Move for Your Mind - Pilot Trial

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment; Mild Dementia; Fall Prevention
• Interventions: Drug: Vi-De 3; Other: Jaques-Dalcroze eurhythmics; Other: Home exercise program

• Registration Number: NCT02279316
• Lead Sponsor: University of Zurich

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-04
• Study First Submitted QC: 2014-10-27
• Study First Posted: 2014-10-31
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

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

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Jaques-Dalcroze eurhythmics	Vi-De 3	Jaques-Dalcroze eurhythmics (60min/wk) + 800 IU Vitamin D3
Jaques-Dalcroze eurhythmics	Jaques-Dalcroze eurhythmics	Jaques-Dalcroze eurhythmics (60min/wk) + 800 IU Vitamin D3
Home exercise program	Vi-De 3	Home exercise strength program (3x30min/wk) + 800 IU vitamin D
Home exercise program	Home exercise program	Home exercise strength program (3x30min/wk) + 800 IU vitamin D
Vitamin D only	Vi-De 3	800 IU Vi-De 3

Primary Outcome Measures

Name	Time	Method
Rate of falls (any falls, low trauma falls, injurious falls) during 12 month follow-up	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.

Secondary Outcome Measures

Name	Time	Method
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)	Baseline, 6 & 12 months	assessed by a GAITRite analysis system
Cognitive function	Baseline, 6 & 12 months	assessed using the Montreal Cognitive Assessment (MoCA)
Alertness	Baseline, 6 & 12 months	Alertness will be assessed using the two subtests "alertness" and "split alertness" of the test of attentional performance (TAP)
Quality of life	Baseline, 6 and 12 months	evaluated using the SF-36 questionnaire

Trial Locations

Locations (1)

Centre on Aging and Mobility, University of Zurich, Waid City Hospital; 🇨🇭 Zurich, Switzerland