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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03384602
Other study ID # 2017-01288
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 14, 2017
Est. completion date November 2023

Study information

Verified date May 2023
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 195
Est. completion date November 2023
Est. primary completion date November 2, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 70 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Dalcroze Eurhythmics Program
music-based multi-task exercise in group setting
home exercise strength program
simple strength exercise program to perform individually at home

Locations

Country Name City State
Switzerland Centre on Aging and Mobility, University of Zurich, Waid City Hospital Zürich

Sponsors (11)

Lead Sponsor Collaborator
University of Zurich 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, Switzerland, University Hospital, Toulouse, France, Vontobel Foundation, Switzerland, Waid City Hospital, Zurich, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other Structural brain changes 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. 12 months
Other Daily physical activity assessed with the Nurse's Health Study physical activity questionnaire excerpt. 12 months
Other Effect of life-time physical activity Retrospective Physical Activity Survey modified after Kriska et al. (1988) Baseline
Other TNF-alpha Blood sample assessment: TNF-alpha 12 months
Other VEGF Blood sample assessment: VEGF 12 months
Other BDNF Blood sample assessment: BDNF 12 months
Other Sr IL-6 Blood sample assessment: Sr IL-6 12 months
Other 25-hydroxyvitamin D Blood sample assessment: 25-hydroxyvitamin D 12 months
Other Hearing Pure-tone testing in both ears 12 months
Other Effect of life-time cognitive activities Cognitive Activities Questionnaire (CAQ) 12 months
Primary Change in cognitive function assessed with the CERAD-plus test 12 months
Primary Rate of falls The circumstances and injuries associated with the fall will be ascertained with a questionnaire. 12 months
Secondary Proportion of seniors with any falls and injurious falls Participants will record incident falls in the study diary. 12 months
Secondary Rate of injurious falls The number of falls that resulted in any injury will be examined and categorized according to severity of the injury. 12 months
Secondary Cognitive function: verbal fluency test The verbal fluency test (animal naming) is part of the CERAD test battery (change over 12 months will be evaluated) 12 months
Secondary Cognitive function: Boston Naming test The Boston Naming test (15 items) is part of the CERAD test battery (change over 12 months will be evaluated) 12 months
Secondary Cognitive function: Mini Mental State Exam The Mini Mental State Exam is part of the CERAD test battery (change over 12 months will be evaluated) 12 months
Secondary Cognitive function: Word List Learning Word List Learning is part of the CERAD test battery (change over 12 months will be evaluated) 12 months
Secondary Cognitive function: Word List Recall Word List Recall is part of the CERAD test battery (change over 12 months will be evaluated) 12 months
Secondary Cognitive function: Word List Recognition Word List Recognition (10 original words, 10 foils) is part of the CERAD-plus test battery (change over 12 months will be evaluated) 12 months
Secondary Cognitive function: Constructional Praxis Constructional Praxis is part of the CERAD test battery (change over 12 months will be evaluated) 12 months
Secondary Cognitive function: Constructional Praxis Recall Constructional Praxis Recall is part of the CERAD test battery (change over 12 months will be evaluated) 12 months
Secondary Cognitive function: Trial Making Test A The Trial Making Test A is part of the CERAD-Plus test battery (change over 12 months will be evaluated) 12 months
Secondary Cognitive function: Trial Making Test B The Trial Making Test B is part of the CERAD-Plus test battery (change over 12 months will be evaluated) 12 months
Secondary Cognitive function: Phonematic Fluency Test The Phonematic Fluency test (S-words) is part of the CERAD-Plus test battery (change over 12 months will be evaluated) 12 months
Secondary Incident MCI Based on the results from the CERAD-plus test battery 12 months
Secondary Functional decline: gait speed Gait speed will be measured with a stop watch over a distance of 4 meters. 12 months
Secondary Functional decline: timed up and go test Assessed with the standard timed up and go test protocol 12 months
Secondary Functional decline: repeated sit-to-stand test Assessed with the repeated sit-to-stand test protocol 12 months
Secondary Functional decline: grip strength Assessed using a Martin Vigorimeter 12 months
Secondary Functional decline: short physical performance battery Assessed using the short physical performance battery 12 months
Secondary Change in gait variability under single task condition Assessed with a GAITRite® gait analysis system (Platinum CIR Systems, PA, USA) and/or Gait Up gait analysis system (Gait UP SA, Lausanne, Switzerland) 12 months
Secondary Change in gait variability under dual task condition Assessed with a GAITRite® gait analysis system (Platinum CIR Systems, PA, USA) and/or Gait Up gait analysis system (Gait UP SA, Lausanne, Switzerland) 12 months
Secondary Quality of life: EuroQuol Assessed using the German Version of EuroQuol EQ5D-3L questionnaire according to the Austrian reference scale 12 months
Secondary Quality of life: RAND 36-Item Short Form Survey Assessed using the RAND 36-Item Short Form Survey (SF-36) 12 months
Secondary Mental Health: Geriatric Depression Scale Assessed with the short form of the Geriatric Depression Scale (GDS) 12 months
Secondary Changes in IGF-1 Blood marker analyses: IGF-1 12 months
Secondary Changes in biomarkers of inflammation: hr-CRP Blood marker analyses: hr-CRP 12 months
Secondary Changes in biomarkers of inflammation: IL-6 Blood marker analyses: IL-6 12 months
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