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Inactivity Behavior and Exercise Bariers in Patients With Behçet Disease

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ClinicalTrials.gov Identifier: NCT03837236
Recruitment Status : Recruiting
First Posted : February 12, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Songul Baglan Yentur, Gazi University

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.

Condition or disease Intervention/treatment Phase
Behçet Disease Other: Study group Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Inactivity Behavior and Exercise Bariers in Patients With Behçet Disease
Actual Study Start Date : February 8, 2019
Estimated Primary Completion Date : May 8, 2019
Estimated Study Completion Date : November 8, 2019


Arm Intervention/treatment
Experimental: 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.
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.




Primary Outcome Measures :
  1. International Physical Activity Questionnaire (IPAQ)- Short Form [ Time Frame: 1 minute ]
    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.

  2. the Exercise Benefits/Barriers Scale [ Time Frame: 2 minutes ]
    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.


Secondary Outcome Measures :
  1. Fatigue Severity Scale [ Time Frame: 2 minutes ]
    This scale consists of nine questions; each question is scored from 1 to 7, in which a high FSS score indicates severe fatigue.

  2. Beck Depression Inventory [ Time Frame: 1 minute ]
    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.

  3. Short Form McGill Pain Questionnaire [ Time Frame: 2 minutes ]
    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).

  4. Behçet's Disease Quality of Life Questionnaire [ Time Frame: 5 minutes ]
    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. Pittsburgh Sleep Quality Index [ Time Frame: 2 minutes ]
    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.

  6. 6 minute walk test [ Time Frame: 6 minutes ]
    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.

  7. Behçet Disease Current Activity Form (BDCAF) [ Time Frame: 5 minutes ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03837236


Contacts
Contact: Songul Baglan Yentur +90 312 216 26 12 songulbaglan23@hotmail.com

Locations
Turkey
Gazi University Recruiting
Ankara, Turkey, 06560
Contact: Songul Baglan Yentur    +90 506 272 6511    songulbaglan23@hotmail.com   
Sub-Investigator: Devrim Can Sarac         
Sub-Investigator: Gizem Tore         
Sub-Investigator: Fulden Sari         
Sub-Investigator: Nuh Atas         
Sub-Investigator: Mehmet Akif Ozturk         
Sub-Investigator: Deran Oskay         
Sponsors and Collaborators
Gazi University
Investigators
Study Director: Deran Oskay Gazi University Faculty of Health Sciences

Publications of Results:
Responsible Party: Songul Baglan Yentur, Research Assistant, Gazi University
ClinicalTrials.gov Identifier: NCT03837236     History of Changes
Other Study ID Numbers: 25
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Songul Baglan Yentur, Gazi University:
Behçet disease
Physical activity level
Exercise barriers

Additional relevant MeSH terms:
Eye Diseases
Behcet Syndrome
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Panuveitis
Uveitis
Uveal Diseases
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases
Skin Diseases, Vascular