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Effect of Exercise on Disease Activity in Patients With Ankylosing Spondylitis by SIRI and SII

Primary Purpose

Ankylosing Spondylitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
home-based exercises
Sponsored by
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring ankylosing spondylitis, exercise, systemic inflammatory response index, systemic inflammation index

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Being diagnosed with ankylosing spondylitis according to the modified New York criteria and/or ASAS criteria Exclusion Criteria: Presence of neurological disease (Epilepsy, stroke, Parkinson's, etc.) Severe cardiac disease (coronary artery disease, history of myocardial infarction and angina, heart failure) Pacemaker users Patients with COPD and advanced respiratory failure Hypertension and diabetes that cannot be controlled with medication malignancy Acute or chronic infections Organ/System dysfunction History of previous upper and lower extremity orthopedic surgery Patients with joint prosthesis Insufficient cooperation Pregnancy Cognitive dysfunction Dementia Presence of psychiatric illness

Sites / Locations

  • Bakırkoy Dr Sadı Konuk Hospıtal

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Group One

Group Two

Arm Description

AS patients diagnosed according to ASAS criteria under pharmacological treatment using NSAID ,anti-tnf and DMARD

AS patients diagnosed according to ASAS criteria under pharmacological treatment using NSAID ,anti-tnf and DMARD ;and will take exercise program including; joint range of motion and stretching exercises for cervical, thoracic and lumbar spine, stretching for erector spina, hamstring and shoulder muscles, chest expansion, abdominal and diaphragmatic breathing exercises . Exercises will be performed at submaximal level, paying attention to blood pressure, arterial (TA) and heart rate.For the patients in the exercise group, it was planned to perform the exercise program 5 days a week in 1 set with 10 repetitions, 40 minutes/day.

Outcomes

Primary Outcome Measures

Changed BASDAI score >2 in home-based exercise group measured by BASDAI-Bath Ankylosing Spondylitis Disease Activity Index at 10 week
The BASDAI index consists of 6 questions about disease activity. Patients are required to answer the questions considering their last week's situation and mark an appropriate point on the 10 cm horizontal line. At the beginning and end of the 10 cm horizontal line, there are the words "not at all - very severe". The average of the 2 questions about morning stiffness will be taken, added to the total of the first 4 questions, and a combined score will be obtained by dividing by 5.A higher score indicates higher disease activity.

Secondary Outcome Measures

SII-systemic inflammation index
systemic inflammation index (SII) is defined as "platelet count × neutrophil count/lymphocyte count"
SIRI-systemic inflammatory response index
The systemic inflammatory response index (SIRI) is defined as "neutrophil count × monocytes/lymphocyte counts".
BASMI-Bath Ankylosing Spondylitis Metrology Index
BASMI consists of five clinical measurements: cervical rotation, tragus wall distance, lumbar flexion, trunk lateral flexion and intermalleolar distance.10 is highest score and indicates worst situtation.BASMI both groups before the treatment, after 6 weeks exercise program and when the treatment ends (4 weeks after) will be compared
ASDAS-CRP-Ankylosing Spondylitis Disease Activity Score-CRP
The ASDAS evaluation consists of four questions to be answered by the patients and the results of the acute phase reactants CRP mg/L or ESH mm/sec . Three of the questions are some questions used in BASDAI(question 2,3,6)Patients are asked to answer these questions using a VAS on a 10 cm or 100 mm long horizontal or vertical lineThe point that patients show on the VAS is calculated in cm/mm. ASDAS-CRP/ESH will be calculated together with the CRP or ESH results in the formula. Mild disease activity <1.3 Moderate disease activity 1.3-2.1 High disease activity 2.1-3.5 Very high disease activity is evaluated as >3.5
BASFI-Bath Ankylosing Spondylitis Functional Index
BASFI includes 8 items related to daily activities and 2 items related to the patient's daily life skills. Each item is evaluated on a 10 cm visual analog scale. At the beginning and end of the scale, the words "I can do it easily - I can't" are located. The patients are asked to mark on the line, considering how difficult they have been while doing the tasks during the past week. The average of 10 scales gives the total BASFI score. The total score is between 0-10. A high score indicates poor function.
ASDAS-ESR-Ankylosing Spondylitis Disease Activity Score-ESR
The ASDAS evaluation consists of four questions to be answered by the patients and the results of the acute phase reactants CRP mg/L or ESH mm/sec . Three of the questions are some questions used in BASDAI(question 2,3,6)Patients are asked to answer these questions using a VAS on a 10 cm or 100 mm long horizontal or vertical lineThe point that patients show on the VAS is calculated in cm/mm. ASDAS-CRP/ESH will be calculated together with the CRP or ESH results in the formula. Mild disease activity <1.3 Moderate disease activity 1.3-2.1 High disease activity 2.1-3.5 Very high disease activity is evaluated as >3.5
ASQoL-Ankylosing Spondylitis Quality of Life Index
The scale consists of 18 sentences questioning whether the patients have limitations in activities of daily living, pain, fatigue and morning stiffness, concerns about their illness, and depressed mood. The patient will be asked to answer each question as yes or no, taking into account the latest situation. Yes 1 point, no 0 points will be recorded and the total score will be calculated.
VAS-Visual Analog Scale
Pain is measured by visual analog scale (VAS). The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm).
HAD Scale-Hospital Anxiety-Depression Scale
Considering the last few days, each question is scored between 0-3 for the answers of the patients who are asked to give the answer that best expresses how they feel. Questions 1, 3, 5, 7, 9, 11, 13 give anxiety scores; Questions 2, 4, 6, 8, 10, 12, 14 give depression scores. The total score is obtained by summing the scores for each question. 0-7 points will be considered normal, 8-10 points will be considered borderline, while 11 points and above will be considered abnormal.

