NCT05527158

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P25-P50 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 2, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 2, 2022

Status Verified

August 1, 2022

Enrollment Period

1.1 years

First QC Date

August 28, 2022

Last Update Submit

August 30, 2022

Conditions

Rheumatoid ArthritisYiJinJing ExerciseHand FunctionRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Pain Visual Analogue Scale

    week 12

  • The number of swollen joints, painful joints, and deformed joints

    week 12

  • Morning stiffness duration

    week 12

  • Handgrip strength

    week 12

  • Range of motion(ROM)

    week 12

  • +4 more secondary outcomes

Study Arms (2)

Yi Jin Jing exercise

EXPERIMENTAL

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

Routine care

NO INTERVENTION

routine joint rehabilitation guidance, such as joint energy conservation and joint protection, basic daily activities without additional exercise.

Interventions

Yi Jin Jing exerciseBEHAVIORAL

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

Yi Jin Jing exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • meet the RA criteria by the American College of Rheumatology(ACR)/the European League Against Rheumatism(EULAR) in 2010 or the ACR in 1987
  • between the ages of 18 and 65, regardless of gender
  • DAS28≤3.2
  • joint function in grades I to II or X-ray in stages I to II
  • no use or maintenance of a stable dose of DMARDs, biological agents, or hormones within 4 weeks prior to screening
  • wrist joints or finger joints (MCP, PIP) were swollen or painful
  • tested for hand dysfunction by a professional rheumatologist
  • volunteer to participate

You may not qualify if:

  • Yijinjing exercise experience within the last 3 months
  • severe joint deformity (including subluxation and severe ulnar deviation) and joint ankylosis
  • other diseases affecting limb function such as trauma, fractures, infections, tumors, congenital malformations
  • present with complication diseases such as serious cardiovascular, brain, liver, lung, kidney, and hematopoietic system diseases
  • a moderate or severe cognitive impairment that unable to cooperate with the treatment
  • unwilling to join

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, 100053, China

RECRUITING

Related Publications (1)

  • Chang T, Ma X, Gong X, Xia C, Jiang Q, Zhang R. Effect of traditional Chinese Yijinjing exercise on hand dysfunction in rheumatoid arthritis patients: a randomized controlled trial. Front Med (Lausanne). 2024 Nov 11;11:1454982. doi: 10.3389/fmed.2024.1454982. eCollection 2024.

    PMID: 39588189DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • JIANG Quan, M.D

    Guang'anmen Hospital of China Academy of Chinese Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

JIANG Quan, M.D

CONTACT

+8613901081632doctorjq@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Professor

Study Record Dates

First Submitted

August 28, 2022

First Posted

September 2, 2022

Study Start

November 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

September 2, 2022

Record last verified: 2022-08

Locations

CN(1)