Exergaming in People With Major Neurocognitive Disorder
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ClinicalTrials.gov Identifier: NCT04436302 |
Recruitment Status : Unknown
Verified June 2020 by Davy Vancampfort, KU Leuven.
Recruitment status was: Recruiting
First Posted : June 18, 2020
Last Update Posted : June 18, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Randomised Controlled Trial Major Neurocognitive Disorder Long-term Care Facility Physical Activity Cognitive Impairment | Device: Exergame device | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | The Efficacy of Exergaming in People With Major Neurocognitive Disorder Residing in Long-term Care Facilities: A Randomized Controlled Trial |
Actual Study Start Date : | January 2, 2019 |
Estimated Primary Completion Date : | September 30, 2020 |
Estimated Study Completion Date : | September 30, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Intervention
Dividat senso exergame device
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Device: Exergame device
motor-cognitive training
Other Name: Dividat senso |
Active Comparator: Control
Listening to music
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Device: Exergame device
motor-cognitive training
Other Name: Dividat senso |
- MoCA [ Time Frame: 2 years ]Montréal Cognitive Assessment
- SPPB [ Time Frame: 2 years ]Short Physical Performance Battery
- NPI [ Time Frame: 2 years ]Neuropsychiatric Inventory
- CSDD [ Time Frame: 2 years ]Cornell Scale for Depression in Dementia
- DQOL [ Time Frame: 2 years ]Dementia Quality of Life
- (I)ADL [ Time Frame: 2 years ]Activities of daily living

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria included:
- a Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 diagnosis of MNCD (American Psychiatric Association, 2013)
- aged 65 years or older
- a score of minimum 10 on the Mini-Mental State Examination (MMSE)
- residing at least two weeks in the care facility at the time of inclusion
- being physically capable of doing standing exercises (whether or not with extra support).
Possible causes of MNCD were vascular dementia, Alzheimer's disease, mixed dementia, Parkinson's disease or Lewy body disease.
Exclusion criteria consisted of:
- any unstable cardiovascular or other health condition which according to the American College of Sports Medicine Standards might lead to unsafe participation
- a score lower than 10 on the MMSE
- a planned transfer to another setting within the following two months.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04436302
Contact: Nathalie Swinnen | 0032484657187 | nathalie.swinnen@kuleuven.be | |
Contact: Davy Vancampfort | +32 16 37 65 64 | davy.vancampfort@kuleuven.be |
Belgium | |
Long-term care facility 'de Wingerd' | Recruiting |
Leuven, Vlaams Brabant, Belgium, 3000 | |
Contact: Riekje Akkerman |
Responsible Party: | Davy Vancampfort, Professor, KU Leuven |
ClinicalTrials.gov Identifier: | NCT04436302 |
Other Study ID Numbers: |
042020 |
First Posted: | June 18, 2020 Key Record Dates |
Last Update Posted: | June 18, 2020 |
Last Verified: | June 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Dementia Neurocognitive Disorders Mental Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases |