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

21 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

50

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Sperimentale: 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.
Comportamentale: 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.
Comparatore attivo: 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.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Disease Activity
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Inflammatory Cytokine Levels
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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%
Lasso di tempo: 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%
Lasso di tempo: 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%
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Izmir University of Economics

Collaboratori

The Scientific and Technological Research Council of Turkey

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 dicembre 2026

Completamento primario (Stimato)

1 ottobre 2027

Completamento dello studio (Stimato)

1 ottobre 2028

Date di iscrizione allo studio

Primo inviato

11 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

21 settembre 2026

Primo Inserito (Effettivo)

22 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 settembre 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • İEU_SYY_7

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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