Exercise for Preeclampsia
(PAMPER Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: East Carolina University
Must not be taking: Fetal development drugs
Disqualifiers: HIV, Lupus, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this study is to compare the effects of aerobic (AE), resistance (RE), and combination (AERE) exercise throughout pregnancy on selected maternal and fetal/neonatal physiological variables in women at-risk for preeclampsia. The central hypothesis of this project is that exercise will decrease severity and occurrence of preeclampsia symptoms, thus improving maternal, pregnancy, and birth outcomes.
Aim 1. Determine the influence of different exercise modes during pregnancy at risk of preeclampsia on maternal cardiometabolic health.
Aim 2. Determine the most effective exercise mode in pregnancy at risk of preeclampsia on improving birth and infant health outcomes.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it excludes those taking medicines that affect fetal development.
What data supports the effectiveness of the treatment Exercise Modes, Physical Activity, Aerobic Exercise, Resistance Exercise, Aerobic+Resistance Exercise for Preeclampsia?
Research suggests that regular physical activity, including aerobic exercise, may help reduce the risk of preeclampsia by improving blood vessel function and reducing oxidative stress (damage caused by free radicals). Studies have shown that women who engage in physical activity during pregnancy have a lower incidence of preeclampsia.
12345Is exercise safe for pregnant women, including those at risk for preeclampsia?
Research shows that exercise during pregnancy, including aerobic and resistance exercises, is generally safe for pregnant women, even those at risk for preeclampsia. Studies found no increase in adverse events or risks to mothers and babies, and exercise did not affect delivery methods or lead to health complications.
678910How does exercise differ from other treatments for preeclampsia?
Exercise as a treatment for preeclampsia is unique because it focuses on physical activity to potentially reduce the risk and effects of the condition, unlike other treatments that may involve medication or early delivery. Studies suggest that exercise can have a protective effect against preeclampsia, offering a non-invasive and natural approach to managing the condition.
4791112Eligibility Criteria
This trial is for healthy women aged 18-40, less than 16 weeks pregnant with one baby. Participants should have a BMI between 18.5 and 45.0, lead a sedentary lifestyle, and must be cleared by their obstetric provider to join.Inclusion Criteria
I am a healthy pregnant woman, aged 18-40, less than 16 weeks along, with a normal pregnancy, and have been cleared by my doctor.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants engage in aerobic, resistance, or combination exercise throughout pregnancy to assess effects on maternal and fetal/neonatal physiological variables.
36 weeks
Weekly exercise sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment, focusing on birth outcomes and infant health.
4 weeks
Participant Groups
The study compares the effects of different types of exercise on women at risk for preeclampsia: aerobic (AE), resistance (RE), and a combination of both (AERE). It aims to see which exercise mode best reduces symptoms and improves health outcomes for mother and baby.
4Treatment groups
Experimental Treatment
Active Control
Group I: RE GroupExperimental Treatment1 Intervention
The RE group will perform 12-15 repetitions of 10-12 resistance exercises in a circuit, for 3 sets, with a rest period of 30-60 seconds between sets as needed.\[172\] Seated isokinetic exercise using resistance machines will target all major muscle groups. Light dumbbells and resistance bands will be used if the participant is unable to lift the minimal load on machines. Core exercises will be performed at the end of the session (i.e. seated side bends)
All exercise participants will be prescribed exercise that meets guidelines of the American College of Obstetricians and Gynecologists (ACOG), American College of Sports Medicine (ACSM), and the American Heart Association (AHA); 150 minutes per week, moderate intensity (60-80% aerobic capacity, Rating of Perceived Exertion, RPE, 12-15) per week. These limits are the same as those that generated previous positive findings for our preliminary data.
Group II: AERE GroupExperimental Treatment1 Intervention
AERE group will alternate between AE exercise and RE; for this group, RE exercises will consist of 1 set of 12-15 repetitions of 4 resistance exercises, then 5 minutes of AE, then repeat this cycle with different exercises.
