CHUTE: Personalized Rehabilitation Program for Elderly Patients That Fall

Sponsor
Lille Catholic University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02862379
Collaborator
(none)
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59
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: home-based program
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Evaluation of a Personalized Rehabilitation Program for Elderly Patients That Fall : Impact on the Fear of Falling
Study Start Date :
Sep 1, 2014
Anticipated Primary Completion Date :
Aug 1, 2019
Anticipated Study Completion Date :
Aug 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Number of falls the previous year before inclusion [at baseline]

  2. Life Space Assessment scale [Change from baseline at 6 months and 12 months]

  3. 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

  4. Walking and talking test [Change from baseline at 6 months and 12 months]

  5. 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

  6. 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]

  7. EuroQol five dimensions questionnaire (EQ-5D) [Change from baseline at 6 months and 12 months]

    Questionnaire about quality of life

  8. Incidence of falls during one year [through the study completion, an average of 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Esprad Chute, Ghicl Lomme France 59462

Sponsors and Collaborators

  • Lille Catholic University

Investigators

  • Principal Investigator: Brigitte Romagny, ESPRAD CHUTE, GHICL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lille Catholic University
ClinicalTrials.gov Identifier:
NCT02862379
Other Study ID Numbers:
  • RC-P0034
First Posted:
Aug 11, 2016
Last Update Posted:
Nov 21, 2018
Last Verified:
Nov 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No

Study Results

No Results Posted as of Nov 21, 2018