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

NCT07327073 | Not Yet Recruiting

• 1 other identifier: AhiEvranU-FTR-NK-AS
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ankylosing Spondylitis (AS); Irisin

Keywords

ankylosing spondylitis; exercise; irisin

Outcome Measures

Primary Outcomes (1)

• 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.

  Before treatment and after treatment (week 8)

Secondary Outcomes (5)

• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  Before treatment, after treatment (week 8)

• Ankylosing Spondylitis Activity Scoring-CRP (ASDAS-CRP)

  Before treatment, after treatment (week 8)

• Bath Ankylosing Spondylitis Functional Index (BASFI)

  Before treatment, after treatment (week 8)

• Bath Ankylosing Spondylitis Metrology Index (BASMI)

  Before treatment, after treatment (week 8)

• Ankylosing Spondylitis Quality of Life Scale (ASQoL)

  Before treatment, after treatment (week 8)

Study Arms (3)

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.

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.

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.

Other: control group

Interventions

High-Intensity Interval Training 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.

high-intensity exercise

Moderate-Intensity Continuous Exercise 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.

moderate intensity exercise

control group 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.

control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead
• Scientific Research Projects: collaborator

Study Sites (1)

Kırşehir Ahi Evran Üniversitesi

Kırşehir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing; Motor Activity

Interventions

High-Intensity Interval Training; Control Groups

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Nazife Kapan Tunçer Asst. Prof.

CONTACT

+905555839701; nazifekapan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: January 8, 2026
• Study Start: January 30, 2026
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)