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

NCT05387057 | Completed

• 1 other identifier: BASEC Nr. 2022-00386
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Exergames; Mild Neurocognitive Disorder; Cognition; Neuroscience; Exercise; Training

Outcome Measures

Primary Outcomes (1)

• Changes in Global Cognition

  The German Version of the Quick Mild Cognitive Impairment Screen (Qmci) will be used to assess the overall level of cognitive functioning of the study population (doi: 10.1007/978-3-319-44775-9\_12). Although being a screening instrument, the Qmci was shown to be equally sensitive with similar responsiveness to change over time as compared to the ADAS-Cog (which is considered the gold standard for assessing the efficacy of antidementia treatments) (doi: 10.3233/JAD-170991 and 10.3233/JAD-170991). The Qmci can be completed within 3 - 5 minutes and is scored as a point rate out of a maximum score of 100. It comprises six subtests: orientation (10 points), registration (5 points), clock drawing (15 points), delayed recall (20 points), verbal fluency (20 points), and logical memory (30 points). The Qmci will be administered according to the guidelines provided by O'Caoimh and Molloy in 2017 (doi: 10.1007/978-3-319-44775-9\_12).

  Both, the pre- and the post-measurements of the primary outcome measurement will take place within two weeks prior to starting or after completing the intervention.

Secondary Outcomes (25)

• Changes in Learning and Memory - Part 1

  Both, the pre- and the post-measurements of all secondary outcome measurements will take place within two weeks prior to starting or after completing the intervention.

• Changes in Learning and Memory - Part 2

  Both, the pre- and the post-measurements of all secondary outcome measurements will take place within two weeks prior to starting or after completing the intervention.

• Changes in Complex Attention - Part 1

  Both, the pre- and the post-measurements of all secondary outcome measurements will take place within two weeks prior to starting or after completing the intervention.

• Changes in Complex Attention - Part 2

  Both, the pre- and the post-measurements of all secondary outcome measurements will take place within two weeks prior to starting or after completing the intervention.

• Changes in Executive Function - Part 1

  Both, the pre- and the post-measurements of all secondary outcome measurements will take place within two weeks prior to starting or after completing the intervention.

Study Arms (2)

Intervention Group - Exergame Training

EXPERIMENTAL

Participants in the intervention group will perform a twelve-week training intervention in addition to their usual care (as provided by the (memory) clinics where the patients are recruited). The training intervention will be prescribed according to our newly developed exergame-based training concept (called 'Brain-IT' exergame-based training concept). Our complete 'Brain-IT' exergame-based training concept has recently been published including sufficient details about the exergame components as well as the exercise and training characteristics (i.e. including all predefined levels of task demands as well as the detailed progression rules) to allow full replication (i.e. consider supplementary file 3 of doi: 10.3389/fnagi.2021.734012). This training concept was planned and will be reported using the Consensus on Exercise Reporting Template (CERT; doi: 10.1136/bjsports-2016-096651).

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

Usual Care

ACTIVE COMPARATOR

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

Behavioral: Usual Care

Interventions

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

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).

Intervention Group - Exergame Training

Usual Care BEHAVIORAL

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

Usual Care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• (1 = mNCD) clinical diagnosis of 'Mild Neurocognitive Disorder' according to the International Classification of Diseases 11th Revision (ICD-XI) or the Diagnostic and statistical manual of mental disorders (DSM-5®)) OR (2 = sMCI) patients screened for mild cognitive impairment (sMCI) according to the following criteria: (a) informant (i.e. healthcare professionals)-based suspicion of MCI confirmed by (b) an objective screening of MCI based on the German Version of the Quick Mild Cognitive Impairment Screen with (b1) a recommended cut-off score for cognitive impairment (MCI or dementia) of \< 62/100 (doi: 10.3233/JAD-161204), while (b2) not falling below the cut-off score for dementia (i.e. \< 45/100 (doi: 10.3233/JAD-161204)).
• German speaking
• able to stand at least for 10 min without assistance

You may not qualify if:

• mobility impairments (i.e. gait, balance) that prevent experiment participation
• presence of additional, clinically relevant (i.e. acute and/or symptomatic) neurological disorders (i.e. epilepsy, stroke, multiple sclerosis, Parkinson's disease, brain tumors, or traumatic disorders of the nervous system)
• presence of any other unstable or uncontrolled diseases
• high blood pressure (self-reported; systolic ≥ 140 mmHg and/or Diastolic ≥ 90 mmHg)
• Chronic respiratory condition
• uncontrolled type 2 Diabetes
• Condition or therapy that weakens the immune system
• unstable Cardiovascular Disease
• Cancer (present and/or under treatment)
• Serious obesity (BMI ≥ 40 kg/m2)

Sponsors & Collaborators

• Eling DeBruin: lead

Study Sites (1)

ETH Zurich

Zurich, 8093, Switzerland

Location

Related Publications (3)

• Manser P, de Bruin ED. Making the Best Out of IT: Design and Development of Exergames for Older Adults With Mild Neurocognitive Disorder - A Methodological Paper. Front Aging Neurosci. 2021 Dec 9;13:734012. doi: 10.3389/fnagi.2021.734012. eCollection 2021.

  PMID: 34955806 BACKGROUND

• Manser P, de Bruin ED. "Brain-IT": Exergame training with biofeedback breathing in neurocognitive disorders. Alzheimers Dement. 2024 Jul;20(7):4747-4764. doi: 10.1002/alz.13913. Epub 2024 May 29.

  PMID: 38809948 RESULT

• Manser P, Michels L, Schmidt A, Barinka F, de Bruin ED. Effectiveness of an Individualized Exergame-Based Motor-Cognitive Training Concept Targeted to Improve Cognitive Functioning in Older Adults With Mild Neurocognitive Disorder: Study Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Feb 6;12:e41173. doi: 10.2196/41173.

  PMID: 36745483 DERIVED

MeSH Terms

Conditions

Neurocognitive Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Mental Disorders; Behavior

Study Officials

• Eling D de Bruin, PhD

  ETH Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study will be conducted as a single-blinded study: the outcome evaluator of the pre- and post-measurements will be blinded to group allocation. Blinding of participants will not be possible since usual care will be used as a control intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: Allocation ratio = 1 (Intervention) : 1 (Control) stratified by gender and per institute (study site)

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 24, 2022
• Study Start: June 22, 2022
• Primary Completion: February 14, 2024
• Study Completion: February 14, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-05

Locations

CH (1)