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面对面与在线监督的多中心多组分产前运动计划对孕妇身体活动、体能和健康生活方式的影响:基于SPIRIT 2025的积极妊娠试验方案

Impact of in-person versus online supervised multicentre multicomponent prenatal exercise programme on maternal physical activity, fitness and healthy lifestyle: the Active Pregnancy trial SPIRIT 2025-based protocol.

作者信息

Santos-Rocha Rita, Branco Marco, Prior de Freitas Joana, Castro Bárbara, Pinto Adelaide Teixeira, Silva-Santos Sandra, Nogueira-Silva Cristina, Oviedo-Caro Miguel Angel, Szablewska Anna, Szumilewicz Anna

机构信息

ESDRM Sport Sciences School of Rio Maior, Santarém Polytechnic University, Rio Maior, Portugal.

SPRINT Sport Physical Activity and Health Research and Innovation Center, Rio Maior, Portugal.

出版信息

BMJ Open Sport Exerc Med. 2025 Jul 11;11(3):e002767. doi: 10.1136/bmjsem-2025-002767. eCollection 2025.

DOI:10.1136/bmjsem-2025-002767
PMID:40657545
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12248212/
Abstract

Many studies have supported the positive effects of an active lifestyle on the prevention and treatment of pregnancy-related complications, as well as maintaining fitness and functionality. The COVID-19 pandemic has underscored the need for virtual approaches to health interventions; however, few studies have examined the effectiveness of these interventions. The Standard Protocol Items: Recommendations for Interventional Trials 2025 guidelines were followed to describe the protocol of the ACTIVE PREGNANCY trial, an intervention study that delivers a physical exercise programme in-person (IN) and online (ON) to improve maternal physical activity (PA), fitness and healthy lifestyle parameters in pregnant women. Pregnant women will be invited to participate in a multisite, multicomponent exercise programme delivered either IN or ON by qualified exercise physiologists. Both groups will receive an exercise intervention delivered in different real-life environments. Participants will undergo basic fitness field tests and complete questionnaires assessing PA, fitness and lifestyle parameters before starting the exercise programme and after completing 12 weeks of the intervention. Researchers will test whether the intervention is beneficial in maintaining or improving maternal parameters after 12 weeks and will compare the effectiveness of different exercise modes. Subgroups of maternal age and weekly volume of PA will also be analysed. Primary outcomes: PA volume and health-related and functional fitness. Secondary outcomes: healthy lifestyle parameters. Additional outcomes: satisfaction with the exercise interventions and resources. This study was approved by the Ethics Committee of Santarém Polytechnic University and registered on ClinicalTrials.gov (NCT06954454). Findings will be disseminated via publications, conferences and training programmes.

摘要

许多研究都支持积极的生活方式对预防和治疗与妊娠相关的并发症以及维持健康和功能的积极作用。新冠疫情凸显了采用虚拟方式进行健康干预的必要性;然而,很少有研究考察这些干预措施的有效性。本研究遵循《2025年干预性试验标准方案条目:建议》指南,描述了ACTIVE PREGNANCY试验的方案,这是一项干预性研究,通过面对面(IN)和在线(ON)方式提供体育锻炼计划,以改善孕妇的身体活动(PA)、健康状况和健康生活方式参数。将邀请孕妇参加由合格的运动生理学家以面对面或在线方式提供的多地点、多组分运动计划。两组都将在不同的现实生活环境中接受运动干预。参与者将在开始运动计划前和完成12周干预后接受基本的健康现场测试,并完成评估身体活动、健康状况和生活方式参数的问卷。研究人员将测试该干预措施在12周后是否有利于维持或改善孕妇的各项参数,并比较不同运动模式的有效性。还将分析孕妇年龄和每周身体活动量的亚组。主要结局:身体活动量以及与健康相关的功能性健康状况。次要结局:健康生活方式参数。额外结局:对运动干预和资源的满意度。本研究已获得桑塔雷姆理工大学伦理委员会的批准,并在ClinicalTrials.gov(NCT06954454)上注册。研究结果将通过出版物、会议和培训项目进行传播。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eef5/12248212/26e924b8e5a0/bmjsem-11-3-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eef5/12248212/d1f51ba80115/bmjsem-11-3-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eef5/12248212/26e924b8e5a0/bmjsem-11-3-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eef5/12248212/d1f51ba80115/bmjsem-11-3-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eef5/12248212/26e924b8e5a0/bmjsem-11-3-g002.jpg

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本文引用的文献

1
SPIRIT 2025 statement: updated guideline for protocols of randomized trials.《SPIRIT 2025声明:随机试验方案的更新指南》
Nat Med. 2025 Apr 29. doi: 10.1038/s41591-025-03668-w.
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Validation of a pregnancy-adapted Mediterranean Diet Adherence Screener (preg-MEDAS): a validation study nested in the Improving Mothers for a better PrenAtal Care Trial BarCeloNa (IMPACT BCN) trial.验证一种妊娠适应型地中海饮食依从性筛查工具(preg-MEDAS):一项嵌套于改善母亲产前保健试验(IMPACT BCN)的验证研究。
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Polish Society of Gynecologists and Obstetricians (PTGiP) and Polish Society of Sports Medicine (PTMS) recommendations on physical activity during pregnancy and the postpartum period.
波兰妇产科医师协会(PTGiP)和波兰运动医学协会(PTMS)关于孕期及产后身体活动的建议。
Ginekol Pol. 2023 Aug 21. doi: 10.5603/GP.a2023.0080.
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Update and Novel Validation of a Pregnancy Physical Activity Questionnaire.更新和验证妊娠体力活动问卷。
Am J Epidemiol. 2023 Oct 10;192(10):1743-1753. doi: 10.1093/aje/kwad130.
5
The Importance Assigned by Pregnant Women to the Quality Characteristics of Fitness Instructors. A Qualitative Study.孕妇对健身教练素质特征的重视程度:一项定性研究
J Multidiscip Healthc. 2023 Jan 27;16:277-284. doi: 10.2147/JMDH.S293693. eCollection 2023.
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Can we hit prenatal depression and anxiety through HIIT? The effectiveness of online high intensity interval training in pregnant women during the COVID-19 pandemic: a randomized controlled trial.我们能否通过高强度间歇训练(HIIT)来应对产前抑郁和焦虑?新冠疫情期间在线高强度间歇训练对孕妇的有效性:一项随机对照试验。
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Assessment of physical fitness during pregnancy: validity and reliability of fitness tests, and relationship with maternal and neonatal health - a systematic review.孕期体能评估:体能测试的有效性和可靠性及其与母婴健康的关系——一项系统综述
BMJ Open Sport Exerc Med. 2022 Sep 23;8(3):e001318. doi: 10.1136/bmjsem-2022-001318. eCollection 2022.
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Active Pregnancy: A Physical Exercise Program Promoting Fitness and Health during Pregnancy-Development and Validation of a Complex Intervention.积极妊娠:促进妊娠期间健康的身体锻炼计划——复杂干预的制定与验证。
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