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Completed

NCT Number: NCT05398536

Kinesiophobia in 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).

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Haliç University

Istanbul, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • being age over 18
  • being volunteer

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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.

  3. International Physical Activity Questionnaire (IPAQ)

    Time frame: at the enrollment

    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)

Sponsors and collaborators

Lead sponsor

Halic University

Other

Registry information

Official study title

Kinesiophobia and Related Factors in Adult Patients With Familial Mediterranean Fever

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 1, 2022
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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