Prevention of FallsRESPECTNCT03622554
Strengthening Equilibrium and Educational Support in Preventing Falls in the Thermal Center
A study testing Adapted Physical Activity (APA) and Therapeutic Patient Education (ETP) in people with Prevention of Falls, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Preventing falls among people 65 years of age or older is a priority to promote healthy aging and reduce the number of hospitalizations, institutionalizations and years lived with disability. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Prevention of Falls
- What is being tested?
- Adapted Physical Activity (APA) and Therapeutic Patient Education (ETP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 269 participants
- Where
- 1 siteFrance
- Study dates
- 9 Aug 2018to 11 Nov 2019
- 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
- Patient aged 65 and over,
- Presence of at least one chronic pathology justifying treatment and cure
- Subject having a history of fall in the last year (at least one fall)
- Subject having at least one risk factor of falling among the following 3: balance disorder, decreased muscle strength or gait disorder
Who cannot join
- Subject considered by the investigators as not being able to participate in the program (inability to answer questionnaires, to perform tests, for example).
- Patient under the protection of justice, under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Preventing falls among people 65 years of age or older is a priority to promote healthy aging and reduce the number of hospitalizations, institutionalizations and years lived with disability. A preliminary study carried out at the Balaruc-les-Bains Thermal Center showed that one-third of people aged 65 are at significant risk of falling. Thermal establishments could therefore play a role in initiating measures to prevent falls among people aged 65 and over screened at risk.The main objective is to evaluate the impact on the incidence of falls at 12 months (M12) to add to the usual care (control group) a program combining, during the treatment, adapted physical activities (APA) and a Therapeutic patient education (FTE) followed by an educational follow-up for 12 months (intervention group) for people aged 65 and over who were at risk of falling on arrival at the Thermal
- Conditions
- Prevention of Falls
- Being tested
- Adapted Physical Activity (APA), Therapeutic Patient Education (ETP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Physical Activity (APA)Other
12 APA sessions of 60 minutes
Therapeutic Patient Education (ETP)Other
Personalized ETP with 3 group sessions (1h30) and one at the end of the course (1h) and educational follow-up by phone at 3, 6 and 12 months
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | Curist taking a spa treatment of 3 weeks in the usual conditions for each Center |
| Intervention | Experimental | Addition to the usual cure: -12 adapted physical activity (APA) sessions of 60 minutes to improve the balance , muscular strength, endurance and suppleness without creating additional fatigue for the curists
- personalized therapeutic patient education (ETP) with an individual assessment at the beginning of the treatment (1h), 3 group sessions (1h30) and an end-of-cure interview (1h) and an educational follow-up by phone at 3, 6 and 12 months Receives: Other: Adapted Physical Activity (APA); Other: Therapeutic Patient Education (ETP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of falls at 12 months
To evaluate the impact on the incidence of falls at 12 months (M12) to add to the usual care (control group) a program combining, during the treatment, adapted physical activities (APA) and therapeutic patient education ( ETP), followed by an educational follow-up for 12 months (intervention group) for people aged 65 and over who were at risk of falling on arrival at the Thermal Center
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start9 Aug 2018
- Primary completion11 Nov 2019
- Study completion11 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of FallsStudies 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
- None (open label)
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Association Francaise pour la Recherche Thermale
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622554
- Sponsor's protocol ID
- UF7664
- Acronym
- RESPECT
- Status last verified
- Apr 2021
- First submitted
- 6 Aug 2018
- Last updated
- 30 Apr 2021
- 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 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Equilibrium and Educational Support in Preventing Falls in the Thermal Center
- ClinicalTrials.gov ID
- NCT03622554
- Acronym / sponsor ID
- RESPECT / UF7664
- Conditions
- Prevention of Falls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Association Francaise pour la Recherche Thermale
- Study start
- 9 Aug 2018 (actual)
- Primary completion
- 11 Nov 2019 (actual)
- Study completion
- 11 Nov 2019 (actual)
- First posted
- 9 Aug 2018 (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.
Preventing falls among people 65 years of age or older is a priority to promote healthy aging and reduce the number of hospitalizations, institutionalizations and years lived with disability. A preliminary study carried out at the Balaruc-les-Bains Thermal Center showed that one-third of people aged 65 are at significant risk of falling. Thermal establishments could therefore play a role in initiating measures to prevent falls among people aged 65 and over screened at risk.The main objective is to evaluate the impact on the incidence of falls at 12 months (M12) to add to the usual care (control group) a program combining, during the treatment, adapted physical activities (APA) and a Therapeutic patient education (FTE) followed by an educational follow-up for 12 months (intervention group) for people aged 65 and over who were at risk of falling on arrival at the Thermal
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –Curist taking a spa treatment of 3 weeks in the usual conditions for each Center |
| Intervention | Experimental | Other: Adapted Physical Activity (APA), Other: Therapeutic Patient Education (ETP)Addition to the usual cure: -12 adapted physical activity (APA) sessions of 60 minutes to improve the balance , muscular strength, endurance and suppleness without creating additional fatigue for the curists - personalized therapeutic patient education (ETP) with an individual assessment at the beginning of the treatment (1h), 3 group sessions (1h30) and an end-of-cure interview (1h) and an educational follow-up by phone at 3, 6 and 12 months |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patient aged 65 and over,
- Presence of at least one chronic pathology justifying treatment and cure
- Subject having a history of fall in the last year (at least one fall)
- Subject having at least one risk factor of falling among the following 3: balance disorder, decreased muscle strength or gait disorder
Key exclusion criteria (2 listed)
- Subject considered by the investigators as not being able to participate in the program (inability to answer questionnaires, to perform tests, for example).
- Patient under the protection of justice, under guardianship or curatorship
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 |
|---|---|---|
| Adapted Physical Activity (APA)12 APA sessions of 60 minutes | Other | Intervention |
| Therapeutic Patient Education (ETP)Personalized ETP with 3 group sessions (1h30) and one at the end of the course (1h) and educational follow-up by phone at 3, 6 and 12 months | Other | Intervention |
Primary outcome
Incidence of falls at 12 months
Time frame: 12 months
To evaluate the impact on the incidence of falls at 12 months (M12) to add to the usual care (control group) a program combining, during the treatment, adapted physical activities (APA) and therapeutic patient education ( ETP), followed by an educational follow-up for 12 months (intervention group) for people aged 65 and over who were at risk of falling on arrival at the Thermal Center
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 30 Apr 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Physical Activity (APA) and Therapeutic Patient Education (ETP) in people with Prevention of Falls, run by University Hospital, Montpellier 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 4 inclusion and 2 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 30 Apr 2021. 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?
Incidence of falls at 12 months (time frame: 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 30 Apr 2021; AzTrials last refreshed its copy on 6 Nov 2026.