Axial Spondyloarthritis and Ankylosing SpondylitisNCT07833033
Effects of Land- and Water-Based Exercise in Axial Spondyloarthritis
A study testing Land-Based Combined Exercise Program, Aquatic Combined Exercise Program and Home Exercise Program in people with Axial Spondyloarthritis and Ankylosing Spondylitis, run by Izmir University of Economics at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Axial Spondyloarthritis and Ankylosing Spondylitis
- What is being tested?
- Land-Based Combined Exercise Program, Aquatic Combined Exercise Program and Home Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2026to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Izmir University of Economics
Izmir
Barış Gürpınar, 00902322792525, baris.gurpinar@izmirekonomi.edu.tr
About this study
Official title: 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.
- Being tested
- Land-Based Combined Exercise Program, Aquatic Combined Exercise Program, Home Exercise Program
- Medical subject headings
- Axial Spondyloarthritis, Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Land-Based Combined Exercise ProgramBehavioural
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 ProgramBehavioural
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 ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Land-Based Exercise Group | Experimental | 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. Receives: Behavioral: Land-Based Combined Exercise Program |
| Aquatic Exercise Group | Experimental | 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. Receives: Behavioral: Aquatic Combined Exercise Program |
| Control Group | Active comparator | 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. Receives: Behavioral: Home Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Activity
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.
Measured: Baseline
Disease Activity
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.
Measured: at the end of the 8-week intervention
Disease Activity
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.
Measured: at 3-month follow-up after completion of the intervention
Secondary outcomes (42)
Inflammatory Cytokine Levels
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.
Measured: Baseline
Inflammatory Cytokine Levels
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.
Measured: at the end of the 8-week intervention
Inflammatory Cytokine Levels
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.
Measured: at 3-month follow-up after completion of the intervention
Inflammation-Related Gene Expression in PBMCs
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
Measured: Baseline
Inflammation-Related Gene Expression in PBMCs
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
Measured: at the end of the 8-week intervention
Inflammation-Related Gene Expression in PBMCs
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
Measured: at 3-month follow-up after completion of the intervention
BASFI - Functional Status
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.
Measured: Baseline
BASFI - Functional Status
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.
Measured: at the end of the 8-week intervention
BASFI - Functional Status
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.
Measured: at 3-month follow-up after completion of the intervention
BASMI - Spinal Mobility
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.
Measured: Baseline
BASMI - Spinal Mobility
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.
Measured: at the end of the 8-week intervention
BASMI - Spinal Mobility
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.
Measured: at 3-month follow-up after completion of the intervention
Static Postural Balance
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.
Measured: Baseline
Static Postural Balance
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.
Measured: at the end of the 8-week intervention
Static Postural Balance
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.
Measured: at 3-month follow-up after completion of the intervention
Pulmonary Function-FEV1
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
Measured: Baseline
Pulmonary Function-FEV1
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
Measured: at the end of the 8-week intervention
Pulmonary Function-FVC
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
Measured: baseline
Leg Muscle Strength
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).
Measured: Baseline
Leg Muscle Strength
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).
Measured: at the end of the 8-week intervention
Leg Muscle Strength
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).
Measured: at 3-month follow-up after completion of the intervention
Back Muscle Strength
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).
Measured: Baseline
Back Muscle Strength
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).
Measured: at the end of the 8-week intervention
Back Muscle Strength
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).
Measured: at 3-month follow-up after completion of the intervention
ASQoL - Quality of Life
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.
Measured: Baseline
ASQoL - Quality of Life
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.
Measured: at the end of the 8-week intervention
ASQoL - Quality of Life
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.
