Traditional Chinese Yijinjing Exercise on Hand Dysfunction in Rheumatoid Arthritis Patients

Not Applicable

• Conditions: YiJinJing Exercise; Randomized Controlled Trial; Rheumatoid Arthritis; Hand Function
• Interventions: Behavioral: Yi Jin Jing exercise

• Registration Number: NCT05527158
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.

Study Timeline

• Study Start: 2021-11-01
• Status Verified: 2022-08
• Study First Submitted: 2022-08-28
• Study First Submitted QC: 2022-08-30
• Last Update Submitted: 2022-08-30
• Study First Posted: 2022-09-02
• Last Update Posted: 2022-09-02
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yi Jin Jing exercise	Yi Jin Jing exercise	Yi Jin Jing exercise three times per week for 12 weeks. Each exercise lasts an hour and consists of three fundamental Yijinjing exercises.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Pain Visual Analogue Scale	week 12	0 signifying "no pain" and 10 signifying "the worst intolerable agony"
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.
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.
Morning stiffness duration	week 12	The time (minutes) of the patient's self-reported morning stiffness
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 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.
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(°).
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).

Trial Locations

Locations (1)

Guang'anmen Hospital, China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, China