ElderlyAGIRNCT02393014
Physical Activity and Fall Prevention in Geriatric Inpatients in Acute caRe: Feasibility Study
A study testing Simple physical exercises in people with Elderly, run by University Hospital, Angers at 1 site in France.
Trial summary
This study aims to evaluate the feasibility and the impact on physical performance and falls occurence among geriatric inpatients hospitalized in acute care unit. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Elderly
- What is being tested?
- Simple physical exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2015to Jun 2016
- 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
- Being 65 years old and older
- Being hospitalized in geriatric acute care unit of Angers University Hospital.
- No contraindications to physical activity practice.
- No contraindications to standing station and sitting station.
- Participants having given and signed an informed participation consent. If the participant is unable to answer, we will retain the disagreement expressed by a trusted person.
- Being affiliated to French social security
Who cannot join
- Refusal of participation
- Persons aged under 65.
- Topics including hospitalization at the entrance should not exceed 3 days.
- Participation in concomitant clinical trial.
- Civil Protection Measures such as trusteeship, guardianship or backup justice underway.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Activité Physique et prévention de la Chute du Patient âGé hospItalisé en Court séjouR: Etude de faisabilité (AGIR)
This study aims to evaluate the feasibility and the impact on physical performance and falls occurence among geriatric inpatients hospitalized in acute care unit.
Read the detailed description
Having developed many tools to determine fall risk of 65 years and older patients, Angers University Hospital plans to develop a corrective action to prevent the occurrence of falls in this population.
This study aims to assess the feasibility of a physical activity program with 3 difficulty levels (depending on the patient's risk of falling): easy (low fall risk), moderate (average fall risk) and difficult (high fall risk).
The implementation process should be simply and fastly applicable in practice for routine care by paramedics.
- Conditions
- Elderly
- Being tested
- Simple physical exercises
- Keywords
- 65 years old or older, hospitalized in, geriatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple physical exercisesProcedure or surgery
- The participant must stay out of the bed 3 hours. This pre-required level prevents the occurrence of acute postural mismatch which can occur when elderly patients are bedridden and too long increases the risk of falling.
- The participant stands standing in static equilibrium to a chair holding the back of it for 2 minutes. Depending on the patient's abilities, the exercise will be done on both feet or one foot.
- The participant performs a transfer activity of sitting to standing repeated 5 times (FTSS test). According to the patient's abilities, the exercise will be done with physical assistance or not.
| Study group | Role | What they receive |
|---|---|---|
| Low fall risk | Experimental | low fall risk patients Receives: Procedure: Simple physical exercises |
| Medium fall risk | Experimental | medium fall risk patients Receives: Procedure: Simple physical exercises |
| High fall risk | Experimental | high fall risk patients Receives: Procedure: Simple physical exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants in each category of fall risk having realized 75% and more of the exercises of at least one of the three difficulty levels of the physical activity program
The feasibility of the interventions of each fall risk category is defined as "at least 80% of the participants of a category having completed 75% and more of the exercises".
Measured: up to 15 months
Secondary outcomes (4)
Change of number of patients having realized the Five Time Sit and Stand (FTSS) test.
Measured: up to 15 months
For the patients having achieved FTSS test, the realization time (in seconds).
Measured: up to 60 seconds
Measure (by the medical team) of the difficulty to set up and carry out the exercises
This measure will be assessed with a scale : "very easy" ; "easy" ; "feasible" ; "difficult" ; "impossible"
Measured: up to 20 days
Time needed by the paramedical team to achieve the exercises
Measured: up to 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393014
- Sponsor's protocol ID
- 2014-30
- Acronym
- AGIR
- Status last verified
- Feb 2015
- First submitted
- 5 Feb 2015
- Last updated
- 22 Sep 2016
- Results posted
- No
Publications
Noublanche F, Simon R, Ben-Sadoun G, Annweiler C. Physical Activity and Fall Prevention in Geriatric Inpatients in an Acute Care Unit (AGIR Study): Protocol for a Usability Study. JMIR Res Protoc. 2022 Jul 11;11(7):e32288. doi: 10.2196/32288.
