Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women. (BedRest-1)
17. Juni 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
140
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Montse Palacio, MD, PhD
- Telefonnummer: 9946 +34932275400
- E-Mail: secmmf@clinic.cat
Studieren Sie die Kontaktsicherung
- Name: Federico Migliorelli, Migliorelli, MD, PhD
- Telefonnummer: 9946 +34932275400
- E-Mail: secmmf@clinic.cat
Studienorte
-
-
Barcelona
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Barcelona, Barcelona, Spanien, 08028
- Hospital Clínic de Barcelona
-
Kontakt:
- Montse Palacio, MD, PhD
- Telefonnummer: 9946 +34932275400
- E-Mail: secmmf@clinic.cat
-
Kontakt:
- Federico Migliorelli, MD, PhD
- Telefonnummer: 9946 +34932275400
- E-Mail: secmmf@clinic.cat
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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
|
Speziell entwickeltes und strukturiertes Übungsprogramm (basierend auf Widerstand/Kraft, konzipiert für die Ausführung im Bett oder mit minimaler Mobilität).
Es handelt sich um eine Adaption des von Brun CR et al. beschriebenen Übungsprogramms (Brun CR, Shoemaker JK, Bocking A, Hammond JA, Poole M, Mottola MF).
Bettruheübungen, Aktivitätseinschränkungen und Risikoschwangerschaften: eine Machbarkeitsstudie.
Angewandte Physiologie, Ernährung und Stoffwechsel.
2011;36(4):577-582).
|
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Kein Eingriff: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Machbarkeitsbewertung der Umsetzung des Übungsprogramms: Zeitaufwand für die Rekrutierung der Stichprobengröße
Zeitfenster: Bis zum Studienabschluss vergehen durchschnittlich 6 Monate
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Zeitaufwand für die Rekrutierung der Stichprobengröße (in Tagen)
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Bis zum Studienabschluss vergehen durchschnittlich 6 Monate
|
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Machbarkeitsbewertung der Umsetzung des Übungsprogramms: Anzahl der Frauen, die eine Teilnahme an der Studie ablehnten
Zeitfenster: Bis zum Studienabschluss vergehen durchschnittlich 6 Monate
|
Anzahl der Frauen, die die Teilnahme an der Studie abgelehnt haben
|
Bis zum Studienabschluss vergehen durchschnittlich 6 Monate
|
|
Machbarkeitsbewertung der Umsetzung des Übungsprogramms: Anzahl der Frauen, die auf die Teilnahme an der Studie verzichten
Zeitfenster: Bis zum Studienabschluss vergehen durchschnittlich 6 Monate
|
Anzahl der Frauen, die die Teilnahme an der Studie aufgeben
|
Bis zum Studienabschluss vergehen durchschnittlich 6 Monate
|
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Machbarkeitsbewertung der Umsetzung des Übungsprogramms: Einhaltung des Programms
Zeitfenster: Bis zum Studienabschluss vergehen durchschnittlich 6 Monate
|
Einhaltung des Programms (Anzahl der Tage der tatsächlichen Durchführung des Übungsprogramms während der Zulassung)
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Bis zum Studienabschluss vergehen durchschnittlich 6 Monate
|
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Zufriedenheitsbewertung
Zeitfenster: Bei Lieferung
|
Ein speziell für den Fall erstellter Fragebogen, der verschiedene Bereiche bewertet (Länge der Sitzungen, Härte der Sitzungen, tägliche Wiederholung der Sitzungen, Schwierigkeit bestimmter Übungen, Bereitschaft zur Wiederholung im Falle einer Wiederaufnahme, Gesamtzufriedenheit mit der Aufnahme in das Programm). ) – Likert-Skala (1 bis 5, wobei 1 überhaupt nicht zufrieden und 5 sehr zufrieden ist).
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Bei Lieferung
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Physiological parameters: Rectus femoris area measurement
Zeitfenster: Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
|
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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
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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
Zeitfenster: 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
Zeitfenster: 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:
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
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Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Baseline Maternal and fetal characteristics: Evaluation of physical activity (GAQ-P questionnaire)
Zeitfenster: 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.
|
Baseline
|
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Baseline Maternal and fetal characteristics: Maternal age
Zeitfenster: Baseline
|
Maternal age (In years)
|
Baseline
|
|
Baseline Maternal and fetal characteristics: Maternal weight
Zeitfenster: Baseline
|
Maternal weight (In kg)
|
Baseline
|
|
Baseline Maternal and fetal characteristics: Ethnic group
Zeitfenster: 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
Zeitfenster: Baseline
|
Gestational age at recruitment (in weeks + days)
|
Baseline
|
|
Baseline Maternal and fetal characteristics: Twin pregnancy
Zeitfenster: Baseline
|
Twin pregnancy (yes/no)
|
Baseline
|
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Baseline Maternal and fetal characteristics: Fetal growth percentile at admission
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
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Maternal and fetal characteristics during hospital admission: Diet during the admission
Zeitfenster: 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
|
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Maternal and fetal characteristics during hospital admission: Daily fluid intake
Zeitfenster: 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
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Perinatal outcomes: Gestational age at delivery
Zeitfenster: Whitin 24h after delivery and 6 weeks postpartum
|
Gestational age at delivery (in weeks + days
|
Whitin 24h after delivery and 6 weeks postpartum
|
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Perinatal outcomes: Birthweight
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
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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
Zeitfenster: 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
Zeitfenster: 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
|
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Perinatal outcomes: Breastfeeding rates
Zeitfenster: Whitin 24h after delivery and 6 weeks postpartum
|
Breastfeeding rates
|
Whitin 24h after delivery and 6 weeks postpartum
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Federico Migliorelli, MD, PhD, Gynecologist especialist on Maternal fetal medicine
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. September 2026
Primärer Abschluss (Geschätzt)
1. September 2027
Studienabschluss (Geschätzt)
1. September 2029
Studienanmeldedaten
Zuerst eingereicht
4. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
17. Juni 2026
Zuerst gepostet (Tatsächlich)
18. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
18. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
17. Juni 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- BedRest Pregnancy Study
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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