Traditional Chinese Yijinjing Exercise on Hand Dysfunction in Rheumatoid Arthritis Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Impact of Traditional Chinese Yijinjing Exercise on Hand Dysfunction in Rheumatoid Arthritis Patients:a Randomized Controlled Trial Protocol

Conditions
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Rheumatoid Arthritis, YiJinJing Exercise, Hand Function, Randomized Controlled Trial

Intervention / Treatment
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* Behavioral: Yi Jin Jing exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 DAS28≤3.2 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yi Jin Jing exercise<br>Yi Jin Jing exercise three times per week for 12 weeks. Each exercise lasts an hour and consists of three fundamental Yijinjing exercises. | Behavioral: Yi Jin Jing exercise<br>* Yi Jin Jing of The General Administration of Sport of China, which consists of twelve operational processes as the standard intervention<br>|
| No Intervention: Routine care<br>routine joint rehabilitation guidance, such as joint energy conservation and joint protection, basic daily activities without additional exercise. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Michigan Hand Outcomes Questionnaire (MHQ) | 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. | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Visual Analogue Scale | 0 signifying no pain and 10 signifying the worst intolerable agony | week 12 | 
| The number of swollen joints, painful joints, and deformed joints | Number of the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal- phalangeal I-V, proximal interphalangeal I-V and knees which are swollen, painful or deformed. | week 12 | 
| Morning stiffness duration | The time (minutes) of the patient's self-reported morning stiffness | week 12 | 
| Handgrip strength | An electronic gripper will be used to assess handgrip strength (kg). Be carried out three times, the final result set by the average value. | week 12 | 
| Range of motion(ROM) | Use a protractor to calculate the wrist flexion, dorsiflexion, ulnar deviation, radial deviation, MCP flexion, PIP flexion, and finger dorsiflexion angles(°). | week 12 | 
| Health Assessment Questionnaire Disability Index(HAQ) | Health Assessment Questionnaire Disability Index(HAQ) contains 20 questions about daily activities such as dressing, brushing, getting up, eating, strolling, maintaining personal hygiene, touching, and holding. For each question, there is a four level that is scored from 0 (without any difficulty) to 3 (unable to do). | week 12 | 
| The Self-rating anxiety scale (SAS) | The Self-rating Anxiety Scale (SAS) mainly consists of 20 items rated on a 4-point scale that from 0(no or little time) to 3(most or all of time). | week 12 | 
| The self-rating depression scale (SDS) | The Self-rating Anxiety Scale (SAS) mainly consists of 20 items rated on a 4-point scale that from 0(no or little time) to 3(most or all of time). | week 12 | 
| Wrist joint ultrasonography Outcome Measures in Rheumatology (OMERACT) score | Using the EULAR-OMERACT to classify rheumatoid arthritis synovitis and tenosynovitis. | week 12 |