PubMed 35816381
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activité Physique et prévention de la Chute du Patient âGé hospItalisé en Court séjouR: Etude de faisabilité (AGIR)
- ClinicalTrials.gov ID
- NCT02393014
- Acronym / sponsor ID
- AGIR / 2014-30
- Conditions
- Elderly
- Keywords
- 65 years old or older, hospitalized in, geriatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Apr 2015
- Primary completion
- Jun 2016 (actual)
- First posted
- 19 Mar 2015 (estimated)
- 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.
This study aims to evaluate the feasibility and the impact on physical performance and falls occurence among geriatric inpatients hospitalized in acute care unit.
Detailed description
Having developed many tools to determine fall risk of 65 years and older patients, Angers University Hospital plans to develop a corrective action to prevent the occurrence of falls in this population.
This study aims to assess the feasibility of a physical activity program with 3 difficulty levels (depending on the patient's risk of falling): easy (low fall risk), moderate (average fall risk) and difficult (high fall risk).
The implementation process should be simply and fastly applicable in practice for routine care by paramedics.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low fall risk | Experimental | Procedure: Simple physical exerciseslow fall risk patients |
| Medium fall risk | Experimental | Procedure: Simple physical exercisesmedium fall risk patients |
| High fall risk | Experimental | Procedure: Simple physical exerciseshigh fall risk patients |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Being 65 years old and older
- Being hospitalized in geriatric acute care unit of Angers University Hospital.
- No contraindications to physical activity practice.
- No contraindications to standing station and sitting station.
- Participants having given and signed an informed participation consent. If the participant is unable to answer, we will retain the disagreement expressed by a trusted person.
Key exclusion criteria (5 listed)
- Refusal of participation
- Persons aged under 65.
- Topics including hospitalization at the entrance should not exceed 3 days.
- Participation in concomitant clinical trial.
- Civil Protection Measures such as trusteeship, guardianship or backup justice underway.
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 |
|---|---|---|
| Simple physical exercises1. The participant must stay out of the bed 3 hours. This pre-required level prevents the occurrence of acute postural mismatch which can occur when elderly patients are bedridden and too long increases the risk of falling. 2. The participant stands standing in static equilibrium to a chair holding the back of it for 2 minutes. Depending on the patient's abilities, the exercise will be done on both feet or one foot. 3. The participant performs a transfer activity of sitting to standing repeated 5 times (FTSS test). According to the patient's abilities, the exercise will be done with physical assistance or not. | Procedure or surgery | High fall risk, Low fall risk, Medium fall risk |
Primary outcome
Number of participants in each category of fall risk having realized 75% and more of the exercises of at least one of the three difficulty levels of the physical activity program
Time frame: up to 15 months
The feasibility of the interventions of each fall risk category is defined as "at least 80% of the participants of a category having completed 75% and more of the exercises".
4 secondary outcomes
Change of number of patients having realized the Five Time Sit and Stand (FTSS) test.
Time frame: up to 15 months
For the patients having achieved FTSS test, the realization time (in seconds).
Time frame: up to 60 seconds
Measure (by the medical team) of the difficulty to set up and carry out the exercises
Time frame: up to 20 days
Time needed by the paramedical team to achieve the exercises
Time frame: up to 20 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
- Derived from this study: PubMed 35816381Noublanche F, Simon R, Ben-Sadoun G, Annweiler C. Physical Activity and Fall Prevention in Geriatric Inpatients in an Acute Care Unit (AGIR Study): Protocol for a Usability Study. JMIR Res Protoc. 2022 Jul 11;11(7):e32288. doi: 10.2196/32288.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simple physical exercises in people with Elderly, run by University Hospital, Angers at 1 site 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants in each category of fall risk having realized 75% and more of the exercises of at least one of the three difficulty levels of the physical activity program (time frame: up to 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02393014, which also lists 1 linked publication.
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 22 Sep 2016.