Personalized Rehabilitation Program for Elderly Patients That Fall

Not Applicable

Completed

• Conditions: Elderly; Rehabilitation; Falls
• Interventions: Behavioral: home-based program

• Registration Number: NCT02862379
• Lead Sponsor: Lille Catholic University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2016-08-01
• Study First Submitted QC: 2016-08-08
• Study First Posted: 2016-08-11
• Primary Completion: 2021-01
• Study Completion: 2021-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Elderly patients that fall	home-based program	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.

Primary Outcome Measures

Name	Time	Method
Falls Efficacy Scale (FES-I)	Change from baseline at 6 months and 12 months	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.

Secondary Outcome Measures

Name	Time	Method
Number of falls the previous year before inclusion	at baseline
Life Space Assessment scale	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
Incidence of falls during one year	through the study completion, an average of 12 months
Tinetti test	Change from baseline at 6 months and 12 months	It is a clinical test for assessing a person's static and dynamic balance abilities
Get up and go test	Change from baseline at 6 months and 12 months	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
Walking and talking test	Change from baseline at 6 months and 12 months
EuroQol five dimensions questionnaire (EQ-5D)	Change from baseline at 6 months and 12 months	Questionnaire about quality of life

Trial Locations

Locations (1)

Esprad Chute, Ghicl; 🇫🇷 Lomme, France