MOVE for Your MIND

Cognitive Decline Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03384602
• Other study ID #: 2017-01288
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction
• Fall

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