AgeingINCOMENCT04803799
Effects of an Exergame Focused on Cognitive-motor Interference on the Cognitive and Motor Capacities of Older Adults
A study testing Training Programme in people with Ageing, run by University Hospital, Limoges at 2 sites in France.
Trial summary
Ageing is accompanied by a high risk of developing physical or cognitive impairments, as well as a decrease in abilities to perform two tasks simultaneously, contributing to loss of autonomy. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Ageing
- What is being tested?
- Training Programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesFrance
- Study dates
- 14 Apr 2021to 31 Mar 2022
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- A person over 75 years of age who :
- resides in one of the two Municipal Autonomy Residences (RAM) of the City of Limoges (Durkheim or Casseaux), or a member of a senior club of the communal social action centre
- has normal or corrected vision and hearing
Who cannot join
- Person presenting :
- psychiatric disorders or neurological pathologies (cardiovascular accidents, Parkinson's disease, Alzheimer's, dementia) diagnosed
- taking medication that affects walking or balance
- a need for technical assistance (double cane-crutch, walker)
- an inability to carry out the proposed training programme
- person unable to understand the Protocol
Trial locations and contacts
2 sites in 1 country.
France2 sites
Résidence Autonomie CASSEAUX
Limoges, 87000
Résidence Autonomie DURKHEIM
Limoges, 87000
About this study
Ageing is accompanied by a high risk of developing physical or cognitive impairments, as well as a decrease in abilities to perform two tasks simultaneously, contributing to loss of autonomy.
Interventions based on the performance of cognitive-motor dual tasks show positive effects on cognitive, physical and emotional development on dual-tasking capabilities. Exergames, interactive serious games combining physical activity and technology, are a certain type of cognitive-motor dual task training. These exergames appear to be cognitively effective, discussed on a physical level, not studied on dual task functions. It is likely that a dual task cognitive-motor with the support of a exercise leads to the same benefits as training without the need for special support.
Read more
In addition, the exergames benefit from specific features such as a good immersion and a playful aspect that increase the participant's adhesion. Moreover, the level of security of this type of programme has been little studied. It is likely that cognitive-motor dual tasks training supported by an exercise programme leads to few undesirable events and good adherence.
Many of the recommendations specific needs gaming state that it is important to develop systems that respond to the needs specific to the population concerned in order to be effective. Within the laboratory HAVAE has been developed a tool, the "virtual carpet":
association between a video-projected scene and a monitoring system of position of the participants. This system makes it possible to use as a grid of play the cartography and iconography of the City of Limoges. The investigators suppose that this emphasis on local heritage will encourage the participants leaving their homes, thereby increasing their level of physical activity and their quality of life.
- Conditions
- Ageing
- Being tested
- Training Programme
- Keywords
- Cognitive, motor, abilities, exergame
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training ProgrammeOther
Cognitive-motor dual task exercises corresponding to associations between different motor tasks and different cognitive tasks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Training programme using Exergame as a support over a 12 week period Receives: Other: Training Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural control under dual-task condition change
assessed by posturography (mm/s)
Measured: Week 3, Week 17
Secondary outcomes (19)
Mental inhibition under dual-task condition change
assessed by Stroop test time (s)
Measured: Week 3, Week 17, Week 31
Mental inhibition under dual-task condition change
assessed by Stroop test errors (n)
Measured: Week 3, Week 17, Week 31
Mental inhibition change single-task condition
assessed by Stroop test time (s)
Measured: Week 3, Week 17, Week 31
Mental inhibition change single-task condition
assessed by Stroop test errors (n)
Measured: Week 3, Week 17, Week 31
Mental flexibility change
assessed by TMT time (s)
Measured: Week 3, Week 17, Week 31
Mental flexibility change
assessed by Stroop test errors (n)
Measured: Week 3, Week 17, Week 31
Working memory change
assessed by 2N-Back test errors (n)
Measured: Week 3, Week 17, Week 31
Mobility change
assessed by TUG time (s)
Measured: Week 3, Week 17, Week 31
Balance change
assessed by BBS score
Measured: Week 3, Week 17, Week 31
Fear of falling
assessed by FES-I score
Measured: Week 3, Week 17, Week 31
Postural control under single-task condition change
assessed by posturography (mm/s)
Measured: Week 3, Week 17, Week 31
Reported physical activity level change
assessed by QAPPA score
Measured: Week 3, Week 17, Week 31
Traqued physical activity level change
assessed by embeded Armband
Measured: Week 3, Week 17, Week 31
City exploration change
assessed by the city's points of interest visits
Measured: Week 17, Week 31
Quality of life change
assessed by EQ5D5L score
Measured: Week 3, Week 17, Week 31
Safety features of the training programme
number, nature, severity and causes of the occurrence of adverse events during the intervention
Measured: Week 17
Compliance
assessed by number of sessions carried out
Measured: Week 17
Drop-out
assessed by the number of participants who do not complete the program
Measured: Week 17
Motivation change
assessed by EMAPS score
Measured: Week 3, Week 17, Week 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start14 Apr 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
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 AgeingStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803799
- Sponsor's protocol ID
- 87RI20_0047 (INCOME)
- Acronym
- INCOME
- Status last verified
- Mar 2022
- First submitted
- 8 Mar 2021
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gallou-Guyot M, Mandigout S, Marie R, Robin L, Daviet JC, Perrochon A. Feasibility and potential cognitive impact of a cognitive-motor dual-task training program using a custom exergame in older adults: A pilot study. Front Aging Neurosci. 2023 Feb 2;15:1046676. doi: 10.3389/fnagi.2023.1046676. eCollection 2023.
