Effect of Exercise on Disease Activity in Patients With Ankylosing Spondylitis by SIRI and SII
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| ClinicalTrials.gov Identifier: NCT05703932 |
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Recruitment Status :
Not yet recruiting
First Posted : January 30, 2023
Last Update Posted : January 30, 2023
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ankylosing Spondylitis | Other: home-based exercises | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Effect of Exercise on Disease Activity in Patients With Ankylosing Spondylitis by Systemic Inflammatory Response Index (SIRI) and Systemic Inflammation Index (SII) |
| Estimated Study Start Date : | February 1, 2023 |
| Estimated Primary Completion Date : | February 1, 2024 |
| Estimated Study Completion Date : | April 15, 2024 |
| Arm | Intervention/treatment |
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No Intervention: Group One
AS patients diagnosed according to ASAS criteria under pharmacological treatment using NSAID ,anti-tnf and DMARD
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Active Comparator: Group Two
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.
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Other: home-based exercises
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. |
- Changed BASDAI score >2 in home-based exercise group measured by BASDAI-Bath Ankylosing Spondylitis Disease Activity Index at 10 week [ Time Frame: 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.
- SII-systemic inflammation index [ Time Frame: 10 week ]systemic inflammation index (SII) is defined as "platelet count × neutrophil count/lymphocyte count"
- SIRI-systemic inflammatory response index [ Time Frame: 10 week ]The systemic inflammatory response index (SIRI) is defined as "neutrophil count × monocytes/lymphocyte counts".
- BASMI-Bath Ankylosing Spondylitis Metrology Index [ Time Frame: 10 week ]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 [ Time Frame: 10 week ]
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 [ Time Frame: 10 week ]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 [ Time Frame: 10 week ]
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 [ Time Frame: 10 week ]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 [ Time Frame: 10 week ]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 [ Time Frame: 10 week ]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.
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
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): NCT05703932
| Contact: Isil Ustun | 905053117449 | isil_altan@yahoo.com.tr | |
| Contact: Merve Irem Ucar | 905342046699 | ucariremm@gmail.com |
| Turkey | |
| Bakırkoy Dr Sadı Konuk Hospıtal | |
| Istanbul, Bakirkoy, Turkey, 34147 | |
| Contact: Bakırkoy Dr Sadı Konuk Hospıtal +90 (212) 414 71 71 | |
| Principal Investigator: Isil Ustun | |
| Sub-Investigator: Merve Irem Ucar | |
| Study Director: | Isil Ustun |
| Responsible Party: | Işıl Üstün, Principal Investigator, Bakirkoy Dr. Sadi Konuk Research and Training Hospital |
| ClinicalTrials.gov Identifier: | NCT05703932 |
| Other Study ID Numbers: |
1 |
| First Posted: | January 30, 2023 Key Record Dates |
| Last Update Posted: | January 30, 2023 |
| Last Verified: | January 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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ankylosing spondylitis exercise systemic inflammatory response index systemic inflammation index |
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Spondylitis Spondylarthritis Spondylitis, Ankylosing Bone Diseases, Infectious Infections Bone Diseases |
Musculoskeletal Diseases Spinal Diseases Arthritis Joint Diseases Spondylarthropathies Ankylosis |