Inactivity Behavior and Exercise Bariers in Patients With Behçet Disease

NCT03837236 | Unknown

• 1 other identifier: 25
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Behçet Disease

Keywords

Behçet disease; Physical activity level; Exercise barriers

Outcome Measures

Primary Outcomes (2)

• International Physical Activity Questionnaire (IPAQ)- Short Form

  This questionnaire obtains information about how much time is spent while walking and in moderate and vigorous activities and sitting duration in the last 7 days. The questionnaire records the activity of four intensity levels: 1) vigorous-intensity activity, 2) moderate-intensity activity, 3) walking, and 4) sitting. Durations are multiplied by known METs per activity and the results for all items are summed for the overall physical activity score. Scores for walking and for moderate and vigorous activities are sums of corresponding item scores. A sitting question is not included in physical activity score. The questionnaire is scored as: those who score high on the IPAQ engage in vigorous intensity activity of at least 1500 MET minutes a week, those who score modarete on the IPAQ of at least 600 MET minutes a week, those who score a low level of physical activity on the IPAQ means that not meeting any of the criteria for either moderate or high levels of physical activity.

  1 minute

• the Exercise Benefits/Barriers Scale

  It consists of 43 items including benefits of exercise (e.g. I enjoy exercise) and barriers (e.g. Exercising takes too much of my time). Benefits subscale scores range between 29 and 116 while barriers subscale scores range between 14 and 56. The higher the score on the Barriers scale, the greater the perception of barriers to exercise.

  2 minutes

Secondary Outcomes (7)

• Fatigue Severity Scale

  2 minutes

• Beck Depression Inventory

  1 minute

• Short Form McGill Pain Questionnaire

  2 minutes

• Behçet's Disease Quality of Life Questionnaire

  5 minutes

• Pittsburgh Sleep Quality Index

  2 minutes

Study Arms (1)

Study group

EXPERIMENTAL

Evaluation parameters will be performed to the patients. 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.

Other: Study group

Interventions

Study group OTHER

Evaluation parameters will be performed to the patients. 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.

Study group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University

Ankara, 06560, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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.

  PMID: 19026127 RESULT

• 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.

  PMID: 24488418 RESULT

MeSH Terms

Conditions

Behcet Syndrome

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

Study Officials

• Deran Oskay

  Gazi University Faculty of Health Sciences

  STUDY DIRECTOR

Central Study Contacts

Songul Baglan Yentur

CONTACT

+90 312 216 26 12; songulbaglan23@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: February 12, 2019
• Study Start: February 8, 2019
• Primary Completion: May 8, 2019
• Study Completion: November 8, 2019
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)