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

NCT04403438 | Completed

• 1 other identifier: 10840098-604.01.01-E.14697
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Behcet Disease; COVID; FMF

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (1)

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.

Interventions

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. 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.

patients with behçet's or fmf

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

IstanbulU

Istanbul, Bakırköy, 34740, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Behcet Syndrome

Interventions

Sleep; Quality of Life; Pyrin

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health; Cytoskeletal Proteins; Proteins; Amino Acids, Peptides, and Proteins; Tripartite Motif Proteins

Study Officials

• nejla uzun, MSc, Pt

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc, Pt

Study Record Dates

• First Submitted: May 23, 2020
• First Posted: May 27, 2020
• Study Start: April 1, 2020
• Primary Completion: May 1, 2020
• Study Completion: March 15, 2021
• Last Updated: February 4, 2025

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)