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

NCT05703932 | Completed

• 1 other identifier: 1
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankylosing Spondylitis

Keywords

ankylosing spondylitis; exercise; systemic inflammatory response index; systemic inflammation index

Outcome Measures

Primary Outcomes (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.

  10 week

Secondary Outcomes (9)

• SII-systemic inflammation index

  10 week

• 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

Study Arms (2)

Control

NO INTERVENTION

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

Home-Based Exercise Therapy Group

ACTIVE COMPARATOR

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.

Other: home-based exercises

Interventions

home-based exercises OTHER

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.

Home-Based Exercise Therapy Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Bakırkoy Dr Sadı Konuk Hospıtal

Istanbul, Bakirkoy, 34147, Turkey (Türkiye)

Location

Related Publications (21)

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MeSH Terms

Conditions

Spondylitis, Ankylosing; Motor Activity

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Behavior

Study Officials

• Isil Ustun

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 30, 2023
• Study Start: February 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)