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Study on the influence of Tai Chi rehabilitation program on the intervention effect of hypertension patients and its mechanism

Registration number：

ITMCTR2024000813

Date of Last Refreshed on：

2024-12-13

Date of Registration：

2024-12-13

Registration Status：

Retrospective registration

Public title：

Study on the influence of Tai Chi rehabilitation program on the intervention effect of hypertension patients and its mechanism

English Acronym：

Scientific title：

Study on the influence of Tai Chi rehabilitation program on the intervention effect of hypertension patients and its mechanism

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Hui Fang

Study leader：

Shaojun Lyu

Applicant telephone：

+86 17701327499

Study leader's telephone：

+86 137 0120 3670

Applicant Fax：

Study leader's fax：

Applicant E-mail：

fanghuiwonderful@163.com

Study leader's E-mail：

l13121860699@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

19 Xinjiekouwai Avenue Haidian District Beijing China

Study leader's address：

19 Xinjiekouwai Avenue Haidian District Beijing China

Applicant postcode：

100875

Study leader's postcode：

100875

Applicant's institution：

Beijing Normal University

Approved by ethic committee：

Approved No. of ethic committee：

2022011H

Approved file of Ethical Committee：

View

Name of the ethic committee：

Experimental Ethics Committee of College of Physical Education and Sport of Beijing Normal University

Date of approved by ethic committee：

2022/7/1 0:00:00

Contact Name of the ethic committee：

Yunchao Ma

Contact Address of the ethic committee：

19 Xinjiekouwai Avenue Haidian District Beijing China

Contact phone of the ethic committee：

+86 131 6161 5533

Contact email of the ethic committee：

mayunchaoqf@163.com

Primary sponsor：

Beijing Normal University

Primary sponsor's address：

19 Xinjiekouwai Avenue Haidian District Beijing China

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Institution
hospital：

Beijing Normal University

Address：

19 Xinjiekouwai Avenue Haidian District Beijing China

Source(s) of funding：

Introduction of Talents - Wushu and Ethnic Traditional Sports Promotion Research Project Beijing Normal University

Target disease：

Hypertension

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

To use tai Chi regimen to intervene in patients with hypertension and discusses the therapeutic effect of tai chi regimen on patients with hypertension. To provide a new perspective of health promotion for the clinical treatment of patients with hypertension. To provide evidence-based basis for clinical intervention of Taijiquan and to provide a Chinese program of prevention and treatment with traditional health exercises for patients with hypertension.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) Patients with essential hypertension; (2) Patients who meet the diagnostic criteria of grade 1 and 2 Western medicine for hypertension; Grade 1 hypertension is defined as systolic blood pressure of 140-159mmHg and diastolic blood pressure of 90-99mmHg. Grade 2 hypertension is defined as a systolic blood pressure of 160-179 mmHg and a diastolic blood pressure of 100-109 mmHg. (3) Aged 30-70 years old male or female; (4) The subjects can understand the purpose of the clinical trial voluntarily participate in and sign the informed consent.

Exclusion criteria：

(1) Women during pregnancy and breastfeeding; (2)Serious adverse reactions to therapeutic drugs or ineffective drug treatment; (3) Patients with secondary hypertension or refractory hypertension; (4) unable to complete the prescribed exercise program; (5) Patients who participated in other clinical trials or performed regular tai chi exercises within the past 3 months; (6) The investigator judged that the patient had poor compliance and could not complete the clinical trial as required.

Study execute time：

From 2022-08-01

To      2023-05-01

Recruiting time：

From 2022-08-01

To      2023-05-01

Interventions：

30

Group：

Blank Control

Sample size：

Intervention：

The blank control group maintained their daily lifestyle without any regular exercise intervention

Intervention code：

30

Group：

Tai Chi rehabilitation program

Sample size：

Intervention：

The systematic Tai Chi rehabilitation program is composed of four parts: Quanjing Daoru Bafa Wubu of Tai Chi Tai Chi Yunjingong and Tai Chi Songjinggong

Intervention code：

30

Group：

Conventional Exercise rehabilitation program

Sample size：

Intervention：

The systematic Conventional Exercise rehabilitation program is composed of four parts: warm-up exercises, aerobic exercises, resistance exercises, and finishing and relaxation.

Intervention code：

Total sample size ： 90

Countries of recruitment
and research settings：

Country：

China

Province：

Shandong Province

City：

Institution/hospital：

Boshan District Hospital of Traditional Chinese Medicine

Level of the institution：

Secondary A

Country：

China

Province：

Shandong Province

City：

Institution/hospital：

Zibo Wandresher Hospital

Level of the institution：

Tertiary B

Outcomes：

Outcome：

Blood Sugar

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Waist-hip ratio

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Pittsburgh Sleepiness Scale

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Exercise Adherence Self-Rating Scale

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Hormone

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

TCM syndrome scale

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Quality of Life Scale (SCL-90)

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Immune factor

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Basic motor skills

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Montreal Cognitive Assessment Scale

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Blood pressure

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Epigenetic regulation

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

miRNA

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Indicators of intestinal flora and metabolites

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Neurotransmitter

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Heart rate

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Vascular endothelial function

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Grip

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

BMI

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Oxidative stress

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Body composition

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

RAAS system

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Glycolipid metabolism

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Blood

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

Stool

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

Saliva

Tissue：

Fate of sample 

Destruction after use

Note：

Completed

30
Min age years
70
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

Randomization was performed after subjects completed all screening tests and met the inclusion/exclusion criteria as judged by the investigator. Randomization was performed by a third party. Randomization was used to assign subjects to the three study groups in a 1:1:1 ratio. Randomized grouping sequences were generated by the SAS/PLAN process. Each random assignment sequence was sequentially placed into numbered airtight opaque envelopes sealed and stored. After determining the number of the enrolled patients the researcher opened the envelopes according to the corresponding numbers and administered the appropriate treatment to the patients according to the randomized grouping respectively.

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：

None

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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