Randomised Controlled TrialNCT04436302
Exergaming in People With Major Neurocognitive Disorder
A study testing Exergame device in people with Randomised Controlled Trial and Major Neurocognitive Disorder, run by Davy Vancampfort at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Randomised Controlled Trial, Major Neurocognitive Disorder, Long-term Care Facility
- What is being tested?
- Exergame device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Jan 2019to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Long-term care facility 'de Wingerd'
Leuven, Vlaams Brabant, 3000
Riekje Akkerman
About this study
Official title: 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.
Read the 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.
- Conditions
- Randomised Controlled Trial, Major Neurocognitive Disorder, Long-term Care Facility, Physical Activity, Cognitive Impairment
- Being tested
- Exergame device
- Medical subject headings
- Motor Activity, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exergame deviceDevice
Also called Dividat senso
motor-cognitive training
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Dividat senso exergame device Receives: Device: Exergame device |
| Control | Active comparator | Listening to music Receives: Device: Exergame device |
What is being measured
The primary outcome is the main question the study is designed to answer.
MoCA
Montréal Cognitive Assessment
Measured: 2 years
SPPB
Short Physical Performance Battery
Measured: 2 years
NPI
Neuropsychiatric Inventory
Measured: 2 years
CSDD
Cornell Scale for Depression in Dementia
Measured: 2 years
DQOL
Dementia Quality of Life
Measured: 2 years
(I)ADL
Activities of daily living
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start2 Jan 2019
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Randomised Controlled TrialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Davy Vancampfort
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Davy Vancampfort, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436302
- Sponsor's protocol ID
- 042020
- Status last verified
- Jun 2020
- First submitted
- 3 Jun 2020
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33785077
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Exergaming in People With Major Neurocognitive Disorder Residing in Long-term Care Facilities: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04436302
- Acronym / sponsor ID
- 042020
- Conditions
- Randomised Controlled Trial, Major Neurocognitive Disorder, Long-term Care Facility, Physical Activity, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Davy VancampfortUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Exergame deviceDividat senso exergame device |
| Control | Active comparator | Device: Exergame deviceListening to music |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exergame deviceAlso: Dividat sensomotor-cognitive training | Device | Control, Intervention |
Primary outcome
MoCA
Time frame: 2 years
Montréal Cognitive Assessment
SPPB
Time frame: 2 years
Short Physical Performance Battery
NPI
Time frame: 2 years
Neuropsychiatric Inventory
CSDD
Time frame: 2 years
Cornell Scale for Depression in Dementia
DQOL
Time frame: 2 years
Dementia Quality of Life
(I)ADL
Time frame: 2 years
Activities of daily living
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Derived from this study: PubMed 33785077Swinnen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exergame device in people with Randomised Controlled Trial and Major Neurocognitive Disorder, run by Davy Vancampfort at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nathalie Swinnen (0032484657187, nathalie.swinnen@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MoCA (time frame: 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04436302, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020.