JMIR Publications

ABSTRACT

Background:

Simultaneous motor-cognitive training is 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 exergaming. The literature points to opportunities for improvement in the application of exergames in individuals with mNCD by developing novel exergames and exergame-based training concepts that are specifically tailored to mNCD patients and ensure implementation of effective training components.

Objective:

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

Methods:

A two-arm, parallel-group, single-blinded pilot randomized controlled trial (RCT) with a 1 : 1 allocation ratio (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. The intervention group will perform a twelve-week training intervention according to the ‘Brain-IT’ training concept in addition to usual care. As primary outcome, global cognitive functioning will be assessed. As secondary outcomes, domain-specific cognitive functioning, brain structure and function, spatiotemporal parameters of gait, instrumental activities of daily living (IADL), psychosocial factors, and resting cardiac vagal modulation will be assessed. Pre- and post-measurements will take place within two weeks prior to starting and after completing the intervention. A two-way analysis of covariance (ANCOVA) or an equivalent non-parametric statistical analysis (e.g. Quade’s non-parametric ANCOVA) will be computed for all primary and secondary outcomes, with the pre-measurement value as covariate for the predicting group factor and the post-measurement value as outcome variable. To discover whether the effects are substantive, partial eta-squared (η2p) effect sizes will be calculated for all primary and secondary outcomes.

Results:

Upon initial submission of this study protocol, 13 patients were contacted by the study team. Four patients were included in the study, two patients were excluded because they were not eligible, and seven patients are currently being informed about the study in detail. Of the four included patients, two have already completed all pre-measurements and are currently in week 2 of the intervention period. Data collection is expected to be completed by December 2023 at latest. A manuscript of the results will be submitted for publication in a peer-review open-access journal in 2024.

Conclusions:

The study will contribute to the evidence base in the highly relevant area of prevention of disability due to cognitive impairment, which has been declared a public health priority by the World Health Organization. Clinical Trial: The study was registered at clinicaltrials.gov prior to the start of patients’ recruitment (NCT05387057; date of registration: 18 May 2022).