Effects of a Serious Game With Elderly People

Functional Autonomy Clinical Trial

Official title:

Effects of a Serious Game Based Exercise Program on the Functional Autonomy in Older Adults Living in Nursing Homes : SERIOUS AUTONOMY

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03836911
• Other study ID #: RECHMPL18_0006
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2019
• Est. completion date: October 1, 2024

Study information

• Verified date: June 2023
• Source: University Hospital, Montpellier
• Contact: Chokri BOUBAKRI, PhD
• Phone: 0467335502
• Email: c-boubakri[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Other known NCT identifiers

• NCT03694795

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 234
• Est. completion date: October 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Functional Autonomy

Intervention

Other:
• serious game
Effect of serious game on elderly in comparison of the physical activity adapted meeting
• classic program
Effect of serious game on elderly in comparison of the physical activity adapted meeting

Locations

Country	Name	City	State
France	EHPAD Les Aigueillières	Montferrier Sur Lez
France	EHPAD Françoise Gauffier CCAS de Montpellier	Montpellier
France	Ehpad Maison de Famille	Montpellier
France	EHPAD Pierre Laroque CCAS de Montpellier	Montpellier
France	EHPAD Le Barry	Muret
France	EHPAD Marie-Antoinette	Muret
France	EHPAD Résidence La Camargue, Nimes (Groue Orpéa)	Nîmes
France	EHPAD Résidence Château Notre Dame (Groupe Orpéa)	Parignargues
France	EHPAD Belleviste	Saint-Gély-du-Fesc
France	EHPAD Caroline Baron	Toulouse
France	Ehpad La Cotonniere	Toulouse
France	EHPAD LA houlette	Toulouse
France	Ehpad Le Bois Vert	Toulouse
France	Ehpad Pastelliere	Toulouse
France	EHPAD Le Grand Marquisat	Tournefeuille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short Physical Performance Baterry (SPPB)	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	Short Physical Performance Baterry (SPPB)	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
Secondary	incidence of fall	incidence of fall	3 months
Secondary	incidence of fall	incidence of fall	6 months
Secondary	Balance	Timed Up and Go Test, Tinetti Test and unipodal standing in simple and dual-task	at baseline (T0)
Secondary	Balance	Timed Up and Go Test, Tinetti Test and unipodal standing in simple and dual-task	3 months
Secondary	Cognition	Mini Mental State Examination	At inclusion
Secondary	Cognition	Mini Mental State Examination	3 months
Secondary	Satisfaction evaluation	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
Secondary	Satisfaction evaluation	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
Secondary	Evaluation of the quality of life	SF12 questionnaire	At inclusion
Secondary	Evaluation of the quality of life	SF12 questionnaire	3 months