NCT03384602

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

December 14, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 27, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2022

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

3.9 years

First QC Date

October 16, 2017

Last Update Submit

August 7, 2024

Conditions

Keywords

subjective cognitive declinefalls preventioncognitive functiondalcroze eurhythmicshome exercise programseniors

Outcome Measures

Primary Outcomes (2)

  • Change in cognitive function

    assessed with the CERAD-plus test

    12 months

  • Rate of falls

    The circumstances and injuries associated with the fall will be ascertained with a questionnaire.

    12 months

Secondary Outcomes (27)

  • Proportion of seniors with any falls and injurious falls

    12 months

  • Rate of injurious falls

    12 months

  • Cognitive function: verbal fluency test

    12 months

  • Cognitive function: Boston Naming test

    12 months

  • Cognitive function: Mini Mental State Exam

    12 months

  • +22 more secondary outcomes

Other Outcomes (10)

  • Structural brain changes

    12 months

  • Daily physical activity

    12 months

  • Effect of life-time physical activity

    Baseline

  • +7 more other outcomes

Study Arms (3)

Dalcroze Eurhythmics program

ACTIVE COMPARATOR

music-based multi-task exercise intervention

Other: Dalcroze Eurhythmics Program

home exercise strength program

ACTIVE COMPARATOR

simple strength training program to perform individually at home

Other: home exercise strength program

Control group

NO INTERVENTION

no change in the daily activities, no exercise intervention

Interventions

music-based multi-task exercise in group setting

Dalcroze Eurhythmics program

simple strength exercise program to perform individually at home

home exercise strength program

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre on Aging and Mobility, University of Zurich

Zurich, 8037, Switzerland

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

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

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Two intervention groups: Active I = Dalcroze Eurhythmic Program Active II: simple home exercise program Control group: no change in daily activities, no intervention
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2017

First Posted

December 27, 2017

Study Start

December 14, 2017

Primary Completion

November 2, 2021

Study Completion

November 2, 2022

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations