Fear to Fall Reduction in Geriatric Patients Who Suffered Previous Falls

Not Applicable

• Conditions: Geriatric Disorder
• Interventions: Other: Physiotherapy intervention; Behavioral: Cognitive-behavioural Intervention

• Registration Number: NCT02727374
• Lead Sponsor: University of Valencia

Brief 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

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 Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-03-22
• Study First Submitted QC: 2016-04-01
• Study First Posted: 2016-04-04
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-05
• Last Update Posted: 2017-06-07
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EXPERIMENTAL	Cognitive-behavioural Intervention	Physiotherapy intervention, plus cognitive-behavioural intervention
EXPERIMENTAL	Physiotherapy intervention	Physiotherapy intervention, plus cognitive-behavioural intervention
CONTROL	Physiotherapy intervention	Physiotherapy intervention

Primary Outcome Measures

Name	Time	Method
Fear Related Psychological Concerns (Balance)	Prospective change from baseline to end of intervention (8 weeks)	Assessed in terms of the Activities-Specific Balance Confidence (ABC) scale results
Fear Related Psychological Concerns (Falls)	Prospective change from baseline to end of intervention (8 weeks)	Assessed in terms of the Falls Efficacy Scale International (FES-I) results
Fear Related Psychological Concerns (Fear)	Prospective change from baseline to end of intervention (8 weeks)	Assessed in terms of the Visual Analog Scale results (0-10)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Valencia; 🇪🇸 Valencia, Spain