Efficacy and Safety of a 12-Week Taekwondo Training Program in Patients With Ankylosing Spondylitis and Axial Spondyloarthritis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 3
- 主要终点
- Ankylosing Spondylitis Disease Activity Score (ASDAS)
研究概览
简要总结
The goal of this clinical trial is to learn if Taekwondo training works to help adults with ankylosing spondylitis and axial spondyloarthritis. It will also learn about the safety of Taekwondo training for these adults.
The main questions are as follows:
- Will Taekwondo training affect disease activity, functional improvement, and quality of life?
- Will there be a difference between adults who participate in Taekwondo training and adults who continue with their usual treatment?
- Is Taekwondo training safe for adults with ankylosing spondylitis and axial spondyloarthritis, and will it be an appropriate exercise for these adults?
- Is there a possibility to develop a structured Taekwondo-based exercise program for adults with musculoskeletal disorders?
Participants will:
- Be a part of the Taekwondo training group or the control group for 12 weeks (where the control group will later participate in the same 12 week Taekwondo for comparison)
- Be assessed within 2 weeks before the start of the training
- Be assessed within 1 week after completing the training
详细描述
This study is designed as a single-blind, parallel-group, exploratory pilot randomized controlled trial to evaluate the efficacy and safety of a 12-week Taekwondo training program in patients with ankylosing spondylitis and axial spondyloarthritis.
1) Total Taekwondo Intervention Period: 24 Weeks
- Initial 12 weeks: Comparison between the Taekwondo training group and the control group in an RCT.
- Post-RCT 12 weeks: The control group receives the same Taekwondo training, allowing for a pre- and post-intervention comparison.
2) Assessment Time Points
- Baseline (Pre-Intervention): Within 2 weeks before the start of the 12-week Taekwondo training.
- End of RCT (Post-Intervention): Within 1 week after completing the initial 12-week Taekwondo training.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with axial spondyloarthritis (axSpA) according to the ASAS classification criteria.
- •Age: Between 19 and 59 years old.
- •Stable medication or non-medication treatment:
- •Patients whose medication regimen has remained stable for at least the past 3 months.
- •Patients who have not taken medication for axSpA for at least the past 3 months.
排除标准
- •Participants will be excluded from the study if they meet any of the following conditions:
- •History of orthopedic surgery or fractures within the past 12 months.
- •History of cardiovascular diseases, including ischemic heart disease, cardiomyopathy, heart failure, or stroke.
- •Advanced ankylosis in ankylosing spondylitis, as confirmed by radiographic or CT imaging:
- •- Complete ankylosis of at least two regions of the cervical, lumbar, or thoracic spine (i.e., continuous syndesmophyte formation or complete ossification between vertebral bodies).
- •Presence of other musculoskeletal abnormalities or conditions that may limit exercise performance.
- •Diagnosis of cancer within the past 5 years
- •Regular exercise participation within the past 6 months (defined as exercising for at least 60 minutes per session, three or more times per week).
- •Major changes in medication for axial spondyloarthritis during the study period, including:
- •Initiation or discontinuation of biologic agents or targeted therapies.
- •Significant changes in the continued use of NSAIDs or sulfasalazine.
- •Significant changes in the continued use of systemic glucocorticoids.
研究组 & 干预措施
Taekwondo training group
Participants will undergo a 12-week Taekwondo training program, consisting of three 60-minute sessions per week.
干预措施: 12-week Taekwondo training (Other)
Control group
Participants will maintain their usual daily activities for 12 weeks without any structured exercise intervention.
结局指标
主要结局
Ankylosing Spondylitis Disease Activity Score (ASDAS)
时间窗: Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)
The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a composite index that quantifies disease activity in axial spondyloarthritis, incorporating C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR) along with patient-reported outcomes. ASDAS is a continuous measure, with higher scores indicating greater disease activity. Disease activity is classified as follows: ASDAS \<1.3 (inactive disease), 1.3-2.1 (low activity), 2.1-3.5 (high activity), and \>3.5 (very high activity).
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
时间窗: Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a self-reported questionnaire designed to assess disease activity in axial spondyloarthritis. It consists of six questions evaluating fatigue, spinal pain, joint pain/swelling, areas of localized tenderness, and morning stiffness (duration and severity). Scores range from 0 (no disease activity) to 10 (worst disease activity), with higher scores indicating greater disease activity.
Functional Assessment: Bath Ankylosing Spondylitis Functional Index (BASFI)
时间窗: Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training)
The Bath Ankylosing Spondylitis Functional Index (BASFI) is a self-reported 10-item questionnaire designed to assess functional impairment in patients with axial spondyloarthritis. The questions evaluate activities related to daily living and physical function, including mobility, bending, and the ability to perform tasks. Each item is scored on a 0 to 10 scale, where 0 represents no functional limitation and 10 represents the worst functional limitation. Higher BASFI scores indicate greater functional impairment and worse physical function.
次要结局
- Short Form-12 Health Survey Version 2 (SF-12v2)(Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training))
- Fatigue Severity Scale (FSS)(Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training))
- Ankylosing Spondylitis Quality of Life (ASQoL)(Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training))
- ASAS Health Index (ASAS-HI)(Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training))
- Bath Ankylosing Spondylitis Metrology Index (BASMI)(Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training))
- chest expansion(Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training))
- Numeric Rating Scale (NRS)(Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training))
- Body mass index (BMI)(Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training))
- waist circumference(Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training))
- Korean version of the Center for Epidemiologic Studies Depression Scale - Revised (K-CESD-R)(Baseline (Pre-intervention), Week 12 (after RCT), and Week 24 (after control group Taekwondo training))
研究者
Nam, Seoung Wan
Assistant Professor, Division of Rheumatology, Department of Internal Medicine
Wonju Severance Christian Hospital