Functional AutonomyNCT03836911
Effects of a Serious Game With Elderly People
A study testing serious game and classic program in people with Functional Autonomy, run by University Hospital, Montpellier at 15 sites in France.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Functional Autonomy
- What is being tested?
- serious game and classic program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 15 sitesFrance
- Study dates
- 28 Feb 2019to 28 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- older adults aged 65 and over, living in nursing homes and able to walk without technical assistance and sign an informed consent.
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
EHPAD Les Aigueillières
Montferrier-sur-Lez
EHPAD Françoise Gauffier CCAS de Montpellier
Montpellier
Ehpad Maison de Famille
Montpellier
EHPAD Pierre Laroque CCAS de Montpellier
Montpellier
EHPAD Le Barry
Muret
EHPAD Marie-Antoinette
Muret
EHPAD Résidence La Camargue, Nimes (Groue Orpéa)
Nîmes
EHPAD Résidence Château Notre Dame (Groupe Orpéa)
Parignargues
EHPAD Belleviste
Saint-Gély-du-Fesc
EHPAD Caroline Baron
Toulouse
Ehpad La Cotonniere
Toulouse
EHPAD LA houlette
Toulouse
Ehpad Le Bois Vert
Toulouse
Ehpad Pastelliere
Toulouse
EHPAD Le Grand Marquisat
Tournefeuille
About this study
Official title: Effects of a Serious Game Based Exercise Program on the Functional Autonomy in Older Adults Living in Nursing Homes : SERIOUS AUTONOMY
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.
Read the 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
- Conditions
- Functional Autonomy
- Being tested
- serious game, classic program
- Keywords
- Institutionalized olders adults, SERIOUS GAME
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serious gameOther
Effect of serious game on elderly in comparison of the physical activity adapted meeting
classic programOther
Effect of serious game on elderly in comparison of the physical activity adapted meeting
| Study group | Role | What they receive |
|---|---|---|
| serious game | Active comparator | the effect on physical performance of a personalized, 12-weeks rehabilitation program using a serious game Receives: 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 Receives: Other: classic program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (11)
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.
Measured: 6 months
incidence of fall
incidence of fall
Measured: 3 months
incidence of fall
incidence of fall
Measured: 6 months
Balance
Timed Up and Go Test, Tinetti Test and unipodal standing in simple and dual-task
Measured: at baseline (T0)
Balance
Timed Up and Go Test, Tinetti Test and unipodal standing in simple and dual-task
Measured: 3 months
Cognition
Mini Mental State Examination
Measured: At inclusion
Cognition
Mini Mental State Examination
Measured: 3 months
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
Measured: At inclusion
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
Measured: 3 months
Evaluation of the quality of life
SF12 questionnaire
Measured: At inclusion
Evaluation of the quality of life
SF12 questionnaire
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start28 Feb 2019
- Primary completion28 Oct 2022
- Study completion28 Oct 2022
Why it stopped: Sanitary context (COVID19)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional AutonomyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836911
- Sponsor's protocol ID
- RECHMPL18_0006
- Status last verified
- Jan 2025
- First submitted
- 17 Sep 2018
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Serious Game Based Exercise Program on the Functional Autonomy in Older Adults Living in Nursing Homes : SERIOUS AUTONOMY
- ClinicalTrials.gov ID
- NCT03836911
- Acronym / sponsor ID
- RECHMPL18_0006
- Conditions
- Functional Autonomy
- Keywords
- Institutionalized olders adults, SERIOUS GAME
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sanitary context (COVID19)
- Enrolment
- 136 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 28 Oct 2022 (actual)
- First posted
- 11 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| serious game | Active comparator | Other: serious gamethe effect on physical performance of a personalized, 12-weeks rehabilitation program using a serious game |
| Classic program | Other | Other: classic programthe effect on physical performance of a personalized, 12-weeks rehabilitation program using a classical exercise program in older subjects living in a nursing home |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- older adults aged 65 and over, living in nursing homes and able to walk without technical assistance and sign an informed consent.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serious gameEffect of serious game on elderly in comparison of the physical activity adapted meeting | Other | serious game |
| classic programEffect of serious game on elderly in comparison of the physical activity adapted meeting | Other | Classic program |
Primary outcome
Short Physical Performance Baterry (SPPB)
Time frame: 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.
11 secondary outcomes
Short Physical Performance Baterry (SPPB)
Time frame: 6 months
incidence of fall
Time frame: 3 months
incidence of fall
Time frame: 6 months
Balance
Time frame: at baseline (T0)
Balance
Time frame: 3 months
Cognition
Time frame: At inclusion
Cognition
Time frame: 3 months
Satisfaction evaluation
Time frame: At inclusion
Satisfaction evaluation
Time frame: 3 months
Evaluation of the quality of life
Time frame: At inclusion
Evaluation of the quality of life
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Sanitary context (COVID19)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing serious game and classic program in people with Functional Autonomy, run by University Hospital, Montpellier at 15 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sanitary context (COVID19)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Baterry (SPPB) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.