MFYM - P: Move for Your Mind - Pilot Trial

Sponsor

University of Zurich (Other)

Overall Status

Completed

CT.gov ID

NCT02279316

Collaborator

Waid City Hospital, Zurich (Other)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Mild Cognitive Impairment Mild Dementia Fall Prevention	Drug: Vi-De 3 Other: Jaques-Dalcroze eurhythmics Other: Home exercise program	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Prevention

Official Title:

Home Exercise, Vitamin D and Dalcroze Eurhythmics for Seniors With Mild Cognitive Impairment (MCI) or Mild Dementia

Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Sep 1, 2016

Actual Study Completion Date :

Sep 1, 2016

Arms and Interventions

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

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

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

Other Names:

Vitamin D, cholecalciferol

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

progression of MCI/mild dementia [6 &12 months]
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.
Musculoskeletal pain [baseline, 6 and 12 month]
assessed using McGill pain map. Number of painful joints will be assessed using a joint map.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre on Aging and Mobility, University of Zurich, Waid City Hospital	Zurich		Switzerland	8037

Sponsors and Collaborators

University of Zurich
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