Falling Risks in Elderly Adults : a Prospective Cohort Study

Fall Clinical Trial

Official title:

Falling Risks in Elderly Adults: a Prospective Cohort Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03361059
• Other study ID #: HGADFS11052017-01
• Status: Enrolling by invitation
• Start date: March 15, 2017
• Est. completion date: August 15, 2018

Study information

• Verified date: May 2018
• Source: Hospital Donación Francisco Santojanni
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 600
• Est. completion date: August 15, 2018
• Est. primary completion date: May 19, 2018
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fall

Locations

Country	Name	City	State
Argentina	Hospital Donación Francisco Santojanni	Ciudad Autonoma de Buenos Aire	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Donación Francisco Santojanni

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fall	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