Clinical trial NCT03836911: Effects of a Serious Game With Elderly People
Official title: Effects of a Serious Game Based Exercise Program on the Functional Autonomy in Older Adults Living in Nursing Homes : SERIOUS AUTONOMY
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Functional Autonomy
Keywords: Institutionalized olders adults
SERIOUS GAME
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-02-11
Enrollment: 136
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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.

Primary outcomes:
measure: Short Physical Performance Baterry (SPPB)
timeFrame: 3 months
Secondary outcomes:
measure: Short Physical Performance Baterry (SPPB)
timeFrame: 6 months
measure: incidence of fall
timeFrame: 3 months
measure: incidence of fall
timeFrame: 6 months
measure: Balance
timeFrame: at baseline (T0)
measure: Balance
timeFrame: 3 months
measure: Cognition
timeFrame: At inclusion
measure: Cognition
timeFrame: 3 months
measure: Satisfaction evaluation
timeFrame: At inclusion
measure: Satisfaction evaluation
timeFrame: 3 months
measure: Evaluation of the quality of life
timeFrame: At inclusion
measure: Evaluation of the quality of life
timeFrame: 3 months
Other outcomes:
Locations:
city: Montferrier Sur Lez
country: France
facility: EHPAD Les Aigueillières
city: Montpellier
country: France
facility: EHPAD Françoise Gauffier CCAS de Montpellier
city: Montpellier
country: France
facility: Ehpad Maison de Famille
city: Montpellier
country: France
facility: EHPAD Pierre Laroque CCAS de Montpellier
city: Muret
country: France
facility: EHPAD Le Barry
city: Muret
country: France
facility: EHPAD Marie-Antoinette
city: Nîmes
country: France
facility: EHPAD Résidence La Camargue, Nimes (Groue Orpéa)
city: Parignargues
country: France
facility: EHPAD Résidence Château Notre Dame (Groupe Orpéa)
city: Saint-Gély-du-Fesc
country: France
facility: EHPAD Belleviste
city: Toulouse
country: France
facility: EHPAD Caroline Baron
city: Toulouse
country: France
facility: Ehpad La Cotonniere
city: Toulouse
country: France
facility: EHPAD LA houlette
city: Toulouse
country: France
facility: Ehpad Le Bois Vert
city: Toulouse
country: France
facility: Ehpad Pastelliere
city: Tournefeuille
country: France
facility: EHPAD Le Grand Marquisat
Study officials:
References: