Effectiveness of a Novel Exergame-Based Training Concept for Older Adults With Mild Neurocognitive Disorder

NCT05387057 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2024-06-04

No results posted yet for this study

Summary

BACKGROUND:

Simultaneous motor-cognitive training interventions are considered promising to prevent the decline in cognitive functioning in older adults with mild neurocognitive disorder (mNCD) and can be highly motivating when applied in form of exergames.

OBJECTIVES:

This study systematically explores the effectiveness of a newly developed exergame-based motor-cognitive training concept (called 'Brain-IT') targeted to improve cognitive functioning in older adults with mNCD.

METHODS:

A two-arm, parallel-group, single-blinded (i.e. outcome evaluator of pre- and post-measurements blinded to group allocation) randomized controlled trial with an allocation ration of 1 : 1 (i.e. intervention : control) including 34 - 40 older adults with mNCD will be conducted between May 2022 and December 2023. The control group will proceed with usual care as provided by the (memory) clinics where the patients are recruited while the intervention group will perform a twelve-week training intervention according to the newly developed 'Brain-IT' exergame-based training concept in addition to usual care. As a primary outcome, global cognitive functioning will be assessed using the Quick Mild Cognitive Impairment Screen (Qmci). As secondary outcomes, domain-specific cognitive functioning, brain structure and function, spatiotemporal parameters of gait, instrumental activities of daily living, psychosocial factors (e.g. quality of life, and levels of depression, anxiety, stress), and cardiac vagal modulation (heart rate variability at rest) will be assessed. Both, the pre- and the post-measurements will take place within two weeks prior to starting or after completing the intervention.

Conditions

  • Mild Neurocognitive Disorder

Interventions

BEHAVIORAL

Exergame training according to the 'Brain-IT' exergame-based training concept

For an overview, our 'Brain-IT' exergame-based training concept consists of an individually adapted multi-domain exergame-based simultaneous cognitive-motor training with incorporated cognitive tasks that will be adopted with a deficit-oriented focus on the neurocognitive domains of (1) learning and memory, (2) executive function, (3) complex attention, and (4) visuospatial skills. According to the training concept, each participant is instructed to train 5x/week for 24 min per session resulting in a weekly exercise volume of 120 min. All training sessions are planned to take place at participant's homes using the exergame training system 'Senso Flex' (Dividat AG, Schindellegi, Switzerland). For a detailed description of the complete 'Brain-IT' exergame-based training concept with sufficient details to allow full replication, consider our methodological paper (doi: 10.3389/fnagi.2021.734012).

BEHAVIORAL

Usual Care

The control group will proceed with usual care as provided by the (memory) clinics where the patients are recruited.

Sponsors & Collaborators

  • Eling DeBruin

    lead OTHER

Principal Investigators

  • Eling D de Bruin, PhD · ETH Zurich

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-22
Primary Completion
2024-02-14
Completion
2024-02-14

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05387057 on ClinicalTrials.gov