Rheumatoid ArthritisNCT05527158
Traditional Chinese Yijinjing Exercise on Hand Dysfunction in Rheumatoid Arthritis Patients
A study testing Yi Jin Jing exercise in people with Rheumatoid Arthritis and YiJinJing Exercise, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis, YiJinJing Exercise, Hand Function
- What is being tested?
- Yi Jin Jing exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, 100053
Quan Jiang, M.D, 8613901081632 ext 0, doctorjq@126.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Yi Jin Jing exercise
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yi Jin Jing exerciseBehavioural
Yi Jin Jing of The General Administration of Sport of China, which consists of twelve operational processes as the standard intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 12
Secondary outcomes (9)
Pain Visual Analogue Scale
0 signifying "no pain" and 10 signifying "the worst intolerable agony"
Measured: 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.
Measured: week 12
Morning stiffness duration
The time (minutes) of the patient's self-reported morning stiffness
Measured: 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.
Measured: 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(°).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: week 12
Wrist joint ultrasonography Outcome Measures in Rheumatology (OMERACT) score
Using the EULAR-OMERACT to classify rheumatoid arthritis synovitis and tenosynovitis.
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start1 Nov 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quan Jiang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- JIANG Quan, M.D, Principal investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527158
- Sponsor's protocol ID
- 52018
- Status last verified
- Aug 2022
- First submitted
- 28 Aug 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39588189
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Traditional Chinese Yijinjing Exercise on Hand Dysfunction in Rheumatoid Arthritis Patients:a Randomized Controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT05527158
- Acronym / sponsor ID
- 52018
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yi Jin Jing exercise | Experimental | Behavioral: Yi Jin Jing exerciseYi Jin Jing exercise three times per week for 12 weeks. Each exercise lasts an hour and consists of three fundamental Yijinjing exercises. |
| Routine care | No intervention | –routine joint rehabilitation guidance, such as joint energy conservation and joint protection, basic daily activities without additional exercise. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yi Jin Jing exerciseYi Jin Jing of The General Administration of Sport of China, which consists of twelve operational processes as the standard intervention | Behavioural | Yi Jin Jing exercise |
Primary outcome
The Michigan Hand Outcomes Questionnaire (MHQ)
Time frame: week 12
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.
9 secondary outcomes
Pain Visual Analogue Scale
Time frame: week 12
The number of swollen joints, painful joints, and deformed joints
Time frame: week 12
Morning stiffness duration
Time frame: week 12
Handgrip strength
Time frame: week 12
Range of motion(ROM)
Time frame: week 12
Health Assessment Questionnaire Disability Index(HAQ)
Time frame: week 12
The Self-rating anxiety scale (SAS)
Time frame: week 12
The self-rating depression scale (SDS)
Time frame: week 12
Wrist joint ultrasonography Outcome Measures in Rheumatology (OMERACT) score
Time frame: week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Derived from this study: PubMed 39588189Chang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JIANG Quan, M.D principal investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yi Jin Jing exercise in people with Rheumatoid Arthritis and YiJinJing Exercise, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JIANG Quan, M.D (+8613901081632 ext. 0, doctorjq@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Michigan Hand Outcomes Questionnaire (MHQ) (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05527158, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2022.