Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women. (BedRest-1)
2026年6月17日 更新者：Hospital Clinic of Barcelona
Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women
This study aims to evaluate the impact of a specifically designed exercise program for hospitalized high-risk pregnant individuals on bed rest.
This is a specifically designed physical activiity program, consisting of a resistance and strength exercises intended to be performed even while in bed and seeks to address physical and emotional health challenges during hospitalization.
The study will compare outcomes between participants who follow the exercise program and those receiving standard care.
Primary outcomes include physical and emotional health parameters, quality of life, and sleep quality.
Secondary outcomes focus on feasibility, adherence, and participant satisfaction.
This research addresses the gap in physical activity guidelines for pregnant individuals on bed rest and explores the potential benefits of exercise to improve maternal well-being and postpartum recovery.
研究概览
详细说明
This study investigates the feasibility and potential benefits of a specifically designed exercise program for hospitalized high-risk pregnant individuals on bed rest. The program includes resistance and strength exercises tailored to be safely performed while in bed, aiming to counteract the physiological and psychological deconditioning associated with prolonged inactivity during hospitalization.
Prolonged bed rest during pregnancy, often prescribed for high-risk conditions, can result in muscle atrophy, reduced cardiovascular capacity, and psychological distress, including anxiety, stress, and depression. Despite the known adverse effects of inactivity, there is limited evidence on structured exercise programs for this population. This study seeks to fill that gap by testing an intervention designed to mitigate these negative outcomes.
Participants will be randomized into two groups: an exercise group (EG) and a no-exercise group (NEG). The EG will perform daily supervised exercises, lasting approximately 30 minutes, under the guidance of trained staff. The NEG will follow standard care without structured physical activity. The study evaluates physical health parameters (e.g., activity levels, muscle strength), mental health outcomes (e.g., anxiety, depression, stress), sleep quality, and quality of life. Secondary objectives include assessing program feasibility, recruitment rates, adherence, and participant satisfaction.
Data collection will include validated self-reported questionnaires, wearable devices (accelerometers), and clinical measures. Key endpoints will be compared between groups at regular intervals during hospitalization and at six weeks postpartum.
This pilot randomized controlled trial aims to generate knowledge on the acceptability, safety, and preliminary effectiveness of bed-rest exercise programs in high-risk pregnancies, with the goal of informing future larger-scale studies and addressing an unmet need in maternal care.
研究类型
介入性
注册 (估计的)
140
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Montse Palacio, MD, PhD
- 电话号码：9946 +34932275400
- 邮箱：secmmf@clinic.cat
研究联系人备份
- 姓名：Federico Migliorelli, Migliorelli, MD, PhD
- 电话号码：9946 +34932275400
- 邮箱：secmmf@clinic.cat
学习地点
-
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Barcelona
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Barcelona、Barcelona、西班牙、08028
- Hospital Clinic de Barcelona
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接触：
- Montse Palacio, MD, PhD
- 电话号码：9946 +34932275400
- 邮箱：secmmf@clinic.cat
-
接触：
- Federico Migliorelli, MD, PhD
- 电话号码：9946 +34932275400
- 邮箱：secmmf@clinic.cat
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Maternal age of 18 or more
- Delivery not expected within 1 week after recruitment.
- Language ability to understand the study.
- Informed consent signed.
Exclusion Criteria:
- Fetal death
- Severe mental health disorders and substance abuse disorders.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Exercise group
Pregnant women admitted in the Maternal Intermediate Care Unit who will follow the standard management for its complication and will receiving the intervention and monitored according to study procedures
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专门设计和结构化的锻炼计划（基于阻力/力量，设计为在床上或最小活动范围内执行）。
它改编自 Brun CR 等人（Brun CR、Shoemaker JK、Bocking A、Hammond JA、Poole M、Mottola MF.
卧床休息锻炼、活动限制和高风险妊娠：可行性研究。
应用生理学、营养学和新陈代谢。
2011；36（4）：577-582）。
|
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无干预：Non-exercise group
Pregnant women admitted in the Maternal Intermediate Care Unit who will follow the standard management for its complication without any specific instructions to engage in physical activity, also monitored according to study procedures.
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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 |
|---|---|---|
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演练方案实施可行性评估：招募样本量所需时间
大体时间：完成学习，平均需要 6 个月
|
招募样本量所需的时间（以天为单位）
|
完成学习，平均需要 6 个月
|
|
实施锻炼计划的可行性评估：拒绝参加研究的女性人数
大体时间：完成学习，平均需要 6 个月
|
拒绝参加该研究的女性人数
|
完成学习，平均需要 6 个月
|
|
实施锻炼计划的可行性评估：放弃参与研究的女性人数
大体时间：完成学习，平均需要 6 个月
|
放弃参与研究的女性人数
|
完成学习，平均需要 6 个月
|
|
演习计划实施的可行性评估：遵守计划
大体时间：完成学习，平均需要 6 个月
|
遵守计划（入院期间实际执行锻炼计划的天数）
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完成学习，平均需要 6 个月
|
|
满意度评价
大体时间：交货时
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专门针对评估不同领域的案例制作的调查问卷（课程长度、课程难度、每日重复课程、特定练习的难度、重新入学时重复的意愿、对课程的总体满意度） ) - Likert 量表（1 至 5，1 表示完全不满意，5 表示非常满意）。
|
交货时
|
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Physiological parameters: Rectus femoris area measurement
大体时间：Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
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Loss of rectus femoris area (cm2) in a relaxed state, assessed by ultrasound
|
Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
|
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Physiological parameters: Time spent in moderate or vigorous activity
大体时间：Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
|
Time spent in moderate or vigorous activity (in minutes, summarized as average per day).
|
Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
|
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Physiological parameters: Total physical activity
大体时间：Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
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Total physical activity (average per day in mG).
|
Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
|
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Physiological parameters: Handgrip strength test.
大体时间：Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
|
Handgrip strength test (in kg, adjusted for gender and age).
|
Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
|
|
Mental health/emotional parameters: GAD-7
大体时间：Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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GAD-7: Generalized Anxiety Disorder assessment scale (score ranging from 0 to 21).
The higher the results, higher is the severity of anxiety.
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Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
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Mental health/emotional parameters: Perceived Stress Scale (PSS-10)
大体时间：Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Perceived Stress Scale (PSS-10) (score ranging from 0 to 40).
The higher the results, higher is the perception of stress.
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Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
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Mental health/emotional parameters: Edinburg Postpartum Depression Scale
大体时间：Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Edinburg Postpartum Depression Scale (EPDS) (score -ranging from 0 to 30- and percentage of score ≥9).
The higher the total score, more intense is the emotional stress.
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Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
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Sleep cycle and Quality of life parameters: Sleep average per night
大体时间：Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery
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Sleep average per night (in minutes)
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Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery
|
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Sleep cycle and Quality of life parameters: WHOQOL-BREF score
大体时间：Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery
|
Abbreviated version of the World Health Organization Quality of Life Assessment scale (WHOQOL-BREF) (score ranging from 0 to 100).
The higher the score, better is the perception of quality of life.
|
Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery
|
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Mental health/emotional parameters: SAM: The Self-Assessment Manikin
大体时间：Daily
|
Visual standardized measure of emotional tone that covers 3 different affective domains (valence, arousal and sense of control).
Responses are made by selecting the manikin that best represents the emotional state of the patient.
The patient selection is afterwards converted into a numerical result with higher scores indicating more positive affective tone.
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Daily
|
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Mental health/emotional parameters: RRS: The Ruminative Response Scale
大体时间：Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
10-item questionnaire intended to measure rumination, tendency to worriedness and repetitive thinking in front of stressful situations.
(score ranking from 10 to 40).
Higher scores indicate a higher tendeny to ruminate and a vulnerability trait to psychological distress
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Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
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Mental health/emotional parameters: BDI-II:
大体时间：Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Questionnaire to measuring depression at a cognitive, affective and behavioral level.
For the present study only 4 items related to hedonic experience will be selected.
Higher scores in each item indicate severity in the loss of hedonic capacity.
Reponses are made by using a 4-point Likert scale.
|
Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
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Physiological parameters: Muscle Ultrasound
大体时间：Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
Muscle ultrasound will be conducted weekly by blinded sonographers using a linear probe (7.5 - 10 MHz).
All images will be acquired in triplicate, and the average value will be used for analysis.
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Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Physiological parameters: Maternal Cardiac Ultrasound
大体时间：Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
Transthoracic echocardiography will be performed using standardised imaging protocols.
All measurements will be performed in triplicate when feasible, and averaged for analysis.
Standardization of acquisition settings and operator blinding to clinical data will be ensured to reduce measurement bias.
|
Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Baseline Maternal and fetal characteristics: Evaluation of physical activity (GAQ-P questionnaire)
大体时间：Baseline
|
The questionnarie self-clasisfies how often and for how long the participant engages in light-, moderate-, or vigorous-intensity physical activity.
It also assesses whether the participant should consult her obstetric health care provider before beginning or continuing physical activity during pregnancy.
The GAQP is a screening and classification tool and does not generate a numerical summary score.
Therefore, no minimun or maximum applies, and higher or lower scores do not indicate a better or worse outcome.
