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

21 września 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

50

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 70 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: 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.
Eksperymentalny: 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.
Behawioralne: 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.
Aktywny komparator: 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.
Behawioralne: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Disease Activity
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Inflammatory Cytokine Levels
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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%
Ramy czasowe: 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%
Ramy czasowe: 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%
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Izmir University of Economics

Współpracownicy

The Scientific and Technological Research Council of Turkey

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 grudnia 2026

Zakończenie podstawowe (Szacowany)

1 października 2027

Ukończenie studiów (Szacowany)

1 października 2028

Daty rejestracji na studia

Pierwszy przesłany

11 września 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

21 września 2026

Pierwszy wysłany (Rzeczywisty)

22 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

22 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

21 września 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • İEU_SYY_7

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

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

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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