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Ankylosing SpondylitisNCT05703932

Examining the Effect of Home-Based Exercise on Disease Activity in Patients With Ankylosing Spondylitis Using SIRI and SII

A study testing home-based exercises in people with Ankylosing Spondylitis, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Ankylosing Spondylitis
What is being tested?
home-based exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2023to 1 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Being diagnosed with ankylosing spondylitis according to the modified New York criteria and/or ASAS criteria

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Bakırkoy Dr Sadı Konuk Hospıtal

    Istanbul, Bakirkoy, 34147

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
home-based exercises
Keywords
ankylosing spondylitis, exercise, systemic inflammatory response index, systemic inflammation index
Medical subject headings
Spondylitis, Ankylosing, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • home-based exercisesOther

    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.

Study groups in NCT05703932
Study groupRoleWhat they receive
ControlNo interventionAS patients diagnosed according to ASAS criteria under pharmacological treatment using NSAID ,anti-tnf and DMARD
Home-Based Exercise Therapy GroupActive comparatorAS 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.
Receives: Other: home-based exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 10 week

Secondary outcomes (9)

  1. SII-systemic inflammation index

    systemic inflammation index (SII) is defined as "platelet count × neutrophil count/lymphocyte count"

    Measured: 10 week

  2. SIRI-systemic inflammatory response index

    The systemic inflammatory response index (SIRI) is defined as "neutrophil count × monocytes/lymphocyte counts".

    Measured: 10 week

  3. 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

    Measured: 10 week

  4. 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

    Measured: 10 week

  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.

    Measured: 10 week

  6. 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

    Measured: 10 week

  7. 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.

    Measured: 10 week

  8. 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).

    Measured: 10 week

  9. 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.

    Measured: 10 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2023
  2. Study start1 Feb 2023
  3. Primary completion1 Mar 2024
  4. Study completion1 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05703932
Sponsor's protocol ID
1
Status last verified
Feb 2025
First submitted
6 Jan 2023
Last updated
19 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Results of the study will be written as a manuscript. In Turkey, we do not have a system sharing data to other researchers

Publications

  • Lee JH, Choi M, Rim THT, Lee SC, Lee CS. Clinical Characteristics and Prognostic Factors in Ankylosing Spondylitis Associated Uveitis. Ocul Immunol Inflamm. 2019;27(1):64-69. doi: 10.1080/09273948.2017.1359630. Epub 2017 Oct 11.

    PubMed 29020487

  • Stolwijk C, Essers I, van Tubergen A, Boonen A, Bazelier MT, De Bruin ML, de Vries F. The epidemiology of extra-articular manifestations in ankylosing spondylitis: a population-based matched cohort study. Ann Rheum Dis. 2015 Jul;74(7):1373-8. doi: 10.1136/annrheumdis-2014-205253. Epub 2014 Mar 21.

    PubMed 24658834

  • Chetrit M, Khan MA, Kapadia S. State of the Art Management of Aortic Valve Disease in Ankylosing Spondylitis. Curr Rheumatol Rep. 2020 May 14;22(6):23. doi: 10.1007/s11926-020-00898-4.

    PubMed 32410005

  • Magrey MN, Lewis S, Asim Khan M. Utility of DXA scanning and risk factors for osteoporosis in ankylosing spondylitis-A prospective study. Semin Arthritis Rheum. 2016 Aug;46(1):88-94. doi: 10.1016/j.semarthrit.2016.03.003. Epub 2016 Mar 9.

    PubMed 27162010

  • Dominguez CJ, Ugalde PF, Vilchez DR, Carretero-Dios H, Estevez EC. Positive and negative affective states and disease activity in ankylosing spondylitis. Rheumatol Int. 2015 Mar;35(3):519-24. doi: 10.1007/s00296-014-3107-y. Epub 2014 Aug 15.

    PubMed 25123554

  • Poddubnyy D, Rudwaleit M, Haibel H, Listing J, Marker-Hermann E, Zeidler H, Braun J, Sieper J. Rates and predictors of radiographic sacroiliitis progression over 2 years in patients with axial spondyloarthritis. Ann Rheum Dis. 2011 Aug;70(8):1369-74. doi: 10.1136/ard.2010.145995. Epub 2011 May 27.