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Baseline
|
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Baseline Maternal and fetal characteristics: Maternal age
大体时间：Baseline
|
Maternal age (In years)
|
Baseline
|
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Baseline Maternal and fetal characteristics: Maternal weight
大体时间：Baseline
|
Maternal weight (In kg)
|
Baseline
|
|
Baseline Maternal and fetal characteristics: Ethnic group
大体时间：Baseline
|
Ethnic group classified as: - White/European - Hispanic/latin American - Black/African Americans - Arabic - Asian
|
Baseline
|
|
Baseline Maternal and fetal characteristics: Gestational age at recruitment
大体时间：Baseline
|
Gestational age at recruitment (in weeks + days)
|
Baseline
|
|
Baseline Maternal and fetal characteristics: Twin pregnancy
大体时间：Baseline
|
Twin pregnancy (yes/no)
|
Baseline
|
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Baseline Maternal and fetal characteristics: Fetal growth percentile at admission
大体时间：Baseline
|
Fetal growth percentile at admission (customized for gender and multiplicity)
|
Baseline
|
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Baseline Maternal and fetal characteristics: Medical condition that justifies hospital admission
大体时间：Baseline
|
Medical condition that justifies hospital admission (hypertensive disorders, preterm labor, rupture of membranes, antepartum bleeding, others)
|
Baseline
|
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Baseline Maternal and fetal characteristics: Musculoskeletal limitations
大体时间：Baseline
|
Musculoskeletal limitations (injuries or pathologies) (yes/no and description)
|
Baseline
|
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Maternal and fetal characteristics during hospital admission: Medication while admitted
大体时间：Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
Medication while admitted (antihypertensive treatment, tocolysis, magnesium sulphate, antibiotics, corticosteroids, others)
|
Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
|
Maternal and fetal characteristics during hospital admission: Length of stay in the intermediate care unit
大体时间：Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
Length of stay in the intermediate care unit (in days)
|
Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
|
Maternal and fetal characteristics during hospital admission: Length of hospital admission
大体时间：Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
Length of hospital admission (in days)
|
Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
|
Maternal and fetal characteristics during hospital admission: Fetal CTG
大体时间：Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
Fetal CTG description
|
Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
|
Maternal and fetal characteristics during hospital admission: Diet during the admission
大体时间：Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
Diet during the admission (in Kcal and special needs)
|
Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
|
Maternal and fetal characteristics during hospital admission: Daily fluid intake
大体时间：Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
Daily fluid intake (in mL)
|
Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
|
Perinatal outcomes: Gestational age at delivery
大体时间：Whitin 24h after delivery and 6 weeks postpartum
|
Gestational age at delivery (in weeks + days
|
Whitin 24h after delivery and 6 weeks postpartum
|
|
Perinatal outcomes: Birthweight
大体时间：Whitin 24h after delivery and 6 weeks postpartum
|
Birthweight (in grams) and percentile
|
Whitin 24h after delivery and 6 weeks postpartum
|
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Perinatal outcomes: SGA/growth restriction
大体时间：Whitin 24h after delivery and 6 weeks postpartum
|
SGA/growth restriction (yes/no) and classification, if any
|
Whitin 24h after delivery and 6 weeks postpartum
|
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Perinatal outcomes: Mode of delivery
大体时间：Whitin 24h after delivery and 6 weeks postpartum
|
Mode of delivery (spontaneous, assisted, cesarean section)
|
Whitin 24h after delivery and 6 weeks postpartum
|
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Perinatal outcomes: Composite adverse maternal outcome
大体时间：Whitin 24h after delivery and 6 weeks postpartum
|
Composite adverse maternal outcome (yes/no considering any of the following: re-intervention, endometritis, infection of surgical wound, curettage, admission to intensive care unit, hysterectomy, need for transfusion, postpartum hemorrhage requiring medication other than oxytocin or ergometrine, maternal sepsis, death)
|
Whitin 24h after delivery and 6 weeks postpartum
|
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Perinatal outcomes: Neonatal admission to neonatal intensive care unit
大体时间：Whitin 24h after delivery and 6 weeks postpartum
|
Neonatal admission to neonatal intensive care unit (yes/no)
|
Whitin 24h after delivery and 6 weeks postpartum
|
|
Perinatal outcomes: Composite adverse neonatal outcome
大体时间：Whitin 24h after delivery and 6 weeks postpartum
|
Composite adverse neonatal outcome: (yes/no considering any of the following: respiratory morbidity - respiratory distress syndrome or transient tachypnea - requiring intubation, moderate-severe bronchopulmonary dysplasia, intraventricular hemorrhage grade III-IV, early-onset sepsis, periventricular leukomalacia, necrotizing enterocolitis, retinopathy requiring laser, fetal or neonatal death)
|
Whitin 24h after delivery and 6 weeks postpartum
|
|
Perinatal outcomes: Breastfeeding rates
大体时间：Whitin 24h after delivery and 6 weeks postpartum
|
Breastfeeding rates
|
Whitin 24h after delivery and 6 weeks postpartum
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Federico Migliorelli, MD, PhD、Gynecologist especialist on Maternal fetal medicine
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2027年9月1日
研究完成 (估计的)
2029年9月1日
研究注册日期
首次提交
2026年6月4日
首先提交符合 QC 标准的
2026年6月17日
首次发布 (实际的)
2026年6月18日
研究记录更新
最后更新发布 (实际的)
2026年6月18日
上次提交的符合 QC 标准的更新
2026年6月17日
最后验证
2026年5月1日
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
- BedRest Pregnancy Study
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Individual participant data (IPD) will not be shared with esteranl researchers.
Study finding will be reported in peer-reviewed scientific journals and presented at scientific meetings in aggregate form, without disclosure of identifiable participant information.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.