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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04803799
Other study ID # 87RI20_0047 (INCOME)
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 14, 2021
Est. completion date March 31, 2022

Study information

Verified date March 2022
Source University Hospital, Limoges
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date March 31, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Training Programme
Cognitive-motor dual task exercises corresponding to associations between different motor tasks and different cognitive tasks.

Locations

Country Name City State
France Résidence Autonomie CASSEAUX Limoges
France Résidence Autonomie DURKHEIM Limoges

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postural control under dual-task condition change assessed by posturography (mm/s) Week 3, Week 17
Secondary Mental inhibition under dual-task condition change assessed by Stroop test time (s) Week 3, Week 17, Week 31
Secondary Mental inhibition under dual-task condition change assessed by Stroop test errors (n) Week 3, Week 17, Week 31
Secondary Mental inhibition change single-task condition assessed by Stroop test time (s) Week 3, Week 17, Week 31
Secondary Mental inhibition change single-task condition assessed by Stroop test errors (n) Week 3, Week 17, Week 31
Secondary Mental flexibility change assessed by TMT time (s) Week 3, Week 17, Week 31
Secondary Mental flexibility change assessed by Stroop test errors (n) Week 3, Week 17, Week 31
Secondary Working memory change assessed by 2N-Back test errors (n) Week 3, Week 17, Week 31
Secondary Mobility change assessed by TUG time (s) Week 3, Week 17, Week 31
Secondary Balance change assessed by BBS score Week 3, Week 17, Week 31
Secondary Fear of falling assessed by FES-I score Week 3, Week 17, Week 31
Secondary Postural control under single-task condition change assessed by posturography (mm/s) Week 3, Week 17, Week 31
Secondary Reported physical activity level change assessed by QAPPA score Week 3, Week 17, Week 31
Secondary Traqued physical activity level change assessed by embeded Armband Week 3, Week 17, Week 31
Secondary City exploration change assessed by the city's points of interest visits Week 17, Week 31
Secondary Quality of life change assessed by EQ5D5L score Week 3, Week 17, Week 31
Secondary Safety features of the training programme number, nature, severity and causes of the occurrence of adverse events during the intervention Week 17
Secondary Compliance assessed by number of sessions carried out Week 17
Secondary Drop-out assessed by the number of participants who do not complete the program Week 17
Secondary Motivation change assessed by EMAPS score Week 3, Week 17, Week 31
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