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Clinical Trials/NCT04436315
NCT04436315
Unknown
Not Applicable

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

Davy Vancampfort1 site in 1 country60 target enrollmentApril 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Exergame
Sponsor
Davy Vancampfort
Enrollment
60
Locations
1
Primary Endpoint
Cognitive functions
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2021
End Date
December 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Davy Vancampfort
Responsible Party
Sponsor Investigator
Principal Investigator

Davy Vancampfort

Professor

KU Leuven

Eligibility Criteria

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

Outcomes

Primary Outcomes

Cognitive functions

Time Frame: 2 years

Montréal Cognitive Assessment Mini-Mental State Examination

Motor functions

Time Frame: 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

Time Frame: 2 years

Recruitment rate Adherence Attrition Time management of the assessments during pre-/post-measurements and the intervention Safety

Mental health

Time Frame: 2 years

Cornell Scale for Depression in Dementia Neuropsychiatric Inventory Dementia Quality of Life

Study Sites (1)

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