Falling Risks in Elderly Adults : a Prospective Cohort Study

May 22, 2018 updated by: Victoria Di Giorgio, Hospital Donación Francisco Santojanni

Falling Risks in Elderly Adults: a Prospective Cohort Study

Introduction: the prevalence of falls in adults aged 65 years or older living in the community is 30%, being the second cause of accidental fatal injury and the fifth cause of death. About 20 to 30% of falls result in injuries: 10% constitute serious injuries, from which 5% are fractures. As a result, older adults decrease their mobility, are afraid of falling depressed and socially isolated, increasing the risk of later falls, death and health costs. Falls and their consequences can be prevented, so knowing and assessing the demographic, medical, self-perceived and functional characteristics constitutes an important information for health professionals. Given the high rate (29.59%) of older adults treated at the Physical Therapy outpatient consult of the "Hospital Francisco Santojanni" and the relevance of falls in this population, it is convenient to take a behavior and start by knowing their risk characteristics.

Objectives: to determine the incidence of falls of adults aged 65 years and older, seen in the Physical Therapy outpatient consult of the "Hospital Francisco Santojanni"; to describe the characteristics of these population and to identify the potential risk-of-falling factors.

Subjects and Methods: observational, prospective, longitudinal cohort study. Demographic (age and sex), medical (history of falls, visual alterations, medication and walking aids), self-perceived (fear of falling and instability perception) and functional characteristics (Test of Timed up and Go, Dynamic Index of gait and balance tests) will be evaluated in those patients of 65 years or more who initiate physical treatment in the outpatient consult of the of the "Hospital Francisco Santojanni" "Autonomous City of Buenos Aires, from March 2017 to February 2018, with a follow-up of 6 months until August 2018, to verify the development of the fall event

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Buenos Aires
      • Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, C1408INH
        • Hospital Donación Francisco Santojanni

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

outpatient elderly patients of 65 years or more living in the community

Description

Inclusion Criteria:

  • Patients of 65 years or more treated at the Physical Therapy outpatient consult of the " Hospital Francisco Santojanni" that they walk at least inside their home and have signed informed consent

Exclusion Criteria:

  • patients who walk with partial body weight load
  • patients using a lower limb immobilization device

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fall
Time Frame: From May 2017 to August 2018
an event that results in a change of body position that forces a person to make contact with the ground or other support surface at a lower level, unintentionally and unexpectedly, without being the consequence of an important intrinsic event (such as loss of consciousness, sudden onset of paralysis or epileptic seizure), or unavoidable external danger (such as the collapse of a chair or violent blow). The outcome variable will be measured by a phone call.
From May 2017 to August 2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2017

Primary Completion (Actual)

May 19, 2018

Study Completion (Anticipated)

August 15, 2018

Study Registration Dates

First Submitted

November 10, 2017

First Submitted That Met QC Criteria

November 28, 2017

First Posted (Actual)

December 4, 2017

Study Record Updates

Last Update Posted (Actual)

May 23, 2018

Last Update Submitted That Met QC Criteria

May 22, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • HGADFS11052017-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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