NCT05398536

Brief 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 8, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2018

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

May 26, 2022

Last Update Submit

August 13, 2025

Conditions

Keywords

Kinesiophobiafear-avoidancephysical activityfamilial Mediterranean fever

Outcome Measures

Primary Outcomes (3)

  • 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

    at the enrollment

  • 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.

    at the enrollment

  • 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)

    at the enrollment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • being age over 18
  • being volunteer

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haliç University

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

KinesiophobiaMotor ActivityFamilial Mediterranean Fever

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental DisordersBehaviorHereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Seda Saka, PT, PhD

    Haliç University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT PhD

Study Record Dates

First Submitted

May 26, 2022

First Posted

June 1, 2022

Study Start

January 8, 2018

Primary Completion

March 27, 2018

Study Completion

December 20, 2018

Last Updated

August 15, 2025

Record last verified: 2025-08

Locations