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

NCT03622554 | Completed

• 1 other identifier: UF7664
• Study Type: interventional
• Target: 269
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Other: Adapted Physical Activity (APA); Other: Therapeutic Patient Education (ETP)

Interventions

Adapted Physical Activity (APA) OTHER

12 APA sessions of 60 minutes

Intervention

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

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Association Francaise pour la Recherche Thermale: collaborator

Study Sites (1)

University hospital of Montpellier

Montpellier, 34295, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 9, 2018
• Study Start: August 9, 2018
• Primary Completion: November 11, 2019
• Study Completion: November 11, 2019
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)