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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
Sponsor:
Information provided by (Responsible Party):
Davy Vancampfort, KU Leuven

Study Description
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Brief Summary:
This randomized controlled trial explores the efficacy of an 8-week standing exergaming program in people with major neurocognitive disorder (MNCD) residing in long-term care facilities.

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

Detailed Description:
This randomized controlled trial explores the efficacy of an 8-week standing exergaming program in people with major neurocognitive disorder (MNCD) residing in long-term care facilities. Fifty inpatients with mild to moderate MNCD will be randomly assigned to three times weekly for eight weeks 15 min of exergaming versus watching preferred music videos. The Montréal Cognitive Assessment (MoCA), Short Physical Performance Battery (SPPB), Neuropsychiatric Inventory (NPI), Cornell Scale for Depression in Dementia (CSDD), Dementia Quality of Life (DQoL), Katz activities of daily living (ADL) and Instrumental ADL (IADL) are measured at baseline and post intervention.
Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nursing Homes

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention
Dividat senso exergame device
 Device: Exergame device
motor-cognitive training
Other Name: Dividat senso
Active Comparator: Control
Listening to music
 Device: Exergame device
motor-cognitive training
Other Name: Dividat senso


Outcome Measures
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Primary Outcome Measures :
  1. MoCA [ Time Frame: 2 years ]
    Montréal Cognitive Assessment

  2. SPPB [ Time Frame: 2 years ]
    Short Physical Performance Battery

  3. NPI [ Time Frame: 2 years ]
    Neuropsychiatric Inventory

  4. CSDD [ Time Frame: 2 years ]
    Cornell Scale for Depression in Dementia

  5. DQOL [ Time Frame: 2 years ]
    Dementia Quality of Life

  6. (I)ADL [ Time Frame: 2 years ]
    Activities of daily living


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Nathalie Swinnen 0032484657187 nathalie.swinnen@kuleuven.be
Contact: Davy Vancampfort +32 16 37 65 64 davy.vancampfort@kuleuven.be

Locations
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Belgium
Long-term care facility 'de Wingerd' Recruiting
Leuven, Vlaams Brabant, Belgium, 3000
Contact: Riekje Akkerman         
Sponsors and Collaborators
Davy Vancampfort
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dementia
Neurocognitive Disorders
Mental Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases