Ankylosing Spondylitis (AS)NCT07327073
The Effect of Exercise on Serum Irisin Levels and Clinical Parameters in Patients With Axial Spondyloarthritis.
A study testing High-Intensity Interval Training and Moderate-Intensity Continuous Exercise in people with Ankylosing Spondylitis (AS) and Irisin, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate the effects of high-intensity intermittent exercise and moderate-intensity continuous exercise on serum irisin levels, disease activity, functional status, and quality of life in patients with axial spondyloarthritis. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankylosing Spondylitis (AS), Irisin
- What is being tested?
- High-Intensity Interval Training and Moderate-Intensity Continuous Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2026to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients diagnosed with axillary spondyloarthropathy according to ASAS diagnostic criteria,
- Having a high disease severity (ASDAS-CRP above 2.1),
- Being sedentary (not engaging in physical activity at least 3 days a week in the last 3 months),
- Having no change in ankylosing spondylitis medical treatment in the last 3 months,
- Not having any orthopedic, neurological, cardiovascular, or mental disease that would affect exercise,
- Not using any assistive devices for ambulation,
- Having a BMI of 25 kg/m2 or less,
- Male and female patients aged 18-50 years.
Who cannot join
- Those with uncontrolled cardiopulmonary disease (such as hypertension, chronic obstructive pulmonary disease, heart failure),
- Having comorbidities that reduce exercise capacity,
- Pregnancy,
- Malignancy,
- Those with a recent history of surgery,
- Those who have engaged in regular exercise (aquatic exercise, land exercise, etc.) in the previous 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kırşehir Ahi Evran Üniversitesi
Kırşehir
Nazife Kapan Tunçer Asst. Prof., +905555839701, nazifekapan@gmail.com
About this study
Official title: The Effect of High-intensity Intermittent Exercise and Moderate-intensity Continuous Exercise on Serum Irisin Levels, Disease Activity, Functional Status, and Quality of Life in Patients With Axial Spondyloarthritis: a Prospective, Randomized Study
This study aimed to investigate the effects of high-intensity intermittent exercise and moderate-intensity continuous exercise on serum irisin levels, disease activity, functional status, and quality of life in patients with axial spondyloarthritis.
Read the detailed description
Axial spondyloarthritis (axSpA) is a chronic inflammatory rheumatic disease affecting young individuals, with a prevalence of 0.3-1.4%. The main features of the disease include inflammatory back pain, reduced joint mobility, and functional disability. In addition, accumulating evidence over recent years has demonstrated that inflammatory rheumatic diseases are associated with an increased risk of cardiovascular disease. Exercise constitutes an important component of the management of inflammatory rheumatic diseases and is widely used to reduce pain and improve joint mobility.
Irisin is a myokine secreted by skeletal muscle through the cleavage of the membrane protein fibronectin type III domain-containing protein 5 (FNDC-5). Irisin is considered a mediator of exercise-induced metabolic benefits and has been shown to exert protective effects in several non-metabolic diseases. At the molecular level, irisin contributes to increased energy expenditure and metabolic regulation by promoting the browning of white adipose tissue. Previous studies have demonstrated that serum irisin levels increase following exercise.
Studies evaluating the role of irisin in ankylosing spondylitis have reported lower serum irisin levels in patients with more severe disease manifestations. However, no studies investigating the effects of exercise therapy on serum irisin levels in patients with axial spondyloarthritis have been identified in the literature. Previous research has focused on the relationship between disease severity and serum irisin levels, as well as the association between serum irisin levels and cardiovascular disease in patients with ankylosing spondylitis. Overall, low serum irisin levels are thought to be indicative of subclinical atherosclerosis, increased cardiovascular risk, and more severe disease. Evaluating the relationship between serum irisin levels and exercise in patients with axial spondyloarthritis may provide important contributions to disease management and follow-up. Therefore, the present study aimed to investigate the effects of high-intensity intermittent exercise and moderate-intensity continuous exercise on serum irisin levels, disease activity, functional status, and quality of life in patients with axial spondyloarthritis.
- Conditions
- Ankylosing Spondylitis (AS), Irisin
- Being tested
- High-Intensity Interval Training, Moderate-Intensity Continuous Exercise, control group
- Keywords
- ankylosing spondylitis, exercise, irisin
- 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.
