Traditional Chinese Yijinjing Exercise on Hand Dysfunction in Rheumatoid Arthritis Patients

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05527158
• Other study ID #: 52018
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: December 2022

Study information

• Verified date: August 2022
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: JIANG Quan, M.D
• Phone: +8613901081632
• Email: doctorjq[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Hand Function
• Randomized Controlled Trial
• Rheumatoid Arthritis

Intervention

Behavioral:
• Yi Jin Jing exercise
Yi Jin Jing of The General Administration of Sport of China, which consists of twelve operational processes as the standard intervention

Locations

Country	Name	City	State
China	Guang'anmen Hospital, China Academy of Chinese Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain Visual Analogue Scale	0 signifying "no pain" and 10 signifying "the worst intolerable agony"	week 12
Secondary	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
Secondary	Morning stiffness duration	The time (minutes) of the patient's self-reported morning stiffness	week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Wrist joint ultrasonography Outcome Measures in Rheumatology (OMERACT) score	Using the EULAR-OMERACT to classify rheumatoid arthritis synovitis and tenosynovitis.	week 12