Move for Your Mind - Pilot Trial

NCT02279316 | Completed DMC

• 1 other identifier: SNCTP000000580
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Mild Dementia; Fall Prevention

Keywords

Dalcroze eurhythmics; home exercise; vitamin D; mild cognitive impairment; MCI; mild dementia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

• Cognitive function

  Baseline, 6 & 12 months

• Alertness

  Baseline, 6 & 12 months

• Quality of life

  Baseline, 6 and 12 months

Other Outcomes (2)

• progression of MCI/mild dementia

  6 &12 months

• Musculoskeletal pain

  baseline, 6 and 12 month

Study Arms (3)

Jaques-Dalcroze eurhythmics

EXPERIMENTAL

Jaques-Dalcroze eurhythmics (60min/wk) + 800 IU Vitamin D3

Drug: Vi-De 3; Other: Jaques-Dalcroze eurhythmics

Home exercise program

EXPERIMENTAL

Home exercise strength program (3x30min/wk) + 800 IU vitamin D

Drug: Vi-De 3; Other: Home exercise program

Vitamin D only

OTHER

800 IU Vi-De 3

Drug: Vi-De 3

Interventions

Vi-De 3 DRUG

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.

Also known as: Vitamin D, cholecalciferol

Home exercise program; Jaques-Dalcroze eurhythmics; Vitamin D only

Jaques-Dalcroze eurhythmics OTHER

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.

Jaques-Dalcroze eurhythmics

Home exercise program OTHER

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

Home exercise program

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of Zurich: lead
• Waid City Hospital, Zurich: collaborator

Study Sites (1)

Centre on Aging and Mobility, University of Zurich, Waid City Hospital

Zurich, Canton of Zurich, 8037, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 32695433 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Heike Bischoff-Ferrari, Prof.

  Director Geriatric Clinic University Hospital Zurich and Centre on Aging and Mobility, University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2014
• First Posted: October 31, 2014
• Study Start: October 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 17, 2016

Record last verified: 2016-11

Locations

CH (1)