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Completed

NCT Number: NCT02279316

Move for Your Mind - Pilot Trial

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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Fall Prevention Mental Disorders Mild Dementia Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Zurich, Canton of Zurich, 8037, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

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.

Other names: Vitamin D, cholecalciferol

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.

Home exercise program

Other

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

Primary outcomes

  1. 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

    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 outcomes

  1. 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

  2. Gait variability (stride time, stride length and gait speed)

    Time frame: Baseline, 6 & 12 months

    assessed by a GAITRite analysis system

  3. Cognitive function

    Time frame: Baseline, 6 & 12 months

    assessed using the Montreal Cognitive Assessment (MoCA)

  4. Alertness

    Time frame: Baseline, 6 & 12 months

    Alertness will be assessed using the two subtests "alertness" and "split alertness" of the test of attentional performance (TAP)

  5. Quality of life

    Time frame: Baseline, 6 and 12 months

    evaluated using the SF-36 questionnaire

Other outcomes

  1. progression of MCI/mild dementia

    Time frame: 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.

  2. Musculoskeletal pain

    Time frame: baseline, 6 and 12 month

    assessed using McGill pain map. Number of painful joints will be assessed using a joint map.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Waid City Hospital, Zurich

Registry information

Official study title

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

Acronym: MFYM - P

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 31, 2014
Registry last updated
Nov 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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