Exergaming in People With Major Neurocognitive Disorder

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04436302
• Other study ID #: 042020
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: June 2020
• Source: KU Leuven
• Contact: Nathalie Swinnen
• Phone: 0032484657187
• Email: nathalie.swinnen[@]kuleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Dementia
• Long-term Care Facility
• Major Neurocognitive Disorder
• Neurocognitive Disorders
• Physical Activity
• Randomised Controlled Trial

Intervention

Device:
• Exergame device
motor-cognitive training

Locations

Country	Name	City	State
Belgium	Long-term care facility 'de Wingerd'	Leuven	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Davy Vancampfort

Country where clinical trial is conducted

Belgium, 

Outcome

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