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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorKirsehir Ahi Evran Universitesi

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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,

Disqualifiers

Those with uncontrolled cardiopulmonary disease (such as hypertension, chronic obstructive pulmonary disease, heart failure),

Having comorbidities that reduce exercise capacity,

Pregnancy,

Malignancy,

Trial design

Design model

Parallel

Treatments tested in this trial

  • High-Intensity Interval Training

    Other intervention

    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 Exercise

    Other intervention

    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 group

    Other intervention

    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.

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: high-intensity exerciseExperimental treatment 1 intervention
Group B: moderate intensity exerciseExperimental treatment 1 intervention
Group C: controlActive comparator 1 intervention

Trial outcomes

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.

Time frame
Before treatment and after treatment (week 8)

Secondary outcomes

1

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.

Time frame
Before treatment, after treatment (week 8)
2

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.

Time frame
Before treatment, after treatment (week 8)
3

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.

Time frame
Before treatment, after treatment (week 8)
4

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.

Time frame
Before treatment, after treatment (week 8)

Other outcomes

Sponsors and contacts

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Kirsehir Ahi Evran Universitesi

Lead sponsor

Scientific Research Projects

Collaborator

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