Impact of Exercise Prescription on Obstetric and Neonatal Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- Controlled chronic hypertension
研究概览
简要总结
The aim of this study is to assess the impact of structured physical activity with smartwatch remote monitoring on glycemic control, blood pressure control, obstetric complications and neonatal outcomes in women with GDM, chronic hypertension and obesity. A prospective, longitudinal, single-arm intervention study with 310 pregnant women was conducted over a period of 18 months. Participants received individualized exercise prescriptions based on international guidelines, complemented by smartwatch monitoring and regular telephonic feedback. Outcomes were compared between subgroups of women who adhere to the recommended exercise guidelines and those who did not, across three high-risk populations (GDM, chronic hypertension and obesity).
详细描述
A prospective, longitudinal, single-arm, intervention (prospective cohort) study was conducted in the Obstetric Department of Hospital of Coimbra, Portugal, for a total period of 18 months after a one-year recruitment period between February 2024 and January 2025, with data collection continuing until the final participant had given birth.
Clinical monitoring for high-risk pregnancies takes place solely in a hospital setting. This includes at least monthly visits and standardized trimester ultrasounds, with supplementary scans schedule as needed for fetal development and well-being based on the underlying conditions.
All pregnant patients attending their first obstetric consultation for either Endocrinology/Obstetric (if diagnosis of gestational diabetes or obesity with previous bariatric surgery) or Hypertension/Obstetric (if chronic hypertension) were recruited for the trial.
Study participants were enrolled via screening referrals initiated by both internal or external healthcare providers.
At the first visit, pregnant women were notified of an upcoming telephone contact from the research team. After clinical record verification, a phone interview was conducted to explain the project and collect demographic, anthropometric and obstetric data. After confirming the absence of exercise contraindications, researchers assessed the participants' pre-pregnancy healthy lifestyle habits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women aged 16 years or older with a confirmed diagnosis of gestational diabetes (fasting blood glucose greater than 92 mg/dL in first trimester; or values in the oral glucose tolerance test in second trimester greater than 92/180/153 mg/dL, respectively at 0 hours, 1 hour after glucose ingestion, and 2 hours after)
- •Pregnant women aged 16 or older with chronic hypertension or a history of bariatric surgery and pre-pregnancy Body Mass Index (BMI) above 30Kg/m
- •Eligibility further required consistent clinical adherence defined as attending all schedule appointments with the obstetric team without unjustified absences
排除标准
- •multiple gestations
- •risk of preterm labor
- •history of premature delivery due to a non-maternal cause
- •persistent vaginal bleeding
- •placenta previa beyond 28 weeks' gestation
- •cervical insufficiency
- •any limiting systemic, respiratory or cardiovascular disease.
研究组 & 干预措施
women who adhere to the recommended exercise prescription
Subsequently, participants received proactive counselling on the exercise modalities most effective for their specific pathologies, including guidance on the intensity, frequency and duration required for optimal health outcomes. This intervention included information on local exercise facilities and access to digital platforms (YouTube Channel - Active Pregnancy) featuring safe, evidence-based activities tailored for pregnancy. Prescriptions were individualized, incorporating patient preferences to determine the most suitable activity types and schedules.
Participants were equipped with a smartwatch to monitor physical activity, specifically tracking heart rate, step count, distance and average speed throughout the pregnancy. They were instructed to activate the device's 'training' mode at the commencement of each exercise session. Subsequently, activity data were synced to a dedicated mobile application for later extraction and analysis from the research team.
干预措施: Physical activity plan (Behavioral)
women who did not adhere to the recommended exercise prescription
Pregnant women who despite the active recommendation did not adhere to the prescribed physical activity plan
干预措施: Women who received information but did not engaged in a physical activity routine (Behavioral)
结局指标
主要结局
Controlled chronic hypertension
时间窗: From date of recruitment, usually first apointment, until the date of delivery, assessed up to 32 weeks.
Chronic hypertension was categorized as poorly controlled when medication adjustments or new therapies were necessary to achieve blood pressure values below the 140/90 mmHg threshold
Glycemic control
时间窗: From date of recruitment, usually first apointment, until the date of delivery, assessed up to 32 weeks.
Glycemic control was categorized as uncontrolled if pharmacological intervention was required to meet clinical targets typically defined as having more than five weekly blood glucose readings outside the recommended range (fasting plasma glucose ≥ 95 mg/dL and/or 1-hour postprandial glucose ≥ 140 mg/dL) and no association with alimentary mistakes.
Excessive weight gain
时间窗: From date of recruitment, usually first apointment, until the date of delivery, assessed up to 32 weeks.
Excessive weight gain was defined according to the Portuguese Directorate General of Health (DGS) guidelines (more than 18kg for women with pre-pregnancy BMI\<18.5 kg/m 2 ; more than 16kg if previous BMI between 18.5-24.9 kg/m 2 ; more than 11.5kg if previous BMI between 25-29.9 kg/m 2 ; and more than 9kg if previous BMI above 30 kg/m 2 )
次要结局
- Preterm delivery(Diagnosed after delivery)
- Low Birth weight(Data available at one point, after delivery)
- Pre eclampsia(After diagnosis until delivery, up to 20 weeks.)
研究者
Filipa Coutinho
MD, Attending Physician, Internal Medicine
Unidade Local de Saúde de Coimbra, EPE