- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01261884
Exercise in Pregnancy for Reduction of Blood Pressure in Obese Patients
Exercise Intervention in Pregnancy for Reduction of Blood Pressure in Obese Gravidas
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Pennsylvania
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Hershey, Pennsylvania, Spojené státy, 17033
- Penn State Milton S. Hershey Medical Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Cvičební intervence
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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.
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Žádný zásah: Routine prenatal care
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Experimentální: Exercise support
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
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Change in mean arterial blood pressure
Časové okno: <13 weeks gestation-postpartum visit
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<13 weeks gestation-postpartum visit
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
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Proteinurie
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Hypertension of pregnancy or preeclampsia
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Gestational weight gain
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Neonatal weight
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Serum markers for hypertension risk
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Activity level
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Measured with activity logos
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Number of steps per week
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Pedometer measurement
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Weight retention at postpartum visit
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Mode of delivery
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Vaginal versus cesarean
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 33905
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