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临床试验/NCT07255677
NCT07255677尚未招募不适用

Effect of Stretching Exercises Versus Aerobic Exercises on Preeclampsia

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年11月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Measurement of arterial blood pressure

研究概览

简要总结

The purpose of the study is to compare between the effect of stretching exercises and aerobic exercises on preeclampsia.

详细描述

Preeclampsia increases maternal morbidity and mortality since the 1980s, Studies from the World Health Organization also showed an increased risk of hemorrhagic stroke with history of hypertension in pregnancy. In addition to this increased risk of thrombosis, there is also increased morbidity and mortality associated specifically with stroke in these women. PE lead to preterm delivery and increase neonatal morbidity such as Intrauterine Growth Restriction (IUGR), Risk of Fet al Demise/Stillbirth, and infants have a nine times greater incidence of respiratory distress syndrome than full-term neonate.

Medical treatments of preeclampsia . have a lot of side effects on mother and fetus. So, we are going to study more effective noninvasive therapy methods to prevent and decrease the risk of PE. In this randomized controlled study (RCT).

Several studies have explored the impact of exercise on the management and prevention of preeclampsia:

The Effect of Maternal Exercise Program on Fet al Growth in Pre-Eclampsia: A Prospective, Randomized Controlled Clinical Trial investigated the impact of a structured maternal exercise program on fet al growth in women diagnosed with preeclampsia. The findings suggested that regular, supervised exercise could positively influence fet al growth parameters in this cases. Impact of Exercise Training on Preeclampsia: Potential Preventive Mechanisms This review examined the potential mechanisms through which exercise training might reduce the risk of developing preeclampsia. The authors discussed how regular physical activity could improve endothelial function, reduce oxidative stress, and modulate immune responses, thereby potentially lowering preeclampsia risk. Aerobic Exercise Training in Formerly Preeclamptic Women: Effects on Venous Reserve In this study, they examined the effects of aerobic exercise training on venous reserves in 24 normotensive formerly preeclamptic women and 20 controls. Before and after 12-week aerobic exercise training, they demonstrate that 12 weeks of aerobic exercise training effectively improves venous reserve capacity in postpartum women. An umbrella review by Martínez highlighted that prenatal exercise can lead to systolic blood pressure (SBP) reductions of about 9.6 mmHg, alongside significant reductions in diastolic blood pressure (DBP) - with substantial evidence quality. In 2023 a meta-analysis of 14 RCTs (2010-2023) confirmed that prenatal physical activity reduces the risk of gestational hypertensive disorders by 56% and lowers SBP by 2.64 mmHg and DBP by 1.99 mmHg. More specifically, a meta-analysis focusing on aerobic and resistance training showed that while exercise didn't significantly change BP in low-risk pregnancies, in at-risk women it reduced SBP by 3.91 mmHg and DBP by 2.9 mmHg.

Another meta-analysis of 18 RCTs reported overall mean reductions of SBP by 3.19 mmHg and DBP by 2.14 mmHg in exercising pregnant women compared to controls.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 30 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Their ages ranged from 20-30 years old.
  • •Their body mass index (BMI) didn't exceed 35 Kg\m
  • •All women primigravida.
  • •All women are complaining of mild preeclampsia.

排除标准

  • •Chronic disease (diabetes mellitus, thyroid, hypertension, nephrotic).
  • •Vaginal bleeding.
  • •Placenta previa.
  • •Physical and psychological disorders.

研究组 & 干预措施

Stretching exercises program + Antihypertensive drugs

Experimental

It will consist of 30 women with mild preeclampsia. They will be treated with a stretching exercise program, conducted three times per week for six weeks, alongside antihypertensive drugs.

干预措施: Stretching exercises program (Other)

Stretching exercises program + Antihypertensive drugs

Experimental

It will consist of 30 women with mild preeclampsia. They will be treated with a stretching exercise program, conducted three times per week for six weeks, alongside antihypertensive drugs.

干预措施: Antihypertensive drugs (Drug)

Aerobic exercises program + Antihypertensive drugs

Experimental

It will consist of 30 women with mild preeclampsia. They will be treated with an aerobic exercise program, conducted three times per week for six weeks, alongside antihypertensive drugs.

干预措施: Aerobic exercises program (Other)

Aerobic exercises program + Antihypertensive drugs

Experimental

It will consist of 30 women with mild preeclampsia. They will be treated with an aerobic exercise program, conducted three times per week for six weeks, alongside antihypertensive drugs.

干预措施: Antihypertensive drugs (Drug)

结局指标

主要结局

Measurement of arterial blood pressure

时间窗: 6 weeks

Arterial blood pressure will be measured from the right arm while the woman is in a half-lying position. The measurement will be the mean of three trials. Each woman in both groups will be assessed before and after the six-week treatment period.

Measurement of proteinuria

时间窗: 6 weeks

Each woman in both groups will be asked to collect a 24-hour urine sample in sterilized glass bottles for measurement of protein levels. This collection will take place before and after the six-week treatment period.

次要结局

  • Body mass index (BMI) measurement(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mai Khaled Abdrabo Naeem

Principal Investigator

Cairo University

研究点 (1)

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