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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Changed BASDAI score >2 in home-based exercise group measured by BASDAI-Bath Ankylosing Spondylitis Disease Activity Index at 10 week
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being diagnosed with ankylosing spondylitis according to the modified New York criteria and/or ASAS criteria
排除标准
- •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
- •Presence of psychiatric illness
研究组 & 干预措施
Control
AS patients diagnosed according to ASAS criteria under pharmacological treatment using NSAID ,anti-tnf and DMARD
Home-Based Exercise Therapy Group
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.
干预措施: home-based exercises (Other)
结局指标
主要结局
Changed BASDAI score >2 in home-based exercise group measured by BASDAI-Bath Ankylosing Spondylitis Disease Activity Index at 10 week
时间窗: 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.
次要结局
- SIRI-systemic inflammatory response index(10 week)
- BASMI-Bath Ankylosing Spondylitis Metrology Index(10 week)
- ASDAS-CRP-Ankylosing Spondylitis Disease Activity Score-CRP(10 week)
- BASFI-Bath Ankylosing Spondylitis Functional Index(10 week)
- SII-systemic inflammation index(10 week)
- ASDAS-ESR-Ankylosing Spondylitis Disease Activity Score-ESR(10 week)
- ASQoL-Ankylosing Spondylitis Quality of Life Index(10 week)
- VAS-Visual Analog Scale(10 week)
- HAD Scale-Hospital Anxiety-Depression Scale(10 week)
研究者
Işıl Üstün
Principal Investigator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
