Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women. (BedRest-1)
17 giugno 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Stimato)
140
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Montse Palacio, MD, PhD
- Numero di telefono: 9946 +34932275400
- Email: secmmf@clinic.cat
Backup dei contatti dello studio
- Nome: Federico Migliorelli, Migliorelli, MD, PhD
- Numero di telefono: 9946 +34932275400
- Email: secmmf@clinic.cat
Luoghi di studio
-
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Barcelona
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Barcelona, Barcelona, Spagna, 08028
- Hospital Clinic De Barcelona
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Contatto:
- Montse Palacio, MD, PhD
- Numero di telefono: 9946 +34932275400
- Email: secmmf@clinic.cat
-
Contatto:
- Federico Migliorelli, MD, PhD
- Numero di telefono: 9946 +34932275400
- Email: secmmf@clinic.cat
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-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Programma di esercizi specificatamente progettato e strutturato (basato su resistenza/forza, progettato per essere eseguito a letto o con mobilità minima).
È un adattamento del programma di esercizi descritto da Brun CR et al (Brun CR, Shoemaker JK, Bocking A, Hammond JA, Poole M, Mottola MF.
Esercizio di riposo a letto, limitazione delle attività e gravidanze ad alto rischio: uno studio di fattibilità.
Fisiologia applicata, nutrizione e metabolismo.
2011;36(4):577-582).
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Nessun intervento: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Valutazione di fattibilità dell'attuazione del programma di esercizi: tempo necessario per reclutare la dimensione del campione
Lasso di tempo: Fino al completamento degli studi, in media 6 mesi
|
Tempo necessario per reclutare la dimensione del campione (in giorni)
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Fino al completamento degli studi, in media 6 mesi
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Valutazione di fattibilità dell'attuazione del programma di esercizi: numero di donne che hanno rifiutato di partecipare allo studio
Lasso di tempo: Fino al completamento degli studi, in media 6 mesi
|
Numero di donne che hanno rifiutato di partecipare allo studio
|
Fino al completamento degli studi, in media 6 mesi
|
|
Valutazione di fattibilità dell'attuazione del programma di esercizi: Numero di donne che rinunciano a partecipare allo studio
Lasso di tempo: Fino al completamento degli studi, in media 6 mesi
|
Numero di donne che rinunciano a partecipare allo studio
|
Fino al completamento degli studi, in media 6 mesi
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Valutazione di fattibilità dell'attuazione del programma di esercitazioni: Aderenza al programma
Lasso di tempo: Fino al completamento degli studi, in media 6 mesi
|
Aderenza al programma (numero di giorni di effettiva esecuzione del programma di esercizi durante il ricovero)
|
Fino al completamento degli studi, in media 6 mesi
|
|
Valutazione della soddisfazione
Lasso di tempo: Alla consegna
|
Un questionario realizzato appositamente per il caso valutando diversi domini (durata delle sessioni, durezza delle sessioni, ripetizione quotidiana delle sessioni, difficoltà in esercizi particolari, disponibilità a ripetere in caso di riammissione, soddisfazione complessiva di essere inseriti nel programma ) - Scala Likert (da 1 a 5, dove 1 non è affatto soddisfatto e 5 molto soddisfatto).
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Alla consegna
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Physiological parameters: Rectus femoris area measurement
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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:
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Baseline Maternal and fetal characteristics: Evaluation of physical activity (GAQ-P questionnaire)
Lasso di tempo: 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
Lasso di tempo: Baseline
|
Maternal age (In years)
|
Baseline
|
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Baseline Maternal and fetal characteristics: Maternal weight
Lasso di tempo: Baseline
|
Maternal weight (In kg)
|
Baseline
|
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Baseline Maternal and fetal characteristics: Ethnic group
Lasso di tempo: 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
Lasso di tempo: Baseline
|
Gestational age at recruitment (in weeks + days)
|
Baseline
|
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Baseline Maternal and fetal characteristics: Twin pregnancy
Lasso di tempo: Baseline
|
Twin pregnancy (yes/no)
|
Baseline
|
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Baseline Maternal and fetal characteristics: Fetal growth percentile at admission
Lasso di tempo: 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
Lasso di tempo: Baseline
|
Medical condition that justifies hospital admission (hypertensive disorders, preterm labor, rupture of membranes, antepartum bleeding, others)
|
Baseline
|
|
Baseline Maternal and fetal characteristics: Musculoskeletal limitations
Lasso di tempo: 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
Lasso di tempo: 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
|
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Maternal and fetal characteristics during hospital admission: Length of stay in the intermediate care unit
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
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Perinatal outcomes: Composite adverse neonatal outcome
Lasso di tempo: 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
Lasso di tempo: Whitin 24h after delivery and 6 weeks postpartum
|
Breastfeeding rates
|
Whitin 24h after delivery and 6 weeks postpartum
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Federico Migliorelli, MD, PhD, Gynecologist especialist on Maternal fetal medicine
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 settembre 2026
Completamento primario (Stimato)
1 settembre 2027
Completamento dello studio (Stimato)
1 settembre 2029
Date di iscrizione allo studio
Primo inviato
4 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
17 giugno 2026
Primo Inserito (Effettivo)
18 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
18 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
17 giugno 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- BedRest Pregnancy Study
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano 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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .