Familial Mediterranean Fever and Behçet: Analysis Before and After Covid19 Pandemic

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

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.

Study Overview

• Status: Completed
• Conditions: COVID; FMF; Behcet Disease
• Intervention / Treatment: Other: ıt will be compared pain, sleep, fatigue, physical activity level and quality of life and questioning exercise habits before and after the covid-19 outbreak in patients with Behçet and FMF.

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• Turkey
  • Bakırköy
    • Istanbul, Bakırköy, Turkey, 34740
      • IstanbulU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with behçet's or fmf	Other: ıt will be compared pain, sleep, fatigue, physical activity level and quality of life and questioning exercise habits before and after the covid-19 outbreak in patients with Behçet and FMF.; ıt will be compared pain, sleep, fatigue, physical activity level and quality of life and questioning exercise habits before and after the covid-19 outbreak in patients with Behçet and FMF.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IPAQ-SF	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.	one assesment baseline
Numeric Rating Scale	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	one assesment baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short-Form 36 Health Survey (SF-36)	It is a scale which was found by Ware in 1987 and examined the quality of life of people. Turkish validity was provided in the study of Koçyiğit et al. The scale consisting of 36 questions was divided into its own subtitles and was made to measure the functional status of the person.	one assesment baseline
Exercise Stage of Change Questionnaire	it consists of five questions. The participant is asked to choose only one of these five situations that match the current exercise level.	one assesment baseline
Exercise Self-Efficacy Questionnaire	This six-point five-point Likert-type scale determines the self-confidence of individuals to begin exercise. The lowest 6 and the highest 30 points are obtained from the scale. The high scores obtained from the scale indicate that the individual trusts him / herself and has a high chance of success in change.	one assesment baseline
Decisional Balance Questionnaire	Items 2, 4, 6, 8, 10 on a scale consisting of a total of 10 items are expressions designed to evaluate the perceived harm of not exercising, items 1, 3, 5, 7, and 9 are intended to evaluate the perceived benefits of exercising.	one assesment baseline

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Principal Investigator: nejla uzun, MSc, Pt, Istanbul University - Cerrahpasa

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): March 15, 2021

Study Registration Dates

• First Submitted: May 23, 2020
• First Submitted That Met QC Criteria: May 23, 2020
• First Posted (Actual): May 27, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 2, 2025
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Vascular Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Eye Diseases; Skin Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Vascular; Gram-Negative Bacterial Infections; Skin Diseases, Genetic; Uveal Diseases; Vasculitis; Panuveitis; Uveitis, Anterior; Uveitis; COVID-19; Brucellosis; Familial Mediterranean Fever; Hereditary Autoinflammatory Diseases; Behcet Syndrome
• Other Study ID Numbers: 10840098-604.01.01-E.14697

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No