    PubMed 21622969

  • Deng J, Xu S, Gao X, Xu S, Shuai Z, Pan F. Red Cell Distribution Width and Mean Platelet Volume in Patients With Ankylosing Spondylitis: A Systematic Review and Meta-analysis. J Clin Rheumatol. 2021 Oct 1;27(7):292-297. doi: 10.1097/RHU.0000000000001174.

    PubMed 31478944

  • Sezgin M, Tecer D, Kanik A, Kekik FS, Yesildal E, Akaslan E, Yildirim G, Sahin G. Serum RDW and MPV in Ankylosing Spondylitis: Can they show the disease activity? Clin Hemorheol Microcirc. 2017;65(1):1-10. doi: 10.3233/CH-162067.

    PubMed 27258203

  • Gokmen F, Akbal A, Resorlu H, Gokmen E, Guven M, Aras AB, Erbag G, Komurcu E, Akbal E, Cosar M. Neutrophil-Lymphocyte Ratio Connected to Treatment Options and Inflammation Markers of Ankylosing Spondylitis. J Clin Lab Anal. 2015 Jul;29(4):294-8. doi: 10.1002/jcla.21768. Epub 2014 May 21.

    PubMed 24849656

  • Wu J, Yan L, Chai K. Systemic immune-inflammation index is associated with disease activity in patients with ankylosing spondylitis. J Clin Lab Anal. 2021 Sep;35(9):e23964. doi: 10.1002/jcla.23964. Epub 2021 Aug 21.

    PubMed 34418163

  • Topkan E, Mertsoylu H, Kucuk A, Besen AA, Sezer A, Sezen D, Bolukbasi Y, Selek U, Pehlivan B. Low Systemic Inflammation Response Index Predicts Good Prognosis in Locally Advanced Pancreatic Carcinoma Patients Treated with Concurrent Chemoradiotherapy. Gastroenterol Res Pract. 2020 Jul 30;2020:5701949. doi: 10.1155/2020/5701949. eCollection 2020.

    PubMed 32802045

  • Sun L, Hu W, Liu M, Chen Y, Jin B, Xu H, Du S, Xu Y, Zhao H, Lu X, Sang X, Zhong S, Yang H, Mao Y. High Systemic Inflammation Response Index (SIRI) Indicates Poor Outcome in Gallbladder Cancer Patients with Surgical Resection: A Single Institution Experience in China. Cancer Res Treat. 2020 Oct;52(4):1199-1210. doi: 10.4143/crt.2020.303. Epub 2020 Jul 21.

    PubMed 32718144

  • Lin J, Chen L, Chen Q, Zhuang Z, Bao X, Qian J, Hong Y, Yan L, Lin L, Shi B, Qiu Y, Pan L, Wei L, Zheng X, Wang J, Liu F, He B, Chen F. Prognostic value of preoperative systemic inflammation response index in patients with oral squamous cell carcinoma: Propensity score-based analysis. Head Neck. 2020 Nov;42(11):3263-3274. doi: 10.1002/hed.26375. Epub 2020 Jul 18.

    PubMed 32681711

  • Xu Y, He H, Zang Y, Yu Z, Hu H, Cui J, Wang W, Gao Y, Wei H, Wang Z. Systemic inflammation response index (SIRI) as a novel biomarker in patients with rheumatoid arthritis: a multi-center retrospective study. Clin Rheumatol. 2022 Jul;41(7):1989-2000. doi: 10.1007/s10067-022-06122-1. Epub 2022 Mar 9.

    PubMed 35266094

  • Ozdemir O. Quality of life in patients with ankylosing spondylitis: relationships with spinal mobility, disease activity and functional status. Rheumatol Int. 2011 May;31(5):605-10. doi: 10.1007/s00296-009-1328-2. Epub 2010 Jan 5.

    PubMed 20049451

Questions about this trial

What is this clinical trial studying?

A study testing home-based exercises in people with Ankylosing Spondylitis, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05703932, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.

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