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Move for Your Mind - Pilot Trial (MFYM - P)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02279316
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : November 17, 2016
Sponsor:
Collaborator:
Waid City Hospital, Zurich
Information provided by (Responsible Party):
University of Zurich

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : October 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

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 Name: 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 Name: Vitamin D, cholecalciferol

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

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 Name: Vitamin D, cholecalciferol




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279316


Locations
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Switzerland
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
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Principal Investigator: Heike Bischoff-Ferrari, Prof. Director Geriatric Clinic University Hospital Zurich and Centre on Aging and Mobility, University of Zurich

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02279316    
Other Study ID Numbers: SNCTP000000580
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: November 17, 2016
Last Verified: November 2016
Keywords provided by University of Zurich:
Dalcroze eurhythmics
home exercise
vitamin D
mild cognitive impairment
MCI
mild dementia
Additional relevant MeSH terms:
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Dementia
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents