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Completed

NCT Number: NCT03384602

MOVE for Your MIND

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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre on Aging and Mobility, University of Zurich

Zurich, 8037, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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)
  • Currently engaged in regular (once a week or more) strength training instructed by a professional teacher and including the explicit aim to improve muscle strength, or regular (once a week or more) Dalcroze eurhythmics classes
  • Active cancer or current cancer treatment
  • Inability to read and/or speak German necessary to understand the instructions

Treatment and study plan

Dalcroze Eurhythmics Program

Other

music-based multi-task exercise in group setting

home exercise strength program

Other

simple strength exercise program to perform individually at home

Primary outcomes

  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 outcomes

  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) and/or Gait Up gait analysis system (Gait UP SA, Lausanne, Switzerland)

  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) and/or Gait Up gait analysis system (Gait UP SA, Lausanne, Switzerland)

  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 outcomes

  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

  10. Effect of life-time cognitive activities

    Time frame: 12 months

    Cognitive Activities Questionnaire (CAQ)

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Age Stiftung, Zurich, Switzerland
  • Felix Platter Hospital, Basel, Switzerland
  • Ferrari Data Solution
  • Gemeinnützige Stiftung EMPIRIS, Alzheimer Fund, Zurich Switzerland
  • JungDiagnostics, Hamburg, Germany
  • Stiftung für Demenzforschung in Basel, Switzerland
  • Swiss National Science Foundation
  • University Hospital, Toulouse, France
  • Vontobel Foundation, Switzerland
  • Waid City Hospital, Zurich, Switzerland

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Dec 27, 2017
Registry last updated
Aug 9, 2024

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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