NCT04436302

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 18, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

June 18, 2020

Status Verified

June 1, 2020

Enrollment Period

1.7 years

First QC Date

June 3, 2020

Last Update Submit

June 15, 2020

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (2)

Intervention

EXPERIMENTAL

Dividat senso exergame device

Device: Exergame device

Control

ACTIVE COMPARATOR

Listening to music

Device: Exergame device

Interventions

motor-cognitive training

Also known as: Dividat senso
ControlIntervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Long-term care facility 'de Wingerd'

Leuven, Vlaams Brabant, 3000, Belgium

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Motor ActivityCognitive Dysfunction

Condition Hierarchy (Ancestors)

BehaviorCognition DisordersNeurocognitive DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 3, 2020

First Posted

June 18, 2020

Study Start

January 2, 2019

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

June 18, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations