Effets of a Serious Game With Elderly People

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 1, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

October 15, 2018

Estimated Primary Completion Date

October 15, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Short Physical Performance Baterry (SPPB)[ Time Frame: 3 months ]

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

incidence of fall[ Time Frame: up to 6 months ]
SPPB score at 6 months

Descriptive Information

Brief Title ^ICMJE

Effets of a Serious Game With Elderly People

Official Title ^ICMJE

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

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 , we 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 exercices program

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Prevention

Condition ^ICMJE

Intervention ^ICMJE

Diagnostic Test: 12-weeks rehabilitation program using a serious game
Effect of serious game on elderly in comparison of the physical activity adapted meeting
Other: 12-weeks rehabilitation program using a classical exercises program
Effect of serious game on elderly in comparison of the physical activity adapted meeting

Study Arms

Experimental: rehabilitation program using a serious game
the effect on physical performance of a personalized, 12-weeks rehabilitation program using a serious game in older subjects living in a nursing home.
Active Comparator: rehabilitation program using a classical 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.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

234

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

October 15, 2021

Estimated Primary Completion Date

October 15, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - older adults aged 65 and over, living in nursing homes and able to walk without technical assistance - 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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

65 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

France

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

University Hospital, Montpellier

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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