Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Exergaming in People With Major Neurocognitive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04436302
Recruitment Status : Recruiting
First Posted : June 18, 2020
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Davy Vancampfort, KU Leuven

Tracking Information
First Submitted Date  ICMJE June 3, 2020
First Posted Date  ICMJE June 18, 2020
Last Update Posted Date June 18, 2020
Actual Study Start Date  ICMJE January 2, 2019
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2020)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exergaming in People With Major Neurocognitive Disorder
Official Title  ICMJE The Efficacy of Exergaming in People With Major Neurocognitive Disorder Residing in Long-term Care Facilities: A Randomized Controlled Trial
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Randomised Controlled Trial
  • Major Neurocognitive Disorder
  • Long-term Care Facility
  • Physical Activity
  • Cognitive Impairment
Intervention  ICMJE Device: Exergame device
motor-cognitive training
Other Name: Dividat senso
Study Arms  ICMJE
  • Experimental: Intervention
    Dividat senso exergame device
    Intervention: Device: Exergame device
  • Active Comparator: Control
    Listening to music
    Intervention: Device: Exergame device
Publications * Swinnen N, Vandenbulcke M, de Bruin ED, Akkerman R, Stubbs B, Firth J, Vancampfort D. The efficacy of exergaming in people with major neurocognitive disorder residing in long-term care facilities: a pilot randomized controlled trial. Alzheimers Res Ther. 2021 Mar 30;13(1):70. doi: 10.1186/s13195-021-00806-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 15, 2020)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2020
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nathalie Swinnen 0032484657187 nathalie.swinnen@kuleuven.be
Contact: Davy Vancampfort +32 16 37 65 64 davy.vancampfort@kuleuven.be
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04436302
Other Study ID Numbers  ICMJE 042020
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Davy Vancampfort, KU Leuven
Study Sponsor  ICMJE Davy Vancampfort
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account KU Leuven
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP