Traditional Chinese Yijinjing Exercise on Hand Dysfunction in Rheumatoid Arthritis Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis; Randomized Controlled Trial; Hand Function; YiJinJing Exercise
• Intervention / Treatment: Behavioral: Yi Jin Jing exercise

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 Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: JIANG Quan, M.D; Phone Number: +8613901081632; Email: doctorjq@126.com

Study Locations

• China
  • Beijing, China, 100053
    • Recruiting
    • Guang'anmen Hospital, China Academy of Chinese Medical Sciences
    • Contact: Quan Jiang, M.D; Phone Number: 8613901081632 ext 0; Email: doctorjq@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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
No Intervention: Routine care; routine joint rehabilitation guidance, such as joint energy conservation and joint protection, basic daily activities without additional exercise.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Investigators: Principal Investigator: JIANG Quan, M.D, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: August 28, 2022
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Actual): September 2, 2022
• Last Update Submitted That Met QC Criteria: August 30, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: 52018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No