Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women. (BedRest-1)
17 juni 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
140
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Montse Palacio, MD, PhD
- Telefoonnummer: 9946 +34932275400
- E-mail: secmmf@clinic.cat
Studie Contact Back-up
- Naam: Federico Migliorelli, Migliorelli, MD, PhD
- Telefoonnummer: 9946 +34932275400
- E-mail: secmmf@clinic.cat
Studie Locaties
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Barcelona
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Barcelona, Barcelona, Spanje, 08028
- Hospital Clinic de Barcelona
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Contact:
- Montse Palacio, MD, PhD
- Telefoonnummer: 9946 +34932275400
- E-mail: secmmf@clinic.cat
-
Contact:
- Federico Migliorelli, MD, PhD
- Telefoonnummer: 9946 +34932275400
- E-mail: secmmf@clinic.cat
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Specifiek ontworpen en gestructureerd oefenprogramma (gebaseerd op weerstand/kracht, ontworpen voor uitvoering in bed of met minimale mobiliteit).
Het is een aanpassing van het oefenprogramma beschreven door Brun CR et al (Brun CR, Shoemaker JK, Bocking A, Hammond JA, Poole M, Mottola MF.
Bedrustoefeningen, activiteitsbeperking en risicovolle zwangerschappen: een haalbaarheidsstudie.
Toegepaste fysiologie, voeding en metabolisme.
2011;36(4):577-582).
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Geen tussenkomst: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Haalbaarheidsevaluatie van de implementatie van het oefenprogramma: tijd die nodig is om de steekproefomvang te rekruteren
Tijdsspanne: Door voltooiing van de studie, gemiddeld 6 maanden
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Tijd die nodig is om de steekproefomvang te rekruteren (in dagen)
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Door voltooiing van de studie, gemiddeld 6 maanden
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Haalbaarheidsevaluatie van de implementatie van het oefenprogramma: Aantal vrouwen dat weigerde deel te nemen aan het onderzoek
Tijdsspanne: Door voltooiing van de studie, gemiddeld 6 maanden
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Aantal vrouwen dat weigerde deel te nemen aan het onderzoek
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Door voltooiing van de studie, gemiddeld 6 maanden
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Haalbaarheidsevaluatie van de implementatie van het oefenprogramma: Aantal vrouwen dat deelname aan het onderzoek opgeeft
Tijdsspanne: Door voltooiing van de studie, gemiddeld 6 maanden
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Aantal vrouwen dat deelname aan het onderzoek opgeeft
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Door voltooiing van de studie, gemiddeld 6 maanden
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Haalbaarheidsevaluatie van de implementatie van het oefenprogramma: naleving van het programma
Tijdsspanne: Door voltooiing van de studie, gemiddeld 6 maanden
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Naleving van het programma (aantal dagen daadwerkelijke uitvoering van het oefenprogramma tijdens opname)
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Door voltooiing van de studie, gemiddeld 6 maanden
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Tevredenheidsevaluatie
Tijdsspanne: Bij levering
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Een vragenlijst die speciaal voor de casus is gemaakt en waarin verschillende domeinen worden geëvalueerd (duur van de sessies, zwaarte van de sessies, dagelijkse herhaling van de sessies, moeilijkheidsgraad van bepaalde oefeningen, bereidheid om te herhalen in geval van heropname, algemene tevredenheid die in het programma moet worden opgenomen ) - Likert-schaal (1 tot 5, waarbij 1 helemaal niet tevreden is en 5 zeer tevreden).
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Bij levering
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Physiological parameters: Rectus femoris area measurement
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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:
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Baseline Maternal and fetal characteristics: Evaluation of physical activity (GAQ-P questionnaire)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Whitin 24h after delivery and 6 weeks postpartum
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Birthweight (in grams) and percentile
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Whitin 24h after delivery and 6 weeks postpartum
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Perinatal outcomes: SGA/growth restriction
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Whitin 24h after delivery and 6 weeks postpartum
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Neonatal admission to neonatal intensive care unit (yes/no)
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Whitin 24h after delivery and 6 weeks postpartum
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Perinatal outcomes: Composite adverse neonatal outcome
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Federico Migliorelli, MD, PhD, Gynecologist especialist on Maternal fetal medicine
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 september 2026
Primaire voltooiing (Geschat)
1 september 2027
Studie voltooiing (Geschat)
1 september 2029
Studieregistratiedata
Eerst ingediend
4 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
17 juni 2026
Eerst geplaatst (Werkelijk)
18 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
18 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
17 juni 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- BedRest Pregnancy Study
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .