Exercise in Pregnancy for Reduction of Blood Pressure in Obese Patients
Exercise Intervention in Pregnancy for Reduction of Blood Pressure in Obese Gravidas
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Pennsylvania
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Hershey、Pennsylvania、アメリカ、17033
- Penn State Milton S. Hershey Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:運動介入
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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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介入なし:Routine prenatal care
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実験的: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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
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Change in mean arterial blood pressure
時間枠:<13 weeks gestation-postpartum visit
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<13 weeks gestation-postpartum visit
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二次結果の測定
結果測定 |
メジャーの説明 |
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蛋白尿
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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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協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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