All exercise participants will be prescribed exercise that meets guidelines of the American College of Obstetricians and Gynecologists (ACOG), American College of Sports Medicine (ACSM), and the American Heart Association (AHA); 150 minutes per week, moderate intensity (60-80% aerobic capacity, Rating of Perceived Exertion, RPE, 12-15) per week. These limits are the same as those that generated previous positive findings for our preliminary data.
Group III: AE GroupExperimental Treatment1 Intervention
The AE group will exercise on aerobic machines (i.e. treadmill, elliptical, bicycle)
All exercise participants will be prescribed exercise that meets guidelines of the American College of Obstetricians and Gynecologists (ACOG), American College of Sports Medicine (ACSM), and the American Heart Association (AHA); 150 minutes per week, moderate intensity (60-80% aerobic capacity, Rating of Perceived Exertion, RPE, 12-15) per week. These limits are the same as those that generated previous positive findings for our preliminary data.
Group IV: ControlActive Control1 Intervention
The Control group will participate in weekly sessions that focus on stretching, breathing, and healthy lifestyle.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
East Carolina UniversityGreenville, NC
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Who Is Running the Clinical Trial?
East Carolina UniversityLead Sponsor
References
Does physical activity in leisure time early in pregnancy reduce the incidence of preeclampsia or gestational hypertension? [2010]Assessment of the association of physical activity in leisure time with preeclampsia and gestational hypertension in nulliparous women.
The role of regular physical activity in preeclampsia prevention. [2019]Preeclampsia affects 2-7% of pregnancies and is a leading cause of maternal and fetal morbidity and mortality. Despite extensive study, the etiology of preeclampsia is poorly understood. Abnormal placental development, predisposing maternal constitutional factors, oxidative stress, immune maladaptation, and genetic susceptibility have all been hypothesized to contribute to the development of preeclampsia. Physical conditioning and preeclampsia have opposite effects on critical physiological functions. This suggests that regular prenatal exercise may prevent or oppose the progression of the disease. Epidemiologic studies show that occupational and leisure-time physical activity is associated with a reduced incidence of preeclampsia. We hypothesize that this protective effect results from one of more of the following mechanisms: 1) stimulation of placental growth and vascularity, 2) reduction of oxidative stress, and 3) exercise-induced reversal of maternal endothelial dysfunction. Future research should include prospective epidemiological case-control studies that accurately measure occupational and leisure-time physical activity. Controlled randomized clinical trials examining the effects of prenatal exercise on biochemical markers for endothelial dysfunction, placental dysfunction, and oxidative stress are also needed. If future research supports the idea that exercise effectively protects against preeclampsia, this would provide a low-cost intervention that could dramatically improve prenatal care for women at risk of this disease.
Cardiorespiratory fitness in women after severe pre-eclampsia. [2023]To objectively study cardiorespiratory fitness (CRF) and physical activity (PA) and to evaluate limiting factors of exercise intolerance associated with poor CRF after severe pre-eclampsia.
Impact of exercise training on preeclampsia: potential preventive mechanisms. [2022]Preeclampsia is characterized by hypertension and de novo proteinuria after 20 weeks of pregnancy. It is the leading cause of perinatal morbidity and mortality in the developed world, and to date, the only means of treating the disease is by inducing delivery. Many studies have shown the benefits of exercise training on normal pregnancy. Conversely, because the impact of exercise on reducing the risk of preeclampsia has long been debated, the American College of Obstetricians and Gynecologists has yet to support the prescription of exercise training to women at risk of developing the disease. There is, however, a significant body of evidence in support of the protective role of exercise training against preeclampsia. A recent animal study demonstrated that many preeclampsia features can be eliminated with prenatal followed by gestational exercise training. Hence, the present article reviews the literature on the impact of exercise training on preeclampsia risk, as well as the mechanisms that may be involved.
Response of endothelial function and oxidative stress after supervised aerobic exercise training in formerly preeclamptic women. [2023]We sought to investigate effects of aerobic exercise in women with preeclampsia history. 42 women were enrolled. After 16 weeks, we found improvement in endothelial function index and oxidative stress biomarkers in the exercise group. Moreover, the change of endothelial function index was significantly associated with the change of total antioxidant capacity in the exercise group. Our findings showed aerobic exercise improved exercise capacity, endothelial function and oxidative stress in formerly preeclamptic women, and favorable modification of oxidative stress might be a vital pathway of endothelial function's melioration in those women, which deserves further exploration.
The Effects of Exercise during Pregnancy on Gestational Diabetes Mellitus, Preeclampsia, and Spontaneous Abortion among Healthy Women-A Systematic Review and Meta-Analysis. [2023]The aim was to compare the effects of different exercise modalities (aerobic, resistance, aerobic and resistance combined, or mind-body exercise) on gestational diabetes mellitus (GDM), preeclampsia, spontaneous abortion, withdrawal from the study, and adverse events in healthy pregnant women. A systematic search was conducted in February 2022 using MEDLINE, EMBASE, Cochrane library, and SPORT Discus to identify eligible randomized trials. The meta-analysis of 18 studies that examined exercise compared to no exercise showed a reduced risk of GDM (RR: 0.66 (95% CI: 0.50 to 0.86)). No subgroup differences were found regarding modality, intensity, or supervision. Exercise did not reduce the risk of preeclampsia (nine studies, RR: 0.65 (95% CI: 0.42 to 1.03)); however, in subgroup analyses, mind-body exercise and low-intensity exercise seemed to be effective in reduction of preeclampsia. There was no effect of exercise on withdrawal or adverse events found. No studies reported on spontaneous abortion, therefore, exercise during pregnancy is beneficial and safe. In the prevention of GDM, any modality and intensity seem equally effective. Subgroup analyses support an association between mind-body exercise and physical activity with low intensity and reduced risk of preeclampsia, but more high-quality randomized studies are needed. PROSPERO: CRD42022307053.
Maternal and Perinatal Outcomes of Exercise in Pregnant Women with Chronic Hypertension and/or Previous Preeclampsia: A Randomized Controlled Trial. [2022]Objectives. To evaluate the association between physical exercise supervised in pregnant women with chronic hypertension and/or previous preeclampsia and maternal and neonatal outcomes. Method. Randomized controlled trial, which included 116 pregnant women with chronic hypertension and/or previous preeclampsia, considered risk of preeclampsia development. They were divided into two groups: study group that performed physical exercise with a stationary bicycle once a week, for 30 minutes; the intensity was controlled (heart rate 20% above resting values), under professional supervision and a control group that was not engaged in any physical exercise. The data was retrieved from medical charts. Significance level assumed was 5%. Results. Women from study group performed 9.24 ± 7.03 of physical exercise sessions. There were no differences between groups comparing type of delivery and maternal outcomes, including maternal morbidity and hospitalization in intensive unit care, and neonatal outcomes, including birth weight, adequacy of weight to gestational age, prematurity, Apgar scale at first and fifth minutes, hospitalization in intensive unit care, and neonatal morbidity. Conclusions. Physical exercise using a stationary bicycle in pregnant women with chronic hypertension and/or previous preeclampsia, once a week, under professional supervision, did not interfere in the delivery method and did not produce maternal and neonatal risks of the occurrence of morbidity. This trial is registered with ClinicalTrials.gov NCT01395342.
