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

Primary Purpose

Mild Cognitive Impairment, Mild Dementia, Fall Prevention

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Vi-De 3
Jaques-Dalcroze eurhythmics
Home exercise program
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring Dalcroze eurhythmics, home exercise, vitamin D, mild cognitive impairment, MCI, mild dementia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

-

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

Experimental

Experimental

Other

Arm Label

Jaques-Dalcroze eurhythmics

Home exercise program

Vitamin D only

Arm Description

Jaques-Dalcroze eurhythmics (60min/wk) + 800 IU Vitamin D3

Home exercise strength program (3x30min/wk) + 800 IU vitamin D

800 IU Vi-De 3

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of participants who fell at least once during 12 months of follow up
Gait variability (stride time, stride length and gait speed)
assessed by a GAITRite analysis system
Cognitive function
assessed using the Montreal Cognitive Assessment (MoCA)
Alertness
Alertness will be assessed using the two subtests "alertness" and "split alertness" of the test of attentional performance (TAP)
Quality of life
evaluated using the SF-36 questionnaire

Full Information

First Posted
October 4, 2014
Last Updated
November 16, 2016
Sponsor
University of Zurich
Collaborators
Waid City Hospital, Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT02279316
Brief Title
Move for Your Mind - Pilot Trial
Acronym
MFYM - P
Official Title
Home Exercise, Vitamin D and Dalcroze Eurhythmics for Seniors With Mild Cognitive Impairment (MCI) or Mild Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
Waid City Hospital, Zurich

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Mild Dementia, Fall Prevention
Keywords
Dalcroze eurhythmics, home exercise, vitamin D, mild cognitive impairment, MCI, mild dementia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Jaques-Dalcroze eurhythmics
Arm Type
Experimental
Arm Description
Jaques-Dalcroze eurhythmics (60min/wk) + 800 IU Vitamin D3
Arm Title
Home exercise program
Arm Type
Experimental
Arm Description
Home exercise strength program (3x30min/wk) + 800 IU vitamin D
Arm Title
Vitamin D only
Arm Type
Other
Arm Description
800 IU Vi-De 3
Intervention Type
Drug
Intervention Name(s)
Vi-De 3
Other Intervention Name(s)
Vitamin D, cholecalciferol
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Jaques-Dalcroze eurhythmics
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Home exercise program
Intervention Description
The home exercise program is a strengthening program that will consist of five simple exercises.
Primary Outcome Measure Information:
Title
Rate of falls (any falls, low trauma falls, injurious falls) during 12 month follow-up
Description
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.
Time Frame
at month 2, 4, 6, 8, 10 and 12 after baseline
Secondary Outcome Measure Information:
Title
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
Title
Gait variability (stride time, stride length and gait speed)
Description
assessed by a GAITRite analysis system
Time Frame
Baseline, 6 & 12 months
Title
Cognitive function
Description
assessed using the Montreal Cognitive Assessment (MoCA)
Time Frame
Baseline, 6 & 12 months
Title
Alertness
Description
Alertness will be assessed using the two subtests "alertness" and "split alertness" of the test of attentional performance (TAP)
Time Frame
Baseline, 6 & 12 months
Title
Quality of life
Description
evaluated using the SF-36 questionnaire
Time Frame
Baseline, 6 and 12 months
Other Pre-specified Outcome Measures:
Title
progression of MCI/mild dementia
Description
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.
Time Frame
6 &12 months
Title
Musculoskeletal pain
Description
assessed using McGill pain map. Number of painful joints will be assessed using a joint map.
Time Frame
baseline, 6 and 12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 65+ years Diagnosed with MCI or mild dementia by the memory clinic of City Hospital Waid Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heike Bischoff-Ferrari, Prof.
Organizational Affiliation
Director Geriatric Clinic University Hospital Zurich and Centre on Aging and Mobility, University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre on Aging and Mobility, University of Zurich, Waid City Hospital
City
Zurich
ZIP/Postal Code
8037
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
32695433
Citation
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.
Results Reference
derived

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Move for Your Mind - Pilot Trial

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