PregnancyPhase 1/2NCT00741312
Influence of Physical Exercise on Endothelial Function in Pregnant Women
A Phase 1/2 study testing Regular aerobic physical exercise and Activities of daily living in people with Pregnancy and Preeclampsia, run by Universidad del Valle, Colombia at 1 site in Colombia.
Trial summary
The purpose of this study is to determine the effect of regular aerobic exercise on endothelial function in pregnancy. Read more about this study
- Who is it for?
- Ages 16 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Preeclampsia, Exercise
- What is being tested?
- Regular aerobic physical exercise and Activities of daily living
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteColombia
- Study dates
- Oct 2008to Jan 2011
- Phase
- Phase 1/2
- 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 16 to 30 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Primiparous women who have not participated in a structured exercise program, including significant amounts of walking for the past four months are eligible for the trial.
- Live foetus at the routine ultrasound scan and a normal pregnancy.
- Gestational age 16 to 20 weeks
- Written informed consent will be obtained from each woman prior to the inclusion in the study.
Who cannot join
- History of high blood pressure
- Chronic medical illnesses (cancer, renal, endocrinologic, psychiatric, neurologic, infectious and cardiovascular diseases)
- Persistent bleeding after week 12 of gestation
- Poorly controlled thyroid disease
- Placenta praevia, incompetent cervix, polyhydramnios, oligohydramnios
- History of miscarriage in the last twelve months
- Diseases that could interfere with participation (following recommendations from ACSM 2000, ACOG 2003).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Physical Exercise on Endothelial Function in Pregnant Women: Randomized Clinical Trial
The purpose of this study is to determine the effect of regular aerobic exercise on endothelial function in pregnancy.
Read the detailed description
Preeclampsia is a common maternal disease that complicates 5% to 10% of pregnancies and remains as the major cause of maternal and neonatal mortality, especially in developing countries. Cost-effective interventions aimed to prevent the development of preeclampsia are urgently needed. Ethiopathogenesis of preeclampsia involves multiple mechanisms as oxidative stress, endothelial dysfunction, infections, maternal constitutional factors, and others. Regular aerobic exercise recovers endothelial function, decreases oxidative stress and improves maternal constitutional factors.
The purpose of this Controlled Clinical Trial is to determine the effect of regular aerobic exercise on endothelium-dependent brachial artery flow-mediated dilatation. Furthermore, the effect of exercise on biomarkers on vascular function and perinatal outcomes will be evaluated.
- Conditions
- Pregnancy, Preeclampsia, Exercise
- Being tested
- Regular aerobic physical exercise, Activities of daily living
- Keywords
- pregnancy, preeclampsia, exercise
- Medical subject headings
- Pre-Eclampsia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular aerobic physical exerciseBehavioural
Walking (10 minutes), aerobic exercise (30 minutes), stretching (10 minutes) and relaxation exercise (10 minutes). Exercise will be performed at three sessions per week. All sessions will be supervised by a physical therapist and a physical educator.
The exercise-program follows the ACOG and ACSM exercise prescription. Aerobic activities will be performed at moderate intensity (60-70% of maximal heart rate) measured by the 6-20 Borg's rating scale. Each session starts with a 5 minutes of warm up, followed by 30 minutes of aerobic activity, including 5 minutes cool down. This is followed by 15 minutes of circuit strength training of the upper limbs, lower limbs, and deep abdominal stabilization muscles. The last 5 minutes consists of stretching and relaxation exercises.
Activities of daily livingBehavioural
Basic activities of daily living (bathing, dressing, eating, walking) without counseling by a physical therapist.
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Not described Receives: Behavioral: Regular aerobic physical exercise |
| II | Active comparator | Not described Receives: Behavioral: Activities of daily living |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial artery flow-mediated dilation
Measured: Baseline, 8 weeks, 16 weeks
Secondary outcomes (6)
high sensitivity C-Reactive Protein
Measured: Baseline, 16 weeks
Nitrates, Nitrites and cyclic GMP
Measured: Baseline, 16 weeks
Blood lipid profile
Measured: Baseline, 16 weeks
Anthropometric indicators
Measured: Baseline, 8 weeks, 16 weeks
Functional capacity (VO2 Max)
Measured: Baseline, 8 weeks, 16 weeks
Maternal and neonatal outcomes
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2008 (estimated)
- Study startOct 2008
- Primary completionOct 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad del Valle, Colombia
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Cardiovascular de Colombia
- Investigators
- Ana C Plata, MSc, Principal investigator, Universidad del ValleAdalberto Sanchez, PhD, Principal investigator, Universidad del Valle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00741312
- Sponsor's protocol ID
- 182-07
- Status last verified
- Jan 2011
- First submitted
- 22 Aug 2008
- Last updated
- 21 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Pinzon DC, Zamora K, Martinez JH, Florez-Lopez ME, de Plata AC, Mosquera M, Ramirez-Velez R. Type of delivery and gestational age is not affected by pregnant Latin-American women engaging in vigorous exercise: a secondary analysis of data from a controlled randomized trial. Rev Salud Publica (Bogota). 2012 Oct;14(5):731-43.
PubMed 24652353Montoya Arizabaleta AV, Orozco Buitrago L, Aguilar de Plata AC, Mosquera Escudero M, Ramirez-Velez R. Aerobic exercise during pregnancy improves health-related quality of life: a randomised trial. J Physiother. 2010;56(4):253-8. doi: 10.1016/s1836-9553(10)70008-4.
