Move for Your Mind - Pilot Trial

NCT ID: NCT02279316

Last Updated: 2016-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-09-30

Brief Summary

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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

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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

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Mild Cognitive Impairment Mild Dementia Fall Prevention

Keywords

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Dalcroze eurhythmics home exercise vitamin D mild cognitive impairment MCI mild dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Jaques-Dalcroze eurhythmics

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

Group Type EXPERIMENTAL

Vi-De 3

Intervention Type DRUG

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 eurhythmics

Intervention Type OTHER

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 program

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

Group Type EXPERIMENTAL

Vi-De 3

Intervention Type DRUG

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.

Home exercise program

Intervention Type OTHER

The home exercise program is a strengthening program that will consist of five simple exercises.

Vitamin D only

800 IU Vi-De 3

Group Type OTHER

Vi-De 3

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type OTHER

Home exercise program

The home exercise program is a strengthening program that will consist of five simple exercises.

Intervention Type OTHER

Other Intervention Names

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Vitamin D, cholecalciferol

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Waid City Hospital, Zurich

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heike Bischoff-Ferrari, Prof.

Role: PRINCIPAL_INVESTIGATOR

Director Geriatric Clinic University Hospital Zurich and Centre on Aging and Mobility, University of Zurich

Locations

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

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 32695433 (View on PubMed)

Other Identifiers

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SNCTP000000580

Identifier Type: -

Identifier Source: org_study_id