Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women. (BedRest-1)
17 июня 2026 г. обновлено: 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.
Обзор исследования
Статус
Еще не набирают
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
140
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Montse Palacio, MD, PhD
- Номер телефона: 9946 +34932275400
- Электронная почта: secmmf@clinic.cat
Учебное резервное копирование контактов
- Имя: Federico Migliorelli, Migliorelli, MD, PhD
- Номер телефона: 9946 +34932275400
- Электронная почта: secmmf@clinic.cat
Места учебы
-
-
Barcelona
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Barcelona, Barcelona, Испания, 08028
- Hospital Clinic de Barcelona
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Контакт:
- Montse Palacio, MD, PhD
- Номер телефона: 9946 +34932275400
- Электронная почта: secmmf@clinic.cat
-
Контакт:
- Federico Migliorelli, MD, PhD
- Номер телефона: 9946 +34932275400
- Электронная почта: secmmf@clinic.cat
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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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Специально разработанная и структурированная программа упражнений (основанная на сопротивлении/силе, предназначенная для выполнения в постели или с минимальной подвижностью).
Это адаптация программы упражнений, описанной Brun CR и др. (Brun CR, Shoemaker JK, Bocking A, Hammond JA, Poole M, Mottola MF.
Постельный режим, ограничение активности и беременность высокого риска: технико-экономическое обоснование.
Прикладная физиология, питание и обмен веществ.
2011;36(4):577-582).
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Без вмешательства: 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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Технико-экономическая оценка реализации программы учений: время, необходимое для набора размера выборки
Временное ограничение: После завершения обучения в среднем 6 месяцев
|
Время, необходимое для набора размера выборки (в днях)
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После завершения обучения в среднем 6 месяцев
|
|
Технико-экономическое обоснование реализации программы упражнений: количество женщин, отказавшихся от участия в исследовании
Временное ограничение: После завершения обучения в среднем 6 месяцев
|
Количество женщин, отказавшихся от участия в исследовании
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После завершения обучения в среднем 6 месяцев
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Технико-экономическое обоснование реализации программы упражнений: количество женщин, отказавшихся от участия в исследовании
Временное ограничение: После завершения обучения в среднем 6 месяцев
|
Число женщин, отказавшихся от участия в исследовании
|
После завершения обучения в среднем 6 месяцев
|
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Технико-экономическое обоснование реализации программы учений: Соблюдение программы
Временное ограничение: После завершения обучения в среднем 6 месяцев
|
Соблюдение программы (количество дней фактического выполнения программы упражнений при допуске)
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После завершения обучения в среднем 6 месяцев
|
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Оценка удовлетворенности
Временное ограничение: При доставке
|
Анкета, составленная специально для случая, оценивающая различные области (продолжительность занятий, сложность занятий, ежедневное повторение занятий, сложность отдельных упражнений, готовность повторить в случае повторного приема, общая удовлетворенность включением в программу) ) - шкала Лайкерта (от 1 до 5, где 1 совсем не удовлетворен, а 5 — полностью удовлетворен).
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При доставке
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Physiological parameters: Rectus femoris area measurement
Временное ограничение: 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
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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
Временное ограничение: 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).
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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
Временное ограничение: 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).
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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.
Временное ограничение: 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).
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Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
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Mental health/emotional parameters: GAD-7
Временное ограничение: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
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)
Временное ограничение: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery
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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.
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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
Временное ограничение: Daily
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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
Временное ограничение: 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:
Временное ограничение: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
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.
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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: Muscle Ultrasound
Временное ограничение: 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
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Baseline Maternal and fetal characteristics: Evaluation of physical activity (GAQ-P questionnaire)
Временное ограничение: 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
Временное ограничение: Baseline
|
Maternal age (In years)
|
Baseline
|
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Baseline Maternal and fetal characteristics: Maternal weight
Временное ограничение: Baseline
|
Maternal weight (In kg)
|
Baseline
|
|
Baseline Maternal and fetal characteristics: Ethnic group
Временное ограничение: Baseline
|
Ethnic group classified as: - White/European - Hispanic/latin American - Black/African Americans - Arabic - Asian
|
Baseline
|
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Baseline Maternal and fetal characteristics: Gestational age at recruitment
Временное ограничение: Baseline
|
Gestational age at recruitment (in weeks + days)
|
Baseline
|
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Baseline Maternal and fetal characteristics: Twin pregnancy
Временное ограничение: Baseline
|
Twin pregnancy (yes/no)
|
Baseline
|
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Baseline Maternal and fetal characteristics: Fetal growth percentile at admission
Временное ограничение: Baseline
|
Fetal growth percentile at admission (customized for gender and multiplicity)
|
Baseline
|
|
Baseline Maternal and fetal characteristics: Medical condition that justifies hospital admission
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
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Maternal and fetal characteristics during hospital admission: Length of hospital admission
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Whitin 24h after delivery and 6 weeks postpartum
|
Birthweight (in grams) and percentile
|
Whitin 24h after delivery and 6 weeks postpartum
|
|
Perinatal outcomes: SGA/growth restriction
Временное ограничение: 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
|
|
Perinatal outcomes: Mode of delivery
Временное ограничение: Whitin 24h after delivery and 6 weeks postpartum
|
Mode of delivery (spontaneous, assisted, cesarean section)
|
Whitin 24h after delivery and 6 weeks postpartum
|
|
Perinatal outcomes: Composite adverse maternal outcome
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
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Whitin 24h after delivery and 6 weeks postpartum
|
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Perinatal outcomes: Breastfeeding rates
Временное ограничение: Whitin 24h after delivery and 6 weeks postpartum
|
Breastfeeding rates
|
Whitin 24h after delivery and 6 weeks postpartum
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Federico Migliorelli, MD, PhD, Gynecologist especialist on Maternal fetal medicine
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 сентября 2026 г.
Первичное завершение (Оцененный)
1 сентября 2027 г.
Завершение исследования (Оцененный)
1 сентября 2029 г.
Даты регистрации исследования
Первый отправленный
4 июня 2026 г.
Впервые представлено, что соответствует критериям контроля качества
17 июня 2026 г.
Первый опубликованный (Действительный)
18 июня 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
18 июня 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
17 июня 2026 г.
Последняя проверка
1 мая 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- BedRest Pregnancy Study
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Описание плана IPD
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.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .