Hand Function, Randomized Controlled Trial, Rheumatoid Arthritis, YiJinJing Exercise
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALYi Jin Jing exercise
Yi Jin Jing of The General Administration of Sport of China, which consists of twelve operational processes as the standard intervention
Sponsors
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. meet the RA criteria by the American College of Rheumatology(ACR)/the European League Against Rheumatism(EULAR) in 2010 or the ACR in 1987 2. between the ages of 18 and 65, regardless of gender 3. DAS28≤3.2 4. joint function in grades I to II or X-ray in stages I to II 5. no use or maintenance of a stable dose of DMARDs, biological agents, or hormones within 4 weeks prior to screening 6. wrist joints or finger joints (MCP, PIP) were swollen or painful 7. tested for hand dysfunction by a professional rheumatologist 8. volunteer to participate
Exclusion criteria
1. Yijinjing exercise experience within the last 3 months 2. severe joint deformity (including subluxation and severe ulnar deviation) and joint ankylosis 3. other diseases affecting limb function such as trauma, fractures, infections, tumors, congenital malformations 4. present with complication diseases such as serious cardiovascular, brain, liver, lung, kidney, and hematopoietic system diseases 5. a moderate or severe cognitive impairment that unable to cooperate with the treatment 6. unwilling to join
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Michigan Hand Outcomes Questionnaire (MHQ) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of swollen joints, painful joints, and deformed joints | week 12 | 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. |
| Morning stiffness duration | week 12 | The time (minutes) of the patient's self-reported morning stiffness |
| Handgrip strength | week 12 | An electronic gripper will be used to assess handgrip strength (kg). Be carried out three times, the final result set by the average value. |
| Range of motion(ROM) | week 12 | Use a protractor to calculate the wrist flexion, dorsiflexion, ulnar deviation, radial deviation, MCP flexion, PIP flexion, and finger dorsiflexion angles(°). |
| Pain Visual Analogue Scale | week 12 | 0 signifying no pain and 10 signifying the worst intolerable agony |
| The Self-rating anxiety scale (SAS) | week 12 | 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). |
| The self-rating depression scale (SDS) | week 12 | 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). |
| Wrist joint ultrasonography Outcome Measures in Rheumatology (OMERACT) score | week 12 | Using the EULAR-OMERACT to classify rheumatoid arthritis synovitis and tenosynovitis. |
| Health Assessment Questionnaire Disability Index(HAQ) | week 12 | 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). |
Countries
China
Contacts
Primary ContactJIANG Quan, M.D
Outcome results
None listed