Comparison of the Effects of Land- and Water-Based Exercise on Symptoms and Inflammatory Gene Expression in Individuals With Axial Spondyloarthritis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Disease Activity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Land-Based Combined Exercise Program (Behavioral)
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.
干预措施: Aquatic Combined Exercise Program (Behavioral)
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.
干预措施: Home Exercise Program (Behavioral)
结局指标
主要结局
Disease Activity
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Inflammatory Cytokine Levels(Baseline)
- Inflammatory Cytokine Levels(at the end of the 8-week intervention)
- Inflammatory Cytokine Levels(at 3-month follow-up after completion of the intervention)
- Inflammation-Related Gene Expression in PBMCs(Baseline)
- Inflammation-Related Gene Expression in PBMCs(at the end of the 8-week intervention)
- Inflammation-Related Gene Expression in PBMCs(at 3-month follow-up after completion of the intervention)
- BASFI - Functional Status(Baseline)
- BASFI - Functional Status(at the end of the 8-week intervention)
- BASFI - Functional Status(at 3-month follow-up after completion of the intervention)
- BASMI - Spinal Mobility(Baseline)
- BASMI - Spinal Mobility(at the end of the 8-week intervention)
- BASMI - Spinal Mobility(at 3-month follow-up after completion of the intervention)
- Static Postural Balance(Baseline)
- Static Postural Balance(at the end of the 8-week intervention)
- Static Postural Balance(at 3-month follow-up after completion of the intervention)
- Pulmonary Function-FEV1(Baseline)
- Pulmonary Function-FEV1(at the end of the 8-week intervention)
- Pulmonary Function-FVC(baseline)
- Leg Muscle Strength(Baseline)
- Leg Muscle Strength(at the end of the 8-week intervention)
- Leg Muscle Strength(at 3-month follow-up after completion of the intervention)
- Back Muscle Strength(Baseline)
- Back Muscle Strength(at the end of the 8-week intervention)
- Back Muscle Strength(at 3-month follow-up after completion of the intervention)
- ASQoL - Quality of Life(Baseline)
- ASQoL - Quality of Life(at the end of the 8-week intervention)
- ASQoL - Quality of Life(at 3-month follow-up after completion of the intervention)
- Pulmonary Function-FEV1(at 3-month follow-up after completion of the intervention)
- Pulmonary Function-FVC(at the end of the 8-week intervention)
- Pulmonary Function-FVC(at 3-month follow-up after completion of the intervention)
- Pulmonary Function-FEV1/FVC(Baseline)
- Pulmonary Function-FEV1/FVC(at the end of the 8-week intervention)
- Pulmonary Function-FEV1/FVC(at 3-month follow-up after completion of the intervention)
- Pulmonary Function-PEF(Baseline)
- Pulmonary Function-PEF(at the end of the 8-week intervention)
- Pulmonary Function-PEF(at 3-month follow-up after completion of the intervention)
- Pulmonary Function-FEF25-75%(Baseline)
- Pulmonary Function-FEF25-75%(at the end of the 8-week intervention)
- Pulmonary Function-FEF25-75%(at 3-month follow-up after completion of the intervention)
- Pulmonary Function-vital capacity (VC)(Baseline)
- Pulmonary Function-vital capacity (VC)(at the end of the 8-week intervention)
- Pulmonary Function-vital capacity (VC)(at 3-month follow-up after completion of the intervention)
研究者
Barış Gürpınar
Assoc. Prof.
Izmir University of Economics