Full Information

First Posted
January 6, 2023
Last Updated
January 19, 2023
Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05703932
Brief Title
Effect of Exercise on Disease Activity in Patients With Ankylosing Spondylitis by SIRI and SII
Official Title
Effect of Exercise on Disease Activity in Patients With Ankylosing Spondylitis by Systemic Inflammatory Response Index (SIRI) and Systemic Inflammation Index (SII)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2023 (Anticipated)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
April 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

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
The systemic inflammatory response index (SIRI) is defined as "neutrophil count × monocytes/lymphocyte counts". It has been reported that SIRI can predict survival in various types of cancer, including pancreatic cancer , gallbladder cancer , oral squamous cell carcinoma , and cervical cancer. Again, SIRI can demonstrate disease activity in patients with rheumatoid arthritis (RA), It has been reported that it can predict the development of RA-related interstitial lung disease and tumor development . Ankylosing spondylitis management strategies should be aimed at controlling disease activity, improving spinal mobility and functional status . Treatment usually includes the use of anti-inflammatory drugs to reduce pain and stiffness, and the use of disease-modifying drugs to try to stop or prevent disease progression. Patients are also advised to exercise to maintain the mobility of the spine and peripheral joints . Studies on this subject reveal that exercise is as important as drug therapy in the treatment of AS . Again, the importance of exercise in AS was emphasized in the clinical guidelines for the treatment of AS by ASAS (The Assesment in Ankylosing Spondylitis : Working Group) and EULAR (European League Against Rheumatism) . In addition to the effects of exercise on muscle strength, joint limitations, physical performance, endurance capacity and quality of life, its anti-inflammatory effects are also known. In this study, it was aimed to evaluate the effect of exercise therapy on disease activity in AS patients with systemic inflammatory response index (SIRI) and systemic inflammation index (SII). There is not enough evidence in the literature that systemic inflammatory response index (SIRI) and systemic inflammation index (SII) can be used in the evaluation of disease activity in AS.
Detailed Description
Ankylosing spondylitis (AS) is an inflammatory disease of unknown etiology characterized by chronic inflammation of the sacroiliac joints, spine and paraspinal soft tissues. Extra-articular manifestations such as anterior uveitis, inflammatory bowel disease, aortic valve disease and osteoporosis may also occur. Joint fusion and dysfunction may also be seen in progressive disease states. Inflammatory low back pain and morning stiffness are common symptoms of AS. These symptoms lead to limitation of activity and exacerbation of pain in the active phase of the disease. Therefore, evaluation of disease activity in AS is very important in terms of better understanding the pathophysiology of AS, predicting prognosis, and treatment. Currently, two non-specific inflammatory biomarkers, C-reactive protein (CRP) level and erythrocyte sedimentation rate (ESH), are frequently used to monitor disease activity of rheumatic diseases; however, these biomarkers have low sensitivity and specificity . Therefore, it is necessary to identify new indicators that more accurately reflect disease activity. Recently, complete blood cell count parameters have emerged as useful biomarkers of many inflammatory diseases due to their availability and affordability. Previous studies have shown that platelet (PLT), neutrophil, lymphocyte cell counts, red blood distribution width (RDW), neutrophil-lymphocyte ratio (NLR) and platelet-lymphocyte ratio (PLO) are important indicators of systemic inflammation. In addition, it was found that SII (Systemic Inflammation Index), calculated by the formula "platelet count × neutrophil count/lymphocyte count", increased in active-stage AS patients compared to both the healthy control group and other AS patients in remission, and showed a positive correlation with disease activity .The systemic inflammatory response index (SIRI) is defined as "neutrophil count × monocytes/lymphocyte counts". It has been reported that SIRI can predict survival in various types of cancer, including pancreatic cancer, gallbladder cancer , oral squamous cell carcinoma , and cervical cancer. Again, SIRI can demonstrate disease activity in patients with rheumatoid arthritis (RA), It has been reported that it can predict the development of RA-related interstitial lung disease and tumor development . Ankylosing spondylitis management strategies should be aimed at controlling disease activity, improving spinal mobility and functional status . Treatment usually includes the use of anti-inflammatory drugs to reduce pain and stiffness, and the use of disease-modifying drugs to try to stop or prevent disease progression. Patients are also advised to exercise to maintain the mobility of the spine and peripheral joints . Studies on this subject reveal that exercise is as important as drug therapy in the treatment of AS . Again, the importance of exercise in AS was emphasized in the clinical guidelines for the treatment of AS by ASAS (The Assesment in Ankylosing Spondylitis : Working Group) and EULAR (European League Against Rheumatism) . In addition to the effects of exercise on muscle strength, joint limitations, physical performance, endurance capacity and quality of life, its anti-inflammatory effects are also known. In this study, it was aimed to evaluate the effect of exercise therapy on disease activity in AS patients with systemic inflammatory response index (SIRI) and systemic inflammation index (SII). There is not enough evidence in the literature that systemic inflammatory response index (SIRI) and systemic inflammation index (SII) can be used in the evaluation of disease activity in AS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
ankylosing spondylitis, exercise, systemic inflammatory response index, systemic inflammation index

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group One
Arm Type
No Intervention
Arm Description
AS patients diagnosed according to ASAS criteria under pharmacological treatment using NSAID ,anti-tnf and DMARD
Arm Title
Group Two
Arm Type
Active Comparator
Arm Description
AS patients diagnosed according to ASAS criteria under pharmacological treatment using NSAID ,anti-tnf and DMARD ;and will take exercise program including; joint range of motion and stretching exercises for cervical, thoracic and lumbar spine, stretching for erector spina, hamstring and shoulder muscles, chest expansion, abdominal and diaphragmatic breathing exercises . Exercises will be performed at submaximal level, paying attention to blood pressure, arterial (TA) and heart rate.For the patients in the exercise group, it was planned to perform the exercise program 5 days a week in 1 set with 10 repetitions, 40 minutes/day.
Intervention Type
Other
Intervention Name(s)
home-based exercises
Intervention Description
Joint range of motion and stretching exercises for cervical, thoracic and lumbar spine, stretching for erector spina, hamstring and shoulder muscles, chest expansion, abdominal and diaphragmatic breathing exercises will be applied. Exercises will be performed at submaximal level, paying attention to blood pressure, arterial (TA) and heart rate.For the patients in the exercise group, it was planned to perform the exercise program 5 days a week in 1 set with 10 repetitions, 40 minutes/day.
Primary Outcome Measure Information:
Title
Changed BASDAI score >2 in home-based exercise group measured by BASDAI-Bath Ankylosing Spondylitis Disease Activity Index at 10 week
Description
The BASDAI index consists of 6 questions about disease activity. Patients are required to answer the questions considering their last week's situation and mark an appropriate point on the 10 cm horizontal line. At the beginning and end of the 10 cm horizontal line, there are the words "not at all - very severe". The average of the 2 questions about morning stiffness will be taken, added to the total of the first 4 questions, and a combined score will be obtained by dividing by 5.A higher score indicates higher disease activity.
Time Frame
10 week
Secondary Outcome Measure Information:
Title
SII-systemic inflammation index
Description
systemic inflammation index (SII) is defined as "platelet count × neutrophil count/lymphocyte count"
Time Frame
10 week
Title
SIRI-systemic inflammatory response index
Description
The systemic inflammatory response index (SIRI) is defined as "neutrophil count × monocytes/lymphocyte counts".
Time Frame
10 week
Title
BASMI-Bath Ankylosing Spondylitis Metrology Index
Description
BASMI consists of five clinical measurements: cervical rotation, tragus wall distance, lumbar flexion, trunk lateral flexion and intermalleolar distance.10 is highest score and indicates worst situtation.BASMI both groups before the treatment, after 6 weeks exercise program and when the treatment ends (4 weeks after) will be compared
Time Frame
10 week
Title
ASDAS-CRP-Ankylosing Spondylitis Disease Activity Score-CRP
Description
The ASDAS evaluation consists of four questions to be answered by the patients and the results of the acute phase reactants CRP mg/L or ESH mm/sec . Three of the questions are some questions used in BASDAI(question 2,3,6)Patients are asked to answer these questions using a VAS on a 10 cm or 100 mm long horizontal or vertical lineThe point that patients show on the VAS is calculated in cm/mm. ASDAS-CRP/ESH will be calculated together with the CRP or ESH results in the formula. Mild disease activity <1.3 Moderate disease activity 1.3-2.1 High disease activity 2.1-3.5 Very high disease activity is evaluated as >3.5
Time Frame
10 week
Title
BASFI-Bath Ankylosing Spondylitis Functional Index
Description
