The Effects of Aerobic Exercise in Patients With Ankylosing Spondylitis

NCT ID: NCT05968469

Last Updated: 2025-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-30

Study Completion Date

2025-01-12

Brief Summary

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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

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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.

Conditions

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Ankylosing Spondylitis Aerobic Exercise Disease Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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High Intensity Interval Training (HIIT) protocol

Patients who underwent cycling ergometry program including high-intensity interval (HIIT) in the cardiopulmonary rehabilitation unit and stretching exercises for the cervical, thoracic and lumbar regions under the guidance of a physiotherapist

Group Type EXPERIMENTAL

Aerobic exercises with cycling ergometry

Intervention Type DEVICE

A total of 20 sessions of high-intensity interval (HIIT) aerobic exercise program will be applied to the patients using a bicycle ergometer, five days a week and once a day for four weeks. And then, it was planned to perform stretching exercises for the cervical, thoracic and lumbar regions and posture exercises accompanied by a specialist physiotherapist.

The patients will be evaluated by the physician for a total of 3 times at the beginning of the treatment, at the end of the treatment (4th week) and at the 12th week after the start of the treatment. All patients will be evaluated for the parameters in the patient evaluation form, and blood samples taken between 08:00 and 10:00 in the morning and Calprotectin, Visfatin, Leptin, IL-33 serum levels will be measured with the ELISA kit.

Exercise program only:

Patients undergoing cervical, thoracic and lumbar stretching exercises in the hospital with a physiotherapist

Group Type ACTIVE_COMPARATOR

Stretching exercises

Intervention Type OTHER

Stretching exercises for the cervical, thoracic and lumbar regions and posture exercises were planned to be performed with the expert physiotherapist.

The patients will be evaluated by the physician for a total of 3 times at the beginning of the treatment, at the end of the treatment (4th week) and at the 12th week after the start of the treatment. All patients will be evaluated for the parameters in the patient evaluation form, and blood samples taken between 08:00 and 10:00 in the morning and Calprotectin, Visfatin, Leptin, IL-33 serum levels will be measured with the ELISA kit.

Interventions

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Aerobic exercises with cycling ergometry

A total of 20 sessions of high-intensity interval (HIIT) aerobic exercise program will be applied to the patients using a bicycle ergometer, five days a week and once a day for four weeks. And then, it was planned to perform stretching exercises for the cervical, thoracic and lumbar regions and posture exercises accompanied by a specialist physiotherapist.

The patients will be evaluated by the physician for a total of 3 times at the beginning of the treatment, at the end of the treatment (4th week) and at the 12th week after the start of the treatment. All patients will be evaluated for the parameters in the patient evaluation form, and blood samples taken between 08:00 and 10:00 in the morning and Calprotectin, Visfatin, Leptin, IL-33 serum levels will be measured with the ELISA kit.

Intervention Type DEVICE

Stretching exercises

Stretching exercises for the cervical, thoracic and lumbar regions and posture exercises were planned to be performed with the expert physiotherapist.

The patients will be evaluated by the physician for a total of 3 times at the beginning of the treatment, at the end of the treatment (4th week) and at the 12th week after the start of the treatment. All patients will be evaluated for the parameters in the patient evaluation form, and blood samples taken between 08:00 and 10:00 in the morning and Calprotectin, Visfatin, Leptin, IL-33 serum levels will be measured with the ELISA kit.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Afyonkarahisar Health Sciences University

OTHER

Sponsor Role lead

Responsible Party

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Faruk Emre Yulcu

Research Assistant Doctor, Physical Medicine and Rehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nuran EYVAZ, MD

Role: PRINCIPAL_INVESTIGATOR

Afyonkarahisar Health Sciences University

Locations

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Afyonkarahisar Health Sciences University

Afyonkarahisar, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 30278577 (View on PubMed)

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.

Reference Type RESULT
PMID: 26523029 (View on PubMed)

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.

Reference Type RESULT
PMID: 36232862 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/30278577/

Can ultrasound be an assessment tool for sagittal spine mobility and chest expansion in patients with ankylosing spondylitis?

https://pubmed.ncbi.nlm.nih.gov/26523029/

Effects of Aerobic Training in Patients with Ankylosing Spondylitis

https://pubmed.ncbi.nlm.nih.gov/36232862/

Practical Significance of Biomarkers in Axial Spondyloarthritis: Updates on Diagnosis, Disease Activity, and Prognosis

Other Identifiers

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ASHIIT2023

Identifier Type: -

Identifier Source: org_study_id

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