Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women (BedRest)

Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women. A Pilot Study

This pilot study aims to evaluate the impact of a specifically designed exercise program for hospitalized high-risk pregnant individuals on bed rest. The exercise program, focused on resistance and strength training, is adapted for execution 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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Complications; Pregnancy; Bed Rest
• Intervention / Treatment: Other: Exercise

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 pilot 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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Montse Palacio, MD, PhD; Phone Number: 9946 +34932275400; Email: secmmf@clinic.cat
• Study Contact Backup: Name: Federico Migliorelli, MD, PhD; Phone Number: 9946 +34932275400; Email: secmmf@clinic.cat

Study Locations

• Spain
  • Barcelona, Spain, 08028
    • Recruiting
    • Hospital Clinic De Barcelona
    • Contact: Montse Palacio, MD, PhD; Phone Number: 9946 +34932275400; Email: secmmf@clinic.cat
    • Contact: Federico Migliorelli, MD, PhD; Phone Number: 9946 +34932275400; Email: secmmf@clinic.cat
    • Principal Investigator: Montse Palacio, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise group; Pregnant women admitted in the Maternal Intermediate Care Unit who will follow the standard management for its complication and will follow a specific designed exercise program.	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).
No Intervention: Non-exercise group; Pregnant women admitted in the Maternal Intermediate Care Unit who will follow the standard management for its complication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological parameters: Time spent in moderate or vigorous activity	Time spent in moderate or vigorous activity (in minutes, summarized as average per day).	At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum
Physiological parameters: Total physical activity	Total physical activity (average per day in mG).	At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum
Physiological parameters: Handgrip strength test.	Handgrip strength test (in kg, adjusted for gender and age).	At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum
Physiological parameters: Calf Circumference measurement	Calf Circumference measurement (in cm, adjusted for gender and age).	At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum
Mental health/emotional parameters: GAD-7	GAD-7: Generalized Anxiety Disorder assessment scale (score ranging from 0 to 21). The higher the results, higher is the severity of anxiety.	At enrollment, weeks 2, 4 and 6 (if not delivered), at delivery, 6 weeks post-partum
Mental health/emotional parameters: Perceived Stress Scale (PSS-10)	Perceived Stress Scale (PSS-10) (score ranging from 0 to 40). The higher the results, higher is the perception of stress.	At enrollment, weeks 2, 4 and 6 (if not delivered), at delivery, 6 weeks post-partum
Mental health/emotional parameters: Edinburg Postpartum Depression Scale	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.	At enrollment, weeks 2, 4 and 6 (if not delivered), at delivery, 6 weeks post-partum
Sleep cycle and Quality of life parameters: Sleep average per night	Sleep average per night (in minutes)	At enrollment, weeks 2, 4 and 6 (if not delivered), at delivery
Sleep cycle and Quality of life parameters: Insomnia Severity Index (ISI)	Insomnia Severity Index (ISI) (score -ranging from 0 to 28- and percentage of score ≥8). Teh higher the score, the higher the severity of insomnia.	At enrollment, weeks 2, 4 and 6 (if not delivered), at delivery
Sleep cycle and Quality of life parameters: WHOQOL-BREF score	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.	At enrollment, weeks 2, 4 and 6 (if not delivered), at delivery
Feasibility evaluation of the implementation of the exercise program: Time needed to recruit sample size	Time needed to recruit sample size (in days)	Through study completion, an average of 6 months
Feasibility evaluation of the implementation of the exercise program: Number of women who declined to participate in the study	Number of women who declined to participate in the study	Through study completion, an average of 6 months
Feasibility evaluation of the implementation of the exercise program: Number of women who give up participation in the study	Number of women who give up participation in the study	Through study completion, an average of 6 months
Feasibility evaluation of the implementation of the exercise program: Adherence to the program	Adherence to the program (number of days of actual performance of the exercise program while admitted)	Through study completion, an average of 6 months
