Exergaming in People With Major Neurocognitive Disorder

The Efficacy of Exergaming in People With Major Neurocognitive Disorder Residing in Long-term Care Facilities: A Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Physical Activity; Cognitive Impairment; Major Neurocognitive Disorder; Long-term Care Facility; Randomised Controlled Trial
• Intervention / Treatment: Device: Exergame device

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: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nathalie Swinnen; Phone Number: 0032484657187; Email: nathalie.swinnen@kuleuven.be
• Study Contact Backup: Name: Davy Vancampfort; Phone Number: +32 16 37 65 64; Email: davy.vancampfort@kuleuven.be

Study Locations

• Belgium
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • Recruiting
      • Long-term care facility 'de Wingerd'
      • Contact: Riekje Akkerman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Dividat senso exergame device	Device: Exergame device; motor-cognitive training; Other Names: Dividat senso
Active Comparator: Control; Listening to music	Device: Exergame device; motor-cognitive training; Other Names: Dividat senso

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MoCA	Montréal Cognitive Assessment	2 years
SPPB	Short Physical Performance Battery	2 years
NPI	Neuropsychiatric Inventory	2 years
CSDD	Cornell Scale for Depression in Dementia	2 years
DQOL	Dementia Quality of Life	2 years
(I)ADL	Activities of daily living	2 years

Collaborators and Investigators

• Sponsor: Davy Vancampfort

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2019
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 15, 2020
• First Posted (Actual): June 18, 2020

Study Record Updates

• Last Update Posted (Actual): June 18, 2020
• Last Update Submitted That Met QC Criteria: June 15, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Neurocognitive Disorders
• Other Study ID Numbers: 042020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No