ExergameNCT04436315
Intervention Study of an Individualized Exergame Training for People With Major Neurocognitive Disorder
A study testing Motor-cognitive training device in people with Exergame and Major Neurocognitive Disorder, run by Davy Vancampfort at 1 site in Belgium.
Trial summary
This study evaluates the feasibility of the intervention and the study design. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Exergame, Major Neurocognitive Disorder, Long-term Care Facility
- What is being tested?
- Motor-cognitive training device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Apr 2021to 30 Dec 2021
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 60+ years
- Living in residency "de Wingerd" in Leuven (at least two weeks here)
- Being able to straight for minimal 10 minutes without aids
- Visual acuity with correction sufficient to see on a TV screen
- diagnosed with major neurocognitive disorder
Who cannot join
- Mobility impairments that don't allow to play the exergame
- Any unstable cardiovascular or other health condition which according to the American College of Sports Medicine Standards might lead to unsafe participation (e.g. recent cardiac infarction, uncontrolled diabetes or hypertension)
- Orthopaedic or neurological diseases that prevent exergame training
- Rapidly progressive or terminal illness
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
De Wingerd
Leuven, Vlaams Brabant, 3000
Nathalie Swinnen, +3216348215, nathalie.swinnen@kuleuven.be
About this study
This study evaluates the feasibility of the intervention and the study design.
Read the detailed description
This study evaluates the feasibility of the intervention and the study design. Furthermore, it investigates the effects of an exergame training including strength, balance, cognitive and pelvic floor muscle training. The main risk in this study is related to potential accidents/falls during the training (and not mainly to the data acquisition procedures). But as the difficulty of the training game is adaptive, the participants will always be challenged on an appropriate level for their physical condition. Furthermore, before and after the training period, several low risk measurements are conducted. This study contributes to fundamental research investigating how multicomponent exergame training influence physical and cognitive functions.
- Being tested
- Motor-cognitive training device, Active control condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor-cognitive training deviceDevice
Also called Vitaal exergame
Motor-cognitive training device
Active control conditionOther
Also called Physical therapy program
Physical activity program
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Exergame intervention Receives: Device: Motor-cognitive training device |
| Control | Sham comparator | Active control condition Receives: Other: Active control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Recruitment rate Adherence Attrition Time management of the assessments during pre-/post-measurements and the intervention Safety
Measured: 2 years
Motor functions
Recruitment rate Adherence Attrition Time management of the assessments during pre-/post-measurements and the intervention Safety Short Physical Performance Battery
1 - Minute Sit to Stand Test
Measured: 2 years
Cognitive functions
Montréal Cognitive Assessment Mini-Mental State Examination
Measured: 2 years
Mental health
Cornell Scale for Depression in Dementia Neuropsychiatric Inventory Dementia Quality of Life
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 start1 Apr 2021
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (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 ExergameStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 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
- NCT04436315
- Sponsor's protocol ID
- 082020
- Status last verified
- Aug 2021
- First submitted
- 3 Jun 2020
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Swinnen N, de Bruin ED, Guimaraes V, Dumoulin C, De Jong J, Akkerman R, Vandenbulcke M, Stubbs B, Vancampfort D. The feasibility of a stepping exergame prototype for older adults with major neurocognitive disorder residing in a long-term care facility: a mixed methods pilot study. Disabil Rehabil. 2023 Feb 23:1-15. doi: 10.1080/09638288.2023.2182916. Online ahead of print.
PubMed 36824039
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Study of an Individualized Exergame Training for People With Major Neurocognitive Disorder
- ClinicalTrials.gov ID
- NCT04436315
- Acronym / sponsor ID
- 082020
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Davy VancampfortUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (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 study evaluates the feasibility of the intervention and the study design.
Detailed description
This study evaluates the feasibility of the intervention and the study design. Furthermore, it investigates the effects of an exergame training including strength, balance, cognitive and pelvic floor muscle training. The main risk in this study is related to potential accidents/falls during the training (and not mainly to the data acquisition procedures). But as the difficulty of the training game is adaptive, the participants will always be challenged on an appropriate level for their physical condition. Furthermore, before and after the training period, several low risk measurements are conducted. This study contributes to fundamental research investigating how multicomponent exergame training influence physical and cognitive functions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Motor-cognitive training deviceExergame intervention |
| Control | Sham comparator | Other: Active control conditionActive control condition |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 60+ years
- Living in residency "de Wingerd" in Leuven (at least two weeks here)
- Being able to straight for minimal 10 minutes without aids
- Visual acuity with correction sufficient to see on a TV screen
- diagnosed with major neurocognitive disorder
Key exclusion criteria (4 listed)
- Mobility impairments that don't allow to play the exergame
- Any unstable cardiovascular or other health condition which according to the American College of Sports Medicine Standards might lead to unsafe participation (e.g. recent cardiac infarction, uncontrolled diabetes or hypertension)
- Orthopaedic or neurological diseases that prevent exergame training
- Rapidly progressive or terminal illness
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 |
|---|---|---|
| Motor-cognitive training deviceAlso: Vitaal exergameMotor-cognitive training device | Device | Intervention |
| Active control conditionAlso: Physical therapy programPhysical activity program | Other | Control |
Primary outcome
Feasibility
Time frame: 2 years
Recruitment rate Adherence Attrition Time management of the assessments during pre-/post-measurements and the intervention Safety
Motor functions
Time frame: 2 years
Recruitment rate Adherence Attrition Time management of the assessments during pre-/post-measurements and the intervention Safety Short Physical Performance Battery 1 - Minute Sit to Stand Test
Cognitive functions
Time frame: 2 years
Montréal Cognitive Assessment Mini-Mental State Examination
Mental health
Time frame: 2 years
Cornell Scale for Depression in Dementia Neuropsychiatric Inventory Dementia Quality of Life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Derived from this study: PubMed 36824039Swinnen N, de Bruin ED, Guimaraes V, Dumoulin C, De Jong J, Akkerman R, Vandenbulcke M, Stubbs B, Vancampfort D. The feasibility of a stepping exergame prototype for older adults with major neurocognitive disorder residing in a long-term care facility: a mixed methods pilot study. Disabil Rehabil. 2023 Feb 23:1-15. doi: 10.1080/09638288.2023.2182916. Online ahead of print.
- 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 Motor-cognitive training device in people with Exergame 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 5 inclusion and 4 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 24 Aug 2021. 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. Some participants in this study may receive a placebo. 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 (+3216348215, nathalie.swinnen@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 2 years). The study lists 4 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 NCT04436315, 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 24 Aug 2021.