The Impact of Traditional Chinese Yijinjing Exercise on Hand Dysfunction in Rheumatoid Arthritis Patients:a Randomized Controlled Trial Protocol
试验速览
- 阶段
- 不适用
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- The Michigan Hand Outcomes Questionnaire (MHQ)
研究概览
简要总结
This study is a single-blinded, randomized, parallel controlled trial.The purpose of this experiment is to confirm how "Yijinjing" treatment affects hand function, handgrip strength, pain, morning stiffness, and mood disorder in RA patients compared to routine care.
详细描述
To compare the efficacy of Traditional Chinese Exercise Yijinjing and routine care on hand dysfunction,which is the clinical challenge in rheumatoid arthritis (RA), a single- centre,single-blinded, randomized controlled trial will be conducted. Sixty-six RA patients will be randomly allocated (1:1) to treatment with Yijinjing exercise or routine care. The primary outcome is a 10% improvement in the Michigan Hand Outcomes Questionnaire (MHQ) at week 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •meet the RA criteria by the American College of Rheumatology(ACR)/the European League Against Rheumatism(EULAR) in 2010 or the ACR in 1987
- •between the ages of 18 and 65, regardless of gender
- •joint function in grades I to II or X-ray in stages I to II
- •no use or maintenance of a stable dose of DMARDs, biological agents, or hormones within 4 weeks prior to screening
- •wrist joints or finger joints (MCP, PIP) were swollen or painful
- •tested for hand dysfunction by a professional rheumatologist
- •volunteer to participate
排除标准
- •Yijinjing exercise experience within the last 3 months
- •severe joint deformity (including subluxation and severe ulnar deviation) and joint ankylosis
- •other diseases affecting limb function such as trauma, fractures, infections, tumors, congenital malformations
- •present with complication diseases such as serious cardiovascular, brain, liver, lung, kidney, and hematopoietic system diseases
- •a moderate or severe cognitive impairment that unable to cooperate with the treatment
- •unwilling to join
结局指标
主要结局
The Michigan Hand Outcomes Questionnaire (MHQ)
时间窗: week 12
The Michigan Hand Outcomes Questionnaire(MHQ) consists of 37 questions about six categories:(1) overall hand function; (2) activities of daily living; (3) work performance; (4) pain; (5) aesthetics; and (6) patient satisfaction with hand function, measured individually for the left and right hands. Each item is given a value between 0 and 100, with higher scores indicating superior function and higher pain ratings denoting more intense pain.
次要结局
- Pain Visual Analogue Scale(week 12)
- Handgrip strength(week 12)
- The self-rating depression scale (SDS)(week 12)
- Wrist joint ultrasonography Outcome Measures in Rheumatology (OMERACT) score(week 12)
- Morning stiffness duration(week 12)
- The Self-rating anxiety scale (SAS)(week 12)
- The number of swollen joints, painful joints, and deformed joints(week 12)
- Range of motion(ROM)(week 12)
- Health Assessment Questionnaire Disability Index(HAQ)(week 12)
研究者
Quan Jiang
MD, PhD, Professor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences