Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women. (BedRest-1)
17 juni 2026 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
140
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Montse Palacio, MD, PhD
- Telefonnummer: 9946 +34932275400
- E-post: secmmf@clinic.cat
Studera Kontakt Backup
- Namn: Federico Migliorelli, Migliorelli, MD, PhD
- Telefonnummer: 9946 +34932275400
- E-post: secmmf@clinic.cat
Studieorter
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Barcelona
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Barcelona, Barcelona, Spanien, 08028
- Hospital Clinic de Barcelona
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Kontakt:
- Montse Palacio, MD, PhD
- Telefonnummer: 9946 +34932275400
- E-post: secmmf@clinic.cat
-
Kontakt:
- Federico Migliorelli, MD, PhD
- Telefonnummer: 9946 +34932275400
- E-post: secmmf@clinic.cat
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Speciellt utformat och strukturerat träningsprogram (baserat på motstånd/styrka, designat för att utföras i sängen eller minimal rörlighet).
Det är en anpassning från träningsprogrammet som beskrivs av Brun CR et al (Brun CR, Shoemaker JK, Bocking A, Hammond JA, Poole M, Mottola MF.
Sänglägesträning, aktivitetsbegränsning och högriskgraviditeter: en genomförbarhetsstudie.
Tillämpad fysiologi, nutrition och metabolism.
2011;36(4):577-582).
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Inget ingripande: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Genomförbarhetsutvärdering av genomförandet av övningsprogrammet: Tid som behövs för att rekrytera urvalsstorlek
Tidsram: Genom avslutad studie i snitt 6 månader
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Tid som behövs för att rekrytera urvalsstorlek (i dagar)
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Genom avslutad studie i snitt 6 månader
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Genomförbarhetsutvärdering av genomförandet av träningsprogrammet: Antal kvinnor som avböjt att delta i studien
Tidsram: Genom avslutad studie i snitt 6 månader
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Antal kvinnor som avböjt att delta i studien
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Genom avslutad studie i snitt 6 månader
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Förutvärdering av genomförandet av träningsprogrammet: Antal kvinnor som avstår från att delta i studien
Tidsram: Genom avslutad studie i snitt 6 månader
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Antal kvinnor som avstår från att delta i studien
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Genom avslutad studie i snitt 6 månader
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Genomförbarhetsutvärdering av genomförandet av övningsprogrammet: Anslutning till programmet
Tidsram: Genom avslutad studie i snitt 6 månader
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Anslutning till programmet (antal dagar av faktiska utförande av träningsprogrammet under antagning)
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Genom avslutad studie i snitt 6 månader
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Nöjdhetsbedömning
Tidsram: Vid leverans
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Ett frågeformulär som gjorts specifikt för fallet som utvärderar olika domäner (sessionernas längd, sessionernas hårdhet, dagliga upprepningar av sessionerna, svårighetsgrad i särskilda övningar, vilja att upprepa vid återintagning, övergripande tillfredsställelse att inkluderas i programmet ) - Likert-skala (1 till 5, är 1 inte alls nöjd och 5 mycket nöjd).
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Vid leverans
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Physiological parameters: Rectus femoris area measurement
Tidsram: 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
Tidsram: 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
Tidsram: 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.
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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:
Tidsram: 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
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Baseline Maternal and fetal characteristics: Evaluation of physical activity (GAQ-P questionnaire)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Federico Migliorelli, MD, PhD, Gynecologist especialist on Maternal fetal medicine
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 september 2026
Primärt slutförande (Beräknad)
1 september 2027
Avslutad studie (Beräknad)
1 september 2029
Studieregistreringsdatum
Först inskickad
4 juni 2026
Först inskickad som uppfyllde QC-kriterierna
17 juni 2026
Första postat (Faktisk)
18 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 juni 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- BedRest Pregnancy Study
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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.
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