Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women. (BedRest-1)
17 de junho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Intervencional
Inscrição (Estimado)
140
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Montse Palacio, MD, PhD
- Número de telefone: 9946 +34932275400
- E-mail: secmmf@clinic.cat
Estude backup de contato
- Nome: Federico Migliorelli, Migliorelli, MD, PhD
- Número de telefone: 9946 +34932275400
- E-mail: secmmf@clinic.cat
Locais de estudo
-
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Barcelona
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Barcelona, Barcelona, Espanha, 08028
- Hospital Clinic de Barcelona
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Contato:
- Montse Palacio, MD, PhD
- Número de telefone: 9946 +34932275400
- E-mail: secmmf@clinic.cat
-
Contato:
- Federico Migliorelli, MD, PhD
- Número de telefone: 9946 +34932275400
- E-mail: secmmf@clinic.cat
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Exercise group
Pregnant women admitted in the Maternal Intermediate Care Unit who will follow the standard management for its complication and will receiving the intervention and monitored according to study procedures
|
Programa de exercícios especificamente concebido e estruturado (baseado em resistência/força, concebido para ser executado na cama ou com mobilidade mínima).
É uma adaptação do programa de exercícios descrito por Brun CR et al (Brun CR, Shoemaker JK, Bocking A, Hammond JA, Poole M, Mottola MF.
Exercício de repouso na cama, restrição de atividades e gravidez de alto risco: um estudo de viabilidade.
Fisiologia Aplicada, Nutrição e Metabolismo.
2011;36(4):577-582).
|
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Sem intervenção: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Avaliação de viabilidade da implementação do programa de exercícios: Tempo necessário para recrutar o tamanho da amostra
Prazo: Até a conclusão do estudo, uma média de 6 meses
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Tempo necessário para recrutar o tamanho da amostra (em dias)
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Até a conclusão do estudo, uma média de 6 meses
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Avaliação de viabilidade da implementação do programa de exercícios: Número de mulheres que se recusaram a participar do estudo
Prazo: Até a conclusão do estudo, uma média de 6 meses
|
Número de mulheres que se recusaram a participar do estudo
|
Até a conclusão do estudo, uma média de 6 meses
|
|
Avaliação da viabilidade da implementação do programa de exercícios: Número de mulheres que desistem de participar do estudo
Prazo: Até a conclusão do estudo, uma média de 6 meses
|
Número de mulheres que desistem de participar do estudo
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Até a conclusão do estudo, uma média de 6 meses
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Avaliação de viabilidade da implementação do programa de exercícios: Adesão ao programa
Prazo: Até a conclusão do estudo, uma média de 6 meses
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Adesão ao programa (número de dias de realização efetiva do programa de exercícios enquanto internado)
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Até a conclusão do estudo, uma média de 6 meses
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Avaliação de satisfação
Prazo: Na entrega
|
Um questionário feito especificamente para o caso avaliando diferentes domínios (duração das sessões, dureza das sessões, repetição diária das sessões, dificuldade em determinados exercícios, vontade de repetir em caso de readmissão, satisfação geral em ser incluído no programa ) - Escala Likert (1 a 5, sendo 1 nada satisfeito e 5 muito satisfeito).
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Na entrega
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Physiological parameters: Rectus femoris area measurement
Prazo: 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
Prazo: 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
Prazo: 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.
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery
|
Abbreviated version of the World Health Organization Quality of Life Assessment scale (WHOQOL-BREF) (score ranging from 0 to 100).
The higher the score, better is the perception of quality of life.
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Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery
|
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Mental health/emotional parameters: SAM: The Self-Assessment Manikin
Prazo: Daily
|
Visual standardized measure of emotional tone that covers 3 different affective domains (valence, arousal and sense of control).
Responses are made by selecting the manikin that best represents the emotional state of the patient.
The patient selection is afterwards converted into a numerical result with higher scores indicating more positive affective tone.
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Daily
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Mental health/emotional parameters: RRS: The Ruminative Response Scale
Prazo: 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:
Prazo: 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
Prazo: 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Baseline Maternal and fetal characteristics: Evaluation of physical activity (GAQ-P questionnaire)
Prazo: 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
Prazo: Baseline
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Maternal age (In years)
|
Baseline
|
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Baseline Maternal and fetal characteristics: Maternal weight
Prazo: Baseline
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Maternal weight (In kg)
|
Baseline
|
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Baseline Maternal and fetal characteristics: Ethnic group
Prazo: 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
Prazo: Baseline
|
Gestational age at recruitment (in weeks + days)
|
Baseline
|
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Baseline Maternal and fetal characteristics: Twin pregnancy
Prazo: Baseline
|
Twin pregnancy (yes/no)
|
Baseline
|
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Baseline Maternal and fetal characteristics: Fetal growth percentile at admission
Prazo: 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
Prazo: Baseline
|
Medical condition that justifies hospital admission (hypertensive disorders, preterm labor, rupture of membranes, antepartum bleeding, others)
|
Baseline
|
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Baseline Maternal and fetal characteristics: Musculoskeletal limitations
Prazo: 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
Prazo: 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
Prazo: 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
|
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Maternal and fetal characteristics during hospital admission: Length of hospital admission
Prazo: 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
|
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Maternal and fetal characteristics during hospital admission: Fetal CTG
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Whitin 24h after delivery and 6 weeks postpartum
|
Breastfeeding rates
|
Whitin 24h after delivery and 6 weeks postpartum
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Federico Migliorelli, MD, PhD, Gynecologist especialist on Maternal fetal medicine
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de setembro de 2026
Conclusão Primária (Estimado)
1 de setembro de 2027
Conclusão do estudo (Estimado)
1 de setembro de 2029
Datas de inscrição no estudo
Enviado pela primeira vez
4 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
17 de junho de 2026
Primeira postagem (Real)
18 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
18 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
17 de junho de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- BedRest Pregnancy Study
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .