Aerobic and Resistance ExerciseNCT05901402
Application of Aerobic and Resistance Exercise in Blood Glucose Control in Pregnant Women With GDM
A study testing aerobic and resistance exercise in people with Aerobic and Resistance Exercise, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aerobic and Resistance Exercise
- What is being tested?
- aerobic and resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women with GDM without contraindications.
- Pregnant women with GDM who volunteered to participate in the project.
- Pregnant women give informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325027
Xiaofen Zhang, +8613968824305, 7850758@qq.com
About this study
Official title: Application of Aerobic and Resistance Exercise in Blood Glucose Control in Pregnant Women With GDM.
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.
- Conditions
- Aerobic and Resistance Exercise
- Being tested
- aerobic and resistance exercise
- Keywords
- the pregnant women with GDM, blood glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic and resistance exerciseBehavioural
The experimental group performed aerobic resistance exercise during pregnancy every day.
| Study group | Role | What they receive |
|---|---|---|
| The experimental group | Experimental | The experimental group performed aerobic resistance exercise during pregnancy every day. Receives: Behavioral: aerobic and resistance exercise |
| The control group | No intervention | The control group was given traditional nursing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose
Fasting blood glucose in pregnant women with GDM
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Monitor the pulse of pregnant women in the experimental group during exercise until delivery, it can be monitored for up to 10 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start1 Mar 2023
- Primary completion1 May 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aerobic and Resistance ExerciseStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901402
- Sponsor's protocol ID
- SAHoWMU-CR2023-07-102
- Status last verified
- Feb 2024
- First submitted
- 24 Apr 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Aerobic and Resistance Exercise in Blood Glucose Control in Pregnant Women With GDM.
- ClinicalTrials.gov ID
- NCT05901402
- Acronym / sponsor ID
- SAHoWMU-CR2023-07-102
- Conditions
- Aerobic and Resistance Exercise
- Keywords
- the pregnant women with GDM, blood glucose
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental group | Experimental | Behavioral: aerobic and resistance exerciseThe experimental group performed aerobic resistance exercise during pregnancy every day. |
| The control group | No intervention | –The control group was given traditional nursing. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women with GDM without contraindications.
- Pregnant women with GDM who volunteered to participate in the project.
- Pregnant women give informed consent.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aerobic and resistance exerciseThe experimental group performed aerobic resistance exercise during pregnancy every day. | Behavioural | The experimental group |
Primary outcome
Blood glucose
Time frame: Collect blood samples and monitor fasting blood glucose in pregnant womendaily until delivery, it can be monitored for up to 10 months.
Fasting blood glucose in pregnant women with GDM
2 hours blood glucose
Time frame: Collect blood samples and monitor 2 hours postprandial blood glucosedaily until delivery, it can be monitored for up to 10 months.
2 hours postprandial blood glucose in pregnant women with GDM
HbA1c
Time frame: Collect blood samples and monitor monthly until delivery, it can be monitored for up to 10 months.
HbA1c in pregnant women with GDM
Maternal weight gain
Time frame: Monitor weight daily until delivery by weighing scale, it can be monitored for up to 10 months.
Maternal Weight Gain during Pregnancy
Pulse
Time frame: Monitor the pulse of pregnant women in the experimental group during exercise until delivery, it can be monitored for up to 10 months.
The pulse of pregnant women in the experimental group during exercise
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic and resistance exercise in people with Aerobic and Resistance Exercise, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaofen Zhang (+8613968824305, 7850758@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose (time frame: Collect blood samples and monitor fasting blood glucose in pregnant womendaily until delivery, it can be monitored for up to 10 months.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.