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HypertensionNCT01261884

Exercise in Pregnancy for Reduction of Blood Pressure in Obese Patients

A study testing Exercise support and Exercise intervention in people with Hypertension and Pregnancy, run by Milton S. Hershey Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Preeclampsia and other high blood pressure disorders of pregnancy are a significant cause of both maternal and fetal complications of pregnancy. To date, there is no known "cure" for preeclampsia, but studies have shown that exercise may lower the risk of preeclampsia and high blood pressure disorders in pregnancy. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Hypertension, Pregnancy, Preeclampsia
What is being tested?
Exercise support and Exercise intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteUnited States
Study dates
Nov 2010to Jan 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 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Patient's BMI must be ≥ 30 and ≤ 40.
  • Established viable singleton pregnancy <13 weeks

Who cannot join

  • Multiple gestations.
  • Maternal diabetes established pre-pregnancy by standard guidelines
  • Congenital or acquired heart disease
  • Use of antihypertensive medication
  • Inability to exercise
  • Restrictive lung disease
  • History of shortened/incompetent cervix
  • History of preterm labor

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

Other trials in United States

About this study

Official title: Exercise Intervention in Pregnancy for Reduction of Blood Pressure in Obese Gravidas

Preeclampsia and other high blood pressure disorders of pregnancy are a significant cause of both maternal and fetal complications of pregnancy. To date, there is no known "cure" for preeclampsia, but studies have shown that exercise may lower the risk of preeclampsia and high blood pressure disorders in pregnancy. Resistance training also lowers blood pressure, and may be easier to perform in a pregnant population, leading to higher compliance. The investigators propose to perform a novel prospective study of a resistance training regimen on blood pressure in pregnant patients at high risk for developing preeclampsia or high blood pressure.

Read the detailed description

Hypertension affects 5-10 percent of pregnancies, and complications from hypertensive disorders of pregnancy are the third leading cause of maternal death in the United States. Hypertensive disorders of pregnancy, including preeclampsia, lead to preterm delivery, morbidity and mortality of mother, fetus, and neonate, and are a predictor of development of chronic maternal hypertension, cardiovascular disease, and renal disease. Maternal obesity is increasing dramatically in the patient population, and is an independent risk factor for hypertension and preeclampsia, increasing the risk by two- to four-fold. To date, no effective preventative measure has been found to reduce the risk of preeclampsia or hypertension in high risk pregnant patients. However, observational studies have shown that patients who exercise or who have increased physical activity before and during pregnancy have lower rates of preeclampsia, hypertension, and gestational diabetes. Exercise has been shown in numerous studies to be safe in pregnancy, and is recommended by the American College of Obstetrics and Gynecology as part of routine prenatal care. However, aerobic exercise can be viewed by patients to be difficult to perform during pregnancy, particularly when the patient is obese and at later gestations. Adherence to exercise regimens is therefore low in this patient group. Dynamic resistance training has been shown to lower mean blood pressure both acutely and long term in non-pregnant hypertensive patients, and can be performed more easily by patients with mobility issues. This intervention has not been studied in an obese pregnant population for its effects on blood pressure throughout pregnancy.

The long term goal is to develop an intervention that will reduce the barriers to exercise of obese pregnant women that will, in turn, reduce their risk of developing preeclampsia and other hypertensive disorders of pregnancy. The specific objective of this proposal is to study the effect of a structured resistance training exercise intervention on blood pressure in obese pregnant woman, who would be considered high risk for development of hypertensive disorders based on pre-pregnancy BMI. The central hypothesis is that obese pregnant patients who participate in a regular, structured resistance training exercise regimen will have a decrease in mean arterial blood pressure compared to obese pregnant patients who are strongly encouraged to do aerobic exercise (lifestyle intervention) or who participate in routine prenatal care. The investigators formulated this hypothesis, in part, based upon previous studies found in the literature performed in non-pregnant hypertensive patients. The investigators will extrapolate from the experience and methods of the collaborators, who have studied the effects of exercise on gestational diabetes.

Being tested
Exercise support, Exercise intervention
Keywords
Pregnancy, Exercise, Hypertension, Preeclampsia, Resistance exercise
Medical subject headings
Hypertension, Pre-Eclampsia, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise supportBehavioural

    Group B (exercise support) will be given the ACOG pamphlet on exercise in pregnancy, a daily activity log, and a pedometer. This group will be asked to wear the pedometer for 7 consecutive days between Visits 1 and 2, and record daily activities.

  • Exercise interventionBehavioural

    Group C (exercise intervention) will be given the ACOG pamphlet on exercise in pregnancy, a daily activity log, a pedometer, a resistance band, and a handout on specific exercises (type and frequency) to be performed. The study coordinator will demonstrate each exercise and then observe the participant perform each exercise to assure full understanding. In addition to wearing the pedometer for 7 days and completing the activity log, this group will also record compliance with the exercise regimen.

Study groups in NCT01261884
Study groupRoleWhat they receive
Routine prenatal careNo interventionNot described
Exercise supportExperimentalNot described
Receives: Behavioral: Exercise support
Exercise interventionExperimentalNot described
Receives: Behavioral: Exercise intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in mean arterial blood pressure

    Measured: <13 weeks gestation-postpartum visit

Secondary outcomes (9)
  1. Hypertension of pregnancy or preeclampsia

  2. Gestational weight gain

  3. Neonatal weight

  4. Proteinuria

  5. Serum markers for hypertension risk

  6. Activity level

    Measured with activity logos

  7. Number of steps per week

    Pedometer measurement

  8. Weight retention at postpartum visit

  9. Mode of delivery

    Vaginal versus cesarean

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionJul 2014
  4. Study completionJan 2015

Resources

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
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01261884
Sponsor's protocol ID
33905
Status last verified
Jan 2015
First submitted
16 Dec 2010
Last updated
16 Jan 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Exercise support and Exercise intervention in people with Hypertension and Pregnancy, run by Milton S. Hershey Medical Center at 1 site in United States.

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 2 inclusion and 8 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 16 Jan 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 United States. 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?

Change in mean arterial blood pressure (time frame: <13 weeks gestation-postpartum visit). 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 16 Jan 2015.

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