Effects of a Serious Game With Elderly People

Not Applicable

Terminated

• Conditions: Functional Autonomy
• Interventions: Other: classic program; Other: serious game

• Registration Number: NCT03836911
• Lead Sponsor: University Hospital, Montpellier

Brief 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.

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 Timeline

• Study First Submitted: 2018-09-17
• Study First Submitted QC: 2019-02-06
• Study First Posted: 2019-02-11
• Study Start: 2019-02-28
• Primary Completion: 2022-10-28
• Study Completion: 2022-10-28
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 136

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Classic program	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
serious game	serious game	the effect on physical performance of a personalized, 12-weeks rehabilitation program using a serious game

Primary Outcome Measures

Name	Time	Method
Short Physical Performance Baterry (SPPB)	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.

Secondary Outcome Measures

Name	Time	Method
Short Physical Performance Baterry (SPPB)	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.
Balance	3 months	Timed Up and Go Test, Tinetti Test and unipodal standing in simple and dual-task
Cognition	3 months	Mini Mental State Examination
Satisfaction evaluation	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
Evaluation of the quality of life	3 months	SF12 questionnaire
incidence of fall	6 months	incidence of fall

Trial Locations

Locations (15)

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, France