Mild Cognitive ImpairmentMFYM - PNCT02279316
Move for Your Mind - Pilot Trial
A study testing Vi-De 3, Jaques-Dalcroze eurhythmics and Home exercise program in people with Mild Cognitive Impairment and Mild Dementia, run by University of Zurich at 1 site in Switzerland.
Trial summary
Move for your mind is a single blind, 3-arm randomized controlled clinical pilot trial. The study aims to test the effect of a weekly Dalcroze eurhythmics program (arm 1) and a home strength exercise program (arm 2) against control (no exercise) on the rate of falling, quality of life, gait performance and cognitive… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Mild Dementia, Fall Prevention
- What is being tested?
- Vi-De 3, Jaques-Dalcroze eurhythmics and Home exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2014to Sep 2016
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65+ years
- Diagnosed with MCI or mild dementia by the memory clinic of City Hospital Waid
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre on Aging and Mobility, University of Zurich, Waid City Hospital
Zurich, Canton of Zurich, 8037
About this study
Official title: Home Exercise, Vitamin D and Dalcroze Eurhythmics for Seniors With Mild Cognitive Impairment (MCI) or Mild Dementia
Move for your mind is a single blind, 3-arm randomized controlled clinical pilot trial. The study aims to test the effect of a weekly Dalcroze eurhythmics program (arm 1) and a home strength exercise program (arm 2) against control (no exercise) on the rate of falling, quality of life, gait performance and cognitive function. All groups receive vitamin D. In addition the study shall test the feasibility of the recruitment and the interventions in this target population.
The study includes 60 seniors, age 65 and older, with mild cognitive impairment or mild dementia. Participants are recruited by the memory clinic of City Hospital Waid.
During the 12 months follow-up, participants will have 3 clinical visits (baseline, 6 and 12 month). Despite major efforts the target population is very difficult to recruit and adherence to treatment is low. We therefore decided to stop recruitment and to use this trial as a pilot trial for future clinical trials of the same topic.
Read the detailed description
Primary objective To test whether the Jaques-Dalcroze eurhythmics program (1 hour a week for 12 months) and/or the simple home exercise program (3 × 30 min a week for 12 months) will decrease rate of falls in seniors with MCI or mild dementia compared with the control group.
Secondary objectives Objective 1: To test whether the Jaques-Dalcroze eurhythmics program (1 hour a week for 12 months) and/or the simple home exercise program (3 × 30 min a week for 12 months) decreases 12-month risk of falling at least once in seniors with MCI or mild dementia compared with the control group.
Objective 2: To test whether the Jaques-Dalcroze eurhythmics program (1 hour a week for 12 months) and/or the simple home exercise program (3 × 30 min a week for 12 months) improves cognitive func-tion and alertness in seniors with MCI or mild dementia compared with the control group.
Objective 3: To test whether the Jaques-Dalcroze eurhythmics program (1 hour a week for 12 months) and/or the simple home exercise program (3 × 30 min a week for 12 months) decreases gait variability in seniors with MCI or mild dementia compared with the control group.
Objective 4: To test whether the Jaques-Dalcroze eurhythmics program (1 hour a week for 12 months) and/or the simple home exercise program (3 × 30 min a week for 12 months) improves quality of life in seniors with MCI or mild dementia compared with the control group.
- Conditions
- Mild Cognitive Impairment, Mild Dementia, Fall Prevention
- Being tested
- Vi-De 3, Jaques-Dalcroze eurhythmics, Home exercise program
- Keywords
- Dalcroze eurhythmics, home exercise, vitamin D, mild cognitive impairment, MCI, mild dementia
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vi-De 3Drug
Also called Vitamin D, cholecalciferol
All participants receive a dose of 800 IU vitamin D3 per day as a standard of care. 800 IU Vitamin D is the dose that is currently recommended by the Swiss Health Department (Bundesamt für Gesundheit) for seniors over 60.
Jaques-Dalcroze eurhythmicsOther
The Jaques-Dalcroze eurhythmics method includes different courses of motion (multi-task exercises) that are conducted to the rhythm of improvised piano music. A session starts with a short warm-up that includes simple exercises to get body and mind prepared for the rest of the exercise session. The complexity of the exercises increases gradually during the session: starting with single tasks and then combining them into a multi-task exercise gradually increasing complexity.
Home exercise programOther
The home exercise program is a strengthening program that will consist of five simple exercises.
| Study group | Role | What they receive |
|---|---|---|
| Jaques-Dalcroze eurhythmics | Experimental | Jaques-Dalcroze eurhythmics (60min/wk) + 800 IU Vitamin D3 Receives: Drug: Vi-De 3; Other: Jaques-Dalcroze eurhythmics |
| Home exercise program | Experimental | Home exercise strength program (3x30min/wk) + 800 IU vitamin D Receives: Drug: Vi-De 3; Other: Home exercise program |
| Vitamin D only | Other | 800 IU Vi-De 3 Receives: Drug: Vi-De 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of falls (any falls, low trauma falls, injurious falls) during 12 month follow-up
A fall is defined as unintentional coming to rest on the ground, floor, or other lower level (coming to rest against furniture or a wall is not considered a fall). All reported incident falls will be ascertained every 2 month (phone calls at 2, 4, 8 and 10 months and clinical visits at 6 and 12 months after baseline) with a questionnaire evaluating the circumstances of each fall and injuries associated with it. Participants will also receive a diary to record any new health event including a fall. The diary will serve as a supplementary tool to falls evaluation minimizing potential recall bias.
Measured: at month 2, 4, 6, 8, 10 and 12 after baseline
Secondary outcomes (5)
Number of participants who fell at least once during 12 months of follow up
Measured: at month 2, 4, 6, 8, 10 and 12 after baseline
Gait variability (stride time, stride length and gait speed)
assessed by a GAITRite analysis system
Measured: Baseline, 6 & 12 months
Cognitive function
assessed using the Montreal Cognitive Assessment (MoCA)
Measured: Baseline, 6 & 12 months
Alertness
Alertness will be assessed using the two subtests "alertness" and "split alertness" of the test of attentional performance (TAP)
Measured: Baseline, 6 & 12 months
Quality of life
evaluated using the SF-36 questionnaire
Measured: Baseline, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Waid City Hospital, Zurich
- Responsible party
- Sponsor
- Investigators
- Heike Bischoff-Ferrari, Prof., Principal investigator, Director Geriatric Clinic University Hospital Zurich and Centre on Aging and Mobility, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279316
- Sponsor's protocol ID
- SNCTP000000580
- Acronym
- MFYM - P
- Status last verified
- Nov 2016
- First submitted
- 4 Oct 2014
- Last updated
- 17 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fischbacher M, Chocano-Bedoya PO, Meyer U, Bopp I, Mattle M, Kressig RW, Egli A, Bischoff-Ferrari HA. Safety and feasibility of a Dalcroze eurhythmics and a simple home exercise program among older adults with mild cognitive impairment (MCI) or mild dementia: the MOVE for your MIND pilot trial. Pilot Feasibility Stud. 2020 Jul 15;6:101. doi: 10.1186/s40814-020-00645-7. eCollection 2020.
PubMed 32695433
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Exercise, Vitamin D and Dalcroze Eurhythmics for Seniors With Mild Cognitive Impairment (MCI) or Mild Dementia
- ClinicalTrials.gov ID
- NCT02279316
- Acronym / sponsor ID
- MFYM - P / SNCTP000000580
- Conditions
- Mild Cognitive Impairment, Mild Dementia, Fall Prevention
- Keywords
- Dalcroze eurhythmics, home exercise, vitamin D, mild cognitive impairment, MCI, mild dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Waid City Hospital, Zurich
- Study start
- Oct 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 31 Oct 2014 (estimated)
- 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.
Move for your mind is a single blind, 3-arm randomized controlled clinical pilot trial. The study aims to test the effect of a weekly Dalcroze eurhythmics program (arm 1) and a home strength exercise program (arm 2) against control (no exercise) on the rate of falling, quality of life, gait performance and cognitive function. All groups receive vitamin D. In addition the study shall test the feasibility of the recruitment and the interventions in this target population.
The study includes 60 seniors, age 65 and older, with mild cognitive impairment or mild dementia. Participants are recruited by the memory clinic of City Hospital Waid.
During the 12 months follow-up, participants will have 3 clinical visits (baseline, 6 and 12 month). Despite major efforts the target population is very difficult to recruit and adherence to treatment is low. We therefore decided to stop recruitment and to use this trial as a pilot trial for future clinical trials of the same topic.
Detailed description
Primary objective To test whether the Jaques-Dalcroze eurhythmics program (1 hour a week for 12 months) and/or the simple home exercise program (3 × 30 min a week for 12 months) will decrease rate of falls in seniors with MCI or mild dementia compared with the control group.
Secondary objectives Objective 1: To test whether the Jaques-Dalcroze eurhythmics program (1 hour a week for 12 months) and/or the simple home exercise program (3 × 30 min a week for 12 months) decreases 12-month risk of falling at least once in seniors with MCI or mild dementia compared with the control group.
Objective 2: To test whether the Jaques-Dalcroze eurhythmics program (1 hour a week for 12 months) and/or the simple home exercise program (3 × 30 min a week for 12 months) improves cognitive func-tion and alertness in seniors with MCI or mild dementia compared with the control group.
