The Patients With Gestational Diabetes Were Interfered With Qigong.

NCT05951621 | Not Yet Recruiting DMC

• 1 other identifier: ZY(2021-2023)- 0105-14
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Gestational Diabetes Mellitus in Pregnancy

Keywords

Gestational Diabetes Mellitus in Pregnancy; Qigong; Non-drug therapy

Outcome Measures

Primary Outcomes (2)

• Fasting blood glucose

  If the blood glucose level is between 4.0 and 5.4 mmol/L, the result is normal. If the fasting blood glucose level is between 5.5-6.9 mmol/L, the condition is called prediabetes. Diabetes refers to blood sugar greater than 8.5 mmol/L.

  Average peripheral fasting blood glucose measured one week prior to participant enrollment. Fasting blood glucose measured in the first week after the end of 12 weeks of intervention.

• 2-h postprandial plasma glucose

  less than 7.8mmol/L. When the blood glucose is 7.8\~11.1 mmol/L 2 hours after meals, it can be diagnosed as impaired or impaired glucose tolerance.

  Average postprandial blood glucose measured in the week prior to study participant enrollment. Average postprandial 2-hour postprandial peripheral capillary blood glucose measured in the first week after the end of 12 weeks of intervention.

Secondary Outcomes (3)

• Pittsburgh sleep quality index,PSQI

  Weeks 0 and 13

• Self-Rating Depression Scale，SDS

  Weeks 0 and 13

• Self-Rating Anxiety Scale, SAS

  Weeks 0 and 13

Other Outcomes (1)

• Maternal and infant complications during childbirth

  birth

Study Arms (2)

Qigong group

EXPERIMENTAL

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.

Other: Qigong

Control group

EXPERIMENTAL

guidance of nutrition and exercise

Behavioral: guidance of nutrition and exercise

Interventions

Qigong OTHER

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

Qigong group

guidance of nutrition and exercise BEHAVIORAL

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

Control group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old≤ age ≤ 40 years old;
• Those with clear awareness, acceptable reading and language expression skills, and barrier-free communication;
• singleton pregnancy;
• Body mass index (BMI) is lower than 40;
• Agree to participate in this project and sign the informed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chen Chaoyang: lead
• Shanghai First Maternity and Infant Hospital: collaborator

Related Publications (4)

• 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.

  PMID: 35660387 BACKGROUND

• 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.

  PMID: 29055674 BACKGROUND

• 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.

  PMID: 33184151 BACKGROUND

• 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.

  PMID: 28639706 BACKGROUND

MeSH Terms

Interventions

Qigong; Exercise

Intervention Hierarchy (Ancestors)

Breathing Exercises; Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Li Jie, Doctor

  Shanghai University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

chen chaoyang, Master

CONTACT

15002153216; 675694333@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Shanghai Qigong Research Institute Trainee researcher

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 19, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: March 1, 2026
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share