NCT02727374

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 4, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

June 7, 2017

Status Verified

June 1, 2017

Enrollment Period

3 years

First QC Date

March 22, 2016

Last Update Submit

June 5, 2017

Conditions

Geriatric Disorder

Keywords

Fear to FallGeriatricRehabilitationPsychology

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Risk of Falling

    Prospective change from baseline to end of intervention (8 weeks)

  • Center Epidemiological Studies Depression Scale

    Prospective change from baseline to end of intervention (8 weeks)

  • Ryff Scale

    Prospective change from baseline to end of intervention (8 weeks)

Study Arms (2)

EXPERIMENTAL

EXPERIMENTAL

Physiotherapy intervention, plus cognitive-behavioural intervention

Other: Physiotherapy interventionBehavioral: Cognitive-behavioural Intervention

CONTROL

ACTIVE COMPARATOR

Physiotherapy intervention

Other: Physiotherapy intervention

Interventions

Physiotherapy interventionOTHER

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

CONTROLEXPERIMENTAL
Cognitive-behavioural InterventionBEHAVIORAL

Psychological treatment consists of group talks to treat the fear to fall

EXPERIMENTAL

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Community-dwelling older people
  • Looking for Physiotherapy attendance
  • Patients who have suffered at least one fall episode
  • Patients with fear of falling

You may not qualify if:

  • Some cognitive affection that may affect the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Valencia

Valencia, 46010, Spain

Location

Study Officials

  • Celedonia Igual, Professor

    University of Valencia

    PRINCIPAL INVESTIGATOR

  • Jose M Blasco, PhD

    University of Valencia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 22, 2016

First Posted

April 4, 2016

Study Start

December 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

June 7, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will share

Locations

ES(1)