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临床试验/NCT04403438
NCT04403438已完成不适用

Pain, Sleep, Fatigue, Physical Activity Level, Quality of Life and Exercise Habits in Patients With Familial Mediterranean Fever and Behçet: Analysis Before and After Covid19 Pandemic

Istanbul University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
IPAQ-SF

研究概览

简要总结

Behcet' disease (BD) is a chronic inflammatory disease which is characterized by oral and genital ulcers, uveitis and skin lesions. Musculoskeletal involvement such as arthrits, arthralgia, enthesis and sacroiliitis can be seen in course of BD. FMF is an autosomal recessive family disease characterized by abdominal pain, chest pain, joint pain and fever attacks as a result of inflammation of the serous membranes. FMF patients have been shown to experience higher levels of pain, fatigue, depression and anxiety than healthy controls, and this has increased sleep disturbance and reduced quality of life. FMF and BiH have common characteristics such as ethnicity, etiopathogenetic mechanisms, symptoms, and treatment. In December 2019, after the officially detected coronavirus (severe acute respiratory syndrome coranavirus-2 [SARS-CoV-2]) resistant to unknown treatment and rapidly spreading coronavirus in our country on March 11, 2020 in Hubei province of China, the number of cases increased rapidly and virus was isolated in 670 patients within 10 days. Ongoing concerns about the spread of Covid-19 infections have caused many measures to be taken. Among them, social isolation, home quarantine and avoiding collective places are the most important. In our country, in the process of social isolation, the areas of movement of Behçet and FMF patients, like everyone else, were restricted, their stress and anxiety levels increased and their motivation decreased. The aim of our study is to compare the pain, sleep, fatigue, physical activity level and quality of life and question exercise habits before and after the covid-19 outbreak in patients with Behçet and FMF.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being between the ages of 18-65
  • Being diagnosed with FMF at least 1 year ago according to diagnostic criteria
  • A diagnosis of BiH at least 1 year ago according to the International Behçet Working Group
  • Having signed the informed consent form
  • Having a cooperative level that will respond to evaluation scales

排除标准

  • Pregnant women
  • Having other chronic diseases
  • Psychiatric disorders and treated
  • Those with cognitive impairment

结局指标

主要结局

IPAQ-SF

时间窗: one assesment baseline

The Turkish validity and reliability study of this short questionnaire consisting of seven questions, which evaluates in detail the amount of walking performed in the last week and the amount of moderate and difficult physical activity performed in work, transportation, housework, gardening and leisure activities.

Numeric Rating Scale

时间窗: one assesment baseline

It has horizontal and vertical forms. In this scale, the starting point is the point where there is no pain, and the ending point is the end point where the pain is worst

次要结局

  • Short-Form 36 Health Survey (SF-36)(one assesment baseline)
  • Exercise Stage of Change Questionnaire(one assesment baseline)
  • Exercise Self-Efficacy Questionnaire(one assesment baseline)
  • Decisional Balance Questionnaire(one assesment baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nejla Uzun

MSc, Pt

Istanbul University

研究点 (1)

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