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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02727374
Other study ID # CI_UValencia1
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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