A randomized comparative trial of the efficacy and safety of exercise during pregnancy: design and methods. [2006]Use of an exercise intervention for high-risk and vulnerable populations, such as pregnant women at risk for gestational hypertension or preeclampsia, requires special consideration. A comparative trial testing the effects of two types of physical exercises - stretching (a comparator) and walking (a testing intervention) - for sedentary pregnant women at risk for preeclampsia - is presented in this paper. The study was designed to reduce post-randomization bias and dropout rates from both groups, and closely to monitor safety of subjects. The strengths of the study design and methods include use of a run-in phase; use of a stretching exercise as a comparator; multiple ways to measure daily physical activities and the exercise intervention; and tailored support to remove barriers to exercise for subjects. The intervention consists of 40 min of walking at moderate intensity (i.e., 55-69% of maximum heart rate and rating of perceived exhaustion 12-13) five times a week from 18 weeks gestation until birth. The comparator exercise consists of 40 min of stretching exercise without increasing heart rate to more than 10% of resting heart rate, five times a week from 18 weeks gestation until birth. The primary outcome is the incidence of preeclampsia. Secondary outcomes include the physiologic effects of the intervention and birth outcomes.
Exercise and physical activity in the prevention of pre-eclampsia: systematic review. [2018]Exercise and physical activity have been studied and suggested as a way to reduce or minimize the effects of pre-eclampsia. Our aim was to evaluate the association between exercise and/or physical activity and occurrence of pre-eclampsia. We conducted electronic searches without year of publication and language limitations. This was a systematic review designed according to PRISMA. Different databases accessed were as follows: PubMed®; Latin-American and Caribbean Literature in Health Sciences (LILACS); Scientific Electronic Library On-line (SciELO); Physiotherapy Evidence Database (PEDro); and ISI web of Knowledge(SM) . The Medical Subject Headings (MeSH) were as follows: ("exercise" OR "motor activity" OR "physical activity") AND ("pre-eclampsia" OR "eclampsia" OR "hypertension, pregnancy-induced"). Inclusion criteria were studies conducted in adults who were engaged in some physical activity. The selection and methodological evaluation were carried out by two independent reviewers. Risk assessment was made by the odds ratio (OR) and incidence of pre-eclampsia in the population who performed physical activity/exercise. A total of 231 articles were found, 214 of which were excluded based on title and full-text, so that 17 remained. Comparison of six case-control studies showed that physical activity had a protective effect on the development of pre-eclampsia [OR 0.77, 95% confidence interval (CI) 0.64-0.91, p
Adherence to walking or stretching, and risk of preeclampsia in sedentary pregnant women. [2021]Pregnant women at risk for preeclampsia may benefit from the positive effects of exercise, but they may be unlikely to adhere to an exercise program. A randomized trial was conducted with 124 sedentary pregnant women to compare the effects of walking exercise to a stretching exercise on adherence and on the preeclampsia risk factors of heart rate (HR), blood pressure, and weight gain. Walkers exercised less than stretchers both overall and as pregnancy advanced. HR and blood pressure were lower among stretchers than walkers, but weight gain did not differ between the groups. For sedentary pregnant women, a stretching exercise may be more effective than walking in mitigating the risk of preeclampsia due to higher adherence and possible cardiac-physiologic effects.
Increased physical activity is correlated with improved pregnancy outcomes in women with preeclampsia: A retrospective study. [2021]Several studies have focused on the benefits of physical activity to prevent and treat preeclampsia, given that preeclampsia and cardiovascular disease share several risk factors. However, none of these studies have been conducted in Africa. Moreover, it has been demonstrated that exercise training has preventive effects on the development of preeclampsia in mouse models. Therefore, we evaluated the association between the practice of physical activity and the development of this pathology in a Tunisian cohort.
Cardiovascular effects of aerobic exercise training in formerly preeclamptic women and healthy parous control subjects. [2022]Women who have had preeclampsia demonstrate higher prevalence of metabolic syndrome (MetS), impaired vascular function, and increased sympathetic activity and are at increased risk of cardiovascular disease. The aim of this study was to assess the effects of 12 weeks of exercise training (70-80% maximum volume of oxygen utilization) in women who had had preeclampsia on physical fitness, components of MetS, vasculature, and autonomic functions compared with healthy control subjects.