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Effects of an Exergame Focused on Cognitive-motor Interference on the Cognitive and Motor Capacities of Older Adults (INCOME)

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ClinicalTrials.gov Identifier: NCT04803799
Recruitment Status : Recruiting
First Posted : March 18, 2021
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Ageing Other: Training Programme Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of an Exergame Focused on Cognitive-motor Interference on the Cognitive and Motor Capacities of Older Adults
Actual Study Start Date : April 14, 2021
Estimated Primary Completion Date : June 21, 2022
Estimated Study Completion Date : June 21, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental Arm
Training programme using Exergame as a support over a 12 week period
 Other: Training Programme
Cognitive-motor dual task exercises corresponding to associations between different motor tasks and different cognitive tasks.


Outcome Measures
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Primary Outcome Measures :
  1. Postural control under dual-task condition change [ Time Frame: Week 3, Week 17 ]
    assessed by posturography (mm/s)


Secondary Outcome Measures :
  1. Mental inhibition under dual-task condition change [ Time Frame: Week 3, Week 17, Week 31 ]
    assessed by Stroop test time (s)

  2. Mental inhibition under dual-task condition change [ Time Frame: Week 3, Week 17, Week 31 ]
    assessed by Stroop test errors (n)

  3. Mental inhibition change single-task condition [ Time Frame: Week 3, Week 17, Week 31 ]
    assessed by Stroop test time (s)

  4. Mental inhibition change single-task condition [ Time Frame: Week 3, Week 17, Week 31 ]
    assessed by Stroop test errors (n)

  5. Mental flexibility change [ Time Frame: Week 3, Week 17, Week 31 ]
    assessed by TMT time (s)

  6. Mental flexibility change [ Time Frame: Week 3, Week 17, Week 31 ]
    assessed by Stroop test errors (n)

  7. Working memory change [ Time Frame: Week 3, Week 17, Week 31 ]
    assessed by 2N-Back test errors (n)

  8. Mobility change [ Time Frame: Week 3, Week 17, Week 31 ]
    assessed by TUG time (s)

  9. Balance change [ Time Frame: Week 3, Week 17, Week 31 ]
    assessed by BBS score

  10. Fear of falling [ Time Frame: Week 3, Week 17, Week 31 ]
    assessed by FES-I score

  11. Postural control under single-task condition change [ Time Frame: Week 3, Week 17, Week 31 ]
    assessed by posturography (mm/s)

  12. Reported physical activity level change [ Time Frame: Week 3, Week 17, Week 31 ]
    assessed by QAPPA score

  13. Traqued physical activity level change [ Time Frame: Week 3, Week 17, Week 31 ]
    assessed by embeded Armband

  14. City exploration change [ Time Frame: Week 17, Week 31 ]
    assessed by the city's points of interest visits

  15. Quality of life change [ Time Frame: Week 3, Week 17, Week 31 ]
    assessed by EQ5D5L score

  16. Safety features of the training programme [ Time Frame: Week 17 ]
    number, nature, severity and causes of the occurrence of adverse events during the intervention

  17. Compliance [ Time Frame: Week 17 ]
    assessed by number of sessions carried out

  18. Drop-out [ Time Frame: Week 17 ]
    assessed by the number of participants who do not complete the program

  19. Motivation change [ Time Frame: Week 3, Week 17, Week 31 ]
    assessed by EMAPS score


Eligibility Criteria
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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04803799


Contacts
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Contact: Matthieu GALLOU-GUYOT +33 607 087 516 matthieu.gallou-guyot@unilim.fr
Contact: Jean-Christophe DAVIET, Medical Professor jean-christophe.daviet@unilim.fr

Locations
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France
Résidence Autonomie CASSEAUX Recruiting
Limoges, France, 87000
Résidence Autonomie DURKHEIM Recruiting
Limoges, France, 87000
Sponsors and Collaborators
University Hospital, Limoges
More Information
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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT04803799    
Other Study ID Numbers: 87RI20_0047 (INCOME)
First Posted: March 18, 2021    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Limoges:
Cognitive, motor, abilities, exergame