- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04803799
Effects of an Exergame Focused on Cognitive-motor Interference on the Cognitive and Motor Capacities of Older Adults (INCOME)
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 Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Limoges, France, 87000
- Résidence Autonomie CASSEAUX
-
Limoges, France, 87000
- Résidence Autonomie DURKHEIM
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Arm
Training programme using Exergame as a support over a 12 week period
|
Cognitive-motor dual task exercises corresponding to associations between different motor tasks and different cognitive tasks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postural control under dual-task condition change
Time Frame: Week 3, Week 17
|
assessed by posturography (mm/s)
|
Week 3, Week 17
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mental inhibition under dual-task condition change
Time Frame: Week 3, Week 17, Week 31
|
assessed by Stroop test time (s)
|
Week 3, Week 17, Week 31
|
Mental inhibition under dual-task condition change
Time Frame: Week 3, Week 17, Week 31
|
assessed by Stroop test errors (n)
|
Week 3, Week 17, Week 31
|
Mental inhibition change single-task condition
Time Frame: Week 3, Week 17, Week 31
|
assessed by Stroop test time (s)
|
Week 3, Week 17, Week 31
|
Mental inhibition change single-task condition
Time Frame: Week 3, Week 17, Week 31
|
assessed by Stroop test errors (n)
|
Week 3, Week 17, Week 31
|
Mental flexibility change
Time Frame: Week 3, Week 17, Week 31
|
assessed by TMT time (s)
|
Week 3, Week 17, Week 31
|
Mental flexibility change
Time Frame: Week 3, Week 17, Week 31
|
assessed by Stroop test errors (n)
|
Week 3, Week 17, Week 31
|
Working memory change
Time Frame: Week 3, Week 17, Week 31
|
assessed by 2N-Back test errors (n)
|
Week 3, Week 17, Week 31
|
Mobility change
Time Frame: Week 3, Week 17, Week 31
|
assessed by TUG time (s)
|
Week 3, Week 17, Week 31
|
Balance change
Time Frame: Week 3, Week 17, Week 31
|
assessed by BBS score
|
Week 3, Week 17, Week 31
|
Fear of falling
Time Frame: Week 3, Week 17, Week 31
|
assessed by FES-I score
|
Week 3, Week 17, Week 31
|
Postural control under single-task condition change
Time Frame: Week 3, Week 17, Week 31
|
assessed by posturography (mm/s)
|
Week 3, Week 17, Week 31
|
Reported physical activity level change
Time Frame: Week 3, Week 17, Week 31
|
assessed by QAPPA score
|
Week 3, Week 17, Week 31
|
Traqued physical activity level change
Time Frame: Week 3, Week 17, Week 31
|
assessed by embeded Armband
|
Week 3, Week 17, Week 31
|
City exploration change
Time Frame: Week 17, Week 31
|
assessed by the city's points of interest visits
|
Week 17, Week 31
|
Quality of life change
Time Frame: Week 3, Week 17, Week 31
|
assessed by EQ5D5L score
|
Week 3, Week 17, Week 31
|
Safety features of the training programme
Time Frame: Week 17
|
number, nature, severity and causes of the occurrence of adverse events during the intervention
|
Week 17
|
Compliance
Time Frame: Week 17
|
assessed by number of sessions carried out
|
Week 17
|
Drop-out
Time Frame: Week 17
|
assessed by the number of participants who do not complete the program
|
Week 17
|
Motivation change
Time Frame: Week 3, Week 17, Week 31
|
assessed by EMAPS score
|
Week 3, Week 17, Week 31
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 87RI20_0047 (INCOME)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ageing
-
Centre Hospitalier Universitaire de NiceRecruiting
-
Lund UniversityThe Swedish Research Council; Linnaeus UniversityCompleted
-
Norwegian University of Science and TechnologyCompleted
-
University of GlasgowCompleted
-
University of SouthamptonNational Institute for Health Research, United KingdomUnknown
-
Assistance Publique - Hôpitaux de ParisUnknown
-
Wageningen UniversityCompleted
-
Quadram Institute BioscienceNorfolk and Norwich University Hospitals NHS Foundation TrustActive, not recruitingAgeingUnited Kingdom
-
Wageningen UniversityRecruiting
-
Stanford UniversityCompleted
Clinical Trials on Training Programme
-
Istanbul University - Cerrahpasa (IUC)Not yet recruiting
-
Heinrich HussleinCompleted
-
King's College LondonImperial College London; Alzheimer's SocietyCompletedDementia | Mild Cognitive Impairment
-
The University of Hong KongCompleted
-
Hölmich, Per, M.D.Unknown
-
Fundacion Miguel ServetRecruiting
-
Loughborough UniversityRecruitingOlder PeopleUnited Kingdom
-
Education University of Hong KongBaptist Oi Kwan Social ServiceCompleted
-
Centre Hospitalier Universitaire DijonCompleted
-
Hospital Mutua de TerrassaCompleted