Gestational DiabetesNCT05195333
Comparison of Home Exercises and Home Exercise Pogram Taught by Physiotherapist in Women With Gestational Diabetes
A study testing The exercise program in people with Gestational Diabetes, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Participants will be randomized and divided into 3 groups. The exercise program prepared for the 1st group gestational diabetes will be explained to the pregnant women by the physiotherapist and the exercises will be taught to the patient. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- The exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 1 Sep 2022
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Being between 20-40 years old
- 26-30. week of pregnancy
- Diagnosis of gestational diabetes as a result of an oral glucose tolerance test
- BMI>45 kg/m2
- Being physically inactive
Who cannot join
- Being under the age of 18
- History of Type 1 or Type 2 diabetes
- Have had bariatric surgery
- Use of drugs that cause weight gain
- Contraindications preventing exercise
Trial locations and contacts
1 site in 1 country.
About this study
Participants will be randomized and divided into 3 groups. The exercise program prepared for the 1st group gestational diabetes will be explained to the pregnant women by the physiotherapist and the exercises will be taught to the patient. They do these exercises as home exercise with 10 repetitions 3 days a week, until the 34th week of pregnancy. In the second group, the same exercise program will be given to the participants only as a brochure and they will be asked to do 10 repetitions at home, 3 days a week, until the 34th week of pregnancy. In the 3rd group, the participants will not be given any exercise program, they will be asked to continue their routine care.
Read the detailed description
45 pregnant women who applied to Çamlıca Medipol Hospital Gynecology and Obstetrics and were diagnosed with gestational diabetes will be included in the study. Being between the ages of 20-40, pregnancy of 26-30 weeks, being diagnosed with gestational diabetes as a result of oral glucose tolerance test, BMI>45 kg/m2, being physically inactive are inclusion criteria. Exclusion criteria are being younger than 18 years of age, having a history of Type 1 or Type 2 diabetes, having undergone bariatric surgery, using drugs that cause weight gain, and contraindications that prevent exercise. Participants will be randomized and divided into 3 groups. The exercise program prepared for the 1st group gestational diabetes will be explained to the pregnant women by the physiotherapist and the exercises will be taught to the patient. They do these exercises as home exercise with 10 repetitions 3 days a week, until the 34th week of pregnancy. In the second group, the same exercise program will be given to the participants only as a brochure and they will be asked to do 10 repetitions at home, 3 days a week, until the 34th week of pregnancy. In the 3rd group, the participants will not be given any exercise program, they will be asked to continue their routine care. Participants' fasting glucose and HbA1c values, anthropometric measurements, physical activity levels with the "pregnancy physical activity questionnaire (GFAA) and their quality of life with the World Health Organization Quality of Life Scale Short Form will be evaluated.
- Conditions
- Gestational Diabetes
- Being tested
- The exercise program
- Keywords
- gestational diabetes, home exercise, physiotherapist
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The exercise programOther
The exercise program prepared for the 1st group gestational diabetes will be explained to the pregnant women by the physiotherapist and the exercises will be taught to the patient.
The exercise programOther
The same exercise program will be given to the participants only as a brochure and they will be asked to do 10 repetitions at home, 3 days a week, until the 34th week of pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| First group | Experimental | The exercise program prepared for the 1st group gestational diabetes will be explained to the pregnant women by the physiotherapist and the exercises will be taught to the patient. You will be asked to do these exercises as home exercise with 10 repetitions 3 days a week, until the 34th week of pregnancy. Receives: Other: The exercise program |
| Second group | Experimental | The same exercise program will be given to the participants only as a brochure and they will be asked to do 10 repetitions at home, 3 days a week, until the 34th week of pregnancy Receives: Other: The exercise program |
| Third group | No intervention | The participants will not be given any exercise program, they will be asked to continue their routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy physical activity questionnaire for physical activity level measurement
It is a questionnaire that asks pregnant women to report their usual physical activities during the last month and questions the time spent with a total of 32 activities under the subheadings of housework/care activities, professional activities, sports/exercise.
Measured: 5 minutes
HbA1c measurement
HbA1c values of the participants will be done in Medipol University laboratory.
Measured: 10 minutes
Fasting glucose measurements
Fasting glucose values of the participants will be done in Medipol University laboratory.
Measured: 10 minutes
World Health Organization Quality of life Short Form for measurement of quality of life
The scale measures physical, mental, social and environmental well-being and consists of 26 questions.
Measured: 5 minutes
Secondary outcomes (3)
Weight measurement
Weight in kilogram will be measured with weighing machine
Measured: 2 minutes
Height measurement
Height in meters will be measured with tape measure
Measured: 2 minutes
Body mass index (BMI) measurement
Weight and height will be combined to report BMI in kg/m2
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start1 Feb 2022
- Primary completion1 Jun 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, merve yilmaz menek, Istanbul Medipol University Hospital
- Investigators
- MERVE YILMAZ MENEK, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195333
- Sponsor's protocol ID
- Merveymz.
- Status last verified
- Jul 2023
- First submitted
- 30 Dec 2021
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I will publish an article about the results of the study and share it with other researchers.
Publications
Downs DS, Dinallo JM, Birch LL, Paul IM, Ulbrecht JS. Randomized Face-to-Face vs. Home Exercise Interventions in Pregnant Women with Gestational Diabetes. Psychol Sport Exerc. 2017 May;30:73-81. doi: 10.1016/j.psychsport.2017.02.003. Epub 2017 Feb 20.
PubMed 28428728Menek MY, Kaya AK. Comparison of home exercise under supervision and self home exercise in pregnant women with gestational diabetes: randomized controlled trial. Arch Gynecol Obstet. 2024 Mar;309(3):1075-1082. doi: 10.1007/s00404-023-07339-4. Epub 2024 Jan 6.
