The Effect of Exercise on Serum Irisin Levels and Clinical Parameters in Patients With Axial Spondyloarthritis.

January 9, 2026 updated by: Nazife Kapan, Kirsehir Ahi Evran Universitesi

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: high-intensity exercise
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.
Other: High-Intensity Interval Training
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.
Experimental: moderate intensity exercise
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.
Other: Moderate-Intensity Continuous Exercise
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.
Active Comparator: control
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.
Other: control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before treatment and after treatment (week 8)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time Frame: Before treatment, after treatment (week 8)
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.
Before treatment, after treatment (week 8)
Ankylosing Spondylitis Activity Scoring-CRP (ASDAS-CRP)
Time Frame: Before treatment, after treatment (week 8)
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.
Before treatment, after treatment (week 8)
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time Frame: Before treatment, after treatment (week 8)
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.
Before treatment, after treatment (week 8)
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time Frame: Before treatment, after treatment (week 8)
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.
Before treatment, after treatment (week 8)
Ankylosing Spondylitis Quality of Life Scale (ASQoL)
Time Frame: Before treatment, after treatment (week 8)
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.
Before treatment, after treatment (week 8)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kirsehir Ahi Evran Universitesi

Collaborators

Scientific Research Projects

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 30, 2026

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

May 30, 2026

Study Registration Dates

First Submitted

December 25, 2025

First Submitted That Met QC Criteria

December 25, 2025

First Posted (Estimated)

January 8, 2026

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AhiEvranU-FTR-NK-AS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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