Measured: at 3-month follow-up after completion of the intervention
Pulmonary Function-FEV1
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
Measured: at 3-month follow-up after completion of the intervention
Pulmonary Function-FVC
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
Measured: at the end of the 8-week intervention
Pulmonary Function-FVC
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
Measured: at 3-month follow-up after completion of the intervention
Pulmonary Function-FEV1/FVC
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
Measured: Baseline
Pulmonary Function-FEV1/FVC
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
Measured: at the end of the 8-week intervention
Pulmonary Function-FEV1/FVC
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
Measured: at 3-month follow-up after completion of the intervention
Pulmonary Function-PEF
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
Measured: Baseline
Pulmonary Function-PEF
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
Measured: at the end of the 8-week intervention
Pulmonary Function-PEF
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
Measured: at 3-month follow-up after completion of the intervention
Pulmonary Function-FEF25-75%
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
Measured: Baseline
Pulmonary Function-FEF25-75%
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
Measured: at the end of the 8-week intervention
Pulmonary Function-FEF25-75%
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
Measured: at 3-month follow-up after completion of the intervention
Pulmonary Function-vital capacity (VC)
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
Measured: Baseline
Pulmonary Function-vital capacity (VC)
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
Measured: at the end of the 8-week intervention
Pulmonary Function-vital capacity (VC)
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
Measured: at 3-month follow-up after completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axial Spondyloarthritis and Ankylosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir University of Economics
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Barış Gürpınar, Izmir University of Economics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833033
- Sponsor's protocol ID
- İEU_SYY_7
- Status last verified
- Aug 2026
- First submitted
- 11 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to ethical and participant confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Land- and Water-Based Exercise on Symptoms and Inflammatory Gene Expression in Individuals With Axial Spondyloarthritis
- ClinicalTrials.gov ID
- NCT07833033
- Acronym / sponsor ID
- İEU_SYY_7
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Izmir University of EconomicsUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Land-Based Exercise Group | Experimental | Behavioral: Land-Based Combined Exercise ProgramParticipants 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. |
| Aquatic Exercise Group | Experimental | Behavioral: Aquatic Combined Exercise ProgramParticipants 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. |
| Control Group | Active comparator | Behavioral: Home Exercise ProgramParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Land-Based Combined Exercise ProgramParticipants 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. | Behavioural | Land-Based Exercise Group |
| Aquatic Combined Exercise ProgramParticipants 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. | Behavioural | Aquatic Exercise Group |
| Home Exercise ProgramParticipants 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. | Behavioural | Control Group |
Primary outcome
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.
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.
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.
42 secondary outcomes
Inflammatory Cytokine Levels
Time frame: Baseline
Inflammatory Cytokine Levels
Time frame: at the end of the 8-week intervention
Inflammatory Cytokine Levels
Time frame: at 3-month follow-up after completion of the intervention
Inflammation-Related Gene Expression in PBMCs
Time frame: Baseline
Inflammation-Related Gene Expression in PBMCs
Time frame: 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
BASFI - Functional Status
Time frame: Baseline
BASFI - Functional Status
Time frame: at the end of the 8-week intervention
BASFI - Functional Status
Time frame: at 3-month follow-up after completion of the intervention
BASMI - Spinal Mobility
Time frame: Baseline
BASMI - Spinal Mobility
Time frame: at the end of the 8-week intervention
BASMI - Spinal Mobility
Time frame: at 3-month follow-up after completion of the intervention
Static Postural Balance
Time frame: Baseline
Static Postural Balance
Time frame: at the end of the 8-week intervention
Static Postural Balance
Time frame: at 3-month follow-up after completion of the intervention
Pulmonary Function-FEV1
Time frame: Baseline
Pulmonary Function-FEV1
Time frame: at the end of the 8-week intervention
Pulmonary Function-FVC
Time frame: baseline
Leg Muscle Strength
Time frame: Baseline
Leg Muscle Strength
Time frame: at the end of the 8-week intervention
Leg Muscle Strength
Time frame: at 3-month follow-up after completion of the intervention
Back Muscle Strength
Time frame: Baseline
Back Muscle Strength
Time frame: at the end of the 8-week intervention
Back Muscle Strength
Time frame: at 3-month follow-up after completion of the intervention
ASQoL - Quality of Life
Time frame: Baseline
ASQoL - Quality of Life
Time frame: at the end of the 8-week intervention
ASQoL - Quality of Life
Time frame: 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-FVC
Time frame: 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-FEV1/FVC
Time frame: Baseline
Pulmonary Function-FEV1/FVC
Time frame: 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-PEF
Time frame: Baseline
Pulmonary Function-PEF
Time frame: 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-FEF25-75%
Time frame: Baseline
Pulmonary Function-FEF25-75%
Time frame: 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-vital capacity (VC)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No. IPD will not be shared due to ethical and participant confidentiality considerations.
Related trials for Axial Spondyloarthritis and Ankylosing Spondylitis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
Identification of Serum Level of Glutathione Peroxidase 4
Spondyloarthropathy
Not yet recruitingPhase 1
A Study of GKL-006Allo Injection in Patients With Ankylosing Spondylitis
Ankylosing Spondylitis
Active, not recruitingObservational study
Neuropathic Spinal Pain in Ankylosing Spondylitis
Ankylosing Spondylitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Land-Based Combined Exercise Program, Aquatic Combined Exercise Program and Home Exercise Program in people with Axial Spondyloarthritis and Ankylosing Spondylitis, run by Izmir University of Economics at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barış Gürpınar, Assoc. Prof (00902322792525, baris.gurpinar@izmirekonomi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Activity (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.