PubMed 38184491
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Home Exercises and Home Exercise Pogram Taught by Physiotherapist in Women With Gestational Diabetes
- ClinicalTrials.gov ID
- NCT05195333
- Acronym / sponsor ID
- Merveymz.
- Conditions
- Gestational Diabetes
- Keywords
- gestational diabetes, home exercise, physiotherapist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 18 Jan 2022 (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.
Participants will be randomized and divided into 3 groups. The exercise program prepared for the 1st group gestational diabetes will be explained to the pregnant women by the physiotherapist and the exercises will be taught to the patient. They do these exercises as home exercise with 10 repetitions 3 days a week, until the 34th week of pregnancy. In the second group, the same exercise program will be given to the participants only as a brochure and they will be asked to do 10 repetitions at home, 3 days a week, until the 34th week of pregnancy. In the 3rd group, the participants will not be given any exercise program, they will be asked to continue their routine care.
Detailed description
45 pregnant women who applied to Çamlıca Medipol Hospital Gynecology and Obstetrics and were diagnosed with gestational diabetes will be included in the study. Being between the ages of 20-40, pregnancy of 26-30 weeks, being diagnosed with gestational diabetes as a result of oral glucose tolerance test, BMI>45 kg/m2, being physically inactive are inclusion criteria. Exclusion criteria are being younger than 18 years of age, having a history of Type 1 or Type 2 diabetes, having undergone bariatric surgery, using drugs that cause weight gain, and contraindications that prevent exercise. Participants will be randomized and divided into 3 groups. The exercise program prepared for the 1st group gestational diabetes will be explained to the pregnant women by the physiotherapist and the exercises will be taught to the patient. They do these exercises as home exercise with 10 repetitions 3 days a week, until the 34th week of pregnancy. In the second group, the same exercise program will be given to the participants only as a brochure and they will be asked to do 10 repetitions at home, 3 days a week, until the 34th week of pregnancy. In the 3rd group, the participants will not be given any exercise program, they will be asked to continue their routine care. Participants' fasting glucose and HbA1c values, anthropometric measurements, physical activity levels with the "pregnancy physical activity questionnaire (GFAA) and their quality of life with the World Health Organization Quality of Life Scale Short Form will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| First group | Experimental | Other: The exercise programThe exercise program prepared for the 1st group gestational diabetes will be explained to the pregnant women by the physiotherapist and the exercises will be taught to the patient. You will be asked to do these exercises as home exercise with 10 repetitions 3 days a week, until the 34th week of pregnancy. |
| Second group | Experimental | Other: The exercise programThe same exercise program will be given to the participants only as a brochure and they will be asked to do 10 repetitions at home, 3 days a week, until the 34th week of pregnancy |
| Third group | No intervention | –The participants will not be given any exercise program, they will be asked to continue their routine care. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Being between 20-40 years old
- 26-30. week of pregnancy
- Diagnosis of gestational diabetes as a result of an oral glucose tolerance test
- BMI>45 kg/m2
- Being physically inactive
Key exclusion criteria (5 listed)
- Being under the age of 18
- History of Type 1 or Type 2 diabetes
- Have had bariatric surgery
- Use of drugs that cause weight gain
- Contraindications preventing exercise
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 |
|---|---|---|
| The exercise programThe exercise program prepared for the 1st group gestational diabetes will be explained to the pregnant women by the physiotherapist and the exercises will be taught to the patient. | Other | First group |
| The exercise programThe same exercise program will be given to the participants only as a brochure and they will be asked to do 10 repetitions at home, 3 days a week, until the 34th week of pregnancy. | Other | Second group |
Primary outcome
Pregnancy physical activity questionnaire for physical activity level measurement
Time frame: 5 minutes
It is a questionnaire that asks pregnant women to report their usual physical activities during the last month and questions the time spent with a total of 32 activities under the subheadings of housework/care activities, professional activities, sports/exercise.
HbA1c measurement
Time frame: 10 minutes
HbA1c values of the participants will be done in Medipol University laboratory.
Fasting glucose measurements
Time frame: 10 minutes
Fasting glucose values of the participants will be done in Medipol University laboratory.
World Health Organization Quality of life Short Form for measurement of quality of life
Time frame: 5 minutes
The scale measures physical, mental, social and environmental well-being and consists of 26 questions.
3 secondary outcomes
Weight measurement
Time frame: 2 minutes
Height measurement
Time frame: 2 minutes
Body mass index (BMI) measurement
Time frame: 2 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Results publication: PubMed 28428728Downs DS, Dinallo JM, Birch LL, Paul IM, Ulbrecht JS. Randomized Face-to-Face vs. Home Exercise Interventions in Pregnant Women with Gestational Diabetes. Psychol Sport Exerc. 2017 May;30:73-81. doi: 10.1016/j.psychsport.2017.02.003. Epub 2017 Feb 20.
- Derived from this study: PubMed 38184491Menek MY, Kaya AK. Comparison of home exercise under supervision and self home exercise in pregnant women with gestational diabetes: randomized controlled trial. Arch Gynecol Obstet. 2024 Mar;309(3):1075-1082. doi: 10.1007/s00404-023-07339-4. Epub 2024 Jan 6.
- Randomized Face-to-Face vs. Home Exercise Interventions in Pregnant Women with Gestational DiabetesLink provided by the sponsor.
- Individual participant dataSharing planned: No. I will publish an article about the results of the study and share it with other researchers.
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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.
MERVE YILMAZ MENEK principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The exercise program in people with Gestational Diabetes, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 6 Jul 2023. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy physical activity questionnaire for physical activity level measurement (time frame: 5 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05195333, which also lists 2 linked publications.
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 Jul 2023.