Functional decline: gait speed
Gait speed will be measured with a stop watch over a distance of 4 meters.
Functional decline: timed up and go test
Assessed with the standard timed up and go test protocol
Functional decline: repeated sit-to-stand test
Assessed with the repeated sit-to-stand test protocol
Functional decline: grip strength
Assessed using a Martin Vigorimeter
Functional decline: short physical performance battery
Assessed using the short physical performance battery
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)
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)
Quality of life: EuroQuol
Assessed using the German Version of EuroQuol EQ5D-3L questionnaire according to the Austrian reference scale
Quality of life: RAND 36-Item Short Form Survey
Assessed using the RAND 36-Item Short Form Survey (SF-36)
Mental Health: Geriatric Depression Scale
Assessed with the short form of the Geriatric Depression Scale (GDS)
Changes in IGF-1
Blood marker analyses: IGF-1
Changes in biomarkers of inflammation: hr-CRP
Blood marker analyses: hr-CRP
Changes in biomarkers of inflammation: IL-6
Blood marker analyses: IL-6

Full Information

First Posted
October 16, 2017
Last Updated
May 15, 2023
Sponsor
University of Zurich
Collaborators
Swiss National Science Foundation, Switzerland, University Hospital, Toulouse, France, Waid City Hospital, Zurich, Switzerland, Felix Platter Hospital, Basel, Switzerland, JungDiagnostics, Hamburg, Germany, Ferrari Data Solution, Vontobel Foundation, Switzerland, Age Stiftung, Zurich, Switzerland, Gemeinnützige Stiftung EMPIRIS, Alzheimer Fund, Zurich Switzerland, Stiftung für Demenzforschung in Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT03384602
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 14, 2017 (Actual)
Primary Completion Date
November 2, 2021 (Actual)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
Swiss National Science Foundation, Switzerland, University Hospital, Toulouse, France, Waid City Hospital, Zurich, Switzerland, Felix Platter Hospital, Basel, Switzerland, JungDiagnostics, Hamburg, Germany, Ferrari Data Solution, Vontobel Foundation, Switzerland, Age Stiftung, Zurich, Switzerland, Gemeinnützige Stiftung EMPIRIS, Alzheimer Fund, Zurich Switzerland, Stiftung für Demenzforschung in Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline, Fall
Keywords
subjective cognitive decline, falls prevention, cognitive function, dalcroze eurhythmics, home exercise program, seniors

