Fear to Fall Reduction in Geriatric Patients Who Suffered Previous Falls (FFALL_GER)

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

Study Overview

• Status: Unknown
• Conditions: Geriatric Disorder
• Intervention / Treatment: Other: Physiotherapy intervention; Behavioral: Cognitive-behavioural Intervention

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46010
    • University of Valencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EXPERIMENTAL; Physiotherapy intervention, plus cognitive-behavioural 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
Active Comparator: CONTROL; Physiotherapy 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk of Falling	Assessed in terms of the Timed up & Go test	Prospective change from baseline to end of intervention (8 weeks)
Center Epidemiological Studies Depression Scale	This is a measurement scale of depression	Prospective change from baseline to end of intervention (8 weeks)
Ryff Scale	It is a scale for measuring psychological well-being	Prospective change from baseline to end of intervention (8 weeks)

Collaborators and Investigators

• Sponsor: University of Valencia
• Investigators: Principal Investigator: Celedonia Igual, Professor, University of Valencia; Study Director: Jose M Blasco, PhD, University of Valencia

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: March 22, 2016
• First Submitted That Met QC Criteria: April 1, 2016
• First Posted (Estimate): April 4, 2016

Study Record Updates

• Last Update Posted (Actual): June 7, 2017
• Last Update Submitted That Met QC Criteria: June 5, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Rehabilitation; Geriatric; Psychology; Fear to Fall
• Other Study ID Numbers: CI_UValencia1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES