- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01261884
Exercise in Pregnancy for Reduction of Blood Pressure in Obese Patients
Exercise Intervention in Pregnancy for Reduction of Blood Pressure in Obese Gravidas
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Pennsylvania
-
Hershey, Pennsylvania, Verenigde Staten, 17033
- Penn State Milton S. Hershey Medical Center
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Patient's BMI must be ≥ 30 and ≤ 40.
- Established viable singleton pregnancy <13 weeks
Exclusion Criteria:
- 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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Oefen tussenkomst
|
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.
|
|
Geen tussenkomst: Routine prenatal care
|
|
|
Experimenteel: Exercise support
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Change in mean arterial blood pressure
Tijdsspanne: <13 weeks gestation-postpartum visit
|
<13 weeks gestation-postpartum visit
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
|---|---|
|
Proteïnurie
|
|
|
Hypertension of pregnancy or preeclampsia
|
|
|
Gestational weight gain
|
|
|
Neonatal weight
|
|
|
Serum markers for hypertension risk
|
|
|
Activity level
|
Measured with activity logos
|
|
Number of steps per week
|
Pedometer measurement
|
|
Weight retention at postpartum visit
|
|
|
Mode of delivery
|
Vaginal versus cesarean
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 33905
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .