Intervention Study of an Individualized Exergame Training for People With Major Neurocognitive Disorder

Not Applicable

• Conditions: Long-term Care Facility; Exergame; Major Neurocognitive Disorder; Nursing Home
• Interventions: Device: Motor-cognitive training device; Other: Active control condition

• Registration Number: NCT04436315
• Lead Sponsor: Davy Vancampfort

Brief Summary

This study evaluates the feasibility of the intervention and the study design.

Detailed Description

This study evaluates the feasibility of the intervention and the study design. Furthermore, it investigates the effects of an exergame training including strength, balance, cognitive and pelvic floor muscle training. The main risk in this study is related to potential accidents/falls during the training (and not mainly to the data acquisition procedures). But as the difficulty of the training game is adaptive, the participants will always be challenged on an appropriate level for their physical condition. Furthermore, before and after the training period, several low risk measurements are conducted. This study contributes to fundamental research investigating how multicomponent exergame training influence physical and cognitive functions.

Study Timeline

• Study First Submitted: 2020-06-03
• Study First Submitted QC: 2020-06-15
• Study First Posted: 2020-06-18
• Study Start: 2021-04-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-24
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Aged 60+ years
• Living in residency "de Wingerd" in Leuven (at least two weeks here)
• Being able to straight for minimal 10 minutes without aids
• Visual acuity with correction sufficient to see on a TV screen
• diagnosed with major neurocognitive disorder

Exclusion Criteria

• Mobility impairments that don't allow to play the exergame
• Any unstable cardiovascular or other health condition which according to the American College of Sports Medicine Standards might lead to unsafe participation (e.g. recent cardiac infarction, uncontrolled diabetes or hypertension)
• Orthopaedic or neurological diseases that prevent exergame training
• Rapidly progressive or terminal illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Motor-cognitive training device	Exergame intervention
Control	Active control condition	Active control condition

Primary Outcome Measures

Name	Time	Method
Cognitive functions	2 years	Montréal Cognitive Assessment Mini-Mental State Examination
Motor functions	2 years	Recruitment rate Adherence Attrition Time management of the assessments during pre-/post-measurements and the intervention Safety Short Physical Performance Battery; 1 - Minute Sit to Stand Test
Feasibility	2 years	Recruitment rate Adherence Attrition Time management of the assessments during pre-/post-measurements and the intervention Safety
Mental health	2 years	Cornell Scale for Depression in Dementia Neuropsychiatric Inventory Dementia Quality of Life

Trial Locations

Locations (1)

De Wingerd; 🇧🇪 Leuven, Vlaams Brabant, Belgium