Fear to Fall Reduction in Geriatric Patients Who Suffered Previous Falls

Geriatric Disorder Clinical Trial

— FFALL_GER  

Official title:

Fear to Fall Reduction in Geriatric Patients Who Suffered Previous Falls

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02727374
• Other study ID #: CI_UValencia1
• Status: Enrolling by invitation
• Phase: N/A
• First received: March 22, 2016
• Last updated: June 5, 2017
• Start date: December 2015
• Est. completion date: December 2018

Study information

• Verified date: June 2017
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Fear to fall has been proven to be a risk factor affecting those geriatric patients who have previously suffered a fall. In this work it is assessed the effectiveness of a physiotherapy and psychological combined intervention, aimed at reducing the fear to fall in the aforementioned patients

Description:

One of the main consequences of falling is the fear to fall again. This involves changes in the elderly behaviour which leads to a reduction of the physical activity, higher need of cares, reduction of the quality of life and risk of social isolation. In this framework, this works is aimed at performing a treatment to reduce the fear to fall in those geriatrics patients with previous falls, based on the combination of physical activity, health education and cognitive-behavioural psychological treatment targeted to this effect. The reason is that literature points at combined treatment use to present higher effectiveness

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 52
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Community-dwelling older people

• Looking for Physiotherapy attendance

• Patients who have suffered at least one fall episode

• Patients with fear of falling

Exclusion Criteria:

• Some cognitive affection that may affect the intervention

Related Conditions & MeSH terms

• Geriatric Disorder

Intervention

Other:
• Physiotherapy intervention
Physiotherapy intervention consists of conventional exercise program administered to this kind of patients at Hospital Clinico, including strengthening and balance exercises

Behavioral:
• Cognitive-behavioural Intervention
Psychological treatment consists of group talks to treat the fear to fall

Locations

Country	Name	City	State
Spain	University of Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fear Related Psychological Concerns (Falls)	Assessed in terms of the Falls Efficacy Scale International (FES-I) results	Prospective change from baseline to end of intervention (8 weeks)
Primary	Fear Related Psychological Concerns (Balance)	Assessed in terms of the Activities-Specific Balance Confidence (ABC) scale results	Prospective change from baseline to end of intervention (8 weeks)
Primary	Fear Related Psychological Concerns (Fear)	Assessed in terms of the Visual Analog Scale results (0-10)	Prospective change from baseline to end of intervention (8 weeks)
Secondary	Risk of Falling	Assessed in terms of the Timed up & Go test	Prospective change from baseline to end of intervention (8 weeks)
Secondary	Center Epidemiological Studies Depression Scale	This is a measurement scale of depression	Prospective change from baseline to end of intervention (8 weeks)
Secondary	Ryff Scale	It is a scale for measuring psychological well-being	Prospective change from baseline to end of intervention (8 weeks)