CClinicalTrials.gg
CompletedNCT05398536Updated Aug 15, 2025

Kinesiophobia in Familial Mediterranean Fever

An observational study in FMF, sponsored by Halic University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-15.

Sponsored by Halic University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
38
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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).

Read the 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).

02

Conditions studied

  • FMF

Keywords

  • Kinesiophobia
  • fear-avoidance
  • physical activity
  • familial Mediterranean fever
03

In context

Kinesiophobia

243 studies on the registry are indexed under Kinesiophobia; 89 are open to participants now.

This study's enrollment of 38 is below the median of 77 across 98 observational studies indexed under Kinesiophobia.

Browse Kinesiophobia studies →

Lead sponsor

Halic University is the lead sponsor of 80 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • being age over 18
  • being volunteer

Exclusion criteria

Exclusion Criteria:

  • ortopedic, neurologic, cardiopulmonary diseases that prevent physical activity
  • psychological diagnosis and drug usage
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
38 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Tampa Kinesiophobia Scale (TKS)

    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

    Time frame: at the enrollment

  2. Hospital Anxiety and Depression Scale (HADS)

    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.

    Time frame: at the enrollment

  3. International Physical Activity Questionnaire (IPAQ)

    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)

    Time frame: at the enrollment

07

Study locations

1 site
  • Haliç University
    Istanbul, Turkey (Türkiye)
08

References and documents

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. PubMed 29151302 ↗
  • 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. PubMed 24467729 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05398536
Lead sponsor
Halic University
Responsible party
Seda Saka (PT PhD, Halic University) — Principal investigator
First posted
Jun 1, 2022
Start date
Jan 8, 2018
Primary completion
Mar 27, 2018
Completion
Dec 20, 2018
Last update
Aug 15, 2025

Study contacts

Seda Saka, PT, PhD
principal investigator · Haliç University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion