NCT05901402

Brief Summary

Objective:The aim of this study was to explore the rationality and clinical value of aerobic exercise during pregnancy in blood glucose control of pregnant women with GDM, and to provide theoretical basis for more appropriate clinical exercise management. Method:The subjects of gestational diabetes in the hospital from March 2023 to May 2024 were studied. The exercise exercise with daily responsible nurses was based on resistance exercise, mainly with upper limb muscle exercise, supplemented by lower limb muscle exercise and aerobic exercise. Fasting blood glucose, 2 hours postprandial blood glucose and HbA1c in pregnant women with GDM were monitored.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 13, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

1.2 years

First QC Date

April 24, 2023

Last Update Submit

February 4, 2024

Conditions

Aerobic and Resistance Exercise

Keywords

the pregnant women with GDMblood glucose

Outcome Measures

Primary Outcomes (5)

  • Blood glucose

    Fasting blood glucose in pregnant women with GDM

    Collect blood samples and monitor fasting blood glucose in pregnant womendaily until delivery, it can be monitored for up to 10 months.

  • 2 hours blood glucose

    2 hours postprandial blood glucose in pregnant women with GDM

    Collect blood samples and monitor 2 hours postprandial blood glucosedaily until delivery, it can be monitored for up to 10 months.

  • HbA1c

    HbA1c in pregnant women with GDM

    Collect blood samples and monitor monthly until delivery, it can be monitored for up to 10 months.

  • Maternal weight gain

    Maternal Weight Gain during Pregnancy

    Monitor weight daily until delivery by weighing scale, it can be monitored for up to 10 months.

  • Pulse

    The pulse of pregnant women in the experimental group during exercise

    Monitor the pulse of pregnant women in the experimental group during exercise until delivery, it can be monitored for up to 10 months.

Study Arms (2)

The experimental group

EXPERIMENTAL

The experimental group performed aerobic resistance exercise during pregnancy every day.

Behavioral: aerobic and resistance exercise

The control group

NO INTERVENTION

The control group was given traditional nursing.

Interventions

aerobic and resistance exerciseBEHAVIORAL

The experimental group performed aerobic resistance exercise during pregnancy every day.

The experimental group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women with GDM without contraindications.
  • Pregnant women with GDM who volunteered to participate in the project.
  • Pregnant women give informed consent.

You may not qualify if:

  • Pregnant women give up voluntarily.
  • Hypoglycemia: In the presence of dizziness and other uncomfortable symptoms, people should stop exercising immediately, monitor blood sugar, and always prepare candy.
  • Abdominal pain, vaginal bleeding and other symptoms of contraction should stop exercising immediately and seek medical attention in time.
  • Fall: It is recommended to ensure the safety of the sports ground before exercise: keep the ground dry, clean, not easy to slip, no debris; Comfortable clothing and non-slip exercise are recommended.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325027, China

RECRUITING

Central Study Contacts

Xiaofen Zhang

CONTACT

+86139688243057850758@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2023

First Posted

June 13, 2023

Study Start

March 1, 2023

Primary Completion

May 1, 2024

Study Completion

December 1, 2024

Last Updated

February 6, 2024

Record last verified: 2024-02

Locations

CN(1)