Move for Your Mind - Pilot Trial (MFYM - P)

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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment; Mild Dementia; Fall Prevention
• Intervention / Treatment: Drug: Vi-De 3; Other: Jaques-Dalcroze eurhythmics; Other: Home exercise program

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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 65+ years
• Diagnosed with MCI or mild dementia by the memory clinic of City Hospital Waid

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression of MCI/mild dementia	any progression of the cognitive disorder to a more severe state ( will be confirmed based on medical records of the memory clinic of Waid City Hospital. Evaluation of this endpoint will be supported by information from the MoCA and the TAP subtests at baseline, 6, and 12 months clinical visits.	6 &12 months
Musculoskeletal pain	assessed using McGill pain map. Number of painful joints will be assessed using a joint map.	baseline, 6 and 12 month

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Waid City Hospital, Zurich
• Investigators: Principal Investigator: Heike Bischoff-Ferrari, Prof., Director Geriatric Clinic University Hospital Zurich and Centre on Aging and Mobility, University of Zurich

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: October 4, 2014
• First Submitted That Met QC Criteria: October 27, 2014
• First Posted (Estimate): October 31, 2014

Study Record Updates

• Last Update Posted (Estimate): November 17, 2016
• Last Update Submitted That Met QC Criteria: November 16, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: MCI; mild cognitive impairment; vitamin D; home exercise; mild dementia; Dalcroze eurhythmics
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Cognition Disorders; Dementia; Cognitive Dysfunction; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: SNCTP000000580