Clinical trial NCT05703932: Examining the Effect of Home-Based Exercise on Disease Activity in Patients With Ankylosing Spondylitis Using SIRI and SII
Official title: Examining the Effect of Home-Based Exercise on Disease Activity in Patients With Ankylosing Spondylitis Using SIRI (Systemic Inflammatory Response Index) and SII (Systemic Inflammation Index): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankylosing Spondylitis
Keywords: ankylosing spondylitis
exercise
systemic inflammatory response index
systemic inflammation index
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2023-01-30
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changed BASDAI score >2 in home-based exercise group measured by BASDAI-Bath Ankylosing Spondylitis Disease Activity Index at 10 week
timeFrame: 10 week
Secondary outcomes:
measure: SII-systemic inflammation index
timeFrame: 10 week
measure: SIRI-systemic inflammatory response index
timeFrame: 10 week
measure: BASMI-Bath Ankylosing Spondylitis Metrology Index
timeFrame: 10 week
measure: ASDAS-CRP-Ankylosing Spondylitis Disease Activity Score-CRP
timeFrame: 10 week
measure: BASFI-Bath Ankylosing Spondylitis Functional Index
timeFrame: 10 week
measure: ASDAS-ESR-Ankylosing Spondylitis Disease Activity Score-ESR
timeFrame: 10 week
measure: ASQoL-Ankylosing Spondylitis Quality of Life Index
timeFrame: 10 week
measure: VAS-Visual Analog Scale
timeFrame: 10 week
measure: HAD Scale-Hospital Anxiety-Depression Scale
timeFrame: 10 week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakırkoy Dr Sadı Konuk Hospıtal
state: Bakirkoy
Study officials:
name: Isil Ustun
role: STUDY_DIRECTOR
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