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

September 21, 2026 updated by: Barış Gürpınar, Izmir University of Economics

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Land-Based Exercise Group

Participants will receive a supervised, land-based combined exercise program twice weekly for 8 weeks. Each session will include warm-up, high-intensity interval aerobic exercise, breathing combined with mobility exercises, strengthening exercises targeting major muscle groups, and cool-down. Exercise intensity will be monitored using heart rate.
Behavioral: Land-Based Combined Exercise Program

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.
Experimental: Aquatic Exercise Group

Participants will receive a supervised, aquatic combined exercise program twice weekly for 8 weeks in a thermoneutral pool. Each session will include warm-up, high-intensity interval aerobic exercise, breathing combined with mobility exercises, water-resisted strengthening exercises targeting major muscle groups, and cool-down. Exercise intensity will be monitored using heart rate adjusted for water immersion.
Behavioral: Aquatic Combined Exercise Program

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.
Active Comparator: Control Group

Participants will receive education on the effects of physical activity and exercise videos based on home exercise recommendations from the National Axial Spondyloarthritis Society (NASS). The materials will be provided online and in MP4 format, and participants will receive monthly text-message reminders encouraging them to continue the recommended exercises.
Behavioral: Home Exercise Program

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
at the end of the 8-week intervention
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.
at 3-month follow-up after completion of the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
at the end of the 8-week intervention
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.
at 3-month follow-up after completion of the intervention
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
Baseline
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
at the end of the 8-week intervention
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
at 3-month follow-up after completion of the intervention
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.
Baseline
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.
at the end of the 8-week intervention
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.
at 3-month follow-up after completion of the intervention
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.
Baseline
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.
at the end of the 8-week intervention
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.
at 3-month follow-up after completion of the intervention
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.
Baseline
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.
at the end of the 8-week intervention
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.
at 3-month follow-up after completion of the intervention
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
Baseline
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
at the end of the 8-week intervention
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
baseline
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).
Baseline
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).
at the end of the 8-week intervention
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).
at 3-month follow-up after completion of the intervention
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).
Baseline
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).
at the end of the 8-week intervention
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).
at 3-month follow-up after completion of the intervention
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.
Baseline
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.
at the end of the 8-week intervention
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.
at 3-month follow-up after completion of the intervention
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
at 3-month follow-up after completion of the intervention
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
at the end of the 8-week intervention
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
at 3-month follow-up after completion of the intervention
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
Baseline
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
at the end of the 8-week intervention
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
at 3-month follow-up after completion of the intervention
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
Baseline
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
at the end of the 8-week intervention
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
at 3-month follow-up after completion of the intervention
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
Baseline
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
at the end of the 8-week intervention
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
at 3-month follow-up after completion of the intervention
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
Baseline
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
at the end of the 8-week intervention
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
at 3-month follow-up after completion of the intervention

Collaborators and Investigators

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

Sponsor

Izmir University of Economics

Collaborators

The Scientific and Technological Research Council of Turkey

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)

December 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

September 11, 2026

First Submitted That Met QC Criteria

September 21, 2026

First Posted (Actual)

September 22, 2026

Study Record Updates

Last Update Posted (Actual)

September 22, 2026

Last Update Submitted That Met QC Criteria

September 21, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • İEU_SYY_7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared due to ethical and participant confidentiality considerations.

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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