- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05398536
Kinesiophobia in Familial Mediterranean Fever
May 26, 2022 updated by: Seda Saka, Halic University
Kinesiophobia and Related Factors in Adult Patients With Familial Mediterranean Fever
Kinesiophobia is a common problem in patients with rheumatic disease and can cause physical inactivity, social isolation, disability, and poor quality of life.
This study aimed to evaluate kinesiophobia and associated factors in patients with familial Mediterranean fever (FMF).
All patients were evaluated in terms of sociodemographic characteristics and assessed using the Tampa Kinesiophobia Scale (TKS), International Physical Activity Questionnaire (IPAQ), Fatigue Severity Scale (FSS), and Hospital Anxiety and Depression Scale (HADS).
Study Overview
Status
Completed
Conditions
Detailed Description
Familial Mediterranean fever (FMF) is a common autoinflammatory disease among certain ethnic groups living in the Mediterranean basin.
The reported prevalence of FMF among children in Turkey is 9.3/10000.
Kinesiophobia is a common problem in patients with rheumatic disease and can cause physical inactivity, social isolation, disability, and poor quality of life.
This study aimed to evaluate kinesiophobia and associated factors in patients with familial Mediterranean fever (FMF).
All patients were evaluated in terms of sociodemographic characteristics and assessed using the Tampa Kinesiophobia Scale (TKS), International Physical Activity Questionnaire (IPAQ), Fatigue Severity Scale (FSS), and Hospital Anxiety and Depression Scale (HADS).
Study Type
Observational
Enrollment (Actual)
38
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey
- Haliç University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The authors contacted the president of the national Behçet's Disease and Familial Mediterranean Fever Patients Association.
The president invited members to participate in the study by e-mail.
Description
Inclusion Criteria:
- being age over 18
- being volunteer
Exclusion Criteria:
- ortopedic, neurologic, cardiopulmonary diseases that prevent physical activity
- psychological diagnosis and drug usage
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tampa Kinesiophobia Scale (TKS)
Time Frame: at the enrollment
|
The TKS consists of 17 items scored on a 4-point Likert scale and measures fear of movement/(re)injury.
The questions include the parameters of injury/reinjury and fear-avoidance in work-related activities [15].
The total score is obtained by summing all items, and a higher score indicates greater fear of movement.
A total score greater than 37 is regarded as indicating a high level of kinesiophobia
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at the enrollment
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Hospital Anxiety and Depression Scale (HADS)
Time Frame: at the enrollment
|
The scale consists of 14 items divided into the depression and anxiety subscales, each with 7 items.
The items on the scale are scored from 0 to 3 using a 4-point Likert scale.
The scores of the odd-numbered items are summed to obtain the anxiety subscale (HADS-A) score and the even-numbered items are summed to obtain the depression subscale (HADS-D) score.
Possible scores for each subscale range from 0 to 21.
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at the enrollment
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International Physical Activity Questionnaire (IPAQ)
Time Frame: at the enrollment
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In the IPAQ, respondents estimate how often and for how long they engaged in various activities in the last 7 days.
To determine PA levels, the known metabolic equivalent (MET) for each activity is multiplied by its duration and frequency to obtain a score in MET minutes.
MET values used in this study were 8.0 for vigorous physical activity (VPA) [8, 19], 4.0 for moderate physical activity (MPA), and 3.3 for light physical activity (LPA).
The overall PA score is calculated by summing the results of all items [20].
PA levels were classified into 3 categories: inactive (<600 MET-min/week), low PA level (600-3000 MET-min/week), and adequate PA level (>3000 MET-min/week)
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at the enrollment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Seda Saka, PT, PhD, Haliç University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Oskay D, Tuna Z, Duzgun I, Elbasan B, Yakut Y, Tufan A. Relationship between kinesiophobia and pain, quality of life, functional status, disease activity, mobility, and depression in patients with ankylosing spondylitis. Turk J Med Sci. 2017 Nov 13;47(5):1340-1347. doi: 10.3906/sag-1702-93.
- Giese A, Ornek A, Kilic L, Kurucay M, Sendur SN, Lainka E, Henning BF. Anxiety and depression in adult patients with familial Mediterranean fever: a study comparing patients living in Germany and Turkey. Int J Rheum Dis. 2017 Dec;20(12):2093-2100. doi: 10.1111/1756-185X.12297. Epub 2014 Jan 28.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 8, 2018
Primary Completion (ACTUAL)
March 27, 2018
Study Completion (ACTUAL)
December 20, 2018
Study Registration Dates
First Submitted
May 26, 2022
First Submitted That Met QC Criteria
May 26, 2022
First Posted (ACTUAL)
June 1, 2022
Study Record Updates
Last Update Posted (ACTUAL)
June 1, 2022
Last Update Submitted That Met QC Criteria
May 26, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ssaka6
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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