PregnancyNCT01885234
Aerobic Training in Pregnant Women With Gestational Diabetes and Chronic Hypertension
A study testing Aerobic exercise and Stretch exercise in people with Pregnancy and Gestational Diabetes Mellitus, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The aim of the present study is verify glycated hemoglobin (HbA1c) and HOMA behavior in pregnant women with gestational diabetes or chronic hypertension after an aerobic training in cycle-ergometer. The sample is composed by 64 pregnant and sedentary women, 20 weeks' pregnant. Read more about this study
- Who is it for?
- Ages 20 to 27 weeks, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Gestational Diabetes Mellitus, Chronic Hypertension in Obstetric Context
- What is being tested?
- Aerobic exercise and Stretch exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2011to Dec 2015
- 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 27 weeks
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- age > 20 years;
- gestational age between 20 and 27 weeks (date of the last period and confirmed by ultrasound);
- Only one foetus in the womb;
- Without orthopedic limitations;
- Non-smoker;
- Medical clearance for exercise
Who cannot join
- Pre-eclampsia;
- fetal malformations;
- Intrauterine fetal death
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: Aerobic Training Effect in Pregnant Women With Gestational Diabetes and Chronic Hypertension: Randomized Clinical Trial
The aim of the present study is verify glycated hemoglobin (HbA1c) and HOMA behavior in pregnant women with gestational diabetes or chronic hypertension after an aerobic training in cycle-ergometer. The sample is composed by 64 pregnant and sedentary women, 20 weeks' pregnant.
Two experimental groups (gestational diabetes and chronic hypertension, n = 16 each) will perform a low-intensity aerobic training in cycle-ergometer, three times/week, for 45 minutes each session. Two control groups (gestational diabetes and chronic hypertension, n = 16 each) will perform an unique session/week of relaxation and stretching.
Outcomes: first ventilatory threshold, HbA1c,HOMA, type of delivery, weight and height of the newborn.
Read the detailed description
The statistical analysis will consist of:
- descriptive statistic;
- Levene's test
- Shapiro Wilk's normality test
- Parametric or non-parametric test
- a=0.05
- SPSS 17.0
- Being tested
- Aerobic exercise, Stretch exercise
- Keywords
- Glycated hemoglobin, HOMA, Pregnancy, aerobic exercise
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
Pregnant women with Gestational Diabetes and pregnant women with chronic hypertension will perform 50 minutes of aerobic exercise in a bicycle, 3 times a week
Stretch exerciseOther
Pregnant women with Gestational Diabetes and pregnant women with chronic hypertension will perform 50 minutes of stretch exercise, once a week
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise | Experimental | Pregnant women with Gestational Diabetes and pregnant women with chronic hypertension will perform 50 minutes of aerobic exercise in a bicycle, 3 times a week Receives: Other: Aerobic exercise |
| Stretch exercise | Placebo comparator | Pregnant women with Gestational Diabetes and pregnant women with chronic hypertension will perform 50 minutes of stretch exercise, once a week Receives: Other: Stretch exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycated hemoglobin
Measured: day 1 and 10 weeks after training
Secondary outcomes (1)
HOMA
Measured: day 1 and 10 weeks after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startDec 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- José Geraldo L Ramos, MD, Principal investigator, HC Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885234
- Sponsor's protocol ID
- GDM-HAS120008
- Status last verified
- Dec 2015
- First submitted
- 5 Jun 2013
- Last updated
- 22 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Training Effect in Pregnant Women With Gestational Diabetes and Chronic Hypertension: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01885234
- Acronym / sponsor ID
- GDM-HAS120008
- Keywords
- Glycated hemoglobin, HOMA, Pregnancy, aerobic exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Jun 2013 (estimated)
- 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.
The aim of the present study is verify glycated hemoglobin (HbA1c) and HOMA behavior in pregnant women with gestational diabetes or chronic hypertension after an aerobic training in cycle-ergometer. The sample is composed by 64 pregnant and sedentary women, 20 weeks' pregnant.
Two experimental groups (gestational diabetes and chronic hypertension, n = 16 each) will perform a low-intensity aerobic training in cycle-ergometer, three times/week, for 45 minutes each session. Two control groups (gestational diabetes and chronic hypertension, n = 16 each) will perform an unique session/week of relaxation and stretching.
Outcomes: first ventilatory threshold, HbA1c,HOMA, type of delivery, weight and height of the newborn.
Detailed description
The statistical analysis will consist of:
- descriptive statistic;
- Levene's test
- Shapiro Wilk's normality test
- Parametric or non-parametric test
- a=0.05
- SPSS 17.0
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise | Experimental | Other: Aerobic exercisePregnant women with Gestational Diabetes and pregnant women with chronic hypertension will perform 50 minutes of aerobic exercise in a bicycle, 3 times a week |
| Stretch exercise | Placebo comparator | Other: Stretch exercisePregnant women with Gestational Diabetes and pregnant women with chronic hypertension will perform 50 minutes of stretch exercise, once a week |
Who may qualify
- Ages
- 20 to 27 weeks
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- age > 20 years;
- gestational age between 20 and 27 weeks (date of the last period and confirmed by ultrasound);
- Only one foetus in the womb;
- Without orthopedic limitations;
- Non-smoker;
Key exclusion criteria (3 listed)
- Pre-eclampsia;
- fetal malformations;
- Intrauterine fetal death
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 exercisePregnant women with Gestational Diabetes and pregnant women with chronic hypertension will perform 50 minutes of aerobic exercise in a bicycle, 3 times a week | Other | Aerobic exercise |
| Stretch exercisePregnant women with Gestational Diabetes and pregnant women with chronic hypertension will perform 50 minutes of stretch exercise, once a week | Other | Stretch exercise |
Primary outcome
glycated hemoglobin
Time frame: day 1 and 10 weeks after training
1 secondary outcome
HOMA
Time frame: day 1 and 10 weeks after training
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 22 Dec 2015.
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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.
José Geraldo L Ramos, MD principal investigator
HC Porto Alegre
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 exercise and Stretch exercise in people with Pregnancy and Gestational Diabetes Mellitus, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 6 inclusion and 3 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 22 Dec 2015. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
glycated hemoglobin (time frame: day 1 and 10 weeks after training). 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 22 Dec 2015.