Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise.
- Who it may be relevant to
- Registry conditions: Bed Rest, Pregnancy, Pregnancy Complications. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women
Overview
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.
Detailed description
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.
Interventions
- Other Exercise
Specifically designed and structured exercise program (based on resistance/strength, designed to be executed in bed or minimal mobility). It is an adaptation from the exercise program described by Brun CR et al (Brun CR, Shoemaker JK, Bocking A, Hammond JA, Poole M, Mottola MF. Bed-rest exercise, activity restriction, and high-risk pregnancies: a feasibility study. Applied Physiology, Nutrition, and Metabolism. 2011;36(4):577-582).
Primary outcome measures
- Physiological parameters: Rectus femoris area measurement [Time frame: 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 [Time frame: Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum]
- Physiological parameters: Total physical activity [Time frame: Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum]
- Physiological parameters: Handgrip strength test. [Time frame: 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 [Time frame: 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) [Time frame: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum]
- Mental health/emotional parameters: Edinburg Postpartum Depression Scale [Time frame: 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 [Time frame: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery]
- Sleep cycle and Quality of life parameters: WHOQOL-BREF score [Time frame: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery]
- Mental health/emotional parameters: SAM: The Self-Assessment Manikin [Time frame: Daily]
Secondary outcome measures (12)
- Baseline Maternal and fetal characteristics: Evaluation of physical activity (GAQ-P questionnaire) [Time frame: Baseline]
- Baseline Maternal and fetal characteristics: Maternal age [Time frame: Baseline]
- Baseline Maternal and fetal characteristics: Maternal weight [Time frame: Baseline]
- Baseline Maternal and fetal characteristics: Ethnic group [Time frame: Baseline]
- Baseline Maternal and fetal characteristics: Gestational age at recruitment [Time frame: Baseline]
- Baseline Maternal and fetal characteristics: Twin pregnancy [Time frame: Baseline]
- Baseline Maternal and fetal characteristics: Fetal growth percentile at admission [Time frame: Baseline]
- Baseline Maternal and fetal characteristics: Medical condition that justifies hospital admission [Time frame: Baseline]
- Baseline Maternal and fetal characteristics: Musculoskeletal limitations [Time frame: Baseline]
- Maternal and fetal characteristics during hospital admission: Medication while admitted [Time frame: 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 [Time frame: 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 [Time frame: Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Spain · 1 center
- Hospital Clínic de Barcelona — Barcelona
Identifiers
NCT: NCT07657000 · BedRest Pregnancy Study