Prevention of Falls Clinical Trial
— RESPECTOfficial title:
Strengthening Equilibrium and Educational Support in Preventing Falls in the Thermal Center
| NCT number | NCT03622554 |
| Other study ID # | UF7664 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | August 9, 2018 |
| Est. completion date | November 11, 2019 |
| Verified date | April 2021 |
| Source | University Hospital, Montpellier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 269 |
| Est. completion date | November 11, 2019 |
| Est. primary completion date | November 11, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 65 Years and older |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | University hospital of Montpellier | Montpellier |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier | Association Francaise pour la Recherche Thermale |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 12 months |