Overview

This trial has been completed.

Conditions mild cognitive impairment, mild dementia, fall prevention
Treatments vi-de 3, jaques-dalcroze eurhythmics, home exercise program
Sponsor University of Zurich
Collaborator Waid City Hospital, Zurich
Start date October 2014
End date September 2016
Trial size 19 participants
Trial identifier NCT02279316, SNCTP000000580

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose prevention
Arm
(Experimental)
Jaques-Dalcroze eurhythmics (60min/wk) + 800 IU Vitamin D3
vi-de 3 Vitamin D, cholecalciferol
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
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 strength program (3x30min/wk) + 800 IU vitamin D
vi-de 3 Vitamin D, cholecalciferol
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
The home exercise program is a strengthening program that will consist of five simple exercises.
(Other)
800 IU Vi-De 3
vi-de 3 Vitamin D, cholecalciferol
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.

Primary Outcomes

Measure
Rate of falls (any falls, low trauma falls, injurious falls) during 12 month follow-up
time frame: at month 2, 4, 6, 8, 10 and 12 after baseline

Secondary Outcomes

Measure
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
Gait variability (stride time, stride length and gait speed)
time frame: Baseline, 6 & 12 months
Cognitive function
time frame: Baseline, 6 & 12 months
Alertness
time frame: Baseline, 6 & 12 months
Quality of life
time frame: Baseline, 6 and 12 months

Eligibility Criteria

Male or female participants at least 65 years old.

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

Additional Information

Official title Home Exercise, Vitamin D and Dalcroze Eurhythmics for Seniors With Mild Cognitive Impairment (MCI) or Mild Dementia
Principal investigator Heike Bischoff-Ferrari, Prof.
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of Zurich.