Objective 3: To test whether the Jaques-Dalcroze eurhythmics program (1 hour a week for 12 months) and/or the simple home exercise program (3 × 30 min a week for 12 months) decreases gait variability in seniors with MCI or mild dementia compared with the control group.
Objective 4: To test whether the Jaques-Dalcroze eurhythmics program (1 hour a week for 12 months) and/or the simple home exercise program (3 × 30 min a week for 12 months) improves quality of life in seniors with MCI or mild dementia compared with the control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Jaques-Dalcroze eurhythmics | Experimental | Drug: Vi-De 3, Other: Jaques-Dalcroze eurhythmicsJaques-Dalcroze eurhythmics (60min/wk) + 800 IU Vitamin D3 |
| Home exercise program | Experimental | Drug: Vi-De 3, Other: Home exercise programHome exercise strength program (3x30min/wk) + 800 IU vitamin D |
| Vitamin D only | Other | Drug: Vi-De 3800 IU Vi-De 3 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age 65+ years
- Diagnosed with MCI or mild dementia by the memory clinic of City Hospital Waid
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Vi-De 3Also: Vitamin D, cholecalciferolAll participants receive a dose of 800 IU vitamin D3 per day as a standard of care. 800 IU Vitamin D is the dose that is currently recommended by the Swiss Health Department (Bundesamt für Gesundheit) for seniors over 60. | Drug | Home exercise program, Jaques-Dalcroze eurhythmics, Vitamin D only |
| Jaques-Dalcroze eurhythmicsThe Jaques-Dalcroze eurhythmics method includes different courses of motion (multi-task exercises) that are conducted to the rhythm of improvised piano music. A session starts with a short warm-up that includes simple exercises to get body and mind prepared for the rest of the exercise session. The complexity of the exercises increases gradually during the session: starting with single tasks and then combining them into a multi-task exercise gradually increasing complexity. | Other | Jaques-Dalcroze eurhythmics |
| Home exercise programThe home exercise program is a strengthening program that will consist of five simple exercises. | Other | Home exercise program |
Primary outcome
Rate of falls (any falls, low trauma falls, injurious falls) during 12 month follow-up
Time frame: at month 2, 4, 6, 8, 10 and 12 after baseline
A fall is defined as unintentional coming to rest on the ground, floor, or other lower level (coming to rest against furniture or a wall is not considered a fall). All reported incident falls will be ascertained every 2 month (phone calls at 2, 4, 8 and 10 months and clinical visits at 6 and 12 months after baseline) with a questionnaire evaluating the circumstances of each fall and injuries associated with it. Participants will also receive a diary to record any new health event including a fall. The diary will serve as a supplementary tool to falls evaluation minimizing potential recall bias.
5 secondary outcomes
Number of participants who fell at least once during 12 months of follow up
Time frame: at month 2, 4, 6, 8, 10 and 12 after baseline
Gait variability (stride time, stride length and gait speed)
Time frame: Baseline, 6 & 12 months
Cognitive function
Time frame: Baseline, 6 & 12 months
Alertness
Time frame: Baseline, 6 & 12 months
Quality of life
Time frame: Baseline, 6 and 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 17 Nov 2016.
- Derived from this study: PubMed 32695433Fischbacher M, Chocano-Bedoya PO, Meyer U, Bopp I, Mattle M, Kressig RW, Egli A, Bischoff-Ferrari HA. Safety and feasibility of a Dalcroze eurhythmics and a simple home exercise program among older adults with mild cognitive impairment (MCI) or mild dementia: the MOVE for your MIND pilot trial. Pilot Feasibility Stud. 2020 Jul 15;6:101. doi: 10.1186/s40814-020-00645-7. eCollection 2020.
Related trials for Mild Cognitive Impairment
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Loneliness as Risk Factor for Dementia
Mild Cognitive Impairment (MCI), Dementia (Diagnosis)
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease
Alzheimer's Disease
Recruiting
Combating Alzheimer's Through Sleep and Exercise
Dementia, Mild Cognitive Impairment (MCI)
Active, not recruiting
EFFECTS OF AN OUTDOOR MAT PILATES PROGRAM ON NEUROPHYSIOLOGICAL INDICATORS OF ELDERLY INDIVIDUALS WITH MILD COGNITIVE IMPAIRMENT
Cognition Disorders
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 Bischoff-Ferrari, Prof. principal investigator
Director Geriatric Clinic University Hospital Zurich and Centre on Aging and Mobility, 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 Vi-De 3, Jaques-Dalcroze eurhythmics and Home exercise program in people with Mild Cognitive Impairment and Mild Dementia, 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 1 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 17 Nov 2016. 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?
Rate of falls (any falls, low trauma falls, injurious falls) during 12 month follow-up (time frame: at month 2, 4, 6, 8, 10 and 12 after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02279316, which also lists 1 linked publication.
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 17 Nov 2016.