High-Intensity Interval TrainingOther
Patients will be trained at 80% to 100% of their maximum heart rate. For the first 4 weeks, they will train at 80% of their maximum heart rate, then at 85%, 90%, 95%, and finally 100%. This protocol will consist of 4 active periods of 4 minutes each at 80% to 100% of maximum heart rate (percentage to be determined weekly) and 3 rest periods of 3 minutes each at 60-70% of maximum heart rate (4x4 minutes). Each session will include a 5-minute warm-up before HIIT and a 5-minute cool-down after HIIT, for a total exercise time of 35 minutes.
Moderate-Intensity Continuous ExerciseOther
Patients will be trained for 30 minutes at 50% to 70% of their maximum heart rate and with an RPE of 11-13. Each session will include a 5-minute warm-up before MCIT and a 5-minute cool-down after MCIT, for a total exercise time of 40 minutes.
control groupOther
They will be given information and education about their illnesses and will be advised to continue their current medical treatment and attend their follow-up appointments regularly.
| Study group | Role | What they receive |
|---|---|---|
| high-intensity exercise | Experimental | Patients in this group will receive information and education about their condition and will be instructed to continue their current medical treatment and attend follow-up appointments regularly. Additionally, this group will undergo a high-intensity interval training (HIIT) program with a physiotherapist for 40 sessions in total, 5 sessions per week for 8 weeks, each lasting 35 minutes. Patients will work at 80% to 100% of their maximum heart rate. The first 4 weeks will be at 80% of maximum heart rate, followed by 85%, 90%, 95%, and finally 100%. This protocol will consist of 4 active periods of 4 minutes each at 80% to 100% of maximum heart rate (percentage to be determined weekly) and 3 rest periods of 3 minutes each at 60-70% of maximum heart rate (4x4 minutes). Each session will include a 5-minute warm-up before HIIT and a 5-minute cool-down after HIIT, for a total exercise time of 35 minutes. Receives: Other: High-Intensity Interval Training |
| moderate intensity exercise | Experimental | Patients in this group will receive information and education about their condition and will be instructed to continue their current medical treatment and attend regular follow-up appointments. Additionally, these patients will undergo a 40-minute, 5-session, 40-minute moderate-intensity continuous exercise (MCIT) program with a physiotherapist over 8 weeks. Patients will exercise at 50-70% of their maximum heart rate and with an RPE of 11-13 for 30 minutes. Each session will include a 5-minute warm-up before MCIT and a 5-minute cool-down after MCIT, for a total exercise duration of 40 minutes. Receives: Other: Moderate-Intensity Continuous Exercise |
| control | Active comparator | Patients in this group will receive information and education about their illness and will be advised to continue their current medical treatment and attend their follow-up appointments regularly. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum irisin level
Blood samples will be taken from patients one day before the start of treatment, after a 12-hour fast, and again the morning after a 12-hour fast, immediately after the end of treatment. The collected blood samples will be centrifuged at 1500 g for 10 minutes to obtain serum. The obtained serum will be stored at -80°C until the day of the study. The aim of these serum samples is to determine the level of irisin.
Measured: Before treatment and after treatment (week 8)
Secondary outcomes (5)
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
The BASDAI score consists of 6 questions. Patients are asked to rate each question on a scale of 0 to 10, based on their symptoms one week prior, with 'none' receiving 0 points and 'very severe' receiving 10 points. The scores from questions 5 and 6 are then added together, divided by 2, and added to the other scores. The total is then divided by 5 to obtain the BASDAI score. A BASDAI score of 4 or higher indicates that the disease is out of control and that the patient's treatment, particularly biological agents, should be reviewed. To assess treatment response, a 50% improvement in the BASDAI score or at least a 2-unit reduction on a 10-point scale is required.
Measured: Before treatment, after treatment (week 8)
Ankylosing Spondylitis Activity Scoring-CRP (ASDAS-CRP)
The ASDAS score is a combined scoring system that measures disease activity. It is calculated by adding the CRP value to clinical findings. Based on the resulting score, disease activity is grouped as inactive, low, high, and very high. For evaluation to initiate biological therapy, the ASDAS score must be at least 2.1. A change of 1.1 or higher in the ASDAS score is considered a significant improvement, while changes of 2.0 or higher are considered major improvements. A change of 0.9 or higher in the ASDAS score is required for a disease activity flare-up.
