Ankylosing SpondylitisNCT05968469
The Effects of Aerobic Exercise in Patients With Ankylosing Spondylitis
A study testing Aerobic exercises with cycling ergometry and Stretching exercises in people with Ankylosing Spondylitis and Aerobic Exercise, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Ankylosing Spondylitis, Aerobic Exercise, Disease Activity
- What is being tested?
- Aerobic exercises with cycling ergometry and Stretching exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jul 2023to 12 Jan 2025
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Health Sciences University
Afyonkarahisar, 03200
About this study
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
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.
Read the 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.
- Conditions
- Ankylosing Spondylitis, Aerobic Exercise, Disease Activity
- Being tested
- Aerobic exercises with cycling ergometry, Stretching exercises
- Keywords
- Ankylosing Spondylitis, Spinal Mobility, Aerobic Exercise
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercises with cycling ergometryDevice
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.
Stretching exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training (HIIT) protocol | Experimental | 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 Receives: Device: Aerobic exercises with cycling ergometry |
| Exercise program only: | Active comparator | Patients undergoing cervical, thoracic and lumbar stretching exercises in the hospital with a physiotherapist Receives: Other: Stretching exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BASDAI
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) consists of 6 questions about disease activity. Each question is scored on a scale of 0 to 10. High scores means high disease activity. It is a reliable and sensitive to changes index developed to assess disease activity and progression.
Measured: Baseline, after 4 and 12 weeks
Secondary outcomes (7)
Change in BASMI
The Bath Ankylosing Spondylitis Metrology Index (BASMI) is related to the spinal mobility of patients with ankylosing spondylitis. It consists of 5 clinical measurements. The total score of 5 measurements is obtained, the score range is between 0-10, a lower score means better spinal mobility.
Measured: Baseline, after 4 and 12 weeks
Change in BASFI
The Bath Ankylosing Spondylitis Functional Index (BASFI) is a sensitive and reliable index developed for the determination and follow-up of functional status in patients with AS. It consists of 10 questions evaluating the functions of the patients. The final score is obtained by dividing the total score by 10 using the VAS in the range of 0-10 cm for each question. A high score indicates poor function.
Measured: Baseline, after 4 and 12 weeks
Change in ASQOL
The Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) is the most widely used questionnaire to assess quality of life in AS, and it is valid and reliable. In this questionnaire consisting of eighteen questions, patients are asked to answer yes or no to each question. The total score varies between 0-18. High scores indicate serious deterioration in quality of life
Measured: Baseline, after 4 and 12 weeks
Change in ASDAS-CRP
The Ankylosing Spondylitis Disease Activity Score-CRP (ASDAS-CRP) consists of four questions and the acute phase reactants CRP mg/L result. ASDAS-CRP will be calculated together with the CRP result 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 >3.5
Measured: Baseline, after 4 and 12 weeks
Change in Chest Expansion
Chest expansion is determined by measuring the chest circumference following a deep inspiration and forced expiration. The expansion of the chest circumference is recorded in centimetres.
Measured: Baseline, after 4 and 12 weeks
Change in 6 Minute Walk Test
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The score of the test is the distance a patient walks in 6 minutes.
Measured: Baseline, after 4 and 12 weeks
Change in Borg Scale
The Borg scale is a numerical expression of the verbal expression of exercise intensity in patients undergoing cycle ergometry. It allows direct comparison of individuals. 6 to 20 are evaluated. The Borg scale is a numerical expression of the verbal expression of exercise intensity in patients undergoing cycling ergometry. It allows direct comparison of individuals. 6 to 20 are evaluated. As the activity becomes more difficult for the patient, the values given increase.
Measured: Baseline, after 4 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start30 Jul 2023
- Primary completion21 Oct 2024
- Study completion12 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faruk Emre Yulcu, Afyonkarahisar Health Sciences University
- Investigators
- Nuran EYVAZ, MD, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968469
- Sponsor's protocol ID
- ASHIIT2023
- Status last verified
- Jan 2025
- First submitted
- 14 Jul 2023
- Last updated
- 14 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30278577Jennings 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.
PubMed 26523029Diaconu 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.
PubMed 36232862
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05968469
- Acronym / sponsor ID
- ASHIIT2023
- Conditions
- Ankylosing Spondylitis, Aerobic Exercise, Disease Activity
- Keywords
- Ankylosing Spondylitis, Spinal Mobility, Aerobic Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 30 Jul 2023 (actual)
- Primary completion
- 21 Oct 2024 (actual)
- Study completion
- 12 Jan 2025 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training (HIIT) protocol | Experimental | Device: Aerobic exercises with cycling ergometryPatients 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 |
| Exercise program only: | Active comparator | Other: Stretching exercisesPatients undergoing cervical, thoracic and lumbar stretching exercises in the hospital with a physiotherapist |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercises with cycling ergometryA 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. | Device | High Intensity Interval Training (HIIT) protocol |
| Stretching exercisesStretching 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. | Other | Exercise program only: |
Primary outcome
Change in BASDAI
Time frame: Baseline, after 4 and 12 weeks
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) consists of 6 questions about disease activity. Each question is scored on a scale of 0 to 10. High scores means high disease activity. It is a reliable and sensitive to changes index developed to assess disease activity and progression.
7 secondary outcomes
Change in BASMI
Time frame: Baseline, after 4 and 12 weeks
Change in BASFI
Time frame: Baseline, after 4 and 12 weeks
Change in ASQOL
Time frame: Baseline, after 4 and 12 weeks
Change in ASDAS-CRP
Time frame: Baseline, after 4 and 12 weeks
Change in Chest Expansion
Time frame: Baseline, after 4 and 12 weeks
Change in 6 Minute Walk Test
Time frame: Baseline, after 4 and 12 weeks
Change in Borg Scale
Time frame: Baseline, after 4 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Background: PubMed 30278577Yurdakul 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.
- Results publication: PubMed 26523029Jennings 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.
- Results publication: PubMed 36232862Diaconu 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.
- Can ultrasound be an assessment tool for sagittal spine mobility and chest expansion in patients with ankylosing spondylitis?Link provided by the sponsor.
- Effects of Aerobic Training in Patients with Ankylosing SpondylitisLink provided by the sponsor.
- Practical Significance of Biomarkers in Axial Spondyloarthritis: Updates on Diagnosis, Disease Activity, and PrognosisLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nuran EYVAZ, MD principal investigator
Afyonkarahisar Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercises with cycling ergometry and Stretching exercises in people with Ankylosing Spondylitis and Aerobic Exercise, run by Afyonkarahisar Health Sciences University 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 5 inclusion and 10 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 14 Jan 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?
Change in BASDAI (time frame: Baseline, after 4 and 12 weeks). 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 NCT05968469, which also lists 3 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 14 Jan 2025.