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MOVE for Your MIND

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ClinicalTrials.gov Identifier: NCT03384602
Recruitment Status : Recruiting
First Posted : December 27, 2017
Last Update Posted : December 27, 2017
Sponsor:
Collaborators:
Swiss National Science Foundation
University Hospital, Toulouse
Waid City Hospital, Zurich
Felix Platter Hospital
JungDiagnostics, Hamburg, Germany
Ferrari Data Solution, Feldmeilen, Switzerland
Vontobel Foundation
Information provided by (Responsible Party):
University of Zurich

Brief Summary:

Among the most promising interventions targeting both cognitive and functional decline, is Exercise. However, evidence regarding exercise interventions among seniors with cognitive impairment are inconclusive, likely due to challenges of recruitment and adherence. Alternatively, seniors with subjective cognitive decline (SCD), who are not yet meeting objective criteria of cognitive impairment, but have been shown to have twice the conversion rate to dementia compared with healthy seniors, are more likely to be motivated to participate and adhere to exercise interventions. Thus, exercise interventions in seniors with SCD may provide a window of opportunity for early prevention of dementia and falls.

The investigators aim to test the effect of a group exercise (multi-task Jaques-Dalcroze Eurhythmics) and a simple home strength exercise program on change of cognitive function and the rate of falling among seniors with SCD.


Condition or disease Intervention/treatment Phase
Cognitive Decline Fall Other: Dalcroze Eurhythmics Program Other: home exercise strength program Not Applicable

Detailed Description:

In Europe and in Switzerland, the number of seniors age 70 and older is predicted to increase from 25% to 40% by 2030, as is the number of seniors with cognitive impairments, physical frailty and resulting consequences, such as falls and loss of autonomy. One out of three seniors age 65 and one out of two seniors age 80 experience at least one fall per year. Prevalence of dementia increases with age and more than doubles a seniors' risk of falling.

Among the most promising interventions targeting both cognitive and functional decline, is Exercise. However, evidence regarding exercise interventions among seniors with cognitive impairment are inconclusive, likely due to challenges of recruitment and adherence. Alternatively, seniors with subjective cognitive decline (SCD), who are not yet meeting objective criteria of cognitive impairment, but have been shown to have twice the conversion rate to dementia compared with healthy seniors, are more likely to be motivated to participate and adhere to exercise interventions. Thus, exercise interventions in seniors with SCD may provide a window of opportunity for early prevention of dementia and falls.

The investigators aim to test the effect of a group exercise (multi-task Jaques-Dalcroze Eurhythmics) and a simple home strength exercise program on change of cognitive function and the rate of falling among seniors with SCD.

The MOVE for your MIND trial will be a single center, single-blinded randomized controlled clinical trial among 195 senior men and women and a 12 month follow-up. Participants will be community-dwelling seniors, age 70+ who meet the criteria for SCD without evidence for objective cognitive impairment. The 3 treatment arms are: (1) Jaques-Dalcroze Eurhythmics group exercise (1x60min/week), (2) simple home exercise strength program (3x30min/week), (3) control group without exercise intervention. All participants will receive a monthly "Healthy Nutrition" lecture. The hypothesis is that both exercise groups are superior to control. Under these assumptions, and a sample size of 195 seniors, the investigators will have >90% power for change in cognitive function and >80% power for the difference in the rate of falls. Clinical visits will be at baseline, 6 months, and 12 months. Therapeutic interventions for seniors with early subjective signs of cognitive decline that are effective, affordable, and well-tolerated in the prevention of both, cognitive and physical function decline, are urgently needed and will have an outstanding impact on public health as a whole. To the investigator's knowledge, this is the first exercise trial to target seniors with SCD and with the change in cognitive function and the rate of falls as the primary endpoints. Providing an evidence-base for a group- and a home-based exercise will give a choice to patients. Further, the mechanistic biomarker study for brain and muscle health among seniors with SCD will support the findings at the cellular level and whole-brain MRI imaging will support them at a structural level.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two intervention groups: Active I = Dalcroze Eurhythmic Program Active II: simple home exercise program Control group: no change in daily activities, no intervention
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Cognitive Decline and Falls With Dalcroze Eurhythmics and a Simple Home Exercise Strength Program for Seniors With Subjective Cognitive Decline (SCD) - MOVE for Your MIND
Actual Study Start Date : December 14, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dalcroze Eurhythmics program
music-based multi-task exercise intervention
Other: Dalcroze Eurhythmics Program
music-based multi-task exercise in group setting

Active Comparator: home exercise strength program
simple strength training program to perform individually at home
Other: home exercise strength program
simple strength exercise program to perform individually at home

No Intervention: Control group
no change in the daily activities, no exercise intervention



Primary Outcome Measures :
  1. Change in cognitive function [ Time Frame: 12 months ]
    assessed with the CERAD-plus test

  2. Rate of falls [ Time Frame: 12 months ]
    The circumstances and injuries associated with the fall will be ascertained with a questionnaire.


Secondary Outcome Measures :
  1. Proportion of seniors with any falls and injurious falls [ Time Frame: 12 months ]
    Participants will record incident falls in the study diary.

  2. Rate of injurious falls [ Time Frame: 12 months ]
    The number of falls that resulted in any injury will be examined and categorized according to severity of the injury.

  3. Cognitive function: verbal fluency test [ Time Frame: 12 months ]
    The verbal fluency test (animal naming) is part of the CERAD test battery (change over 12 months will be evaluated)

  4. Cognitive function: Boston Naming test [ Time Frame: 12 months ]
    The Boston Naming test (15 items) is part of the CERAD test battery (change over 12 months will be evaluated)

  5. Cognitive function: Mini Mental State Exam [ Time Frame: 12 months ]
    The Mini Mental State Exam is part of the CERAD test battery (change over 12 months will be evaluated)

  6. Cognitive function: Word List Learning [ Time Frame: 12 months ]
    Word List Learning is part of the CERAD test battery (change over 12 months will be evaluated)

  7. Cognitive function: Word List Recall [ Time Frame: 12 months ]
    Word List Recall is part of the CERAD test battery (change over 12 months will be evaluated)

  8. Cognitive function: Word List Recognition [ Time Frame: 12 months ]
    Word List Recognition (10 original words, 10 foils) is part of the CERAD-plus test battery (change over 12 months will be evaluated)

  9. Cognitive function: Constructional Praxis [ Time Frame: 12 months ]
    Constructional Praxis is part of the CERAD test battery (change over 12 months will be evaluated)

  10. Cognitive function: Constructional Praxis Recall [ Time Frame: 12 months ]
    Constructional Praxis Recall is part of the CERAD test battery (change over 12 months will be evaluated)

  11. Cognitive function: Trial Making Test A [ Time Frame: 12 months ]
    The Trial Making Test A is part of the CERAD-Plus test battery (change over 12 months will be evaluated)

  12. Cognitive function: Trial Making Test B [ Time Frame: 12 months ]
    The Trial Making Test B is part of the CERAD-Plus test battery (change over 12 months will be evaluated)

  13. Cognitive function: Phonematic Fluency Test [ Time Frame: 12 months ]
    The Phonematic Fluency test (S-words) is part of the CERAD-Plus test battery (change over 12 months will be evaluated)

  14. Incident MCI [ Time Frame: 12 months ]
    Based on the results from the CERAD-plus test battery

  15. Functional decline: gait speed [ Time Frame: 12 months ]
    Gait speed will be measured with a stop watch over a distance of 4 meters.

  16. Functional decline: timed up and go test [ Time Frame: 12 months ]
    Assessed with the standard timed up and go test protocol

  17. Functional decline: repeated sit-to-stand test [ Time Frame: 12 months ]
    Assessed with the repeated sit-to-stand test protocol

  18. Functional decline: grip strength [ Time Frame: 12 months ]
    Assessed using a Martin Vigorimeter

  19. Functional decline: short physical performance battery [ Time Frame: 12 months ]
    Assessed using the short physical performance battery

  20. Change in gait variability under single task condition [ Time Frame: 12 months ]
    Assessed with a GAITRite® gait analysis system (Platinum CIR Systems, PA, USA) of 8 meters in length. The gait parameters will be collected according to the spatiotemporal gait analysis guidelines.

  21. Change in gait variability under dual task condition [ Time Frame: 12 months ]
    Assessed with a GAITRite® gait analysis system (Platinum CIR Systems, PA, USA) of 8 meters in length. The gait parameters will be collected according to the spatiotemporal gait analysis guidelines.

