Clinical trial NCT02279316: Move for Your Mind - Pilot Trial
Official title: Home Exercise, Vitamin D and Dalcroze Eurhythmics for Seniors With Mild Cognitive Impairment (MCI) or Mild Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Mild Dementia
Fall Prevention
Keywords: Dalcroze eurhythmics
home exercise
vitamin D
mild cognitive impairment
MCI
mild dementia
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Waid City Hospital, Zurich
First posted: 2014-10-31
Enrollment: 19
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Rate of falls (any falls, low trauma falls, injurious falls) during 12 month follow-up
timeFrame: 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
timeFrame: at month 2, 4, 6, 8, 10 and 12 after baseline
measure: Gait variability (stride time, stride length and gait speed)
timeFrame: Baseline, 6 & 12 months
measure: Cognitive function
timeFrame: Baseline, 6 & 12 months
measure: Alertness
timeFrame: Baseline, 6 & 12 months
measure: Quality of life
timeFrame: Baseline, 6 and 12 months
Other outcomes:
measure: progression of MCI/mild dementia
timeFrame: 6 &12 months
measure: Musculoskeletal pain
timeFrame: baseline, 6 and 12 month
Locations:
city: Zurich
country: Switzerland
facility: Centre on Aging and Mobility, University of Zurich, Waid City Hospital
Study officials:
affiliation: Director Geriatric Clinic University Hospital Zurich and Centre on Aging and Mobility, University of Zurich
name: Heike Bischoff-Ferrari, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.