Exergaming in People With Major Neurocognitive Disorder

NCT ID: NCT04436302

Last Updated: 2020-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-02

Study Completion Date

2020-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Randomised Controlled Trial Major Neurocognitive Disorder Long-term Care Facility Physical Activity Cognitive Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

Dividat senso exergame device

Group Type EXPERIMENTAL

Exergame device

Intervention Type DEVICE

motor-cognitive training

Control

Listening to music

Group Type ACTIVE_COMPARATOR

Exergame device

Intervention Type DEVICE

motor-cognitive training

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exergame device

motor-cognitive training

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Dividat senso

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

* 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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Davy Vancampfort

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Davy Vancampfort

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Long-term care facility 'de Wingerd'

Leuven, Vlaams Brabant, Belgium

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nathalie Swinnen

Role: CONTACT

0032484657187

Davy Vancampfort

Role: CONTACT

+32 16 37 65 64

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Riekje Akkerman

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 33785077 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

042020

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cognitive-Motor Training for AD/ADRD Prevention
NCT07160582 NOT_YET_RECRUITING NA
Tablet-based Cognitive Training
NCT04452864 COMPLETED NA