Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women. (BedRest-1)
17. června 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Odhadovaný)
140
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Montse Palacio, MD, PhD
- Telefonní číslo: 9946 +34932275400
- E-mail: secmmf@clinic.cat
Studijní záloha kontaktů
- Jméno: Federico Migliorelli, Migliorelli, MD, PhD
- Telefonní číslo: 9946 +34932275400
- E-mail: secmmf@clinic.cat
Studijní místa
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Barcelona
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Barcelona, Barcelona, Španělsko, 08028
- Hospital Clínic de Barcelona
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Kontakt:
- Montse Palacio, MD, PhD
- Telefonní číslo: 9946 +34932275400
- E-mail: secmmf@clinic.cat
-
Kontakt:
- Federico Migliorelli, MD, PhD
- Telefonní číslo: 9946 +34932275400
- E-mail: secmmf@clinic.cat
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Speciálně navržený a strukturovaný cvičební program (založený na odporu/síle, určený k provádění v posteli nebo s minimální pohyblivostí).
Jde o adaptaci cvičebního programu popsaného Brunem CR et al (Brun CR, Shoemaker JK, Bocking A, Hammond JA, Poole M, Mottola MF.
Cvičení v klidu na lůžku, omezení aktivity a vysoce riziková těhotenství: studie proveditelnosti.
Aplikovaná fyziologie, výživa a metabolismus.
2011;36(4):577-582).
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Žádný zásah: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Hodnocení proveditelnosti implementace cvičebního programu: Čas potřebný k náboru velikosti vzorku
Časové okno: Po ukončení studia v průměru 6 měsíců
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Čas potřebný k náboru velikosti vzorku (ve dnech)
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Po ukončení studia v průměru 6 měsíců
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Hodnocení proveditelnosti realizace cvičebního programu: Počet žen, které odmítly účast ve studii
Časové okno: Po ukončení studia v průměru 6 měsíců
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Počet žen, které se odmítly zúčastnit studie
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Po ukončení studia v průměru 6 měsíců
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Hodnocení proveditelnosti realizace cvičebního programu: Počet žen, které se vzdají účasti ve studii
Časové okno: Po ukončení studia v průměru 6 měsíců
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Počet žen, které se vzdají účasti ve studii
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Po ukončení studia v průměru 6 měsíců
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Hodnocení proveditelnosti realizace cvičebního programu: Dodržování programu
Časové okno: Po ukončení studia v průměru 6 měsíců
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Dodržování programu (počet dnů skutečného provádění cvičebního programu při přijetí)
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Po ukončení studia v průměru 6 měsíců
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Hodnocení spokojenosti
Časové okno: Při dodání
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Dotazník vytvořený speciálně pro daný případ hodnotící různé domény (délka sezení, náročnost sezení, denní opakování sezení, obtížnost jednotlivých cviků, ochota opakovat v případě opětovného přijetí, celková spokojenost se zařazením do programu ) - Likertova škála (1 až 5, 1 vůbec nespokojen a 5 vysoce spokojen).
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Při dodání
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Physiological parameters: Rectus femoris area measurement
Časové okno: 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
Časové okno: Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
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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
Časové okno: 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.
Časové okno: Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
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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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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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:
Časové okno: 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.
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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
Časové okno: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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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
Časové okno: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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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.
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Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Baseline Maternal and fetal characteristics: Evaluation of physical activity (GAQ-P questionnaire)
Časové okno: Baseline
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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
Časové okno: Baseline
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Maternal age (In years)
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Baseline
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Baseline Maternal and fetal characteristics: Maternal weight
Časové okno: Baseline
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Maternal weight (In kg)
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Baseline
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Baseline Maternal and fetal characteristics: Ethnic group
Časové okno: Baseline
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Ethnic group classified as: - White/European - Hispanic/latin American - Black/African Americans - Arabic - Asian
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Baseline
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Baseline Maternal and fetal characteristics: Gestational age at recruitment
Časové okno: Baseline
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Gestational age at recruitment (in weeks + days)
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Baseline
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Baseline Maternal and fetal characteristics: Twin pregnancy
Časové okno: Baseline
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Twin pregnancy (yes/no)
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Baseline
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Baseline Maternal and fetal characteristics: Fetal growth percentile at admission
Časové okno: Baseline
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Fetal growth percentile at admission (customized for gender and multiplicity)
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Baseline
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Baseline Maternal and fetal characteristics: Medical condition that justifies hospital admission
Časové okno: Baseline
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Medical condition that justifies hospital admission (hypertensive disorders, preterm labor, rupture of membranes, antepartum bleeding, others)
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Baseline
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Baseline Maternal and fetal characteristics: Musculoskeletal limitations
Časové okno: Baseline
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Musculoskeletal limitations (injuries or pathologies) (yes/no and description)
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Baseline
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Maternal and fetal characteristics during hospital admission: Medication while admitted
Časové okno: Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Medication while admitted (antihypertensive treatment, tocolysis, magnesium sulphate, antibiotics, corticosteroids, others)
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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 stay in the intermediate care unit
Časové okno: Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Length of stay in the intermediate care unit (in days)
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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
Časové okno: Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Length of hospital admission (in days)
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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: Fetal CTG
Časové okno: Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Fetal CTG description
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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: Diet during the admission
Časové okno: Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Diet during the admission (in Kcal and special needs)
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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: Daily fluid intake
Časové okno: Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Daily fluid intake (in mL)
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Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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Perinatal outcomes: Gestational age at delivery
Časové okno: Whitin 24h after delivery and 6 weeks postpartum
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Gestational age at delivery (in weeks + days
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Whitin 24h after delivery and 6 weeks postpartum
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Perinatal outcomes: Birthweight
Časové okno: Whitin 24h after delivery and 6 weeks postpartum
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Birthweight (in grams) and percentile
|
Whitin 24h after delivery and 6 weeks postpartum
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Perinatal outcomes: SGA/growth restriction
Časové okno: Whitin 24h after delivery and 6 weeks postpartum
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SGA/growth restriction (yes/no) and classification, if any
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Whitin 24h after delivery and 6 weeks postpartum
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Perinatal outcomes: Mode of delivery
Časové okno: Whitin 24h after delivery and 6 weeks postpartum
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Mode of delivery (spontaneous, assisted, cesarean section)
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Whitin 24h after delivery and 6 weeks postpartum
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Perinatal outcomes: Composite adverse maternal outcome
Časové okno: Whitin 24h after delivery and 6 weeks postpartum
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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)
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Whitin 24h after delivery and 6 weeks postpartum
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Perinatal outcomes: Neonatal admission to neonatal intensive care unit
Časové okno: Whitin 24h after delivery and 6 weeks postpartum
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Neonatal admission to neonatal intensive care unit (yes/no)
|
Whitin 24h after delivery and 6 weeks postpartum
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Perinatal outcomes: Composite adverse neonatal outcome
Časové okno: Whitin 24h after delivery and 6 weeks postpartum
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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
Časové okno: Whitin 24h after delivery and 6 weeks postpartum
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Breastfeeding rates
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Whitin 24h after delivery and 6 weeks postpartum
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Federico Migliorelli, MD, PhD, Gynecologist especialist on Maternal fetal medicine
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. září 2026
Primární dokončení (Odhadovaný)
1. září 2027
Dokončení studie (Odhadovaný)
1. září 2029
Termíny zápisu do studia
První předloženo
4. června 2026
První předloženo, které splnilo kritéria kontroly kvality
17. června 2026
První zveřejněno (Aktuální)
18. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
18. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
17. června 2026
Naposledy ověřeno
1. května 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- BedRest Pregnancy Study
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu 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.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .