NCT03836911

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

15 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 11, 2019

Completed
17 days until next milestone

Study Start

First participant enrolled

February 28, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2022

Completed
Last Updated

January 10, 2025

Status Verified

January 1, 2025

Enrollment Period

3.7 years

First QC Date

September 17, 2018

Last Update Submit

January 8, 2025

Conditions

Functional Autonomy

Keywords

Institutionalized olders adultsSERIOUS GAME

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Short Physical Performance Baterry (SPPB)

    6 months

  • incidence of fall

    3 months

  • incidence of fall

    6 months

  • Balance

    at baseline (T0)

  • Balance

    3 months

  • +6 more secondary outcomes

Study Arms (2)

serious game

ACTIVE COMPARATOR

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

Other: serious game

Classic program

OTHER

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

Other: classic program

Interventions

serious gameOTHER

Effect of serious game on elderly in comparison of the physical activity adapted meeting

serious game
classic programOTHER

Effect of serious game on elderly in comparison of the physical activity adapted meeting

Classic program

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • older adults aged 65 and over, living in nursing homes and able to walk without technical assistance and sign an informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

EHPAD Les Aigueillières

Montferrier-sur-Lez, France

Location

EHPAD Françoise Gauffier CCAS de Montpellier

Montpellier, France

Location

Ehpad Maison de Famille

Montpellier, France

Location

EHPAD Pierre Laroque CCAS de Montpellier

Montpellier, France

Location

EHPAD Le Barry

Muret, France

Location

EHPAD Marie-Antoinette

Muret, France

Location

EHPAD Résidence La Camargue, Nimes (Groue Orpéa)

Nîmes, France

Location

EHPAD Résidence Château Notre Dame (Groupe Orpéa)

Parignargues, France

Location

EHPAD Belleviste

Saint-Gély-du-Fesc, France

Location

EHPAD Caroline Baron

Toulouse, France

Location

Ehpad La Cotonniere

Toulouse, France

Location

EHPAD LA houlette

Toulouse, France

Location

Ehpad Le Bois Vert

Toulouse, France

Location

Ehpad Pastelliere

Toulouse, France

Location

EHPAD Le Grand Marquisat

Tournefeuille, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2018

First Posted

February 11, 2019

Study Start

February 28, 2019

Primary Completion

October 28, 2022

Study Completion

October 28, 2022

Last Updated

January 10, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(15)