Measured: Before treatment, after treatment (week 8)
Bath Ankylosing Spondylitis Functional Index (BASFI)
Patients are asked a total of 10 questions, including functional questions, and are asked to rate each question between 0 and 10, with 0 points for 'easy' and 10 points for 'impossible'. The points given for each question are added together and divided by 10 to obtain the BASFI score.
Measured: Before treatment, after treatment (week 8)
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Metrological evaluations of patients are performed using this scoring system. The score is calculated by measuring lumbar lateral flexion, tragus wall distance, modified Schober test, cervical rotation, and intermalleolar distance. It is used as a follow-up parameter in spinal mobility measurements.
Measured: Before treatment, after treatment (week 8)
Ankylosing Spondylitis Quality of Life Scale (ASQoL)
The system consists of 18 questions, where "yes" is worth 1 point and "no" is worth 0 points. Points are added up to calculate the score. A higher score indicates a poorer quality of life.
Measured: Before treatment, after treatment (week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start30 Jan 2026 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing Spondylitis (AS)Studies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Scientific Research Projects
- Responsible party
- Principal investigator, Nazife Kapan, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327073
- Sponsor's protocol ID
- AhiEvranU-FTR-NK-AS
- Status last verified
- Dec 2025
- First submitted
- 25 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High-intensity Intermittent Exercise and Moderate-intensity Continuous Exercise on Serum Irisin Levels, Disease Activity, Functional Status, and Quality of Life in Patients With Axial Spondyloarthritis: a Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT07327073
- Acronym / sponsor ID
- AhiEvranU-FTR-NK-AS
- Conditions
- Ankylosing Spondylitis (AS), Irisin
- Keywords
- ankylosing spondylitis, exercise, irisin
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Collaborators
- Scientific Research Projects
- Study start
- 30 Jan 2026 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 8 Jan 2026 (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.
This study aimed to investigate the effects of high-intensity intermittent exercise and moderate-intensity continuous exercise on serum irisin levels, disease activity, functional status, and quality of life in patients with axial spondyloarthritis.
Detailed description
Axial spondyloarthritis (axSpA) is a chronic inflammatory rheumatic disease affecting young individuals, with a prevalence of 0.3-1.4%. The main features of the disease include inflammatory back pain, reduced joint mobility, and functional disability. In addition, accumulating evidence over recent years has demonstrated that inflammatory rheumatic diseases are associated with an increased risk of cardiovascular disease. Exercise constitutes an important component of the management of inflammatory rheumatic diseases and is widely used to reduce pain and improve joint mobility.
Irisin is a myokine secreted by skeletal muscle through the cleavage of the membrane protein fibronectin type III domain-containing protein 5 (FNDC-5). Irisin is considered a mediator of exercise-induced metabolic benefits and has been shown to exert protective effects in several non-metabolic diseases. At the molecular level, irisin contributes to increased energy expenditure and metabolic regulation by promoting the browning of white adipose tissue. Previous studies have demonstrated that serum irisin levels increase following exercise.
Studies evaluating the role of irisin in ankylosing spondylitis have reported lower serum irisin levels in patients with more severe disease manifestations. However, no studies investigating the effects of exercise therapy on serum irisin levels in patients with axial spondyloarthritis have been identified in the literature. Previous research has focused on the relationship between disease severity and serum irisin levels, as well as the association between serum irisin levels and cardiovascular disease in patients with ankylosing spondylitis. Overall, low serum irisin levels are thought to be indicative of subclinical atherosclerosis, increased cardiovascular risk, and more severe disease. Evaluating the relationship between serum irisin levels and exercise in patients with axial spondyloarthritis may provide important contributions to disease management and follow-up. Therefore, the present study aimed to investigate the effects of high-intensity intermittent exercise and moderate-intensity continuous exercise on serum irisin levels, disease activity, functional status, and quality of life in patients with axial spondyloarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| high-intensity exercise | Experimental | Other: High-Intensity Interval TrainingPatients in this group will receive information and education about their condition and will be instructed to continue their current medical treatment and attend follow-up appointments regularly. Additionally, this group will undergo a high-intensity interval training (HIIT) program with a physiotherapist for 40 sessions in total, 5 sessions per week for 8 weeks, each lasting 35 minutes. Patients will work at 80% to 100% of their maximum heart rate. The first 4 weeks will be at 80% of maximum heart rate, followed by 85%, 90%, 95%, and finally 100%. This protocol will consist of 4 active periods of 4 minutes each at 80% to 100% of maximum heart rate (percentage to be determined weekly) and 3 rest periods of 3 minutes each at 60-70% of maximum heart rate (4x4 minutes). Each session will include a 5-minute warm-up before HIIT and a 5-minute cool-down after HIIT, for a total exercise time of 35 minutes. |
| moderate intensity exercise | Experimental | Other: Moderate-Intensity Continuous ExercisePatients in this group will receive information and education about their condition and will be instructed to continue their current medical treatment and attend regular follow-up appointments. Additionally, these patients will undergo a 40-minute, 5-session, 40-minute moderate-intensity continuous exercise (MCIT) program with a physiotherapist over 8 weeks. Patients will exercise at 50-70% of their maximum heart rate and with an RPE of 11-13 for 30 minutes. Each session will include a 5-minute warm-up before MCIT and a 5-minute cool-down after MCIT, for a total exercise duration of 40 minutes. |
| control | Active comparator | Other: control groupPatients in this group will receive information and education about their illness and will be advised to continue their current medical treatment and attend their follow-up appointments regularly. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients diagnosed with axillary spondyloarthropathy according to ASAS diagnostic criteria,
- Having a high disease severity (ASDAS-CRP above 2.1),
- Being sedentary (not engaging in physical activity at least 3 days a week in the last 3 months),
- Having no change in ankylosing spondylitis medical treatment in the last 3 months,
- Not having any orthopedic, neurological, cardiovascular, or mental disease that would affect exercise,
Key exclusion criteria (6 listed)
- Those with uncontrolled cardiopulmonary disease (such as hypertension, chronic obstructive pulmonary disease, heart failure),
- Having comorbidities that reduce exercise capacity,
- Pregnancy,
- Malignancy,
- Those with a recent history of surgery,
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 |
|---|---|---|
| High-Intensity Interval TrainingPatients will be trained at 80% to 100% of their maximum heart rate. For the first 4 weeks, they will train at 80% of their maximum heart rate, then at 85%, 90%, 95%, and finally 100%. This protocol will consist of 4 active periods of 4 minutes each at 80% to 100% of maximum heart rate (percentage to be determined weekly) and 3 rest periods of 3 minutes each at 60-70% of maximum heart rate (4x4 minutes). Each session will include a 5-minute warm-up before HIIT and a 5-minute cool-down after HIIT, for a total exercise time of 35 minutes. | Other | high-intensity exercise |
| Moderate-Intensity Continuous ExercisePatients will be trained for 30 minutes at 50% to 70% of their maximum heart rate and with an RPE of 11-13. Each session will include a 5-minute warm-up before MCIT and a 5-minute cool-down after MCIT, for a total exercise time of 40 minutes. | Other | moderate intensity exercise |
| control groupThey will be given information and education about their illnesses and will be advised to continue their current medical treatment and attend their follow-up appointments regularly. | Other | control |
Primary outcome
serum irisin level
Time frame: Before treatment and after treatment (week 8)
Blood samples will be taken from patients one day before the start of treatment, after a 12-hour fast, and again the morning after a 12-hour fast, immediately after the end of treatment. The collected blood samples will be centrifuged at 1500 g for 10 minutes to obtain serum. The obtained serum will be stored at -80°C until the day of the study. The aim of these serum samples is to determine the level of irisin.
5 secondary outcomes
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: Before treatment, after treatment (week 8)
Ankylosing Spondylitis Activity Scoring-CRP (ASDAS-CRP)
Time frame: Before treatment, after treatment (week 8)
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: Before treatment, after treatment (week 8)
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time frame: Before treatment, after treatment (week 8)
Ankylosing Spondylitis Quality of Life Scale (ASQoL)
Time frame: Before treatment, after treatment (week 8)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Interval Training and Moderate-Intensity Continuous Exercise in people with Ankylosing Spondylitis (AS) and Irisin, run by Kirsehir Ahi Evran Universitesi 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 8 inclusion and 6 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: opening soon, as of the sponsor's last update on 12 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nazife Kapan Tunçer Asst. Prof. (+905555839701, nazifekapan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum irisin level (time frame: Before treatment and after treatment (week 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2026.