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

Mild Neurocognitive Disorder Clinical Trial

Official title: Effectiveness of an Individualized Exergame-based Motor-Cognitive Training Concept Targeted to Improve Cognitive Functioning in Older Adults With Mild Neurocognitive Disorder - A Randomized Controlled Trial

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. To ameliorate the effectiveness of exergaming, the neurobiological mechanisms as well as the most effective components for exergame interventions remain to be established. Besides establishing the most effective components [i.e., qualitative (e.g., type and content of training) and quantitative (e.g., frequency, intensity/complexity, session duration, intervention dose and adaptation over time) exercise and training variables] of exergames for cognition, it is crucial to also account for the users' perspective when designing and developing novel exergames or training concepts.

On this basis, a novel exergame-based training concept (called the 'Brain-IT' exergame-based training concept) was developed specifically for older adults with mNCD with the aim to halt and/or reduce cognitive decline and improve quality of life in older adults with mNCD. This exergame-based training concept has been developed on basis of a structured, iterative, and evidence-based approach based on a theoretical framework - The 'Multidisciplinary Iterative Design of Exergames (MIDE): A Framework for Supporting the Design, Development, and Evaluation of Exergames for Health'. The 'Brain-IT' exergame-based training concept represents a guideline for applying exergame-based motor-cognitive training by standardizing the training characteristics (e.g. training frequency, duration), as well as the structure and content of the training, whereas the exergame device and the games used within each of the defined neurocognitive domains can be replaced at will by alternative exergames. In this study, our training concept is implemented using the 'Senso (Flex)' (Dividat AG, Schindellegi, Switzerland), because this training device is already widely used for motor-cognitive training within geriatric populations, physiotherapies or in rehabilitation in Switzerland and was found to be suitable to implement our training concept. A step-by-step explanation of our methodological approach including the basis for the decision for the design of the exergame-based training concept as well as the complete 'Brain-IT' exergame-based training concept with sufficient details to allow full replication has been published as a methodological paper (doi: 10.3389/fnagi.2021.734012). The 'Brain-IT' exergame-based training concept has already been tested in a pilot randomized controlled trial and has shown good results in feasibility (i.e. recruitment, adherence, compliance, attrition), usability (i.e. system usability), and acceptance (i.e. enjoyment, training motivation and perceived usefulness) (unpublished work; NCT04996654). Based on the findings of this study, some minor modifications were incorporated to optimize the training concept so that it can be applied in a larger sample of patients to be evaluated on its effectiveness to halt and/or reduce cognitive decline and improve quality of life in older adults with mNCD.

OBJECTIVES & HYPOTHESES:

This study explores the effectiveness of the 'Brain-IT' training to improve global cognitive func-tioning in older adults with mNCD. With this, we aim to get a sufficiently precise estimate of the treatment effect to minimize the sample needed for a future full-scale RCT.

Null Hypothesis (H0): In older adults with mNCD, the addition of the 'Brain-IT' training to usual care has no significant effect on global cognitive functioning compared to usual care.

Alternative Hypothesis (HA): In older adults with mNCD, the addition of the 'Brain-IT' training to usual care results in differing effects on global cognitive functioning compared to usual care.

As secondary objectives, the effects of the 'Brain-IT' training on: (1) domain-specific cognitive functioning (i.e. learning and memory, complex attention, executive function, and visuospatial skills), (2) brain structure and function, (3) spatiotemporal parameters of gait, (4) IADL and (5) psychosocial factors (i.e. QoL, and levels of depression, anxiety, stress), and (6) cardiac vagal modulation (i.e. resting vagally-mediated heart rate variability (vm-HRV)) in older adults with mNCD as compared to usual care will be explored. Brain structure and function will be evaluated to explore possible underlying neural changes of the training in relation to adaptations in cognitive performance. For the remaining outcomes, the following hypotheses were formulated:

Null Hypothesis (H0): In older adults with mNCD, the addition of the 'Brain-IT' training to usual care has no significant effect on (1) domain-specific cognitive functioning, (3) spatiotemporal parameters of gait, (4) IADL and (5) psychosocial factors (i.e. QoL, and levels of depression, anxiety, stress), and (6) cardiac vagal modulation (resting vm-HRV) com-pared to usual care.

Alternative Hypothesis (HA): In older adults with mNCD, the addition the 'Brain-IT' training to usual care results in differing effects on (1) domain-specific cogni-tive functioning, (3) spatiotemporal parameters of gait, (4) IADL, (5) psychosocial factors (i.e. QoL, and levels of depression, anxiety, stress), and (6) cardiac vagal modulation (resting vm-HRV) com-pared to usual care.

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.

After recruitment, interested subjects will be screened on eligibility between May 2022 and September 2023. All potential subjects will be fully informed about the study procedures by providing verbal explanations and an information sheet. Expected effects, benefits and risks of the study will be explained by the investigators, who will also be available to answer open questions and clarify uncertain-ties of participants. It will further be verified, that withdrawal is permitted at any time during the study without having to give a reason. After sufficient time for considerations (i.e. at least 24 h after handing out the study information sheet, but on average around two weeks), suitable patients willing to take part in the study will provide written informed consent in a second in-person meeting with the study team at the interested persons' home or at one of the study centres, depending on their preferences. If eligible patients decline to participate in the study, all data researched by their doctors or therapists and submitted to the study team will be permanently deleted. After providing written informed consent, the participants will be fully screened on eligibility, and the third study appointment (pre-measurements) will be scheduled. For participants recruited in the area of Zurich, the pre-measurements will take place at ETH Hönggerberg (Robert-Gnehm-Platz 1, CH-8093 Zurich). For participants recruited in the area of St.Gallen, the pre-measurements will take place at Eastern Switzerland University of Applied Sciences (Vadianstrasse 29, CH-9000 St.Gallen). The measurements will take approximately 60 - 90 min. For all participants who have no contraindications to MRI, an additional appointment to conduct the MRI scan will be scheduled. The MRI scan will take place at University Hospital Zurich (Rämistrasse 100, CH-8006 Zurich) and will take approximately one hour (including preparation). After completing the pre-measurements, participants will be randomly allocated to the intervention group (i.e. 'exergame group') or control group (i.e. 'usual care'). All participants will be instructed about their respective intervention procedures. For participants in the exergame group, the device will be installed at their homes, they will get a safety instruction and will be familiarized with the exergame training system 'Senso Flex', and the study intervention will be started according to the newly developed 'Brain-IT' exergame-based training concept (see section 'Intervention'). After completing the twelve-week intervention period, post-measurements (POST) will be performed for both groups. Both, the pre- and the post-measurements will take place and within two weeks prior to starting or after completing the intervention. No compensation will be granted to the participants, but detailed feedback on individual performance as well as the study outcomes in general will be provided at the end of the trial if desired. ;

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Neurocognitive Disorder
• Neurocognitive Disorders

• NCT number: NCT05387057
• Study type: Interventional
• Source: Swiss Federal Institute of Technology
• Status: Completed
• Phase: N/A
• Start date: June 22, 2022
• Completion date: February 14, 2024