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

NCT ID: NCT07327073

Last Updated: 2026-01-12

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-30

Study Completion Date

2026-05-30

Brief Summary

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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

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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

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Ankylosing Spondylitis (AS) Irisin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

High-Intensity Interval Training

Intervention Type OTHER

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 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.

Group Type EXPERIMENTAL

Moderate-Intensity Continuous Exercise

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

control group

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Scientific Research Projects

UNKNOWN

Sponsor Role collaborator

Kirsehir Ahi Evran Universitesi

OTHER

Sponsor Role lead

Responsible Party

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Nazife Kapan

Asst. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kırşehir Ahi Evran Üniversitesi

Kırşehir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Nazife Kapan Tunçer Asst. Prof.

Role: CONTACT

+905555839701

Facility Contacts

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Nazife Kapan Tunçer Asst. Prof.

Role: primary

+905555839701

Other Identifiers

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AhiEvranU-FTR-NK-AS

Identifier Type: -

Identifier Source: org_study_id

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