Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04139109
Other study ID # 287826
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 22, 2018
Est. completion date July 22, 2018

Study information

Verified date October 2019
Source Istanbul University-Cerrahpasa
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Survey of Activities and Fear of Falling in the Elderly (SAFE) was originally developed in English to determine the level of fear of falling and its interactions with activities of daily living. The purpose of this study was to translate and cross-culturally adapt the SAFE instrument into Turkish and investigate its psychometric properties.


Description:

The Survey of Activities and Fear of Falling in the Elderly (SAFE) was originally developed in English to determine the level of fear of falling and its interactions with activities of daily living. The purpose of this study was to translate and cross-culturally adapt the SAFE instrument into Turkish and investigate its psychometric properties. One hundred eleven older adults (72 females) with a mean age of 69 years (SD=7.22; range=60-87) were included. For cross-cultural adaptation, two bi-lingual translators used the back-translation procedure. Within a 5-to-7-day period after the first assessment, the participants completed the Turkish version of SAFE (SAFE-T) to evaluate test-retest reliability. Cronbach's alpha (α) was used to assess internal consistency. The correlation with the Turkish version of the Falls Efficiency Scale-International (FES-T) was determined to check the validity.


Recruitment information / eligibility

Status Completed
Enrollment 111
Est. completion date July 22, 2018
Est. primary completion date April 22, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria:

1. age over 60 years old

2. ability to read and write in Turkish

3. score =24 on the Mini-Mental State Exam

4. >3 according to the Functional Ambulation Category (FAC)

5. no pathology in visual ability and hearing

Exclusion Criteria:

1. neurologist-diagnosed dementia or Alzheimer's disease

2. ambulatory only with a wheelchair

3. amputated lower extremity

Study Design


Locations

Country Name City State
Turkey Istanbul University-Cerrahpasa Istanbul Bakirkoy

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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 — View Citation

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 J — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The Survey of Activities and Fear of Falling in the Elderly The Survey of Activities and Fear of Falling in the Elderly (SAFE), is a reliable (a = 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)
Secondary The Survey of Activities and Fear of Falling in the Elderly The Survey of Activities and Fear of Falling in the Elderly (SAFE), is a reliable (a = 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)
Secondary Falls Efficiency Scale-International 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 (a = 0.94) and valid (r = - 0.83) instrument, was used in the present study. Baseline (First assessment)
Secondary History of Fall Frequency of falls in the last six months was questioned. Baseline (First assessment)
Secondary Leg Pain Presence of leg pain at rest and during activity was questioned. Baseline (First assessment)
See also
  Status Clinical Trial Phase
Completed NCT04612842 - Engaging Older Adults in Fall Prevention Using Motivational Interviewing (MI) N/A
Enrolling by invitation NCT03297632 - Improving Muscle Strength, Mass and Physical Function in Older Adults N/A
Completed NCT06063187 - Technology-based Fall Risk Assessments for Older Adults in Low-income Settings
Withdrawn NCT04470895 - Impact of Drugs on the Risk of Falls in the Fracture Department of the Paris Saint-Joseph Hospital Group
Recruiting NCT05940779 - Relationship Between the Risk of Falls and Frailty, and the Effect of a Physical Exercise Program on These Conditions in the Elderly: a Randomized Crossover Clinical Trial. N/A
Not yet recruiting NCT05991037 - Relation Between Psychoactive Drugs Overdosage and Severity of Falls in Elderly People N/A
Not yet recruiting NCT05940636 - A Novel Combined Neuromodulation Therapy to Enhance Balance and Neuroplasticity N/A
Completed NCT03566719 - Effect of an Exercise Program on Risk of Fall in a Community Dwelling Older Adults N/A
Not yet recruiting NCT05702801 - Vibratory Stimulation to Improve Balance Recovery N/A
Not yet recruiting NCT04439097 - Effects of Multicomponent Physical Exercise Program and Mediterranean Diet in Alzheimer's Disease N/A
Recruiting NCT04108741 - Augmented Reality Treadmill Training in Patients With Parkinson's Disease N/A
Completed NCT04760392 - Goal-directed Mobilization of Medical Inpatients N/A
Not yet recruiting NCT03680014 - Remote Monitoring and Analysis of Gait and Falls Within an Elderly Population
Recruiting NCT04851405 - Implementing an Evidence-based Exercise Program to Reduce Falls in Community-dwelling Older Adults (Otago) N/A
Completed NCT05090774 - Integrating Fall Prevention Balance Exercises Into a Program for Older Adults With Peripheral Artery Disease (PAD): A Mixed Methods Feasibility Study N/A
Completed NCT04334746 - The Discriminative Ability of the Four Balance Measures for Fall History
Completed NCT03341728 - The Sensorimotor Locus of Balance Control in Elderly Gait N/A
Completed NCT05290571 - Modified Otago Exercise Program on Balance Performance N/A
Completed NCT04622657 - Validity Reliability of The Dubousset Functional Test in Parkinson Disease N/A
Completed NCT05863143 - Intervention on Reducing Risk of Falls Among Community Dwelling Older Adults in Selangor N/A