Satisfaction evaluation	A questionnaire made specifically for the case evaluating different domains (length of the sessions, hardness of the sessions, daily repetition of the sessions, difficulty in particular exercises, willingness to repeat in case of re-admission, overall satisfaction to be included in the program) - Likert scale (1 to 5, being 1 not satisfied at all, and 5 highly satisfied).	At delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline Maternal and fetal characteristics: Evaluation of physical activity (GAQ-P questionnaire)	Evaluation of physical activity using the Get Active Questionnaire for Pregnancy. The questionnaire self-classifies how often and for how long she is engaged in physical activity of a light, moderate or vigorous intensity. Also, it addresses the question whether the woman should speak to her Obstetric Health Care Provider before beginning or continue to be physically active.	At enrollment
Baseline Maternal and fetal characteristics: Maternal age	Maternal age (in years)	At enrollment
Baseline Maternal and fetal characteristics: Maternal weight	Maternal weight (in kg)	At enrollment
Baseline Maternal and fetal characteristics: Ethnic group	Ethnic group classified as: White/European; Hispanic/latin American; Black/African Americans; Arabic; Asian	At enrollment
Baseline Maternal and fetal characteristics: Gestational age at recruitment	Gestational age at recruitment (in weeks + days)	At enrollment
Baseline Maternal and fetal characteristics: Twin pregnancy	Twin pregnancy (yes/no)	At enrollment
Baseline Maternal and fetal characteristics: Fetal growth percentile at admission	Fetal growth percentile at admission (customized for gender and multiplicity)	At enrollment
Baseline Maternal and fetal characteristics: Medical condition that justifies hospital admission	Medical condition that justifies hospital admission (hypertensive disorders, preterm labor, rupture of membranes, antepartum bleeding, others)	At enrollment
Baseline Maternal and fetal characteristics: Musculoskeletal limitations	Musculoskeletal limitations (injuries or pathologies) (yes/no and description)	At enrollment
Maternal and fetal characteristics during hospital admission: Medication while admitted	Medication while admitted (antihypertensive treatment, tocolysis, magnesium sulphate, antibiotics, corticosteroids, others)	At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum
Maternal and fetal characteristics during hospital admission: Length of stay in the intermediate care unit	Length of stay in the intermediate care unit (in days)	At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum
Maternal and fetal characteristics during hospital admission: Length of hospital admission	Length of hospital admission (in days)	At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum
Maternal and fetal characteristics during hospital admission: Fetal CTG	Fetal CTG description	At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum
Maternal and fetal characteristics during hospital admission: Diet during the admission	Diet during the admission (in Kcal and special needs)	At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum
Maternal and fetal characteristics during hospital admission: Daily fluid intake	Daily fluid intake (in mL)	At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum
Perinatal outcomes: Gestational age at delivery	Gestational age at delivery (in weeks + days)	At delivery and 6 weeks post-partum
Perinatal outcomes: Birthweight	Birthweight (in grams) and percentile	At delivery and 6 weeks post-partum
Perinatal outcomes: SGA/growth restriction	SGA/growth restriction (yes/no) and classification, if any	At delivery and 6 weeks post-partum
Perinatal outcomes: Mode of delivery	Mode of delivery (spontaneous, assisted, cesarean section)	At delivery and 6 weeks post-partum
Perinatal outcomes: Composite adverse maternal outcome	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)	At delivery and 6 weeks post-partum
Perinatal outcomes: Neonatal admission to neonatal intensive care unit	Neonatal admission to neonatal intensive care unit (yes/no)	At delivery and 6 weeks post-partum
Perinatal outcomes: Composite adverse neonatal outcome	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)	At delivery and 6 weeks post-partum
Perinatal outcomes: Breastfeeding rates	Breastfeeding rates	At delivery and 6 weeks post-partum

Collaborators and Investigators

• Sponsor: Montse Palacio
• Investigators: Principal Investigator: Montse Palacio, MD, PhD, Head of Maternal Medicine Department

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 22, 2024
• First Submitted That Met QC Criteria: November 30, 2024
• First Posted (Actual): December 3, 2024

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Exercise; Pregnancy; Pregnancy complications; Hospitalization; Bed rest
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Behavior; Pregnancy Complications; Motor Activity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: Bed RestPregnancy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a pilot study designed to evaluate the feasibility and preliminary outcomes of the intervention. As such, no data-sharing plan has been developed. The focus of this study is to generate initial findings to inform the design of future larger-scale studies, where a detailed data-sharing plan may be established.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No