Cognitive DeclineNCT03384602
MOVE for Your MIND
A study testing Dalcroze Eurhythmics Program and home exercise strength program in people with Cognitive Decline and Fall, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline, Fall
- What is being tested?
- Dalcroze Eurhythmics Program and home exercise strength program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Dec 2017to 2 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 70+, living in the community
- Meet the criterion for SCD defined by a score of ≥25 points on the MAC-Q questionnaire
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre on Aging and Mobility, University of Zurich
Zurich, 8037
About this study
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
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.
Read the 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.
- Conditions
- Cognitive Decline, Fall
- Being tested
- Dalcroze Eurhythmics Program, home exercise strength program
- Keywords
- subjective cognitive decline, falls prevention, cognitive function, dalcroze eurhythmics, home exercise program, seniors
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dalcroze Eurhythmics ProgramOther
music-based multi-task exercise in group setting
home exercise strength programOther
simple strength exercise program to perform individually at home
| Study group | Role | What they receive |
|---|---|---|
| Dalcroze Eurhythmics program | Active comparator | music-based multi-task exercise intervention Receives: Other: Dalcroze Eurhythmics Program |
| home exercise strength program | Active comparator | simple strength training program to perform individually at home Receives: Other: home exercise strength program |
| Control group | No intervention | no change in the daily activities, no exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive function
assessed with the CERAD-plus test
Measured: 12 months
Rate of falls
The circumstances and injuries associated with the fall will be ascertained with a questionnaire.
Measured: 12 months
Secondary outcomes (27)
Proportion of seniors with any falls and injurious falls
Participants will record incident falls in the study diary.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 12 months
Cognitive function: Word List Learning
Word List Learning is part of the CERAD test battery (change over 12 months will be evaluated)
Measured: 12 months
Cognitive function: Word List Recall
Word List Recall is part of the CERAD test battery (change over 12 months will be evaluated)
Measured: 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)
Measured: 12 months
Cognitive function: Constructional Praxis
Constructional Praxis is part of the CERAD test battery (change over 12 months will be evaluated)
Measured: 12 months
Cognitive function: Constructional Praxis Recall
Constructional Praxis Recall is part of the CERAD test battery (change over 12 months will be evaluated)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 12 months
Incident MCI
Based on the results from the CERAD-plus test battery
Measured: 12 months
Functional decline: gait speed
Gait speed will be measured with a stop watch over a distance of 4 meters.
Measured: 12 months
Functional decline: timed up and go test
Assessed with the standard timed up and go test protocol
Measured: 12 months
Functional decline: repeated sit-to-stand test
Assessed with the repeated sit-to-stand test protocol
Measured: 12 months
Functional decline: grip strength
Assessed using a Martin Vigorimeter
Measured: 12 months
Functional decline: short physical performance battery
Assessed using the short physical performance battery
Measured: 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)
Measured: 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)
Measured: 12 months
Quality of life: EuroQuol
Assessed using the German Version of EuroQuol EQ5D-3L questionnaire according to the Austrian reference scale
Measured: 12 months
Quality of life: RAND 36-Item Short Form Survey
Assessed using the RAND 36-Item Short Form Survey (SF-36)
Measured: 12 months
Mental Health: Geriatric Depression Scale
Assessed with the short form of the Geriatric Depression Scale (GDS)
Measured: 12 months
Changes in IGF-1
Blood marker analyses: IGF-1
Measured: 12 months
Changes in biomarkers of inflammation: hr-CRP
Blood marker analyses: hr-CRP
Measured: 12 months
Changes in biomarkers of inflammation: IL-6
Blood marker analyses: IL-6
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start14 Dec 2017
- Primary completion2 Nov 2021
- Study completion2 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, 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
- Responsible party
- Sponsor
- Investigators
- Heike A Bischoff, Prof. Dr. med., DrPH, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384602
- Sponsor's protocol ID
- 2017-01288
- Other IDs
- 2017
- Status last verified
- Aug 2024
- First submitted
- 16 Oct 2017
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03384602
- Acronym / sponsor ID
- 2017-01288
- Conditions
- Cognitive Decline, Fall
- Keywords
- subjective cognitive decline, falls prevention, cognitive function, dalcroze eurhythmics, home exercise program, seniors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, 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
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 2 Nov 2022 (actual)
- First posted
- 27 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Dalcroze Eurhythmics program | Active comparator | Other: Dalcroze Eurhythmics Programmusic-based multi-task exercise intervention |
| home exercise strength program | Active comparator | Other: home exercise strength programsimple strength training program to perform individually at home |
| Control group | No intervention | –no change in the daily activities, no exercise intervention |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age 70+, living in the community
- Meet the criterion for SCD defined by a score of ≥25 points on the MAC-Q questionnaire
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dalcroze Eurhythmics Programmusic-based multi-task exercise in group setting | Other | Dalcroze Eurhythmics program |
| home exercise strength programsimple strength exercise program to perform individually at home | Other | home exercise strength program |
Primary outcome
Change in cognitive function
Time frame: 12 months
assessed with the CERAD-plus test
Rate of falls
Time frame: 12 months
The circumstances and injuries associated with the fall will be ascertained with a questionnaire.
27 secondary outcomes
Proportion of seniors with any falls and injurious falls
Time frame: 12 months
Rate of injurious falls
Time frame: 12 months
Cognitive function: verbal fluency test
Time frame: 12 months
Cognitive function: Boston Naming test
Time frame: 12 months
Cognitive function: Mini Mental State Exam
Time frame: 12 months
Cognitive function: Word List Learning
Time frame: 12 months
Cognitive function: Word List Recall
Time frame: 12 months
Cognitive function: Word List Recognition
Time frame: 12 months
Cognitive function: Constructional Praxis
Time frame: 12 months
Cognitive function: Constructional Praxis Recall
Time frame: 12 months
Cognitive function: Trial Making Test A
Time frame: 12 months
Cognitive function: Trial Making Test B
Time frame: 12 months
Cognitive function: Phonematic Fluency Test
Time frame: 12 months
Incident MCI
Time frame: 12 months
Functional decline: gait speed
Time frame: 12 months
Functional decline: timed up and go test
Time frame: 12 months
Functional decline: repeated sit-to-stand test
Time frame: 12 months
Functional decline: grip strength
Time frame: 12 months
Functional decline: short physical performance battery
Time frame: 12 months
Change in gait variability under single task condition
Time frame: 12 months
Change in gait variability under dual task condition
Time frame: 12 months
Quality of life: EuroQuol
Time frame: 12 months
Quality of life: RAND 36-Item Short Form Survey
Time frame: 12 months
Mental Health: Geriatric Depression Scale
Time frame: 12 months
Changes in IGF-1
Time frame: 12 months
Changes in biomarkers of inflammation: hr-CRP
Time frame: 12 months
Changes in biomarkers of inflammation: IL-6
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heike A Bischoff, Prof. Dr. med., DrPH principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dalcroze Eurhythmics Program and home exercise strength program in people with Cognitive Decline and Fall, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive function (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.