search
Back to results

Inactivity Behavior and Exercise Bariers in Patients With Behçet Disease

Primary Purpose

Behçet Disease

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Study group
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Behçet Disease focused on measuring Behçet disease, Physical activity level, Exercise barriers

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gazi UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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).
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.
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.
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.
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.

Full Information

First Posted
February 8, 2019
Last Updated
February 13, 2019
Sponsor
Gazi University
search

1. Study Identification

Unique Protocol Identification Number
NCT03837236
Brief Title
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 8, 2019 (Actual)
Primary Completion Date
May 8, 2019 (Anticipated)
Study Completion Date
November 8, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behçet Disease
Keywords
Behçet disease, Physical activity level, Exercise barriers

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Study group
Intervention Description
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 Measure Information:
Title
International Physical Activity Questionnaire (IPAQ)- Short Form
Description
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.
Time Frame
1 minute
Title
the Exercise Benefits/Barriers Scale
Description
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.
Time Frame
2 minutes
Secondary Outcome Measure Information:
Title
Fatigue Severity Scale
Description
This scale consists of nine questions; each question is scored from 1 to 7, in which a high FSS score indicates severe fatigue.
Time Frame
2 minutes
Title
Beck Depression Inventory
Description
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.
Time Frame
1 minute
Title
Short Form McGill Pain Questionnaire
Description
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).
Time Frame
2 minutes
Title
Behçet's Disease Quality of Life Questionnaire
Description
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.
Time Frame
5 minutes
Title
Pittsburgh Sleep Quality Index
Description
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.
Time Frame
2 minutes
Title
6 minute walk test
Description
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.
Time Frame
6 minutes
Title
Behçet Disease Current Activity Form (BDCAF)
Description
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.
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Songul Baglan Yentur
Phone
+90 312 216 26 12
Email
songulbaglan23@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deran Oskay
Organizational Affiliation
Gazi University Faculty of Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Gazi University
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Songul Baglan Yentur
Phone
+90 506 272 6511
Email
songulbaglan23@hotmail.com
First Name & Middle Initial & Last Name & Degree
Devrim Can Sarac
First Name & Middle Initial & Last Name & Degree
Gizem Tore
First Name & Middle Initial & Last Name & Degree
Fulden Sari
First Name & Middle Initial & Last Name & Degree
Nuh Atas
First Name & Middle Initial & Last Name & Degree
Mehmet Akif Ozturk
First Name & Middle Initial & Last Name & Degree
Deran Oskay

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19026127
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.
Results Reference
result
PubMed Identifier
24488418
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.
Results Reference
result

Learn more about this trial

Inactivity Behavior and Exercise Bariers in Patients With Behçet Disease

We'll reach out to this number within 24 hrs