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A multimodal study of the effect of exercise intervention on osteoarthritis: from Mendelian randomization to clinical empirical exploration in traditional Chinese medicine

Registration number：

ITMCTR2025000409

Date of Last Refreshed on：

2025-02-25

Date of Registration：

2025-02-25

Registration Status：

Prospective registration

Public title：

A multimodal study of the effect of exercise intervention on osteoarthritis: from Mendelian randomization to clinical empirical exploration in traditional Chinese medicine

English Acronym：

Scientific title：

A multimodal study of the effect of exercise intervention on osteoarthritis: from Mendelian randomization to clinical empirical exploration in traditional Chinese medicine

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Zengtao

Study leader：

Zengtao

Applicant telephone：

+86 18826415548

Study leader's telephone：

+86 18826415548

Applicant Fax：

Study leader's fax：

Applicant E-mail：

649204970@qq.com

Study leader's E-mail：

649204970@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

4-1-502 Shuiyue Xinyuan West District Zhongshan City Guangdong Province

Study leader's address：

4-1-502 Shuiyue Xinyuan West District Zhongshan City Guangdong Province

Applicant postcode：

528400

Study leader's postcode：

528400

Applicant's institution：

Zhongshan Hospital of Traditional Chinese Medicine Affiliated to Guangzhou University of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2024ZSZY-LL-KY-289(00)

Approved file of Ethical Committee：

View

Name of the ethic committee：

Zhongshan Hospital of Traditional Chinese Medicine Ethics Committee

Date of approved by ethic committee：

2024/11/27 0:00:00

Contact Name of the ethic committee：

Zhangliyu

Contact Address of the ethic committee：

Zhongshan Hospital of Traditional Chinese Medicine No. 3 Kangxin Road West District Zhongshan City

Contact phone of the ethic committee：

0760-89980301

Contact email of the ethic committee：

zsszyyllwyh@163.com

Primary sponsor：

Zhongshan Hospital of Traditional Chinese Medicine Affiliated to Guangzhou University of Traditional Chinese Medicine

Primary sponsor's address：

Zhongshan Hospital of Traditional Chinese Medicine No. 3 Kangxin Road West District Zhongshan City

Secondary sponsor：

Country：

China

Province：

Guangdong

City：

Zhongshan

Institution
hospital：

Zhongshan Hospital of Traditional Chinese Medicine Affiliated to Guangzhou University of Traditional Chinese Medicine

Address：

Zhongshan Hospital of Traditional Chinese Medicine No. 3 Kangxin Road West District Zhongshan City

Source(s) of funding：

2024 Zhongshan Traditional Chinese Medicine inheritance and innovation development research special support

Target disease：

osteoarthritis

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

Osteoarthritis is a chronic degenerative bone and joint disease with a high disability rate. Non-drug therapy plays an important role in the recommendation of various treatment guidelines. Studies have shown that exercise therapy is an important non-drug intervention for patients with osteoarthritis. Taijiquan and Baduanjin are traditional sports exercises in China. Their movement takes joints as the core which can train muscles and bones outside nourish mind inside promote qi and blood circulation and smooth meridians. Therefore the main purpose of this study was to explore the role of traditional exercise therapy in the treatment of osteoarthritis.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) Age ≥60 years old; (2) Patients with knee osteoarthritis who meet the diagnostic criteria of osteoarthritis in the "Chinese Guidelines for the Diagnosis and Treatment of Osteoarthritis (2024 edition)" of the Chinese Academy of Osteology; (3) The pain symptoms appeared for more than three months and the knee pain score was 0 < VAS pain score < 7; Mild to moderate patients with Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores (0-240) ≤120; (4) clear consciousness normal cognitive function able to communicate normally in writing or language; (5) can walk independently without the aid of tools and can complete the appropriate amount of exercise by themselves; (6) Voluntarily participate in this study and sign the informed consent.

Exclusion criteria：

(1) suffering from serious underlying diseases such as heart failure and malignant tumors; (2) severe depression and other mental diseases cancer patients and can not cooperate; (3) Patients with a history of trauma or ligament injury and relevant joint replacement within 6 months; (4) Patients with severe joint deformity and patients with acute inability to exercise; (5) Drugs or physical therapy for over-the-knee OA within one month; (6) Patients who are currently receiving other regular exercise (i.e. at least 30 minutes per day/week at least 3 days per week).

Study execute time：

From 2025-06-01

To      2026-06-30

Recruiting time：

From 2025-06-01

To      2026-06-30

Interventions：

40

Group：

baduanjin group

Sample size：

Intervention：

baduanjin exercise

Intervention code：

40

Group：

Health education group

Sample size：

Intervention：

Health education

Intervention code：

40

Group：

Tai chi group

Sample size：

Intervention：

tai chi exercise

Intervention code：

Total sample size ： 120

Countries of recruitment
and research settings：

Country：

China

Province：

Guangdong

City：

Zhongshan

Institution/hospital：

Zhongshan Hospital of Traditional Chinese Medicine Affiliated to Guangzhou University of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Outcomes：

Outcome：

WOMAC (Western Ontario and McMaster Universities Arthritis Index (knee osteoarthritis index)

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Berg balance scale

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

six minutes walking ability test

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Health Survey Short Form (SF-36)

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Not yet recruiting

60
Min age years
85
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

Block group random. Doctor Zengtao were divided into Taijiquan group baduanjin group and control group by random number list.

Blinding：

IPD sharing：

No

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

None

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

Case Record Form

Data Managemen Committee：

Not yet

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

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