Move for Your Mind - Pilot Trial

Study Overview
=================
Brief 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 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.

Official Title
-----------------
Home Exercise, Vitamin D and Dalcroze Eurhythmics for Seniors With Mild Cognitive Impairment (MCI) or Mild Dementia

Conditions
-----------------
Mild Cognitive Impairment, Mild Dementia, Fall Prevention

Intervention / Treatment
-----------------
* Drug: Vi-De 3
* Other: Jaques-Dalcroze eurhythmics
* Other: Home exercise program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 65+ years Diagnosed with MCI or mild dementia by the memory clinic of City Hospital Waid Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jaques-Dalcroze eurhythmics<br>Jaques-Dalcroze eurhythmics (60min/wk) + 800 IU Vitamin D3 | Drug: Vi-De 3<br>* 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.<br>* Other names: Vitamin D, cholecalciferol;Other: Jaques-Dalcroze eurhythmics<br>* 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.<br>|
| Experimental: Home exercise program<br>Home exercise strength program (3x30min/wk) + 800 IU vitamin D | Drug: Vi-De 3<br>* 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.<br>* Other names: Vitamin D, cholecalciferol;Other: Home exercise program<br>* The home exercise program is a strengthening program that will consist of five simple exercises.<br>|
| Other: Vitamin D only<br>800 IU Vi-De 3 | Drug: Vi-De 3<br>* 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.<br>* Other names: Vitamin D, cholecalciferol;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at month 2, 4, 6, 8, 10 and 12 after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who fell at least once during 12 months of follow up |  | 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 | Baseline, 6 & 12 months | 
| Cognitive function | assessed using the Montreal Cognitive Assessment (MoCA) | Baseline, 6 & 12 months | 
| Alertness | Alertness will be assessed using the two subtests alertness and split alertness of the test of attentional performance (TAP) | Baseline, 6 & 12 months | 
| Quality of life | evaluated using the SF-36 questionnaire | Baseline, 6 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dalcroze eurhythmics, home exercise, vitamin D, mild cognitive impairment, MCI, mild dementia