Study on the effect and mechanism of three-circle post standing qigong on overweight population based on the theory of

Registration number:

ITMCTR2200006701

Date of Last Refreshed on:

2022-10-12

Date of Registration:

2022-10-12

Registration Status:

Prospective registration

Public title:

Study on the effect and mechanism of three-circle post standing qigong on overweight population based on the theory of

English Acronym:

Scientific title:

Study on the effect and mechanism of three-circle post standing qigong on overweight population based on the theory of

Scientific title acronym:

Study subject ID:

The registration number of the Partner Registry or other register:

ChiCTR2200064599 ; ChiMCTR2200006701

Applicant:

Li Wan

Study leader:

Xianbo Wu

Applicant telephone:

15928677825

Study leader's telephone:

15528084626

Applicant Fax:

Study leader's fax:

Applicant E-mail:

14315444@qq.com

Study leader's E-mail:

10250491@qq.com

Study leader's website(voluntary supply):

Study leader's website
(voluntary supply):

Applicant address:

2 Tiyuan Road, Wuhou District, Chengdu, Sichuan, China

Study leader's address:

2 Tiyuan Road, Wuhou District, Chengdu, Sichuan, China

Applicant postcode:

Study leader's postcode:

Applicant's institution:

Chengdu Sport University

Approved by ethic committee:

Approved No. of ethic committee:

(2022)82号

Approved file of Ethical Committee:

View

Name of the ethic committee:

Ethics Committee of Chengdu Sport University

Date of approved by ethic committee:

2022/10/8 0:00:00

Contact Name of the ethic committee:

Contact Address of the ethic committee:

Contact phone of the ethic committee:

Contact email of the ethic committee:

Primary sponsor:

Chengdu Sport University

Primary sponsor's address:

Chengdu Sport University

Secondary sponsor:

Country:

China

Province:

Sichuan

City:

Chengdu

Institution
hospital:

Chengdu Sport University

Address:

2 Tiyuan Road, Wuhou District, Chengdu, Sichuan, China

Source(s) of funding:

Science technology department of Sichuan province

Target disease:

Overweight

Target disease code:

Study type:

Interventional study

Study design:

randomized controlled trial(parallel group design)

Study phase:

Pilot clinical trial

Objectives of Study:

To systematically evaluate the effect of Three-Circle Post Standing Qigong (TCPSQ )in improving insulin resistance level, body weight, glucose and lipid metabolism of overweight people, A TCM motion scheme for "treat pre-disease" , charactered by TCM theory and physical medicine integration, also will be form.

Description for medicine or protocol of treatment in detail:

Inclusion criteria

(1) Aged 18 to 45 years; (2) diagnose as overweight; (3) voluntarily participate in this research and be able to provide the written informed consent form for participation in the trial and take part in TCPSQ training on time

Exclusion criteria:

(1) secondary overweight due to other disease or oral medication. (2) Being or having been engaged in a long-term regular practice of PSQ or other forms of Qigong or athletic sports; (3) History of dizziness fall or lose consciousness; (4) Those who are not suitable for exercise training due to diseases of the muscle or skeletal system or other contraindications to exercise; (5) History of drug abuse, family history of psychosis, stress disorder, personality disorder and psychoactive substance user. (6) pregnancy and lactation (7) Those who have suffered from malignant tumor, severe consumptive disease, cerebrovascular disease, communicable disease, mental illness, and severe cardiovascular, liver, kidney, gastrointestinal and hematological diseases, musculoskeletal system diseases, or other contraindication to mild to moderate-physical exertion; (8) Those who had taken weight-loss related medications or functional foods within 8 weeks before the start of the study; (9) Those who have participated in or are participating in other clinical trials that affect the evaluation of the results of this study within 8 weeks before the start of this study; (10) Those who inability to comprehend and complete the study assessments or comply with the study instructions.

Study execute time:

From 2022-10-08

To      2023-12-31

Recruiting time:

From 2022-10-12

To      2022-10-30

Interventions:

34

Group:

Standing group

Sample size:

Intervention:

Three circle post standing qigong

Intervention code:

34

Group:

Aerobic exercise group

Sample size:

Intervention:

Aerobic exercise

Intervention code:

Total sample size : 68

Countries of recruitment
and research settings:

Country:

China

Province:

Sichuan

City:

Chengdu

Institution/hospital:

Affiliated Sport Hospital of CDSU

Level of the institution:

A Tertiary special hospital

Outcomes:

Outcome:

body fat rate

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

SF-36 health scale

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Blood lipid

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

fasting plasma glucose test

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

BMI

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

glycosylated hemoglobin

Type:

Primary 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:

Not yet recruiting

Min age years
Max age years

Recruiting status:

Participant age:

Gender:

Both

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

Patients who met the inclusion criteria were randomly divided into 1:1 groups

Blinding:

IPD sharing:

Yes

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

Webdata and resman(http://www.medresman.org.cn);

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

CRF reform

Data Managemen Committee:

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

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above