Kinesiophobia in Familial Mediterranean Fever

Sponsor
Halic University (Other)
Overall Status
Completed
CT.gov ID
NCT05398536
Collaborator
(none)
38
1
11.4
3.3

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    38 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Kinesiophobia and Related Factors in Adult Patients With Familial Mediterranean Fever
    Actual Study Start Date :
    Jan 8, 2018
    Actual Primary Completion Date :
    Mar 27, 2018
    Actual Study Completion Date :
    Dec 20, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Tampa Kinesiophobia Scale (TKS) [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) [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) [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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • being age over 18

    • being volunteer

    Exclusion Criteria:
    • ortopedic, neurologic, cardiopulmonary diseases that prevent physical activity

    • psychological diagnosis and drug usage

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 HaliƧ University Istanbul Turkey

    Sponsors and Collaborators

    • Halic University

    Investigators

    • Principal Investigator: Seda Saka, PT, PhD, HaliƧ University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seda Saka, PT PhD, Halic University
    ClinicalTrials.gov Identifier:
    NCT05398536
    Other Study ID Numbers:
    • ssaka6
    First Posted:
    Jun 1, 2022
    Last Update Posted:
    Jun 1, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Seda Saka, PT PhD, Halic University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 1, 2022