Clinical trial NCT03837236: Inactivity Behavior and Exercise Bariers in Patients With Behçet Disease
Official title: Inactivity Behavior and Exercise Bariers in Patients With Behçet Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Behçet Disease
Keywords: Behçet disease
Physical activity level
Exercise barriers
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2019-02-12
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Behçet's Disease (BD) is a chronic, inflammatory, rheumatic disease that is characterized by mucocutaneous lesions. Promoting physical activity level is one of the major goals in the management of patients with rheumatic diseases, it is important to determine the factors affecting physical activity level and exercise barriers. The aim of this study is to investigate physical activity level and exercise barriers in patients with BD. Physical activity level, exercise barriers, disease activity, fatigue, depression, pain, sleep disorders, aerobic capacity and quality of life will be assessed using International Physical Activity Questionnaire-Short Form (IPAQ),Exercise Benefits/Barriers Scale, Behçet Disease Current Activity Form (BDCAF), Fatigue Severity Scale (FSS), Beck Depression Inventory (BDI), McGill Pain Questionnaire- Short Form (MPQ-SF), Pittsburgh Sleep Quality Index, 6 minute walk test and Behçet's Disease Quality of Life Questionnaire, respectively.

Detailed description: Behçet's Disease (BD) is a chronic, inflammatory, rheumatic disease that is characterized by mucocutaneous lesions and can be seen major organ involvement such as eyes, musculoskeletal system, gastrointestinal system and central nervous system. Gender and clinical findings effect the prognosis of the disease. Physical activity is all body movements requiring energy expenditure over basal metabolism and contraction of skeletal muscle. Promoting physical activity level is one of the major goals in the management of patients with rheumatic diseases because of negative impact of sedentary lifestyle which depends on rheumatic involvement.Impaired quality of life, aerobic capacity, respiratory function and life satisfaction, sleep disorders, depression, anxiety and fatigue are seen commonly in BD patients like the other rheumatic diseases. Because of these symptoms, it is possible and expected that BD patients have low physical activity level. Considering that regular physical activity effects survival for patients and healthy people, it is important to determine the factors affecting physical activity level and exercise barriers. The aim of this study is to investigate physical activity level and exercise barriers in patients with BD. Physical activity level, exercise barriers, disease activity, fatigue, depression, pain, sleep disorders, aerobic capacity and quality of life will be assessed using International Physical Activity Questionnaire-Short Form (IPAQ),Exercise Benefits/Barriers Scale, Behçet Disease Current Activity Form (BDCAF), Fatigue Severity Scale (FSS), Beck Depression Inventory (BDI), McGill Pain Questionnaire- Short Form (MPQ-SF), Pittsburgh Sleep Quality Index, 6 minute walk test and Behçet's Disease Quality of Life Questionnaire, respectively.

Eligibility criteria: Inclusion Criteria:

* Being followed at the Gazi University Faculty of Medicine, Department of Rheumatology with Behçet Disease met the diagnostic criteria proposed at the International Study Group of Behçet Disease.
* The age of 18- 65 years

Exclusion Criteria:

* Illiterate,
* Pregnant
* Diagnosed with malignancy
* Accompaning any other rheumatic diseases except from Fibromyalgia
* Having changes of medical treatment in the last 3 months
* having dysfunction that limited physical activity such as severe neurological impairment, immobility or cooperation deficits

Primary outcomes:
measure: International Physical Activity Questionnaire (IPAQ)- Short Form
timeFrame: 1 minute
measure: the Exercise Benefits/Barriers Scale
timeFrame: 2 minutes
Secondary outcomes:
measure: Fatigue Severity Scale
timeFrame: 2 minutes
measure: Beck Depression Inventory
timeFrame: 1 minute
measure: Short Form McGill Pain Questionnaire
timeFrame: 2 minutes
measure: Behçet's Disease Quality of Life Questionnaire
timeFrame: 5 minutes
measure: Pittsburgh Sleep Quality Index
timeFrame: 2 minutes
measure: 6 minute walk test
timeFrame: 6 minutes
measure: Behçet Disease Current Activity Form (BDCAF)
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
affiliation: Gazi University Faculty of Health Sciences
name: Deran Oskay
role: STUDY_DIRECTOR
References:
citation: Moses Alder N, Fisher M, Yazici Y. Behcet's syndrome patients have high levels of functional disability, fatigue and pain as measured by a Multi-dimensional Health Assessment Questionnaire (MDHAQ). Clin Exp Rheumatol. 2008 Jul-Aug;26(4 Suppl 50):S110-3.
citation: Hatemi G, Merkel PA, Hamuryudan V, Boers M, Direskeneli H, Aydin SZ, Yazici H. Outcome measures used in clinical trials for Behcet syndrome: a systematic review. J Rheumatol. 2014 Mar;41(3):599-612. doi: 10.3899/jrheum.131249. Epub 2014 Feb 1.