BASFI includes 8 items related to daily activities and 2 items related to the patient's daily life skills. Each item is evaluated on a 10 cm visual analog scale. At the beginning and end of the scale, the words "I can do it easily - I can't" are located. The patients are asked to mark on the line, considering how difficult they have been while doing the tasks during the past week. The average of 10 scales gives the total BASFI score. The total score is between 0-10. A high score indicates poor function.
Time Frame
10 week
Title
ASDAS-ESR-Ankylosing Spondylitis Disease Activity Score-ESR
Description
The ASDAS evaluation consists of four questions to be answered by the patients and the results of the acute phase reactants CRP mg/L or ESH mm/sec . Three of the questions are some questions used in BASDAI(question 2,3,6)Patients are asked to answer these questions using a VAS on a 10 cm or 100 mm long horizontal or vertical lineThe point that patients show on the VAS is calculated in cm/mm. ASDAS-CRP/ESH will be calculated together with the CRP or ESH results in the formula. Mild disease activity <1.3 Moderate disease activity 1.3-2.1 High disease activity 2.1-3.5 Very high disease activity is evaluated as >3.5
Time Frame
10 week
Title
ASQoL-Ankylosing Spondylitis Quality of Life Index
Description
The scale consists of 18 sentences questioning whether the patients have limitations in activities of daily living, pain, fatigue and morning stiffness, concerns about their illness, and depressed mood. The patient will be asked to answer each question as yes or no, taking into account the latest situation. Yes 1 point, no 0 points will be recorded and the total score will be calculated.
Time Frame
10 week
Title
VAS-Visual Analog Scale
Description
Pain is measured by visual analog scale (VAS). The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm).
Time Frame
10 week
Title
HAD Scale-Hospital Anxiety-Depression Scale
Description
Considering the last few days, each question is scored between 0-3 for the answers of the patients who are asked to give the answer that best expresses how they feel. Questions 1, 3, 5, 7, 9, 11, 13 give anxiety scores; Questions 2, 4, 6, 8, 10, 12, 14 give depression scores. The total score is obtained by summing the scores for each question. 0-7 points will be considered normal, 8-10 points will be considered borderline, while 11 points and above will be considered abnormal.
Time Frame
10 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being diagnosed with ankylosing spondylitis according to the modified New York criteria and/or ASAS criteria Exclusion Criteria: Presence of neurological disease (Epilepsy, stroke, Parkinson's, etc.) Severe cardiac disease (coronary artery disease, history of myocardial infarction and angina, heart failure) Pacemaker users Patients with COPD and advanced respiratory failure Hypertension and diabetes that cannot be controlled with medication malignancy Acute or chronic infections Organ/System dysfunction History of previous upper and lower extremity orthopedic surgery Patients with joint prosthesis Insufficient cooperation Pregnancy Cognitive dysfunction Dementia Presence of psychiatric illness
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isil Ustun
Phone
905053117449
Email
isil_altan@yahoo.com.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Merve Irem Ucar
Phone
905342046699
Email
ucariremm@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isil Ustun
Official's Role
Study Director
Facility Information:
Facility Name
Bakırkoy Dr Sadı Konuk Hospıtal
City
Istanbul
State/Province
Bakirkoy
ZIP/Postal Code
34147
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bakırkoy Dr Sadı Konuk Hospıtal
Phone
+90 (212) 414 71 71
First Name & Middle Initial & Last Name & Degree
Isil Ustun
First Name & Middle Initial & Last Name & Degree
Merve Irem Ucar

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Results of the study will be written as a manuscript. In Turkey, we do not have a system sharing data to other researchers
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Effect of Exercise on Disease Activity in Patients With Ankylosing Spondylitis by SIRI and SII

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