MOVE for Your MIND

NCT ID: NCT03384602

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 195 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-14
• Study Completion Date: 2022-11-02

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.

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.

Conditions

Cognitive Decline; Fall

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Dalcroze Eurhythmics program

music-based multi-task exercise intervention

Group Type: ACTIVE_COMPARATOR

Dalcroze Eurhythmics Program

Intervention Type: OTHER

music-based multi-task exercise in group setting

home exercise strength program

simple strength training program to perform individually at home

Group Type: ACTIVE_COMPARATOR

home exercise strength program

Intervention Type: OTHER

simple strength exercise program to perform individually at home

Control group

no change in the daily activities, no exercise intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dalcroze Eurhythmics Program

music-based multi-task exercise in group setting

Intervention Type: OTHER

home exercise strength program

simple strength exercise program to perform individually at home

Intervention Type: OTHER

Eligibility 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)
• 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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Swiss National Science Foundation, Switzerland

UNKNOWN

Sponsor Role: collaborator

University Hospital, Toulouse, France

UNKNOWN

Sponsor Role: collaborator

Waid City Hospital, Zurich, Switzerland

UNKNOWN

Sponsor Role: collaborator

Felix Platter Hospital, Basel, Switzerland

UNKNOWN

Sponsor Role: collaborator

JungDiagnostics, Hamburg, Germany

UNKNOWN

Sponsor Role: collaborator

Ferrari Data Solution

OTHER

Sponsor Role: collaborator

Vontobel Foundation, Switzerland

UNKNOWN

Sponsor Role: collaborator

Age Stiftung, Zurich, Switzerland

UNKNOWN

Sponsor Role: collaborator

Gemeinnützige Stiftung EMPIRIS, Alzheimer Fund, Zurich Switzerland

UNKNOWN

Sponsor Role: collaborator

Stiftung für Demenzforschung in Basel, Switzerland

UNKNOWN

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heike A Bischoff, Prof. Dr. med., DrPH

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

Centre on Aging and Mobility, University of Zurich

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

2017-01288

Identifier Type: -

Identifier Source: org_study_id