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The effect of Taichi on KOA patients and the effect of resting state brain functional connectivity

Registration number：

ITMCTR2024000639

Date of Last Refreshed on：

2024-11-03

Date of Registration：

2024-11-03

Registration Status：

Prospective registration

Public title：

The effect of Taichi on KOA patients and the effect of resting state brain functional connectivity

English Acronym：

Scientific title：

The effect of Taichi on KOA patients and the effect of resting state brain functional connectivity

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Yue Hongyu

Study leader：

Yao Fei

Applicant telephone：

+86 15700066813

Study leader's telephone：

+86 13585975106

Applicant Fax：

Study leader's fax：

Applicant E-mail：

yhy03040506@163.com

Study leader's E-mail：

doctoryaofei@126.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

271 Middle Zhijiang Road, Jingan District, Shanghai, China

Study leader's address：

274 Middle Zhijiang Road, Jingan District, Shanghai, China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Shanghai Municipal Hospital of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2024SHL-KY-13-01

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics committee Shanghai Municipal Hospital of Traditional Chinese Medicine

Date of approved by ethic committee：

2024/2/7 0:00:00

Contact Name of the ethic committee：

Ling Li

Contact Address of the ethic committee：

274 Middle Zhijiang Road, Jingan District, Shanghai, China

Contact phone of the ethic committee：

021-56628310

Contact email of the ethic committee：

shszyyyyec@126.com

Primary sponsor：

Shanghai Municipal Hospital of Traditional Chinese Medicine

Primary sponsor's address：

274 Middle Zhijiang Road Jingan District Shanghai China

Secondary sponsor：

Country：

China

Province：

Shanghai

City：

Institution
hospital：

Shanghai Municipal Hospital of Traditional Chinese Medicine

Address：

274 Middle Zhijiang Road Jingan District Shanghai China

Source(s) of funding：

Future Plan for Traditional Chinese Medicine development of Science and Technology of Shanghai Municipal Hospital of Traditional Chinese Medicine

Target disease：

Knee Osteoarthritis

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

Validation of the Therapeutic Efficacy of Taichi in KOA Patients and Exploration of its Impact on Resting-State Brain Functional Connectivity

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1. Meet the diagnostic criteria of KOA set by American College of Rheumatology; 2. Male or female patients aged 40 years or older; 3. Mild to moderate radiographic medial tibiofemoral osteoarthritis (Kellgren - Lawrence score from 1 to 3 in at least one knee; 4. WOMAC pain score >= 40 (visual analog version range from 0 to 100 higher indicating more pain) on at least one of five questions for at least 1 month; 5.Volunteer to participate in the trial and provide written informed consent form. 6. right-handed; 7. Routine cranial magnetic resonance imaging examination showed no abnormality.

Exclusion criteria：

1. History of knee surgery or combined with tumor tuberculosis osteomyelitis in knee joints; 2. Arthroscopy in the past 6 months or intra-articular injection of steroid or hyaluronic acid in the past 3 months; 3. Major medical or physical conditions determined by doctors to preclude exercise including serious acute or chronic organic diseases of cardiovascular hepatic renal cerebrovascular and hematopoietic systems recent stroke psychiatric disease active cancer; 4. Have participated in strength training more than 30 minutes per week in the past 3 months; 5. Have participated in other clinic trials in the past 4 weeks. 6. Patients with contraindications to MRI scanning (patients with pacemakers prosthetic heart valves or various metal implants); 7. Patients with claustrophobia.

Study execute time：

From 2024-11-01

To      2026-02-28

Recruiting time：

From 2024-11-15

To      2025-12-01

Interventions：

15

Group：

Control group

Sample size：

Intervention：

Attention control

Intervention code：

15

Group：

Treatment group

Sample size：

Intervention：

Tai Chi

Intervention code：

Total sample size ： 30

Countries of recruitment
and research settings：

Country：

China

Province：

Shanghai

City：

Institution/hospital：

Shanghai Municipal Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Outcomes：

Outcome：

rfMRI

Type：

Secondary indicator

Measure time point of outcome：

baseline week 12

Measure method：

Outcome：

Dosage of NSAIDs

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

the change in WOMAC pain subscale between baseline and week 12

Type：

Primary indicator

Measure time point of outcome：

baseline， week 12

Measure method：

Outcome：

WOMAC pain, stiffness, physical function subscales and the total score

Type：

Secondary indicator

Measure time point of outcome：

baseline week 6 week 12 week 18

Measure method：

Outcome：

DASS-21

Type：

Secondary indicator

Measure time point of outcome：

baseline, week 6, week 12, week 18

Measure method：

Outcome：

SF-36

Type：

Secondary indicator

Measure time point of outcome：

baseline, week 6, week 12, week 18

Measure method：

Collecting sample(s)
from participants：

Not yet recruiting

40
Min age years
80
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

An independent statistician will use SPSS (version 26.0) to conduct randomization grouping randomly assigning eligible depression patients into the study and control groups.

Blinding：

Due to nature of interventions instructors and participants will not be blinded to the group allocations. The study coordinator will be responsible for informing participants of randomized results and arranging the schedule of interventions. The data managers statisticians evaluators will all be blinded to the group allocation throughout the entire procedure to minimize the risk of bias.

IPD sharing：

Yes

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

contact the researcher for the original data within 6 months after the trial is completed

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

CRF

Data Managemen Committee：

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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