Impact of Exercise Prescription on Obstetric and Neonatal Outcomes
研究概览
地位
详细说明
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.
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.
Follow-up telephonic consultations were conducted every 3-6 weeks to promote exercise adherence. During these calls, the research team characterized the participants' previous activity levels and adjusted prescriptions based on individual tolerability and evolving interests. These contacts persisted until delivery, the emerge of a medical contraindication or at the participants request.
Informational posters were displayed throughout the institution to highlight the primary advantages of prenatal physical activity. These materials included a link to dedicated social media platform design specifically for this study, intended to educate patients, dispel prevalent myths such as the unsubstantiated link between exercise and miscarriage or preterm birth and provide localized information on community exercise facilities and safe home-based workout routines.
The study was conducted in accordance with the Declaration of Helsinki and applicable national regulations for healthcare research and was approved by the Ethics Committee of the Institution (PI OBS.SF.112-2023). Informed consent was obtained from all individual participants. All materials and clinical appointments were provided without any costs for the participants, and all data were collected by healthcare professionals and processed anonymously to ensure participant confidentiality.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Coimbra District
-
Coimbra、Coimbra District、葡萄牙、3004-561
- ULSCoimbra
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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/m2.
- Eligibility further required consistent clinical adherence defined as attending all schedule appointments with the obstetric team without unjustified absences
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:非随机化
- 介入模型:顺序分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器: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. |
pregnant women who engaged in a physical activity routine previously prescribed
|
|
安慰剂比较: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
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No structured physical activity
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Controlled chronic hypertension
大体时间: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
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From date of recruitment, usually first apointment, until the date of delivery, assessed up to 32 weeks.
|
|
Glycemic control
大体时间: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.
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From date of recruitment, usually first apointment, until the date of delivery, assessed up to 32 weeks.
|
|
Excessive weight gain
大体时间: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 )
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From date of recruitment, usually first apointment, until the date of delivery, assessed up to 32 weeks.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Preterm delivery
大体时间:Diagnosed after delivery
|
Preterm birth was considered if deliver occurred before 37 weeks of gestational age
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Diagnosed after delivery
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Low Birth weight
大体时间:Data available at one point, after delivery
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Low birth weight was defined as a birth weight of less than 2500g.
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Data available at one point, after delivery
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Pre eclampsia
大体时间:After diagnosis until delivery, up to 20 weeks.
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Pre eclampsia was defined as a condition that pregnant women develop after 20-weeks gestational age, with new-onset hypertension, usually with accompanying proteinuria, intrauterine growth restriction or other analytic anomalies as elevated liver enzymes, low platelet count or hemolysis.
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After diagnosis until delivery, up to 20 weeks.
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合作者和调查者
调查人员
- 首席研究员:Filipa M Coutinho, MD、Unidade Local de Saude de Coimbra, EPE
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- ULSCoimbra
计划个人参与者数据 (IPD)
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IPD 计划说明
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