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

Primary Purpose

Exergame, Major Neurocognitive Disorder, Long-term Care Facility

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Motor-cognitive training device
Active control condition
Sponsored by
Davy Vancampfort
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exergame

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • De WingerdRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Intervention

Control

Arm Description

Exergame intervention

Active control condition

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 3, 2020
Last Updated
August 23, 2021
Sponsor
Davy Vancampfort
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1. Study Identification

Unique Protocol Identification Number
NCT04436315
Brief Title
Intervention Study of an Individualized Exergame Training for People With Major Neurocognitive Disorder
Official Title
Intervention Study of an Individualized Exergame Training for People With Major Neurocognitive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Davy Vancampfort

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exergame, Major Neurocognitive Disorder, Long-term Care Facility, Nursing Home

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Exergame intervention
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Active control condition
Intervention Type
Device
Intervention Name(s)
Motor-cognitive training device
Other Intervention Name(s)
Vitaal exergame
Intervention Description
Motor-cognitive training device
Intervention Type
Other
Intervention Name(s)
Active control condition
Other Intervention Name(s)
Physical therapy program
Intervention Description
Physical activity program
Primary Outcome Measure Information:
Title
Feasibility
Description
Recruitment rate Adherence Attrition Time management of the assessments during pre-/post-measurements and the intervention Safety
Time Frame
2 years
Title
Motor functions
Description
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
Time Frame
2 years
Title
Cognitive functions
Description
Montréal Cognitive Assessment Mini-Mental State Examination
Time Frame
2 years
Title
Mental health
Description
Cornell Scale for Depression in Dementia Neuropsychiatric Inventory Dementia Quality of Life
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathalie Swinnen
Phone
+3216348215
Email
nathalie.swinnen@kuleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Davy Vancampfort
Phone
+3216376564
Email
davy.vancampfort@kuleuven.be
Facility Information:
Facility Name
De Wingerd
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie Swinnen
Phone
+3216348215
Email
nathalie.swinnen@kuleuven.be

12. IPD Sharing Statement

Plan to Share IPD
No

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

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