Effects of a Serious Game With Elderly People
January 8, 2025 updated by: University Hospital, Montpellier
Effects of a Serious Game Based Exercise Program on the Functional Autonomy in Older Adults Living in Nursing Homes : SERIOUS AUTONOMY
Assessment of the effect of a 12 weeks serious game based exercises program on physical performance in older adults living in nursing homes, in comparison with a control group that benefits from a classical exercise training program including balance, muscle strengthening and walking exercises with the same duration.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Recent reviews of the literature have shown that exergames may have interest in balance rehabilitation, physical performance maintenance, and fall prevention in community dwelling older adults with neurodegenerative disease or at risk of fall. These reviews also show however that classical exergames are not adapted for rehabilitation of patients with functional limitations, which could explain their relatively moderate benefits in those patients.
To overcome this lack, a serious game has been co-developed with medical to be adapted to the specific needs and characteristics of nursing home residents In this study , the investigators propose to compare the effects on physical performance, falls incidence, and quality of life of a 12-weeks serious game based exercise program and a classical exercises program
Study Type
Interventional
Enrollment (Actual)
136
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Montferrier Sur Lez, France
- EHPAD Les Aigueillières
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Montpellier, France
- EHPAD Françoise Gauffier CCAS de Montpellier
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Montpellier, France
- Ehpad Maison de Famille
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Montpellier, France
- EHPAD Pierre Laroque CCAS de Montpellier
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Muret, France
- EHPAD Le Barry
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Muret, France
- EHPAD Marie-Antoinette
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Nîmes, France
- EHPAD Résidence La Camargue, Nimes (Groue Orpéa)
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Parignargues, France
- EHPAD Résidence Château Notre Dame (Groupe Orpéa)
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Saint-Gély-du-Fesc, France
- EHPAD Belleviste
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Toulouse, France
- EHPAD Caroline Baron
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Toulouse, France
- Ehpad La Cotonniere
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Toulouse, France
- EHPAD LA houlette
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Toulouse, France
- Ehpad Le Bois Vert
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Toulouse, France
- Ehpad Pastelliere
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Tournefeuille, France
- EHPAD Le Grand Marquisat
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- older adults aged 65 and over, living in nursing homes and able to walk without technical assistance and sign an informed consent.
Exclusion Criteria:
- subjects with cognitive impairments (MMSE < 14) or with conditions that contra-indicate the involvement in a rehabilitation program for medical or ethics reasons; subjects with a history of seizure.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: serious game
the effect on physical performance of a personalized, 12-weeks rehabilitation program using a serious game
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Effect of serious game on elderly in comparison of the physical activity adapted meeting
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|
Other: Classic program
the effect on physical performance of a personalized, 12-weeks rehabilitation program using a classical exercise program in older subjects living in a nursing home
|
Effect of serious game on elderly in comparison of the physical activity adapted meeting
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short Physical Performance Baterry (SPPB)
Time Frame: 3 months
|
Short Physical Performance Baterry (SPPB) at baseline (T0) and at 3 months.The Short Physical Performance Battery (SPPB) is the sum of the scores on three criteria: the balance test, the walking speed test and the chair lift test.
This test makes it possible to evaluate the physical performance of an individual.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short Physical Performance Baterry (SPPB)
Time Frame: 6 months
|
SPPB score at 6 months.The Short Physical Performance Battery (SPPB) is the sum of the scores on three criteria: the balance test, the walking speed test and the chair lift test.
This test makes it possible to evaluate the physical performance of an individual.
|
6 months
|
|
incidence of fall
Time Frame: 3 months
|
incidence of fall
|
3 months
|
|
incidence of fall
Time Frame: 6 months
|
incidence of fall
|
6 months
|
|
Balance
Time Frame: at baseline (T0)
|
Timed Up and Go Test, Tinetti Test and unipodal standing in simple and dual-task
|
at baseline (T0)
|
|
Balance
Time Frame: 3 months
|
Timed Up and Go Test, Tinetti Test and unipodal standing in simple and dual-task
|
3 months
|
|
Cognition
Time Frame: At inclusion
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Mini Mental State Examination
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At inclusion
|
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Cognition
Time Frame: 3 months
|
Mini Mental State Examination
|
3 months
|
|
Satisfaction evaluation
Time Frame: At inclusion
|
Lickert Scale at inclusion.A Likert scale is a psychometric tool to measure an attitude in individuals.The scale contains for each item a graduation generally comprising five or seven answer choices that qualify the degree of agreement
|
At inclusion
|
|
Satisfaction evaluation
Time Frame: 3 months
|
Lickert Scale at inclusion.A Likert scale is a psychometric tool to measure an attitude in individuals.The scale contains for each item a graduation generally comprising five or seven answer choices that qualify the degree of agreement
|
3 months
|
|
Evaluation of the quality of life
Time Frame: At inclusion
|
SF12 questionnaire
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At inclusion
|
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Evaluation of the quality of life
Time Frame: 3 months
|
SF12 questionnaire
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 28, 2019
Primary Completion (Actual)
October 28, 2022
Study Completion (Actual)
October 28, 2022
Study Registration Dates
First Submitted
September 17, 2018
First Submitted That Met QC Criteria
February 6, 2019
First Posted (Actual)
February 11, 2019
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 8, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- RECHMPL18_0006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.