Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women. (BedRest-1)
17. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Antatt)
140
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Montse Palacio, MD, PhD
- Telefonnummer: 9946 +34932275400
- E-post: secmmf@clinic.cat
Studer Kontakt Backup
- Navn: Federico Migliorelli, Migliorelli, MD, PhD
- Telefonnummer: 9946 +34932275400
- E-post: secmmf@clinic.cat
Studiesteder
-
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Barcelona
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Barcelona, Barcelona, Spania, 08028
- Hospital Clinic de Barcelona
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Ta kontakt med:
- Montse Palacio, MD, PhD
- Telefonnummer: 9946 +34932275400
- E-post: secmmf@clinic.cat
-
Ta kontakt med:
- Federico Migliorelli, MD, PhD
- Telefonnummer: 9946 +34932275400
- E-post: secmmf@clinic.cat
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Spesielt designet og strukturert treningsprogram (basert på motstand/styrke, designet for å utføres i sengen eller minimal mobilitet).
Det er en tilpasning fra treningsprogrammet beskrevet av Brun CR et al (Brun CR, Shoemaker JK, Bocking A, Hammond JA, Poole M, Mottola MF.
Sengeleietrening, aktivitetsbegrensning og høyrisikosvangerskap: en mulighetsstudie.
Anvendt fysiologi, ernæring og metabolisme.
2011;36(4):577-582).
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Ingen inngripen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Mulighetsevaluering av gjennomføring av treningsprogrammet: Tid som trengs for å rekruttere utvalgsstørrelse
Tidsramme: Gjennom studiegjennomføring, gjennomsnittlig 6 måneder
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Tid som trengs for å rekruttere prøvestørrelse (i dager)
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Gjennom studiegjennomføring, gjennomsnittlig 6 måneder
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Mulighetsevaluering av gjennomføring av treningsprogrammet: Antall kvinner som takket nei til å delta i studien
Tidsramme: Gjennom studiegjennomføring, gjennomsnittlig 6 måneder
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Antall kvinner som takket nei til å delta i studien
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Gjennom studiegjennomføring, gjennomsnittlig 6 måneder
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Mulighetsevaluering av gjennomføring av treningsprogrammet: Antall kvinner som gir opp deltakelse i studien
Tidsramme: Gjennom studiegjennomføring, gjennomsnittlig 6 måneder
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Antall kvinner som gir opp deltakelse i studien
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Gjennom studiegjennomføring, gjennomsnittlig 6 måneder
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Mulighetsevaluering av gjennomføring av øvingsprogrammet: Overholdelse av programmet
Tidsramme: Gjennom studiegjennomføring, gjennomsnittlig 6 måneder
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Overholdelse av programmet (antall dager med faktisk utførelse av treningsprogrammet mens innlagt)
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Gjennom studiegjennomføring, gjennomsnittlig 6 måneder
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Tilfredshetsvurdering
Tidsramme: Ved levering
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Et spørreskjema laget spesifikt for caset som evaluerer ulike domener (lengde på øktene, hardhet på øktene, daglig repetisjon av øktene, vanskeligheter med spesielle øvelser, vilje til å gjenta ved gjenopptakelse, generell tilfredshet med å bli inkludert i programmet ) - Likert-skala (1 til 5, er 1 ikke fornøyd i det hele tatt, og 5 svært fornøyd).
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Ved levering
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Physiological parameters: Rectus femoris area measurement
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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:
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Baseline Maternal and fetal characteristics: Evaluation of physical activity (GAQ-P questionnaire)
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline
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Maternal weight (In kg)
|
Baseline
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Baseline Maternal and fetal characteristics: Ethnic group
Tidsramme: 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
Tidsramme: Baseline
|
Gestational age at recruitment (in weeks + days)
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Baseline
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Baseline Maternal and fetal characteristics: Twin pregnancy
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
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
Tidsramme: Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Whitin 24h after delivery and 6 weeks postpartum
|
Composite adverse neonatal outcome: (yes/no considering any of the following: respiratory morbidity - respiratory distress syndrome or transient tachypnea - requiring intubation, moderate-severe bronchopulmonary dysplasia, intraventricular hemorrhage grade III-IV, early-onset sepsis, periventricular leukomalacia, necrotizing enterocolitis, retinopathy requiring laser, fetal or neonatal death)
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Whitin 24h after delivery and 6 weeks postpartum
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Perinatal outcomes: Breastfeeding rates
Tidsramme: Whitin 24h after delivery and 6 weeks postpartum
|
Breastfeeding rates
|
Whitin 24h after delivery and 6 weeks postpartum
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Federico Migliorelli, MD, PhD, Gynecologist especialist on Maternal fetal medicine
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
1. september 2027
Studiet fullført (Antatt)
1. september 2029
Datoer for studieregistrering
Først innsendt
4. juni 2026
Først innsendt som oppfylte QC-kriteriene
17. juni 2026
Først lagt ut (Faktiske)
18. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. juni 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BedRest Pregnancy Study
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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