Kinesiophobia in Familial Mediterranean Fever

FMF Clinical Trial

Official title:

Kinesiophobia and Related Factors in Adult Patients With Familial Mediterranean Fever

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05398536
• Other study ID #: ssaka6
• Status: Completed
• Start date: January 8, 2018
• Est. completion date: December 20, 2018

Study information

• Verified date: May 2022
• Source: Halic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 20, 2018
• Est. primary completion date: March 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• being age over 18
• being volunteer

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Brucellosis
• Familial Mediterranean Fever
• FMF
• Hereditary Autoinflammatory Diseases

Locations

Country	Name	City	State
Turkey	Haliç University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Halic University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Giese A, Örnek 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 — View Citation

Oskay D, Tuna Z, Düzgün 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): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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