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
195 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dalcroze Eurhythmics program
Arm Type
Active Comparator
Arm Description
music-based multi-task exercise intervention
Arm Title
home exercise strength program
Arm Type
Active Comparator
Arm Description
simple strength training program to perform individually at home
Arm Title
Control group
Arm Type
No Intervention
Arm Description
no change in the daily activities, no exercise intervention
Intervention Type
Other
Intervention Name(s)
Dalcroze Eurhythmics Program
Intervention Description
music-based multi-task exercise in group setting
Intervention Type
Other
Intervention Name(s)
home exercise strength program
Intervention Description
simple strength exercise program to perform individually at home
Primary Outcome Measure Information:
Title
Change in cognitive function
Description
assessed with the CERAD-plus test
Time Frame
12 months
Title
Rate of falls
Description
The circumstances and injuries associated with the fall will be ascertained with a questionnaire.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Proportion of seniors with any falls and injurious falls
Description
Participants will record incident falls in the study diary.
Time Frame
12 months
Title
Rate of injurious falls
Description
The number of falls that resulted in any injury will be examined and categorized according to severity of the injury.
Time Frame
12 months
Title
Cognitive function: verbal fluency test
Description
The verbal fluency test (animal naming) is part of the CERAD test battery (change over 12 months will be evaluated)
Time Frame
12 months
Title
Cognitive function: Boston Naming test
Description
The Boston Naming test (15 items) is part of the CERAD test battery (change over 12 months will be evaluated)
Time Frame
12 months
Title
Cognitive function: Mini Mental State Exam
Description
The Mini Mental State Exam is part of the CERAD test battery (change over 12 months will be evaluated)
Time Frame
12 months
Title
Cognitive function: Word List Learning
Description
Word List Learning is part of the CERAD test battery (change over 12 months will be evaluated)
Time Frame
12 months
Title
Cognitive function: Word List Recall
Description
Word List Recall is part of the CERAD test battery (change over 12 months will be evaluated)
Time Frame
12 months
Title
Cognitive function: Word List Recognition
Description
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
Title
Cognitive function: Constructional Praxis
Description
Constructional Praxis is part of the CERAD test battery (change over 12 months will be evaluated)
Time Frame
12 months
Title
Cognitive function: Constructional Praxis Recall
Description
Constructional Praxis Recall is part of the CERAD test battery (change over 12 months will be evaluated)
Time Frame
12 months
Title
Cognitive function: Trial Making Test A
Description
The Trial Making Test A is part of the CERAD-Plus test battery (change over 12 months will be evaluated)
Time Frame
12 months
Title
Cognitive function: Trial Making Test B
Description
The Trial Making Test B is part of the CERAD-Plus test battery (change over 12 months will be evaluated)
Time Frame
12 months
Title
Cognitive function: Phonematic Fluency Test
Description
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
Title
Incident MCI
Description
Based on the results from the CERAD-plus test battery
Time Frame
12 months
Title
Functional decline: gait speed
Description
Gait speed will be measured with a stop watch over a distance of 4 meters.
Time Frame
12 months
Title
Functional decline: timed up and go test
Description
Assessed with the standard timed up and go test protocol
Time Frame
12 months
Title
Functional decline: repeated sit-to-stand test
Description
Assessed with the repeated sit-to-stand test protocol
Time Frame
12 months
Title
Functional decline: grip strength
Description
Assessed using a Martin Vigorimeter
Time Frame
12 months
Title
Functional decline: short physical performance battery
Description
Assessed using the short physical performance battery
Time Frame
12 months
Title
Change in gait variability under single task condition
Description
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
Title
Change in gait variability under dual task condition
Description
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
Title
Quality of life: EuroQuol
Description
Assessed using the German Version of EuroQuol EQ5D-3L questionnaire according to the Austrian reference scale
Time Frame
12 months
Title
Quality of life: RAND 36-Item Short Form Survey
Description
Assessed using the RAND 36-Item Short Form Survey (SF-36)
Time Frame
12 months
Title
Mental Health: Geriatric Depression Scale
Description
Assessed with the short form of the Geriatric Depression Scale (GDS)
Time Frame
12 months
Title
Changes in IGF-1
Description
Blood marker analyses: IGF-1
Time Frame
12 months
Title
Changes in biomarkers of inflammation: hr-CRP
Description
Blood marker analyses: hr-CRP
Time Frame
12 months
Title
Changes in biomarkers of inflammation: IL-6
Description
Blood marker analyses: IL-6
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Structural brain changes
Description
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
Title
Daily physical activity
Description
assessed with the Nurse's Health Study physical activity questionnaire excerpt.
Time Frame
12 months
Title
Effect of life-time physical activity
Description
Retrospective Physical Activity Survey modified after Kriska et al. (1988)
Time Frame
Baseline
Title
TNF-alpha
Description
Blood sample assessment: TNF-alpha
Time Frame
12 months
Title
VEGF
Description
Blood sample assessment: VEGF
Time Frame
12 months
Title
BDNF
Description
Blood sample assessment: BDNF
Time Frame
12 months
Title
Sr IL-6
Description
Blood sample assessment: Sr IL-6
Time Frame
12 months
Title
25-hydroxyvitamin D
Description
Blood sample assessment: 25-hydroxyvitamin D
Time Frame
12 months
Title
Hearing
Description
Pure-tone testing in both ears
Time Frame
12 months
Title
Effect of life-time cognitive activities
Description
Cognitive Activities Questionnaire (CAQ)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heike A Bischoff, Prof. Dr. med., DrPH
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre on Aging and Mobility, University of Zurich, Waid City Hospital
City
Zürich
ZIP/Postal Code
8037
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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