Inactivity Behavior and Exercise Bariers in Patients With Behçet Disease

Behçet Disease Clinical Trial

Official title:

Inactivity Behavior and Exercise Bariers in Patients With Behçet Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03837236
• Other study ID #: 25
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2019
• Est. completion date: November 8, 2019

Study information

• Verified date: February 2019
• Source: Gazi University
• Contact: Songul Baglan Yentur
• Phone: +90 312 216 26 12
• Email: songulbaglan23[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: November 8, 2019
• Est. primary completion date: May 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Behçet Disease
• Behcet Syndrome

Intervention

Other:
• Study group
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.

Locations

Country	Name	City	State
Turkey	Gazi University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Hatemi G, Merkel PA, Hamuryudan V, Boers M, Direskeneli H, Aydin SZ, Yazici H. Outcome measures used in clinical trials for Behçet syndrome: a systematic review. J Rheumatol. 2014 Mar;41(3):599-612. doi: 10.3899/jrheum.131249. Epub 2014 Feb 1. Review. — View Citation

Moses Alder N, Fisher M, Yazici Y. Behçet'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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Fatigue Severity Scale	This scale consists of nine questions; each question is scored from 1 to 7, in which a high FSS score indicates severe fatigue.	2 minutes
Secondary	Beck Depression Inventory	Beck Depression Inventory consists of 21 items related to depressive symptoms such as pessimism, sense of failure, guilt, dissatisfaction, sleep, appetite and fatigue. Each item is scored between 0 and 3. Higher score means increased severity of depression. According to this scale 1-10 points are defined as normal, scores between 11-16 indicate mild mental distress, 17-20 indicate the patient is at the border points for clinical depression, 21-30 indicate moderate depression, severe depression scores are between 31-40 and 40 points above are interpreted as a very serious depression.	1 minute
Secondary	Short Form McGill Pain Questionnaire	This questionnaire consists of 11 sensory and 4 affective descriptive words. These 15 words are scored range between 0 and 4. So three type of pain scores (sensory, affective, total = sensory + affective) are obtained. In McGill Pain Questionnaire, the current level of pain is measured by Visual Analog Scale (VAS) and Likert scale consisting of 6 points (0 = no pain, 1 = mild, 2 = irritating, 3 = bothersome, 4 = terrible, 5 = unbearable).	2 minutes
Secondary	Behçet's Disease Quality of Life Questionnaire	It consists of 15 items about difficulties in social, psychological and daily living effects for patients with BD. All questions have the same five answers including; always (4 points), usually (3 points), sometimes (2 points), rarely (1 point), never (0 point). Total score is calculated by collecting all points, which ranges between 0 and 60 points. The higher score indicated the high quality of life level.	5 minutes
Secondary	Pittsburgh Sleep Quality Index	It is a self-assessment questionnaire which evaluates sleep quality and disturbances over a 1 month time interval. It consists of 19 self-rated items and five questions rated by the bedpartner or roommate which is not included to the total score. . These 19 items are grouped into seven component scores, each weighted equally on a 0-3 scale. The seven component scores are then summed yo yield a global Pittsburgh Sleep Quality Index score, which has a range of 0-2 and the higher score indicates worse sleep quality.	2 minutes
Secondary	6 minute walk test	6MWT is a distance required to fast-paced walk on flat floor in length 30 meters. The aim of the 6MWT is to walk as long as the patient can walk in 6 minutes. Dyspnoea and fatigue level are recorded at the end of the test.	6 minutes
Secondary	Behçet Disease Current Activity Form (BDCAF)	It has 12 components; headache, oral ulcer, genital ulcer, arthralgia, erythema, skin pustule, arthritis, nausea/vomiting/abdominal pain, diarrhea or frank blood per rectum, eye symptoms, nervous and vascular system symptoms. Each component is scored as absent (0 point) or present (1 point) and final BDCAF score is sum of all components with a maximum of 12.	5 minutes