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Traditional Chinese Yijinjing Exercise on Hand Dysfunction in Rheumatoid Arthritis Patients

Primary Purpose

Rheumatoid Arthritis, YiJinJing Exercise, Hand Function

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Yi Jin Jing exercise
Sponsored by
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Guang'anmen Hospital, China Academy of Chinese Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Yi Jin Jing exercise

Routine care

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 28, 2022
Last Updated
August 30, 2022
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05527158
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, YiJinJing Exercise, Hand Function, Randomized Controlled Trial

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Yi Jin Jing exercise
Arm Type
Experimental
Arm Description
Yi Jin Jing exercise three times per week for 12 weeks. Each exercise lasts an hour and consists of three fundamental Yijinjing exercises.
Arm Title
Routine care
Arm Type
No Intervention
Arm Description
routine joint rehabilitation guidance, such as joint energy conservation and joint protection, basic daily activities without additional exercise.
Intervention Type
Behavioral
Intervention Name(s)
Yi Jin Jing exercise
Intervention Description
Yi Jin Jing of The General Administration of Sport of China, which consists of twelve operational processes as the standard intervention
Primary Outcome Measure Information:
Title
The Michigan Hand Outcomes Questionnaire (MHQ)
Description
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.
Time Frame
week 12
Secondary Outcome Measure Information:
Title
Pain Visual Analogue Scale
Description
0 signifying "no pain" and 10 signifying "the worst intolerable agony"
Time Frame
week 12
Title
The number of swollen joints, painful joints, and deformed joints
Description
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.
Time Frame
week 12
Title
Morning stiffness duration
Description
The time (minutes) of the patient's self-reported morning stiffness
Time Frame
week 12
Title
Handgrip strength
Description
An electronic gripper will be used to assess handgrip strength (kg). Be carried out three times, the final result set by the average value.
Time Frame
week 12
Title
Range of motion(ROM)
Description
Use a protractor to calculate the wrist flexion, dorsiflexion, ulnar deviation, radial deviation, MCP flexion, PIP flexion, and finger dorsiflexion angles(°).
Time Frame
week 12
Title
Health Assessment Questionnaire Disability Index(HAQ)
Description
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).
Time Frame
week 12
Title
The Self-rating anxiety scale (SAS)
Description
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).
Time Frame
week 12
Title
The self-rating depression scale (SDS)
Description
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).
Time Frame
week 12
Title
Wrist joint ultrasonography Outcome Measures in Rheumatology (OMERACT) score
Description
Using the EULAR-OMERACT to classify rheumatoid arthritis synovitis and tenosynovitis.
Time Frame
week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JIANG Quan, M.D
Phone
+8613901081632
Ext
0
Email
doctorjq@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JIANG Quan, M.D
Organizational Affiliation
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
City
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quan Jiang, M.D
Phone
8613901081632 ext 0
Email
doctorjq@126.com

12. IPD Sharing Statement

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