Clinical trial NCT05527158: Traditional Chinese Yijinjing Exercise on Hand Dysfunction in Rheumatoid Arthritis Patients
Official title: The Impact of Traditional Chinese Yijinjing Exercise on Hand Dysfunction in Rheumatoid Arthritis Patients:a Randomized Controlled Trial Protocol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
YiJinJing Exercise
Hand Function
Randomized Controlled Trial
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Michigan Hand Outcomes Questionnaire (MHQ)
timeFrame: week 12
Secondary outcomes:
measure: Pain Visual Analogue Scale
timeFrame: week 12
measure: The number of swollen joints, painful joints, and deformed joints
timeFrame: week 12
measure: Morning stiffness duration
timeFrame: week 12
measure: Handgrip strength
timeFrame: week 12
measure: Range of motion(ROM)
timeFrame: week 12
measure: Health Assessment Questionnaire Disability Index(HAQ)
timeFrame: week 12
measure: The Self-rating anxiety scale (SAS)
timeFrame: week 12
measure: The self-rating depression scale (SDS)
timeFrame: week 12
measure: Wrist joint ultrasonography Outcome Measures in Rheumatology (OMERACT) score
timeFrame: week 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: JIANG Quan, M.D
role: PRINCIPAL_INVESTIGATOR
References: