Effects of Land- and Water-Based Exercise in Axial Spondyloarthritis
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.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Barış Gürpınar, Assoc. Prof
- 전화번호: 00902322792525
- 이메일: baris.gurpinar@izmirekonomi.edu.tr
연구 장소
-
-
-
Izmir, 터키 (Türkiye)
- Izmir University of Economics
-
연락하다:
- Barış Gürpınar
- 전화번호: 00902322792525
- 이메일: baris.gurpinar@izmirekonomi.edu.tr
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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. |
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. |
|
실험적: 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. |
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. |
|
활성 비교기: 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. |
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Disease Activity
기간: 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
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Inflammatory Cytokine Levels
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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%
기간: 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%
기간: 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%
기간: 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)
기간: 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)
기간: 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)
기간: 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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- İEU_SYY_7
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD will not be shared due to ethical and participant confidentiality considerations.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .