Strengthening Equilibrium and Educational Support in Preventing Falls in the Thermal Center

NCT ID: NCT03622554

Last Updated: 2021-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 269 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-09
• Study Completion Date: 2019-11-11

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control arm

Curist taking a spa treatment of 3 weeks in the usual conditions for each Center

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

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

Group Type: EXPERIMENTAL

Adapted Physical Activity (APA)

Intervention Type: OTHER

12 APA sessions of 60 minutes

Therapeutic Patient Education (ETP)

Intervention Type: 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

Interventions

Adapted Physical Activity (APA)

12 APA sessions of 60 minutes

Intervention Type: OTHER

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Association Francaise pour la Recherche Thermale

OTHER

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University hospital of Montpellier

Montpellier, , France

Countries

France

Other Identifiers

UF7664

Identifier Type: -

Identifier Source: org_study_id