Move for Your Mind - Pilot Trial

Mild Cognitive Impairment Clinical Trial

— MFYM - P  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02279316
• Other study ID #: SNCTP000000580
• Status: Completed
• Phase: N/A
• First received: October 4, 2014
• Last updated: November 16, 2016
• Start date: October 2014
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Age 65+ years

• Diagnosed with MCI or mild dementia by the memory clinic of City Hospital Waid

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cognition Disorders
• Dementia
• Fall Prevention
• Mild Cognitive Impairment
• Mild Dementia

Intervention

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

Locations

Country	Name	City	State
Switzerland	Centre on Aging and Mobility, University of Zurich, Waid City Hospital	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Waid City Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	progression of MCI/mild dementia	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.	6 &12 months	No
Other	Musculoskeletal pain	assessed using McGill pain map. Number of painful joints will be assessed using a joint map.	baseline, 6 and 12 month	No
Primary	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.	at month 2, 4, 6, 8, 10 and 12 after baseline	No
Secondary	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	No
Secondary	Gait variability (stride time, stride length and gait speed)	assessed by a GAITRite analysis system	Baseline, 6 & 12 months	No
Secondary	Cognitive function	assessed using the Montreal Cognitive Assessment (MoCA)	Baseline, 6 & 12 months	No
Secondary	Alertness	Alertness will be assessed using the two subtests "alertness" and "split alertness" of the test of attentional performance (TAP)	Baseline, 6 & 12 months	No
Secondary	Quality of life	evaluated using the SF-36 questionnaire	Baseline, 6 and 12 months	No