  22. Quality of life: EuroQuol [ Time Frame: 12 months ]
    Assessed using the German Version of EuroQuol EQ5D-3L questionnaire according to the Austrian reference scale

  23. Quality of life: RAND 36-Item Short Form Survey [ Time Frame: 12 months ]
    Assessed using the RAND 36-Item Short Form Survey (SF-36)

  24. Mental Health: Geriatric Depression Scale [ Time Frame: 12 months ]
    Assessed with the short form of the Geriatric Depression Scale (GDS)

  25. Changes in IGF-1 [ Time Frame: 12 months ]
    Blood marker analyses: IGF-1

  26. Changes in biomarkers of inflammation: hr-CRP [ Time Frame: 12 months ]
    Blood marker analyses: hr-CRP

  27. Changes in biomarkers of inflammation: IL-6 [ Time Frame: 12 months ]
    Blood marker analyses: IL-6


Other Outcome Measures:
  1. Structural brain changes [ Time Frame: 12 months ]
    Assessed by voxel based volumetry with a Siemens Avanto 1.5 T (Siemens Erlangen, Germany) deploying the classical dementia protocol (T2_tse_tra_512, T2_tirm_tra_dark-fl_5mm, T2_fl2d_tra_T2, T2_tse_cor_3mm, BC_t1_mpr_tra_iso_2, Ep2d_diff_tra). No contrast agents will be used.

  2. Daily physical activity [ Time Frame: 12 months ]
    assessed with the Nurse's Health Study physical activity questionnaire excerpt.

  3. Effect of life-time physical activity [ Time Frame: Baseline ]
    Retrospective Physical Activity Survey modified after Kriska et al. (1988)

  4. TNF-alpha [ Time Frame: 12 months ]
    Blood sample assessment: TNF-alpha

  5. VEGF [ Time Frame: 12 months ]
    Blood sample assessment: VEGF

  6. BDNF [ Time Frame: 12 months ]
    Blood sample assessment: BDNF

  7. Sr IL-6 [ Time Frame: 12 months ]
    Blood sample assessment: Sr IL-6

  8. 25-hydroxyvitamin D [ Time Frame: 12 months ]
    Blood sample assessment: 25-hydroxyvitamin D

  9. Hearing [ Time Frame: 12 months ]
    Pure-tone testing in both ears



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 70+, living in the community
  • Meet the criterion for SCD defined by a score of ≥25 points on the MAC-Q questionnaire

Exclusion Criteria:

  • Signs of mild cognitive impairment (MCI), MoCA score ≤24
  • Score of ≥5 on the short form of the Geriatric Depression Scale (15items)
  • Inability to walk or to come to the study entre
  • Severe gait impairment or diseases with a risk of recurrent falling (e.g. Parkinson's disease/syndrome, Hemiplegia after stroke, symptomatic stenosis of the spinal canal, polyneuropathy, epilepsy, recurring vertigo, recurring syncope)
  • Heavy alcohol consumption defined as greater (>) 3 drinks (beer, wine or distilled spirits) of alcoholic beverages per day
  • Currently engaged in regular (at least once a week) strength training or Dalcroze eurhythmics classes
  • Active cancer or current cancer treatment
  • Inability to read and/or speak German necessary to understand the instructions

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): NCT03384602


Contacts
Contact: Heike A Bischoff-Ferrari, Prof. Dr. med., DrPH +41 044 255 27 57 heike.bischoff@usz.ch
Contact: Michèle Mattle, MSc +41 044 366 22 17 michele.mattle@usz.ch

Locations
Switzerland
Centre on Aging and Mobility, University of Zurich, Waid City Hospital Recruiting
Zürich, Switzerland, 8037
Contact: Heike A Bischoff-Ferrari, Prof. Dr. med. DrPH       heike.bischoff@usz.ch   
Contact: Michèle Mattle, MSc MPH       michele.mattle@usz.ch   
Sponsors and Collaborators
University of Zurich
Swiss National Science Foundation
University Hospital, Toulouse
Waid City Hospital, Zurich
Felix Platter Hospital
JungDiagnostics, Hamburg, Germany
Ferrari Data Solution, Feldmeilen, Switzerland
Vontobel Foundation
Investigators
Principal Investigator: Heike A Bischoff, Prof. Dr. med., DrPH University of Zurich

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03384602     History of Changes
Other Study ID Numbers: 2017-01288
First Posted: December 27, 2017    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Zurich:
subjective cognitive decline
falls prevention
cognitive function
dalcroze eurhythmics
home exercise program
seniors

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders