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NCT Number: NCT07833033

Effects of Land- and Water-Based Exercise in Axial Spondyloarthritis

Axial spondyloarthritis (axSpA) is a chronic inflammatory disease characterized by pain, morning stiffness, restricted spinal mobility, and systemic manifestations. Exercise is an important component of axSpA management and has beneficial effects on pain, disease activity, quality of life, posture, and pulmonary function. Exercise may also modulate inflammatory responses by altering the expression of genes involved in pro- and anti-inflammatory pathways. However, evidence regarding the effects of different exercise environments on inflammatory gene expression in individuals with axSpA remains limited.

Both land-based and aquatic exercise programs are commonly used in the management of axSpA. Aquatic exercise may provide additional advantages through buoyancy and hydrostatic pressure, which reduce joint loading and facilitate exercise performance. Nevertheless, the comparative effects of land-based and aquatic combined exercise programs, particularly on inflammatory biomarkers and gene expression, have not been sufficiently investigated.

The aim of this randomized controlled trial is to compare the effects of land-based and aquatic combined exercise programs on postural control, disease-related outcomes, inflammatory biomarkers and gene expression, disease activity, quality of life, and pulmonary function in individuals with axSpA. Participants will be randomly allocated to a land-based exercise group, an aquatic exercise group, or a control group. Both exercise groups will complete a 45-minute combined program including aerobic, strengthening, and flexibility exercises twice weekly for 8 weeks. The control group will not participate in a structured exercise program and will receive educational videos. Outcomes will be assessed at baseline, immediately after the 8-week intervention, and at the 3-month follow-up.

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Key information

Conditions

Axial Spondyloarthritis and Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of axial spondyloarthritis (axSpA) according to the Assessment of SpondyloArthritis International Society (ASAS) classification criteria
  • Willingness to participate in the study
  • BASDAI score between 3 and 4
  • Age between 18 and 70 years
  • No change in tumor necrosis factor (TNF) inhibitor treatment within the previous 3 months
  • No regular cardiorespiratory or strengthening exercise (>1 session/week) during the previous 6 months.

Exclusion criteria

  • Regular exercise participation within the previous 6 months
  • Missing 4 consecutive exercise sessions
  • Any condition requiring a change in medical treatment
  • Presence or identification of other comorbidities that may limit exercise capacity.

Treatment and study plan

Land-Based Combined Exercise Program

Behavioral

Participants will perform supervised group exercise sessions (3-4 participants per group) twice weekly for 8 weeks. The program will include warm-up, high-intensity interval aerobic exercise, breathing combined with mobility exercises, strengthening exercises, and cool-down. Aerobic training will consist of running in place, with a 5-minute warm-up at 70% intensity, followed by four 4-minute intervals at 90-95% intensity, with 3 minutes of active recovery at 70% intensity between intervals, and a 3-minute cool-down at 70% intensity. Exercise intensity will be monitored using a Polar heart rate monitor, and target heart rate will be calculated using the Karvonen method. Strengthening will include six individually adapted exercises targeting the major muscle groups using elastic bands and/or free weights. Participants will perform 2-3 sets of 8-10 repetitions, with progressive resistance as tolerated.

Aquatic Combined Exercise Program

Behavioral

Participants will perform supervised group exercise sessions (3-4 participants per group) twice weekly for 8 weeks in a 120-cm-deep thermoneutral pool. The program will include warm-up, high-intensity interval aerobic exercise, breathing combined with mobility exercises, water-resisted strengthening exercises, and cool-down. Aerobic training will consist of running in place, with a 5-minute warm-up at 70% intensity, followed by four 4-minute intervals at 90-95% intensity, with 3 minutes of active recovery at 70% intensity between intervals, and a 3-minute cool-down at 70% intensity. Exercise intensity will be monitored using a Polar heart rate monitor. Target heart rate will be calculated using the Karvonen method and adjusted for the heart rate response to water immersion. Strengthening exercises will target the major muscle groups using aquatic resistance equipment. Participants will perform 2-3 sets of 8-10 repetitions, with progression achieved by increasing movement speed.

Home Exercise Program

Behavioral

Participants will receive education about the effects of physical activity and exercise videos based on home exercise recommendations from the National Axial Spondyloarthritis Society (NASS). Materials will be provided online and in MP4 format. Participants will receive monthly text-message reminders encouraging adherence to the recommended exercises.

Primary outcomes

  1. Disease Activity

    Time frame: Baseline

    Disease activity will be assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). This index is used to assess disease activity and monitor disease progression and prognosis. The mean of the last two questions is calculated first, and this value is then used together with the scores of the first four questions to calculate the overall mean BASDAI score. The total BASDAI score ranges from 0 to 10, with higher scores indicating greater disease activity and therefore a worse outcome.

  2. Disease Activity

    Time frame: at the end of the 8-week intervention

    Disease activity will be assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). This index is used to assess disease activity and monitor disease progression and prognosis. The mean of the last two questions is calculated first, and this value is then used together with the scores of the first four questions to calculate the overall mean BASDAI score. The total BASDAI score ranges from 0 to 10, with higher scores indicating greater disease activity and therefore a worse outcome.

  3. Disease Activity

    Time frame: at 3-month follow-up after completion of the intervention

    Disease activity will be assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). This index is used to assess disease activity and monitor disease progression and prognosis. The mean of the last two questions is calculated first, and this value is then used together with the scores of the first four questions to calculate the overall mean BASDAI score. The total BASDAI score ranges from 0 to 10, with higher scores indicating greater disease activity and therefore a worse outcome.

Secondary outcomes

  1. Inflammatory Cytokine Levels

    Time frame: Baseline

    Serum levels of IL-6, IL-17, IL-23, IL-10, and TNF-α will be quantitatively measured using enzyme-linked immunosorbent assay (ELISA) and expressed as pg/mL.

  2. Inflammatory Cytokine Levels

    Time frame: at the end of the 8-week intervention

    Serum levels of IL-6, IL-17, IL-23, IL-10, and TNF-α will be quantitatively measured using enzyme-linked immunosorbent assay (ELISA) and expressed as pg/mL.

  3. Inflammatory Cytokine Levels

    Time frame: at 3-month follow-up after completion of the intervention

    Serum levels of IL-6, IL-17, IL-23, IL-10, and TNF-α will be quantitatively measured using enzyme-linked immunosorbent assay (ELISA) and expressed as pg/mL.

  4. Inflammation-Related Gene Expression in PBMCs

    Time frame: Baseline

    Expression levels of 13 inflammation-related genes in peripheral blood mononuclear cells (PBMCs) will be assessed using RT-qPCR. Relative gene expression will be normalized to housekeeping genes and calculated using the 2^-ΔΔCt method, with results expressed as fold change

  5. Inflammation-Related Gene Expression in PBMCs

    Time frame: at the end of the 8-week intervention

    Expression levels of 13 inflammation-related genes in peripheral blood mononuclear cells (PBMCs) will be assessed using RT-qPCR. Relative gene expression will be normalized to housekeeping genes and calculated using the 2^-ΔΔCt method, with results expressed as fold change

  6. Inflammation-Related Gene Expression in PBMCs

    Time frame: at 3-month follow-up after completion of the intervention

    Expression levels of 13 inflammation-related genes in peripheral blood mononuclear cells (PBMCs) will be assessed using RT-qPCR. Relative gene expression will be normalized to housekeeping genes and calculated using the 2^-ΔΔCt method, with results expressed as fold change

  7. BASFI - Functional Status

    Time frame: Baseline

    Functional status will be assessed using the Bath Ankylosing Spondylitis Functional Index (BASFI), a 10-item questionnaire assessing physical function and the ability to cope with activities of daily living. Each item is scored from 0 (easy) to 10 (impossible), with higher scores indicating greater functional impairment.

  8. BASFI - Functional Status

    Time frame: at the end of the 8-week intervention

    Functional status will be assessed using the Bath Ankylosing Spondylitis Functional Index (BASFI), a 10-item questionnaire assessing physical function and the ability to cope with activities of daily living. Each item is scored from 0 (easy) to 10 (impossible), with higher scores indicating greater functional impairment.

  9. BASFI - Functional Status

    Time frame: at 3-month follow-up after completion of the intervention

    Functional status will be assessed using the Bath Ankylosing Spondylitis Functional Index (BASFI), a 10-item questionnaire assessing physical function and the ability to cope with activities of daily living. Each item is scored from 0 (easy) to 10 (impossible), with higher scores indicating greater functional impairment.

  10. BASMI - Spinal Mobility

    Time frame: Baseline

    Spinal mobility will be assessed using the Bath Ankylosing Spondylitis Metrology Index (BASMI), which includes cervical rotation, tragus-to-wall distance, lateral lumbar flexion, anterior lumbar flexion, and intermalleolar distance. Lower scores indicate better spinal mobility.

  11. BASMI - Spinal Mobility

    Time frame: at the end of the 8-week intervention

    Spinal mobility will be assessed using the Bath Ankylosing Spondylitis Metrology Index (BASMI), which includes cervical rotation, tragus-to-wall distance, lateral lumbar flexion, anterior lumbar flexion, and intermalleolar distance. Lower scores indicate better spinal mobility.

  12. BASMI - Spinal Mobility

    Time frame: at 3-month follow-up after completion of the intervention

    Spinal mobility will be assessed using the Bath Ankylosing Spondylitis Metrology Index (BASMI), which includes cervical rotation, tragus-to-wall distance, lateral lumbar flexion, anterior lumbar flexion, and intermalleolar distance. Lower scores indicate better spinal mobility.

  13. Static Postural Balance

    Time frame: Baseline

    Static postural balance will be assessed using KINVENT force plates. Participants will stand as still and upright as possible for 10 seconds with eyes open and feet in a comfortable position. The test will be repeated three times, and the trial with the best postural sway performance will be used. Mean center of pressure (CoP) velocity will be recorded.

  14. Static Postural Balance

    Time frame: at the end of the 8-week intervention

    Static postural balance will be assessed using KINVENT force plates. Participants will stand as still and upright as possible for 10 seconds with eyes open and feet in a comfortable position. The test will be repeated three times, and the trial with the best postural sway performance will be used. Mean center of pressure (CoP) velocity will be recorded.

  15. Static Postural Balance

    Time frame: at 3-month follow-up after completion of the intervention

    Static postural balance will be assessed using KINVENT force plates. Participants will stand as still and upright as possible for 10 seconds with eyes open and feet in a comfortable position. The test will be repeated three times, and the trial with the best postural sway performance will be used. Mean center of pressure (CoP) velocity will be recorded.

  16. Pulmonary Function-FEV1

    Time frame: Baseline

    Pulmonary function will be assessed using a portable spirometer (MIR Spirobank II) according to ATS/ERS criteria. FEV1 will be recorded as applicable in absolute values and/or percentage of predicted values

  17. Pulmonary Function-FEV1

    Time frame: at the end of the 8-week intervention

    Pulmonary function will be assessed using a portable spirometer (MIR Spirobank II) according to ATS/ERS criteria. FEV1 will be recorded as applicable in absolute values and/or percentage of predicted values

  18. Pulmonary Function-FVC

    Time frame: baseline

    Pulmonary function will be assessed using a portable spirometer (MIR Spirobank II) according to ATS/ERS criteria. FVC will be recorded as applicable in absolute values and/or percentage of predicted values

  19. Leg Muscle Strength

    Time frame: Baseline

    Leg muscle strength will be assessed using a back-leg dynamometer. Participants will perform a maximal leg extension effort with the knees positioned at approximately 130-140° of flexion. Three measurements will be performed, and the mean value will be recorded in kilograms (kg).

  20. Leg Muscle Strength

    Time frame: at the end of the 8-week intervention

    Leg muscle strength will be assessed using a back-leg dynamometer. Participants will perform a maximal leg extension effort with the knees positioned at approximately 130-140° of flexion. Three measurements will be performed, and the mean value will be recorded in kilograms (kg).

  21. Leg Muscle Strength

    Time frame: at 3-month follow-up after completion of the intervention

    Leg muscle strength will be assessed using a back-leg dynamometer. Participants will perform a maximal leg extension effort with the knees positioned at approximately 130-140° of flexion. Three measurements will be performed, and the mean value will be recorded in kilograms (kg).

  22. Back Muscle Strength

    Time frame: Baseline

    Back muscle strength will be assessed using a back-leg dynamometer. Participants will perform a maximal strength effort according to the standardized dynamometer testing procedure. Three measurements will be performed, and the mean value will be recorded in kilograms (kg).

  23. Back Muscle Strength

    Time frame: at the end of the 8-week intervention

    Back muscle strength will be assessed using a back-leg dynamometer. Participants will perform a maximal strength effort according to the standardized dynamometer testing procedure. Three measurements will be performed, and the mean value will be recorded in kilograms (kg).

  24. Back Muscle Strength

    Time frame: at 3-month follow-up after completion of the intervention

    Back muscle strength will be assessed using a back-leg dynamometer. Participants will perform a maximal strength effort according to the standardized dynamometer testing procedure. Three measurements will be performed, and the mean value will be recorded in kilograms (kg).

  25. ASQoL - Quality of Life

    Time frame: Baseline

    Quality of life will be assessed using the 18-item Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire. Each item is answered "yes" (1 point) or "no" (0 points), yielding a total score ranging from 0 to 18. Higher scores indicate poorer quality of life.

  26. ASQoL - Quality of Life

    Time frame: at the end of the 8-week intervention

    Quality of life will be assessed using the 18-item Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire. Each item is answered "yes" (1 point) or "no" (0 points), yielding a total score ranging from 0 to 18. Higher scores indicate poorer quality of life.

  27. ASQoL - Quality of Life

    Time frame: at 3-month follow-up after completion of the intervention

    Quality of life will be assessed using the 18-item Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire. Each item is answered "yes" (1 point) or "no" (0 points), yielding a total score ranging from 0 to 18. Higher scores indicate poorer quality of life.

  28. Pulmonary Function-FEV1

    Time frame: at 3-month follow-up after completion of the intervention

    Pulmonary function will be assessed using a portable spirometer (MIR Spirobank II) according to ATS/ERS criteria. FEV1 will be recorded as applicable in absolute values and/or percentage of predicted values

  29. Pulmonary Function-FVC

    Time frame: at the end of the 8-week intervention

    Pulmonary function will be assessed using a portable spirometer (MIR Spirobank II) according to ATS/ERS criteria. FVC will be recorded as applicable in absolute values and/or percentage of predicted values

  30. Pulmonary Function-FVC

    Time frame: at 3-month follow-up after completion of the intervention

    Pulmonary function will be assessed using a portable spirometer (MIR Spirobank II) according to ATS/ERS criteria. FVC will be recorded as applicable in absolute values and/or percentage of predicted values

  31. Pulmonary Function-FEV1/FVC

    Time frame: Baseline

    Pulmonary function will be assessed using a portable spirometer (MIR Spirobank II) according to ATS/ERS criteria. FEV1/FVC will be recorded as applicable in absolute values and/or percentage of predicted values

  32. Pulmonary Function-FEV1/FVC

    Time frame: at the end of the 8-week intervention

    Pulmonary function will be assessed using a portable spirometer (MIR Spirobank II) according to ATS/ERS criteria. FEV1/FVC will be recorded as applicable in absolute values and/or percentage of predicted values

  33. Pulmonary Function-FEV1/FVC

    Time frame: at 3-month follow-up after completion of the intervention

    Pulmonary function will be assessed using a portable spirometer (MIR Spirobank II) according to ATS/ERS criteria. FEV1/FVC will be recorded as applicable in absolute values and/or percentage of predicted values

  34. Pulmonary Function-PEF

    Time frame: Baseline

    Pulmonary function will be assessed using a portable spirometer (MIR Spirobank II) according to ATS/ERS criteria. PEF will be recorded as applicable in absolute values and/or percentage of predicted values

  35. Pulmonary Function-PEF

    Time frame: at the end of the 8-week intervention

    Pulmonary function will be assessed using a portable spirometer (MIR Spirobank II) according to ATS/ERS criteria. PEF will be recorded as applicable in absolute values and/or percentage of predicted values

  36. Pulmonary Function-PEF

    Time frame: at 3-month follow-up after completion of the intervention

    Pulmonary function will be assessed using a portable spirometer (MIR Spirobank II) according to ATS/ERS criteria. PEF will be recorded as applicable in absolute values and/or percentage of predicted values

  37. Pulmonary Function-FEF25-75%

    Time frame: Baseline

    Pulmonary function will be assessed using a portable spirometer (MIR Spirobank II) according to ATS/ERS criteria. FEF25-75% will be recorded as applicable in absolute values and/or percentage of predicted values

  38. Pulmonary Function-FEF25-75%

    Time frame: at the end of the 8-week intervention

    Pulmonary function will be assessed using a portable spirometer (MIR Spirobank II) according to ATS/ERS criteria. FEF25-75% will be recorded as applicable in absolute values and/or percentage of predicted values

  39. Pulmonary Function-FEF25-75%

    Time frame: at 3-month follow-up after completion of the intervention

    Pulmonary function will be assessed using a portable spirometer (MIR Spirobank II) according to ATS/ERS criteria. FEF25-75% will be recorded as applicable in absolute values and/or percentage of predicted values

  40. Pulmonary Function-vital capacity (VC)

    Time frame: Baseline

    Pulmonary function will be assessed using a portable spirometer (MIR Spirobank II) according to ATS/ERS criteria. Vital capacity (VC) will be recorded as applicable in absolute values and/or percentage of predicted values

  41. Pulmonary Function-vital capacity (VC)

    Time frame: at the end of the 8-week intervention

    Pulmonary function will be assessed using a portable spirometer (MIR Spirobank II) according to ATS/ERS criteria. Vital capacity (VC) will be recorded as applicable in absolute values and/or percentage of predicted values

  42. Pulmonary Function-vital capacity (VC)

    Time frame: at 3-month follow-up after completion of the intervention

    Pulmonary function will be assessed using a portable spirometer (MIR Spirobank II) according to ATS/ERS criteria. Vital capacity (VC) will be recorded as applicable in absolute values and/or percentage of predicted values

Study contacts

Contact information is provided by the study sponsor or research team.

Barış Gürpınar, Assoc. Prof

CONTACT

[email protected]

00902322792525

Sponsors and collaborators

Lead sponsor

Izmir University of Economics

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

Comparison of the Effects of Land- and Water-Based Exercise on Symptoms and Inflammatory Gene Expression in Individuals With Axial Spondyloarthritis

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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