Effectiveness of Yoga and Combined Exercise in Female With Rheumatoid Arthritis: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Pain Intensity
研究概览
简要总结
This study aims to elucidate the potential benefits of exercise for individuals with rheumatoid arthritis. The findings are expected to contribute to the development of novel and effective therapeutic approaches, ultimately leading to an improved quality of life for patients. For both patients and healthcare professionals, a clearer understanding of exercise's role in rheumatoid arthritis management will serve as a crucial guide in formulating individualized treatment plans. The results of our study will provide valuable insights to aid in developing strategies aimed at enhancing the physical and mental well-being of individuals afflicted with rheumatoid arthritis.
详细描述
Rheumatoid arthritis (RA) is a chronic inflammatory disease that significantly impacts daily life by causing pain, swelling, and restricted movement in the joints. This study aimed to investigate the effects of yoga and combined exercise methods on the symptoms of RA in individuals with the condition, comparing them to a control group that did not engage in exercise. Participants were comprehensively evaluated at baseline, week 8, and week 20 for key variables such as pain level, balance, joint mobility, depression level, fatigue level, and quality of life. This research seeks to reveal the potential benefits of exercise in RA management, thereby contributing to the development of effective treatment approaches that improve patients' quality of life. The findings will help both patients and healthcare professionals better understand the role of exercise in RA treatment, serving as a crucial guide for creating individualized treatment plans. The results are expected to offer valuable insights for developing strategies to enhance the physical and mental health of individuals with RA.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •diagnosis of RA for at least six months according to the ACR criteria
- •aged between 18-65 years,
- •under stabil medications at least four weeks
- •the disease activity score 28 (DAS 28) <2.6 (Remission period) of each patient at least three months
- •ability to provide written informed consent.
排除标准
- •had pain that prevents general mobility,
- •had neurologic, cardiologic (arrhythmias, myocardial infarction, uncontrolled metabolic disease,
- •known electrolyte abnormalities,
- •systolic BP > 200 mm Hg or diastolic BP > 115 mm Hg)
- •respiratory pathology,
- •pregnancy
- •had malignancy
研究组 & 干预措施
Yoga
The yoga program, led by a physiotherapist who is also a certified yoga instructor , with two sessions per week lasting one hour each. It was applied for a total of 8 weeks.
干预措施: Mind-body therapy (Other)
Combined Exercise
Patients in the exercise group were given a program that included warm-up, low-impact aerobic, strengthening, and cooling phases, totaling 60 minutes, repeated twice a week for eight weeks.
干预措施: Exercise (Other)
Control
No exercise was applied to the subjects included in the control group.
结局指标
主要结局
Pain Intensity
时间窗: From enrollment to the end of treatment at 8 weeks and 20 weeks after baseline
The Visual Analogue Scale (VAS) was used for pain intensity assessment in all patients. The scale is a 10-cm line, with the leftmost part showing no pain and the rightmost part showing maximum pain. Patients were asked to point to the proper place on the line according to the pain they experienced last week. An increase of 20% or above indicates clinical significance in VAS.
次要结局
- Balance Index(From enrollment to the end of treatment at 8 weeks and 20 weeks after baseline)
- Mobility Level(From enrollment to the end of treatment at 8 weeks and 20 weeks after baseline)
- Depression Level(From enrollment to the end of treatment at 8 weeks and 20 weeks later baseline)
- Fatigue Level(From enrollment to the end of treatment at 8 weeks and 20 weeks later baseline)
- Quality of Life Level(From enrollment to the end of treatment at 8 weeks and 20 weeks later baseline)
研究者
Sevtap Günay
Associate Professor Doctor
Izmir Katip Celebi University