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

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

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nathalie Swinnen; Phone Number: +3216348215; Email: nathalie.swinnen@kuleuven.be
• Study Contact Backup: Name: Davy Vancampfort; Phone Number: +3216376564; Email: davy.vancampfort@kuleuven.be

Study Locations

• Belgium
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • Recruiting
      • De Wingerd
      • Contact: Nathalie Swinnen; Phone Number: +3216348215; Email: nathalie.swinnen@kuleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; Exergame intervention	Device: Motor-cognitive training device; Motor-cognitive training device; Other Names: Vitaal exergame
SHAM_COMPARATOR: Control; Active control condition	Other: Active control condition; Physical activity program; Other Names: Physical therapy program

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Davy Vancampfort

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2021
• Primary Completion (ANTICIPATED): December 30, 2021
• Study Completion (ANTICIPATED): December 30, 2021

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 15, 2020
• First Posted (ACTUAL): June 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 24, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Neurocognitive Disorders
• Other Study ID Numbers: 082020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No