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Exergaming in People With Major Neurocognitive Disorder

Primary Purpose

Randomised Controlled Trial, Major Neurocognitive Disorder, Long-term Care Facility

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Exergame device
Sponsored by
Davy Vancampfort
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Randomised Controlled Trial

Eligibility Criteria

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

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.

Sites / Locations

  • Long-term care facility 'de Wingerd'Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Dividat senso exergame device

Listening to music

Outcomes

Primary Outcome Measures

MoCA
Montréal Cognitive Assessment
SPPB
Short Physical Performance Battery
NPI
Neuropsychiatric Inventory
CSDD
Cornell Scale for Depression in Dementia
DQOL
Dementia Quality of Life
(I)ADL
Activities of daily living

Secondary Outcome Measures

Full Information

First Posted
June 3, 2020
Last Updated
June 15, 2020
Sponsor
Davy Vancampfort
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1. Study Identification

Unique Protocol Identification Number
NCT04436302
Brief Title
Exergaming in People With Major Neurocognitive Disorder
Official Title
The Efficacy of Exergaming in People With Major Neurocognitive Disorder Residing in Long-term Care Facilities: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
September 30, 2020 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Randomised Controlled Trial, Major Neurocognitive Disorder, Long-term Care Facility, Physical Activity, Cognitive Impairment

7. Study Design

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

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathalie Swinnen
Phone
0032484657187
Email
nathalie.swinnen@kuleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Davy Vancampfort
Phone
+32 16 37 65 64
Email
davy.vancampfort@kuleuven.be
Facility Information:
Facility Name
Long-term care facility '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
Riekje Akkerman

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33785077
Citation
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.
Results Reference
derived

Learn more about this trial

Exergaming in People With Major Neurocognitive Disorder

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