- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07657000
Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women. (BedRest-1)
Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Montse Palacio, MD, PhD
- Puhelinnumero: 9946 +34932275400
- Sähköposti: secmmf@clinic.cat
Tutki yhteystietojen varmuuskopiointi
- Nimi: Federico Migliorelli, Migliorelli, MD, PhD
- Puhelinnumero: 9946 +34932275400
- Sähköposti: secmmf@clinic.cat
Opiskelupaikat
-
-
Barcelona
-
Barcelona, Barcelona, Espanja, 08028
- Hospital Clinic de Barcelona
-
Ottaa yhteyttä:
- Montse Palacio, MD, PhD
- Puhelinnumero: 9946 +34932275400
- Sähköposti: secmmf@clinic.cat
-
Ottaa yhteyttä:
- Federico Migliorelli, MD, PhD
- Puhelinnumero: 9946 +34932275400
- Sähköposti: secmmf@clinic.cat
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Tukevaa hoitoa
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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
|
Erityisesti suunniteltu ja jäsennelty harjoitusohjelma (perustuu vastukseen/voimaan, suunniteltu suoritettavaksi sängyssä tai minimaalisella liikkuvuudella).
Se on muunnos Brun CR:n et al (Brun CR, Shoemaker JK, Bocking A, Hammond JA, Poole M, Mottola MF) kuvaamasta harjoitusohjelmasta.
Vuodelepoharjoitus, aktiivisuuden rajoittaminen ja suuren riskin raskaudet: toteutettavuustutkimus.
Soveltava fysiologia, ravitsemus ja aineenvaihdunta.
2011;36(4):577-582).
|
|
Ei väliintuloa: 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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Harjoitusohjelman toteutuksen toteutettavuusarviointi: Otoskoon rekrytointiin tarvittava aika
Aikaikkuna: Opintojen päättyessä keskimäärin 6 kuukautta
|
Otoskoon rekrytointiin tarvittava aika (päivinä)
|
Opintojen päättyessä keskimäärin 6 kuukautta
|
|
Harjoitusohjelman toteutuksen toteutettavuusarviointi: Tutkimukseen osallistumisesta kieltäytyneiden naisten lukumäärä
Aikaikkuna: Opintojen päättyessä keskimäärin 6 kuukautta
|
Niiden naisten lukumäärä, jotka kieltäytyivät osallistumasta tutkimukseen
|
Opintojen päättyessä keskimäärin 6 kuukautta
|
|
Harjoitusohjelman toteutuksen toteutettavuusarviointi: Tutkimukseen osallistumisesta luopuneiden naisten lukumäärä
Aikaikkuna: Opintojen päättyessä keskimäärin 6 kuukautta
|
Tutkimukseen osallistumisesta luopuneiden naisten lukumäärä
|
Opintojen päättyessä keskimäärin 6 kuukautta
|
|
Harjoitusohjelman toteutuksen toteutettavuusarviointi: Ohjelman noudattaminen
Aikaikkuna: Opintojen päättyessä keskimäärin 6 kuukautta
|
Ohjelman noudattaminen (harjoitusohjelman todellisen suorituksen päivien lukumäärä hyväksynnän aikana)
|
Opintojen päättyessä keskimäärin 6 kuukautta
|
|
Tyytyväisyyden arviointi
Aikaikkuna: Toimituksen yhteydessä
|
Erityisesti tapausta varten tehty kysely, jossa arvioidaan eri osa-alueita (istuntojen kesto, istuntojen kovuus, istuntojen päivittäinen toisto, vaikeus tietyissä harjoituksissa, halukkuus toistaa uudelleenpääsyn yhteydessä, yleinen tyytyväisyys ohjelmaan osallistumiseen ) - Likert-asteikko (1-5, 1 en ollenkaan tyytyväinen ja 5 erittäin tyytyväinen).
|
Toimituksen yhteydessä
|
|
Physiological parameters: Rectus femoris area measurement
Aikaikkuna: 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
|
Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
|
|
Physiological parameters: Time spent in moderate or vigorous activity
Aikaikkuna: 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).
|
Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
|
|
Physiological parameters: Total physical activity
Aikaikkuna: Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
|
Total physical activity (average per day in mG).
|
Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
|
|
Physiological parameters: Handgrip strength test.
Aikaikkuna: Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
|
Handgrip strength test (in kg, adjusted for gender and age).
|
Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
|
|
Mental health/emotional parameters: GAD-7
Aikaikkuna: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
GAD-7: Generalized Anxiety Disorder assessment scale (score ranging from 0 to 21).
The higher the results, higher is the severity of anxiety.
|
Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
|
Mental health/emotional parameters: Perceived Stress Scale (PSS-10)
Aikaikkuna: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
Perceived Stress Scale (PSS-10) (score ranging from 0 to 40).
The higher the results, higher is the perception of stress.
|
Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
|
Mental health/emotional parameters: Edinburg Postpartum Depression Scale
Aikaikkuna: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
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.
|
Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
|
Sleep cycle and Quality of life parameters: Sleep average per night
Aikaikkuna: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery
|
Sleep average per night (in minutes)
|
Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery
|
|
Sleep cycle and Quality of life parameters: WHOQOL-BREF score
Aikaikkuna: 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.
|
Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery
|
|
Mental health/emotional parameters: SAM: The Self-Assessment Manikin
Aikaikkuna: 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.
|
Daily
|
|
Mental health/emotional parameters: RRS: The Ruminative Response Scale
Aikaikkuna: 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
|
Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
|
Mental health/emotional parameters: BDI-II:
Aikaikkuna: 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.
|
Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
|
Physiological parameters: Muscle Ultrasound
Aikaikkuna: 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.
|
Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
|
Physiological parameters: Maternal Cardiac Ultrasound
Aikaikkuna: 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.
|
Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Baseline Maternal and fetal characteristics: Evaluation of physical activity (GAQ-P questionnaire)
Aikaikkuna: 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
|
|
Baseline Maternal and fetal characteristics: Maternal age
Aikaikkuna: Baseline
|
Maternal age (In years)
|
Baseline
|
|
Baseline Maternal and fetal characteristics: Maternal weight
Aikaikkuna: Baseline
|
Maternal weight (In kg)
|
Baseline
|
|
Baseline Maternal and fetal characteristics: Ethnic group
Aikaikkuna: 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
Aikaikkuna: Baseline
|
Gestational age at recruitment (in weeks + days)
|
Baseline
|
|
Baseline Maternal and fetal characteristics: Twin pregnancy
Aikaikkuna: Baseline
|
Twin pregnancy (yes/no)
|
Baseline
|
|
Baseline Maternal and fetal characteristics: Fetal growth percentile at admission
Aikaikkuna: Baseline
|
Fetal growth percentile at admission (customized for gender and multiplicity)
|
Baseline
|
|
Baseline Maternal and fetal characteristics: Medical condition that justifies hospital admission
Aikaikkuna: 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
Aikaikkuna: Baseline
|
Musculoskeletal limitations (injuries or pathologies) (yes/no and description)
|
Baseline
|
|
Maternal and fetal characteristics during hospital admission: Medication while admitted
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
|
Maternal and fetal characteristics during hospital admission: Diet during the admission
Aikaikkuna: 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
|
|
Maternal and fetal characteristics during hospital admission: Daily fluid intake
Aikaikkuna: 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
|
|
Perinatal outcomes: Gestational age at delivery
Aikaikkuna: 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
Aikaikkuna: Whitin 24h after delivery and 6 weeks postpartum
|
Birthweight (in grams) and percentile
|
Whitin 24h after delivery and 6 weeks postpartum
|
|
Perinatal outcomes: SGA/growth restriction
Aikaikkuna: 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
|
|
Perinatal outcomes: Mode of delivery
Aikaikkuna: Whitin 24h after delivery and 6 weeks postpartum
|
Mode of delivery (spontaneous, assisted, cesarean section)
|
Whitin 24h after delivery and 6 weeks postpartum
|
|
Perinatal outcomes: Composite adverse maternal outcome
Aikaikkuna: 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
|
|
Perinatal outcomes: Neonatal admission to neonatal intensive care unit
Aikaikkuna: 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
Aikaikkuna: 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
|
|
Perinatal outcomes: Breastfeeding rates
Aikaikkuna: Whitin 24h after delivery and 6 weeks postpartum
|
Breastfeeding rates
|
Whitin 24h after delivery and 6 weeks postpartum
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Federico Migliorelli, MD, PhD, Gynecologist especialist on Maternal fetal medicine
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- BedRest Pregnancy Study
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .