The Patients With Gestational Diabetes Were Interfered With Qigong.

NCT ID: NCT05951621

Last Updated: 2023-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-30

Study Completion Date

2026-03-31

Brief Summary

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The goal of this clinical trial is to learn about in women with gestational diabetes's health conditions.

The main question\[s\] it aims to answer are:

* Can Qigong control blood glucose in women with gestational diabetes?
* Can Qigong improve mood and sleep in women with gestational diabetes? Participants will required to follow the research team for 3 months of qigong practice。 If there is a comparison group: Researchers will compare Qigong groups to see if Qigong's effects.

Detailed Description

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Conditions

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Gestational Diabetes Mellitus in Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Qigong group

On the basis of nutrition and exercise management and guidance, Qigong is exercised. Offline intensive learning once a week, 45-60 minutes each time, study for 12 weeks, and arrange online theory lecture once a week. In addition to concentrated learning, subjects in this group were required to practice themselves at home, at least once a day, each time for 30 minutes.

Group Type EXPERIMENTAL

Qigong

Intervention Type OTHER

An ancient Chinese system of postures, exercises, breathing techniques, and meditations designed to improve and enhance the body's QI.

Control group

guidance of nutrition and exercise

Group Type EXPERIMENTAL

guidance of nutrition and exercise

Intervention Type BEHAVIORAL

Provide health promotion and guidance to participants on diet and physical exercise

Interventions

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Qigong

An ancient Chinese system of postures, exercises, breathing techniques, and meditations designed to improve and enhance the body's QI.

Intervention Type OTHER

guidance of nutrition and exercise

Provide health promotion and guidance to participants on diet and physical exercise

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 20 years old≤ age ≤ 40 years old;
* Those with clear awareness, acceptable reading and language expression skills, and barrier-free communication;
* singleton pregnancy;
* gestational age between 24 and 28 weeks, with the upper limit of gestational age set at 28 weeks at the time of inclusion to allow for at least 8 weeks of intervention;
* Body mass index (BMI) is lower than 40;
* Agree to participate in this project and sign the informed consent form.

Exclusion Criteria

* Those with previous GDM and diabetes;
* Artificial insemination;
* Those with serious obstetric complications and contraindications;
* Participants in other planned and supervised exercise programs or researchers during the study.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shanghai First Maternity and Infant Hospital

OTHER

Sponsor Role collaborator

Chen Chaoyang

OTHER

Sponsor Role lead

Responsible Party

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Chen Chaoyang

Shanghai Qigong Research Institute Trainee researcher

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Li Jie, Doctor

Role: PRINCIPAL_INVESTIGATOR

Shanghai University of Traditional Chinese Medicine

Central Contacts

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chen chaoyang, Master

Role: CONTACT

15002153216

References

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Jin Y, Chen Z, Li J, Zhang W, Feng S. Effects of the original Gymnastics for Pregnant Women program on glycaemic control and delivery outcomes in women with gestational diabetes mellitus: A randomized controlled trial. Int J Nurs Stud. 2022 Aug;132:104271. doi: 10.1016/j.ijnurstu.2022.104271. Epub 2022 Apr 28.

Reference Type BACKGROUND
PMID: 35660387 (View on PubMed)

Sklempe Kokic I, Ivanisevic M, Biolo G, Simunic B, Kokic T, Pisot R. Combination of a structured aerobic and resistance exercise improves glycaemic control in pregnant women diagnosed with gestational diabetes mellitus. A randomised controlled trial. Women Birth. 2018 Aug;31(4):e232-e238. doi: 10.1016/j.wombi.2017.10.004. Epub 2017 Oct 18.

Reference Type BACKGROUND
PMID: 29055674 (View on PubMed)

Yew TW, Chi C, Chan SY, van Dam RM, Whitton C, Lim CS, Foong PS, Fransisca W, Teoh CL, Chen J, Ho-Lim ST, Lim SL, Ong KW, Ong PH, Tai BC, Tai ES. A Randomized Controlled Trial to Evaluate the Effects of a Smartphone Application-Based Lifestyle Coaching Program on Gestational Weight Gain, Glycemic Control, and Maternal and Neonatal Outcomes in Women With Gestational Diabetes Mellitus: The SMART-GDM Study. Diabetes Care. 2021 Feb;44(2):456-463. doi: 10.2337/dc20-1216. Epub 2020 Nov 12.

Reference Type BACKGROUND
PMID: 33184151 (View on PubMed)

Brown J, Ceysens G, Boulvain M. Exercise for pregnant women with gestational diabetes for improving maternal and fetal outcomes. Cochrane Database Syst Rev. 2017 Jun 22;6(6):CD012202. doi: 10.1002/14651858.CD012202.pub2.

Reference Type BACKGROUND
PMID: 28639706 (View on PubMed)

Other Identifiers

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ZY(2021-2023)- 0105-14

Identifier Type: -

Identifier Source: org_study_id

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