Clinical trial NCT05968469: The Effects of Aerobic Exercise in Patients With Ankylosing Spondylitis
Official title: The Effect of Aerobic Exercise Program on Disease Activity, Quality of Life, Spinal Mobility and Serum Calprotectin, Visfatin, Leptin,IL-33 Levels in Patients With Ankylosing Spondylitis: Ultrasonographic Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankylosing Spondylitis
Aerobic Exercise
Disease Activity
Keywords: Ankylosing Spondylitis
Spinal Mobility
Aerobic Exercise
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 56
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of our study is to investigate the effects of aerobic exercise and stretching exercises applied in high-intensity interval training protocol on disease activity, quality of life, spinal mobility and calprotectin, visfatin, leptin, IL-33 serum levels in patients with Ankylosing Spondylitis.

Detailed description: Ankylosing spondylitis (AS) is a painful and progressive chronic inflammation of the axial skeleton, mainly affecting the vertebral and sacroiliac joints. The management of AS aims to improve and maintain spinal mobility and normal posture, alleviate symptoms, reduce functional limitations and minimise complications. Due to the characteristic features of the disease, recommended spinal mobility exercises and aerobic exercises focus on reducing symptoms, improving functional capacity and quality of life, and improving and maintaining spinal mobility. Calprotectin, visfatin, leptin can be evaluated as biomarkers in inflammatory rheumatic diseases as an alternative to acute phase proteins and may reflect disease activity.

This study was designed as a prospective randomised controlled trial. Participants will be randomized into 2 groups and the intervention group will be given aerobic exercise and stretching exercise, and the other group only stretching exercise. BASDAI, BASMI, BASFI, ASQOL, ASDAS-CRP, Chest Expansion, 6 Minute Walk Test and Borg Scale will be used as assessment parameters.

Calprotectin, Visfatin, Leptin, IL-33 serum levels will be analysed by ELISA kit with blood samples taken in the early morning at the beginning of treatment, at the end of treatment (4th week) and at the 12th week after the beginning of treatment.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with ankylosing spondylitis according to 2009 ASAS diagnostic criteria,
* 20-60 years old, male and female gender,
* No change in anti-rheumatic drugs and dosage in the last 3 months
* Those who have not done regular physical activity in the last 3 months,
* Patients who do not have any orthopedic, neurological or mental illness that may affect exercise will be included in the study.

Exclusion Criteria:

* Active malignancy and/or history of malignancy in the last 5 years,
* Uncontrolled cardiopulmonary disease,
* Unstable angina pectoris, cardiac arrhythmias and myocardial infarction within the last 3 months
* Presence of pregnancy or those planning a pregnancy in the near future,
* History of major surgery (including joint surgery) within the last six months
* Use of assistive devices for ambulation or orthopaedic joint prosthesis
* Patients with total spinal ankyloses
* Patients with a history of syncope, exercise-induced arrhythmia
* Regular exercise in the last 3 months
* Patients with contracture of the knee joint that prevents cycling exercise

Primary outcomes:
measure: Change in BASDAI
timeFrame: Baseline, after 4 and 12 weeks
Secondary outcomes:
measure: Change in BASMI
timeFrame: Baseline, after 4 and 12 weeks
measure: Change in BASFI
timeFrame: Baseline, after 4 and 12 weeks
measure: Change in ASQOL
timeFrame: Baseline, after 4 and 12 weeks
measure: Change in ASDAS-CRP
timeFrame: Baseline, after 4 and 12 weeks
measure: Change in Chest Expansion
timeFrame: Baseline, after 4 and 12 weeks
measure: Change in 6 Minute Walk Test
timeFrame: Baseline, after 4 and 12 weeks
measure: Change in Borg Scale
timeFrame: Baseline, after 4 and 12 weeks
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Afyonkarahisar Health Sciences University
Study officials:
affiliation: Afyonkarahisar Health Sciences University
name: Nuran EYVAZ, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yurdakul OV, Rezvani A. Can ultrasound be an assessment tool for sagittal spine mobility and chest expansion in patients with ankylosing spondylitis? Medicine (Baltimore). 2018 Sep;97(39):e12609. doi: 10.1097/MD.0000000000012609.
citation: Jennings F, Oliveira HA, de Souza MC, Cruz Vda G, Natour J. Effects of Aerobic Training in Patients with Ankylosing Spondylitis. J Rheumatol. 2015 Dec;42(12):2347-53. doi: 10.3899/jrheum.150518. Epub 2015 Nov 1.
citation: Diaconu AD, Ceasovschih A, Sorodoc V, Pomirleanu C, Lionte C, Sorodoc L, Ancuta C. Practical Significance of Biomarkers in Axial Spondyloarthritis: Updates on Diagnosis, Disease Activity, and Prognosis. Int J Mol Sci. 2022 Sep 30;23(19):11561. doi: 10.3390/ijms231911561.