PubMed 21091415Ramirez-Velez R, Aguilar AC, Mosquera M, Garcia RG, Reyes LM, Lopez-Jaramillo P. Clinical trial to assess the effect of physical exercise on endothelial function and insulin resistance in pregnant women. Trials. 2009 Nov 17;10:104. doi: 10.1186/1745-6215-10-104.
PubMed 19919718
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Physical Exercise on Endothelial Function in Pregnant Women: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00741312
- Acronym / sponsor ID
- 182-07
- Conditions
- Pregnancy, Preeclampsia, Exercise
- Keywords
- pregnancy, preeclampsia, exercise
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Universidad del Valle, ColombiaUniversity, hospital or other
- Collaborators
- Fundación Cardiovascular de Colombia
- Study start
- Oct 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 26 Aug 2008 (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 purpose of this study is to determine the effect of regular aerobic exercise on endothelial function in pregnancy.
Detailed description
Preeclampsia is a common maternal disease that complicates 5% to 10% of pregnancies and remains as the major cause of maternal and neonatal mortality, especially in developing countries. Cost-effective interventions aimed to prevent the development of preeclampsia are urgently needed. Ethiopathogenesis of preeclampsia involves multiple mechanisms as oxidative stress, endothelial dysfunction, infections, maternal constitutional factors, and others. Regular aerobic exercise recovers endothelial function, decreases oxidative stress and improves maternal constitutional factors.
The purpose of this Controlled Clinical Trial is to determine the effect of regular aerobic exercise on endothelium-dependent brachial artery flow-mediated dilatation. Furthermore, the effect of exercise on biomarkers on vascular function and perinatal outcomes will be evaluated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Behavioral: Regular aerobic physical exercise |
| II | Active comparator | Behavioral: Activities of daily living |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Primiparous women who have not participated in a structured exercise program, including significant amounts of walking for the past four months are eligible for the trial.
- Live foetus at the routine ultrasound scan and a normal pregnancy.
- Gestational age 16 to 20 weeks
- Written informed consent will be obtained from each woman prior to the inclusion in the study.
Key exclusion criteria (7 listed)
- History of high blood pressure
- Chronic medical illnesses (cancer, renal, endocrinologic, psychiatric, neurologic, infectious and cardiovascular diseases)
- Persistent bleeding after week 12 of gestation
- Poorly controlled thyroid disease
- Placenta praevia, incompetent cervix, polyhydramnios, oligohydramnios
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 |
|---|---|---|
| Regular aerobic physical exerciseWalking (10 minutes), aerobic exercise (30 minutes), stretching (10 minutes) and relaxation exercise (10 minutes). Exercise will be performed at three sessions per week. All sessions will be supervised by a physical therapist and a physical educator. The exercise-program follows the ACOG and ACSM exercise prescription. Aerobic activities will be performed at moderate intensity (60-70% of maximal heart rate) measured by the 6-20 Borg's rating scale. Each session starts with a 5 minutes of warm up, followed by 30 minutes of aerobic activity, including 5 minutes cool down. This is followed by 15 minutes of circuit strength training of the upper limbs, lower limbs, and deep abdominal stabilization muscles. The last 5 minutes consists of stretching and relaxation exercises. | Behavioural | I |
| Activities of daily livingBasic activities of daily living (bathing, dressing, eating, walking) without counseling by a physical therapist. | Behavioural | II |
Primary outcome
Brachial artery flow-mediated dilation
Time frame: Baseline, 8 weeks, 16 weeks
6 secondary outcomes
high sensitivity C-Reactive Protein
Time frame: Baseline, 16 weeks
Nitrates, Nitrites and cyclic GMP
Time frame: Baseline, 16 weeks
Blood lipid profile
Time frame: Baseline, 16 weeks
Anthropometric indicators
Time frame: Baseline, 8 weeks, 16 weeks
Functional capacity (VO2 Max)
Time frame: Baseline, 8 weeks, 16 weeks
Maternal and neonatal outcomes
Time frame: At delivery
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 21 Jan 2011.
- Derived from this study: PubMed 24652353Pinzon DC, Zamora K, Martinez JH, Florez-Lopez ME, de Plata AC, Mosquera M, Ramirez-Velez R. Type of delivery and gestational age is not affected by pregnant Latin-American women engaging in vigorous exercise: a secondary analysis of data from a controlled randomized trial. Rev Salud Publica (Bogota). 2012 Oct;14(5):731-43.
- Derived from this study: PubMed 21091415Montoya Arizabaleta AV, Orozco Buitrago L, Aguilar de Plata AC, Mosquera Escudero M, Ramirez-Velez R. Aerobic exercise during pregnancy improves health-related quality of life: a randomised trial. J Physiother. 2010;56(4):253-8. doi: 10.1016/s1836-9553(10)70008-4.
- Derived from this study: PubMed 19919718Ramirez-Velez R, Aguilar AC, Mosquera M, Garcia RG, Reyes LM, Lopez-Jaramillo P. Clinical trial to assess the effect of physical exercise on endothelial function and insulin resistance in pregnant women. Trials. 2009 Nov 17;10:104. doi: 10.1186/1745-6215-10-104.
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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.
Ana C Plata, MSc principal investigator
Universidad del Valle
Adalberto Sanchez, PhD principal investigator
Universidad del Valle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Regular aerobic physical exercise and Activities of daily living in people with Pregnancy and Preeclampsia, run by Universidad del Valle, Colombia at 1 site in Colombia.
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 4 inclusion and 7 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 21 Jan 2011. 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 Colombia. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Brachial artery flow-mediated dilation (time frame: Baseline, 8 weeks, 16 weeks). 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 NCT00741312, which also lists 3 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 21 Jan 2011.