Intervention Study of an Individualized Exergame Training for People With Major Neurocognitive Disorder
1 other identifier
interventional
60
1 country
1
Brief Summary
This study evaluates the feasibility of the intervention and the study design.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2020
CompletedFirst Posted
Study publicly available on registry
June 18, 2020
CompletedStudy Start
First participant enrolled
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedAugust 24, 2021
August 1, 2021
9 months
June 3, 2020
August 23, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
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
Study Arms (2)
Intervention
EXPERIMENTALExergame intervention
Control
SHAM COMPARATORActive control condition
Interventions
Motor-cognitive training device
Physical activity program
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Davy Vancampfortlead
Study Sites (1)
De Wingerd
Leuven, Vlaams Brabant, 3000, Belgium
Related Publications (1)
Swinnen N, de Bruin ED, Guimaraes V, Dumoulin C, De Jong J, Akkerman R, Vandenbulcke M, Stubbs B, Vancampfort D. The feasibility of a stepping exergame prototype for older adults with major neurocognitive disorder residing in a long-term care facility: a mixed methods pilot study. Disabil Rehabil. 2023 Feb 23:1-15. doi: 10.1080/09638288.2023.2182916. Online ahead of print.
PMID: 36824039DERIVED
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 3, 2020
First Posted
June 18, 2020
Study Start
April 1, 2021
Primary Completion
December 30, 2021
Study Completion
December 30, 2021
Last Updated
August 24, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share