- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04139109
The Turkish Version of the Survey of Activities and Fear of Falling in the Elderly
The Reliability and Validity of the Turkish Version of the Survey of Activities and Fear of Falling in the Elderly
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bakırkoy
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Istanbul, Bakırkoy, Turkey, 34147
- Istanbul University-Cerrahpasa
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- age over 60 years old
- ability to read and write in Turkish
- score ≥24 on the Mini-Mental State Exam
- >3 according to the Functional Ambulation Category (FAC)
- no pathology in visual ability and hearing
Exclusion Criteria:
- neurologist-diagnosed dementia or Alzheimer's disease
- ambulatory only with a wheelchair
- amputated lower extremity
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Survey of Activities and Fear of Falling in the Elderly
Time Frame: Baseline (First assessment)
|
The Survey of Activities and Fear of Falling in the Elderly (SAFE), is a reliable (α = 0.95) and valid (r = 0.91) questionnaire for evaluating activity level, fear of falling, and activity restriction. SAFE assesses 11 community-based and home-based activities. SAFE is scored as the following: Activity level is scored as the number of activities being done. Maximum score is 11 and higher scores indicate a higher activity level. The fear of falling score is computed as the average worry scores across the 11 activities (or across as many of the activities that are done, i.e., if yes to A). Each activity is scored in the range 0 to 3 by recoding the answer. The recoding is described as 0=4 (Not at all worried), 1=3 (A little worried), 2=1 (Somewhat worried) and 3=1 (Very worried). In totally, higher scores indicate a greater fear of falling. Activity restriction is scored by counting the number of activities which is responded "less than you used to". |
Baseline (First assessment)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Survey of Activities and Fear of Falling in the Elderly
Time Frame: Within a 5-to-7-day period after the first assessment (Second assessment)
|
The Survey of Activities and Fear of Falling in the Elderly (SAFE), is a reliable (α = 0.95) and valid (r = 0.91) questionnaire for evaluating activity level, fear of falling, and activity restriction. SAFE assesses 11 community-based and home-based activities. SAFE is scored as the following: Activity level is scored as the number of activities being done. Maximum score is 11 and higher scores indicate a higher activity level. The fear of falling score is computed as the average worry scores across the 11 activities (or across as many of the activities that are done, i.e., if yes to A). Each activity is scored in the range 0 to 3 by recoding the answer. The recoding is described as 0=4 (Not at all worried), 1=3 (A little worried), 2=1 (Somewhat worried) and 3=1 (Very worried). In totally, higher scores indicate a greater fear of falling. Activity restriction is scored by counting the number of activities which is responded "less than you used to". |
Within a 5-to-7-day period after the first assessment (Second assessment)
|
Falls Efficiency Scale-International
Time Frame: Baseline (First assessment)
|
Falls Efficiency Scale-International (FES-I) is a 16-item self-administered questionnaire that was designed to assess fear of falling in community-dwelling older people.
It provides information on the level of concern about falls during daily living activities.
Each item is rated on a four-point scale, where 1=not at all concerned, 2=somewhat concerned, 3=fairly concerned, and 4=very concerned.
The total score ranges from 16 (no concern about falling) to 64 (extreme concern about falling).
The Turkish version of FES-I (FES-T), which was previously reported as a reliable (α = 0.94) and valid (r = - 0.83) instrument, was used in the present study.
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Baseline (First assessment)
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History of Fall
Time Frame: Baseline (First assessment)
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Frequency of falls in the last six months was questioned.
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Baseline (First assessment)
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Leg Pain
Time Frame: Baseline (First assessment)
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Presence of leg pain at rest and during activity was questioned.
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Baseline (First assessment)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Burcu Ersoz Huseyinsinoglu, PhD, Istanbul University-Cerrahpasa
Publications and helpful links
General Publications
- Lachman ME, Howland J, Tennstedt S, Jette A, Assmann S, Peterson EW. Fear of falling and activity restriction: the survey of activities and fear of falling in the elderly (SAFE). J Gerontol B Psychol Sci Soc Sci. 1998 Jan;53(1):P43-50. doi: 10.1093/geronb/53b.1.p43.
- Allison LK, Painter JA, Emory A, Whitehurst P, Raby A. Participation restriction, not fear of falling, predicts actual balance and mobility abilities in rural community-dwelling older adults. J Geriatr Phys Ther. 2013 Jan-Mar;36(1):13-23. doi: 10.1519/JPT.0b013e3182493d20.
- Yardley L, Smith H. A prospective study of the relationship between feared consequences of falling and avoidance of activity in community-living older people. Gerontologist. 2002 Feb;42(1):17-23. doi: 10.1093/geront/42.1.17.
- Gazibara T, Kurtagic I, Kisic-Tepavcevic D, Nurkovic S, Kovacevic N, Gazibara T, Pekmezovic T. Falls, risk factors and fear of falling among persons older than 65 years of age. Psychogeriatrics. 2017 Jul;17(4):215-223. doi: 10.1111/psyg.12217. Epub 2017 Jan 27.
- Ersoz Huseyinsinoglu B, Tufekcioglu Z, Birinci T, Demirdag F. The Reliability and Validity of the Turkish Version of the Survey of Activities and Fear of Falling in the Elderly. J Geriatr Phys Ther. 2021 Apr-Jun 01;44(2):E132-E137. doi: 10.1519/JPT.0000000000000260.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 287826
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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