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

Nursing Home Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04436315
• Other study ID #: 082020
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: August 2021
• Source: KU Leuven
• Contact: Nathalie Swinnen
• Phone: +3216348215
• Email: nathalie.swinnen[@]kuleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Exergame
• Long-term Care Facility
• Major Neurocognitive Disorder
• Neurocognitive Disorders
• Nursing Home

Intervention

Device:
• Motor-cognitive training device
Motor-cognitive training device

Other:
• Active control condition
Physical activity program

Locations

Country	Name	City	State
Belgium	De Wingerd	Leuven	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Davy Vancampfort

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	Recruitment rate Adherence Attrition Time management of the assessments during pre-/post-measurements and the intervention Safety	2 years
Primary	Motor functions	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	2 years
Primary	Cognitive functions	Montréal Cognitive Assessment Mini-Mental State Examination	2 years
Primary	Mental health	Cornell Scale for Depression in Dementia Neuropsychiatric Inventory Dementia Quality of Life	2 years