Personalized Rehabilitation Program for Elderly Patients That Fall (CHUTE)

Evaluation of a Personalized Rehabilitation Program for Elderly Patients That Fall : Impact on the Fear of Falling

The risk of falling affects more than one third of people over 65 years old and over 50% of persons over 80 years. These falls have important consequences for the autonomy of the elderly patient and also increase the risk of sequelae and death.

The goal of this study is to evaluate a personalized rehabilitation program for elderly patients that fall for the first time and to measure the impact on the fear of falling of these patients. This intervention is a home-based program combining exercises, home modifications and education on fall risk factors.

Study Overview

• Status: Completed
• Conditions: Rehabilitation; Elderly; Falls
• Intervention / Treatment: Behavioral: home-based program

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lomme, France, 59462
    • Esprad Chute, Ghicl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Persons who have fallen minimum twice the last year
• 60 years old or more
• Mini Mental State Examination (MMSE) equal or superior to 23/30
• Persons who gave consent to participate in the study
• Persons with severe visual or hearing impairment

Exclusion Criteria:

• Patients with severe disease that might interfere with walking or with program monitoring

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elderly patients that fall; Personalized rehabilitation program for elderly patients that fall for the first time. This intervention is a home-based program combining exercises, home modifications and education on fall risk factors.	Behavioral: home-based program; The objective of the rehabilitation program is to reduce the risk of falls after management of the risk factors identified. This intervention is a home-based program combining exercises, home modifications and education on fall risk factors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Falls Efficacy Scale (FES-I)	The FES is a 10-item validated questionnaire that can be self-administered or completed during an interview. The person is asked to indicate on a 10-level rating scale his/her level of confidence in his/her capacity to accomplish a variety of activities of daily life (e.g., going up and down the stairs, taking a bath or shower) without falling. A FES score is calculated by adding up the score of each item.	Change from baseline at 6 months and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of falls the previous year before inclusion		at baseline
Life Space Assessment scale		Change from baseline at 6 months and 12 months
Get up and go test	It uses the time that a person takes to rise from a chair, walk three metres, turn around, walk back to the chair, and sit down. During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require	Change from baseline at 6 months and 12 months
Walking and talking test		Change from baseline at 6 months and 12 months
Tinetti test	It is a clinical test for assessing a person's static and dynamic balance abilities	Change from baseline at 6 months and 12 months
Measure of the time that the patient is able to stay in station bipedal standing feet together followed by a monopodal support		Change from baseline at 6 months and 12 months
EuroQol five dimensions questionnaire (EQ-5D)	Questionnaire about quality of life	Change from baseline at 6 months and 12 months
Incidence of falls during one year		through the study completion, an average of 12 months

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Investigators: Principal Investigator: Brigitte Romagny, Esprad Chute, Ghicl

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: August 1, 2016
• First Submitted That Met QC Criteria: August 8, 2016
• First Posted (Estimated): August 11, 2016

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: RC-P0034

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
• product manufactured in and exported from the U.S.: No