Evaluation of the Effects of Aerobic Exercise Therapy on Quality of Life, Functional Capacity, Mood, Fatigue, and Inflammatory Markers in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Rheumatoid Arthritis Quality of Life Questionnaire
研究概览
简要总结
This study aims to evaluate the effects of aerobic exercise therapy on quality of life, functional capacity, mood, and fatigue in patients with rheumatoid arthritis. Additionally, the study investigates the impact of aerobic exercise on inflammatory markers, pain, and disease activity.
详细描述
Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease characterized by joint inflammation, pain, and functional limitations. Exercise therapy is widely used in rehabilitation to improve functional capacity and quality of life in RA patients.
In this study, patients with low disease activity RA will be divided into two groups:
Standard medical treatment + education Standard medical treatment + education + aerobic exercise
The aerobic exercise program will be conducted 5 days per week for 6 weeks. Outcomes including functional capacity (VO2 max), quality of life, fatigue, mood, and inflammatory markers will be assessed before and after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with RA according to ACR/EULAR 2010 criteria
- •Female patients aged 30-70 years
- •Low disease activity (DAS-28 < 3.2)
- •Voluntary participation
排除标准
- •Cardiovascular diseases (CAD, heart failure, etc.)
- •Respiratory diseases
- •Neurological disorders
- •BMI > 35
- •Malignancy
- •Pregnancy or breastfeeding
- •Recent medication change (last 3 months)
- •Musculoskeletal conditions preventing exercise
结局指标
主要结局
Rheumatoid Arthritis Quality of Life Questionnaire
时间窗: Baseline and at the end of 6 weeks (42th day)
RAQoL is a disease-specific instrument consisting of 30 items scored as yes/no. Total scores range from 0 to 30, with higher scores indicating poorer quality of life. The Turkish version has established validity and reliability.
Health Assessment Questionnaire (HAQ)
时间窗: Baseline and at the end of 6 weeks (42th day)
HAQ evaluates functional ability in daily living activities using 20 items. Each item is scored from 0 (no difficulty) to 3 (unable to perform). The final score is calculated as the average of item scores, ranging from 0 to 3, with higher scores indicating worse functional status.
Functional Capacity (Cardiopulmonary Fitness)
时间窗: Baseline and at the end of 6 weeks (42th day)
VO₂ max (mL/kg/min) is measured using cardiopulmonary exercise testing (CPET) on a cycle ergometer. It is considered the gold standard for assessing aerobic capacity.
6-Minute Walk Test (6MWT)
时间窗: Baseline and at the end of 6th week (42th day)
The 6MWT evaluates submaximal exercise capacity. Participants are instructed to walk as far as possible within 6 minutes on a 30-meter corridor. Total walking distance (meters) is recorded. Higher distances indicate better functional capacity.
次要结局
- Beck Depression Inventory (BDI)(Baseline and at the end of 6 weeks (42th day))
- Fatigue Severity Scale (FSS)(Baseline and after 6 weeks)
- Visual analogue Scale for pain(Baseline and at the end of 6th week (42th day))
- Disease Activity Score-28 (DAS-28)(Baseline and at the end of 6 weeks (42th day))
- Inflammatory Markers(Baseline and at the end of 6 weeks (42th day))
- The Rheumatoid Arthritis Quality of Life Questionnaire(Baseline and at the end of 6th weeks (42th day))
研究者
Fatima Yaman
Assoc. Prof.
Kutahya Health Sciences University