Clinical trial NCT04403438: Familial Mediterranean Fever and Behçet: Analysis Before and After Covid19 Pandemic
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Behcet Disease
COVID
FMF
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In patients with Behçet and FMF between the ages of 18-65, exercise habits will be questioned by comparing pain, sleep, fatigue, physical activity level and quality of life before and after the covid-19 outbreak.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: IPAQ-SF
timeFrame: one assesment baseline
measure: Numeric Rating Scale
timeFrame: one assesment baseline
Secondary outcomes:
measure: Short-Form 36 Health Survey (SF-36)
timeFrame: one assesment baseline
measure: Exercise Stage of Change Questionnaire
timeFrame: one assesment baseline
measure: Exercise Self-Efficacy Questionnaire
timeFrame: one assesment baseline
measure: Decisional Balance Questionnaire
timeFrame: one assesment baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: IstanbulU
state: Bakırköy
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: nejla uzun, MSc, Pt
role: PRINCIPAL_INVESTIGATOR
References: