Strengthening Equilibrium and Educational Support in Preventing Falls in the Thermal Center (RESPECT)

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 Overview

• Status: Completed
• Conditions: Prevention of Falls
• Intervention / Treatment: Other: Adapted Physical Activity (APA); Other: Therapeutic Patient Education (ETP)

• Study Type: Interventional
• Enrollment (Actual): 269
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • University Hospital of Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control arm; Curist taking a spa treatment of 3 weeks in the usual conditions for each Center
Experimental: 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	Other: Adapted Physical Activity (APA); 12 APA sessions of 60 minutes; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Association Francaise pour la Recherche Thermale

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2018
• Primary Completion (Actual): November 11, 2019
• Study Completion (Actual): November 11, 2019

Study Registration Dates

• First Submitted: August 6, 2018
• First Submitted That Met QC Criteria: August 6, 2018
• First Posted (Actual): August 9, 2018

Study Record Updates

• Last Update Posted (Actual): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: UF7664

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No