PubMed 36819724
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Exergame Focused on Cognitive-motor Interference on the Cognitive and Motor Capacities of Older Adults
- ClinicalTrials.gov ID
- NCT04803799
- Acronym / sponsor ID
- INCOME / 87RI20_0047 (INCOME)
- Conditions
- Ageing
- Keywords
- Cognitive, motor, abilities, exergame
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 18 Mar 2021 (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.
Ageing is accompanied by a high risk of developing physical or cognitive impairments, as well as a decrease in abilities to perform two tasks simultaneously, contributing to loss of autonomy.
Interventions based on the performance of cognitive-motor dual tasks show positive effects on cognitive, physical and emotional development on dual-tasking capabilities. Exergames, interactive serious games combining physical activity and technology, are a certain type of cognitive-motor dual task training. These exergames appear to be cognitively effective, discussed on a physical level, not studied on dual task functions. It is likely that a dual task cognitive-motor with the support of a exercise leads to the same benefits as training without the need for special support.
In addition, the exergames benefit from specific features such as a good immersion and a playful aspect that increase the participant's adhesion. Moreover, the level of security of this type of programme has been little studied. It is likely that cognitive-motor dual tasks training supported by an exercise programme leads to few undesirable events and good adherence.
Many of the recommendations specific needs gaming state that it is important to develop systems that respond to the needs specific to the population concerned in order to be effective. Within the laboratory HAVAE has been developed a tool, the "virtual carpet":
association between a video-projected scene and a monitoring system of position of the participants. This system makes it possible to use as a grid of play the cartography and iconography of the City of Limoges. The investigators suppose that this emphasis on local heritage will encourage the participants leaving their homes, thereby increasing their level of physical activity and their quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Other: Training ProgrammeTraining programme using Exergame as a support over a 12 week period |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- resides in one of the two Municipal Autonomy Residences (RAM) of the City of Limoges (Durkheim or Casseaux), or a member of a senior club of the communal social action centre
- has normal or corrected vision and hearing
Key exclusion criteria (6 listed)
- psychiatric disorders or neurological pathologies (cardiovascular accidents, Parkinson's disease, Alzheimer's, dementia) diagnosed
- taking medication that affects walking or balance
- a need for technical assistance (double cane-crutch, walker)
- an inability to carry out the proposed training programme
- person unable to understand the Protocol
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 |
|---|---|---|
| Training ProgrammeCognitive-motor dual task exercises corresponding to associations between different motor tasks and different cognitive tasks. | Other | Experimental Arm |
Primary outcome
Postural control under dual-task condition change
Time frame: Week 3, Week 17
assessed by posturography (mm/s)
19 secondary outcomes
Mental inhibition under dual-task condition change
Time frame: Week 3, Week 17, Week 31
Mental inhibition under dual-task condition change
Time frame: Week 3, Week 17, Week 31
Mental inhibition change single-task condition
Time frame: Week 3, Week 17, Week 31
Mental inhibition change single-task condition
Time frame: Week 3, Week 17, Week 31
Mental flexibility change
Time frame: Week 3, Week 17, Week 31
Mental flexibility change
Time frame: Week 3, Week 17, Week 31
Working memory change
Time frame: Week 3, Week 17, Week 31
Mobility change
Time frame: Week 3, Week 17, Week 31
Balance change
Time frame: Week 3, Week 17, Week 31
Fear of falling
Time frame: Week 3, Week 17, Week 31
Postural control under single-task condition change
Time frame: Week 3, Week 17, Week 31
Reported physical activity level change
Time frame: Week 3, Week 17, Week 31
Traqued physical activity level change
Time frame: Week 3, Week 17, Week 31
City exploration change
Time frame: Week 17, Week 31
Quality of life change
Time frame: Week 3, Week 17, Week 31
Safety features of the training programme
Time frame: Week 17
Compliance
Time frame: Week 17
Drop-out
Time frame: Week 17
Motivation change
Time frame: Week 3, Week 17, Week 31
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Results publication: PubMed 36819724Gallou-Guyot M, Mandigout S, Marie R, Robin L, Daviet JC, Perrochon A. Feasibility and potential cognitive impact of a cognitive-motor dual-task training program using a custom exergame in older adults: A pilot study. Front Aging Neurosci. 2023 Feb 2;15:1046676. doi: 10.3389/fnagi.2023.1046676. eCollection 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training Programme in people with Ageing, run by University Hospital, Limoges at 2 sites in France.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural control under dual-task condition change (time frame: Week 3, Week 17). 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 NCT04803799, 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 1 Aug 2025.