ElderlyCHUTENCT02862379
Personalized Rehabilitation Program for Elderly Patients That Fall
A study testing home-based program in people with Elderly and Falls, run by Lille Catholic University at 1 site in France.
Trial summary
The risk of falling affects more than one third of people over 65 years old and over 50% of persons over 80 years. These falls have important consequences for the autonomy of the elderly patient and also increase the risk of sequelae and death. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Elderly, Falls, Rehabilitation
- What is being tested?
- home-based program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2014to Jan 2021
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persons who have fallen minimum twice the last year
- 60 years old or more
- Mini Mental State Examination (MMSE) equal or superior to 23/30
- Persons who gave consent to participate in the study
- Persons with severe visual or hearing impairment
Who cannot join
- Patients with severe disease that might interfere with walking or with program monitoring
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Personalized Rehabilitation Program for Elderly Patients That Fall : Impact on the Fear of Falling
The risk of falling affects more than one third of people over 65 years old and over 50% of persons over 80 years. These falls have important consequences for the autonomy of the elderly patient and also increase the risk of sequelae and death.
The goal of this study is to evaluate a personalized rehabilitation program for elderly patients that fall for the first time and to measure the impact on the fear of falling of these patients. This intervention is a home-based program combining exercises, home modifications and education on fall risk factors.
- Conditions
- Elderly, Falls, Rehabilitation
- Being tested
- home-based program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home-based programBehavioural
The objective of the rehabilitation program is to reduce the risk of falls after management of the risk factors identified. This intervention is a home-based program combining exercises, home modifications and education on fall risk factors
| Study group | Role | What they receive |
|---|---|---|
| Elderly patients that fall | Experimental | Personalized rehabilitation program for elderly patients that fall for the first time. This intervention is a home-based program combining exercises, home modifications and education on fall risk factors. Receives: Behavioral: home-based program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Falls Efficacy Scale (FES-I)
The FES is a 10-item validated questionnaire that can be self-administered or completed during an interview. The person is asked to indicate on a 10-level rating scale his/her level of confidence in his/her capacity to accomplish a variety of activities of daily life (e.g., going up and down the stairs, taking a bath or shower) without falling. A FES score is calculated by adding up the score of each item.
Measured: Change from baseline at 6 months and 12 months
Secondary outcomes (8)
Number of falls the previous year before inclusion
Measured: at baseline
Life Space Assessment scale
Measured: Change from baseline at 6 months and 12 months
Get up and go test
It uses the time that a person takes to rise from a chair, walk three metres, turn around, walk back to the chair, and sit down. During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require
Measured: Change from baseline at 6 months and 12 months
Walking and talking test
Measured: Change from baseline at 6 months and 12 months
Tinetti test
It is a clinical test for assessing a person's static and dynamic balance abilities
Measured: Change from baseline at 6 months and 12 months
Measure of the time that the patient is able to stay in station bipedal standing feet together followed by a monopodal support
Measured: Change from baseline at 6 months and 12 months
EuroQol five dimensions questionnaire (EQ-5D)
Questionnaire about quality of life
Measured: Change from baseline at 6 months and 12 months
Incidence of falls during one year
Measured: through the study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startOct 2014
- Primary completionJan 2021
- Study completionJan 2021
Why it stopped: Difficulties encountered in recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brigitte Romagny, Principal investigator, ESPRAD CHUTE, GHICL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862379
- Sponsor's protocol ID
- RC-P0034
- Acronym
- CHUTE
- Status last verified
- Jun 2026
- First submitted
- 1 Aug 2016
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Personalized Rehabilitation Program for Elderly Patients That Fall : Impact on the Fear of Falling
- ClinicalTrials.gov ID
- NCT02862379
- Acronym / sponsor ID
- CHUTE / RC-P0034
- Conditions
- Elderly, Falls, Rehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties encountered in recruiting patients
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Jan 2021 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 11 Aug 2016 (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.
The risk of falling affects more than one third of people over 65 years old and over 50% of persons over 80 years. These falls have important consequences for the autonomy of the elderly patient and also increase the risk of sequelae and death.
The goal of this study is to evaluate a personalized rehabilitation program for elderly patients that fall for the first time and to measure the impact on the fear of falling of these patients. This intervention is a home-based program combining exercises, home modifications and education on fall risk factors.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly patients that fall | Experimental | Behavioral: home-based programPersonalized rehabilitation program for elderly patients that fall for the first time. This intervention is a home-based program combining exercises, home modifications and education on fall risk factors. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Persons who have fallen minimum twice the last year
- 60 years old or more
- Mini Mental State Examination (MMSE) equal or superior to 23/30
- Persons who gave consent to participate in the study
- Persons with severe visual or hearing impairment
Key exclusion criteria (1 listed)
- Patients with severe disease that might interfere with walking or with program monitoring
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 |
|---|---|---|
| home-based programThe objective of the rehabilitation program is to reduce the risk of falls after management of the risk factors identified. This intervention is a home-based program combining exercises, home modifications and education on fall risk factors | Behavioural | Elderly patients that fall |
Primary outcome
Falls Efficacy Scale (FES-I)
Time frame: Change from baseline at 6 months and 12 months
The FES is a 10-item validated questionnaire that can be self-administered or completed during an interview. The person is asked to indicate on a 10-level rating scale his/her level of confidence in his/her capacity to accomplish a variety of activities of daily life (e.g., going up and down the stairs, taking a bath or shower) without falling. A FES score is calculated by adding up the score of each item.
8 secondary outcomes
Number of falls the previous year before inclusion
Time frame: at baseline
Life Space Assessment scale
Time frame: Change from baseline at 6 months and 12 months
Get up and go test
Time frame: Change from baseline at 6 months and 12 months
Walking and talking test
Time frame: Change from baseline at 6 months and 12 months
Tinetti test
Time frame: Change from baseline at 6 months and 12 months
Measure of the time that the patient is able to stay in station bipedal standing feet together followed by a monopodal support
Time frame: Change from baseline at 6 months and 12 months
EuroQol five dimensions questionnaire (EQ-5D)
Time frame: Change from baseline at 6 months and 12 months
Incidence of falls during one year
Time frame: through the study completion, an average of 12 months
Results and safety
The study was stopped early (reason given: Difficulties encountered in recruiting patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- 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.
Brigitte Romagny principal investigator
ESPRAD CHUTE, GHICL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home-based program in people with Elderly and Falls, run by Lille Catholic University 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 5 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 11 Jun 2026. 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 was stopped early (reason given: Difficulties encountered in recruiting patients). 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?
Falls Efficacy Scale (FES-I) (time frame: Change from baseline at 6 months and 12 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 11 Jun 2026.