Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women. (BedRest-1)

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.

Study Overview

• Status: Not yet 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 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): 140
• 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, Migliorelli, MD, PhD; Phone Number: 9946 +34932275400; Email: secmmf@clinic.cat

Study Locations

• Spain
  • Barcelona
    • Barcelona, Barcelona, Spain, 08028
      • Hospital Clínic 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

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 receiving the intervention and monitored according to study procedures	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 without any specific instructions to engage in physical activity, also monitored according to study procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Physiological parameters: Rectus femoris area measurement	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	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	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.	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	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)	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	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	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	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	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	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:	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	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline Maternal and fetal characteristics: Evaluation of physical activity (GAQ-P questionnaire)	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	Maternal age (In years)	Baseline
Baseline Maternal and fetal characteristics: Maternal weight	Maternal weight (In kg)	Baseline
Baseline Maternal and fetal characteristics: Ethnic group	Ethnic group classified as: - White/European - Hispanic/latin American - Black/African Americans - Arabic - Asian	Baseline
Baseline Maternal and fetal characteristics: Gestational age at recruitment	Gestational age at recruitment (in weeks + days)	Baseline
Baseline Maternal and fetal characteristics: Twin pregnancy	Twin pregnancy (yes/no)	Baseline
Baseline Maternal and fetal characteristics: Fetal growth percentile at admission	Fetal growth percentile at admission (customized for gender and multiplicity)	Baseline
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)	Baseline
Baseline Maternal and fetal characteristics: Musculoskeletal limitations	Musculoskeletal limitations (injuries or pathologies) (yes/no and description)	Baseline
Maternal and fetal characteristics during hospital admission: Medication while admitted	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	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	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	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	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	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	Gestational age at delivery (in weeks + days	Whitin 24h after delivery and 6 weeks postpartum
Perinatal outcomes: Birthweight	Birthweight (in grams) and percentile	Whitin 24h after delivery and 6 weeks postpartum
Perinatal outcomes: SGA/growth restriction	SGA/growth restriction (yes/no) and classification, if any	Whitin 24h after delivery and 6 weeks postpartum
Perinatal outcomes: Mode of delivery	Mode of delivery (spontaneous, assisted, cesarean section)	Whitin 24h after delivery and 6 weeks postpartum
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)	Whitin 24h after delivery and 6 weeks postpartum
Perinatal outcomes: Neonatal admission to neonatal intensive care unit	Neonatal admission to neonatal intensive care unit (yes/no)	Whitin 24h after delivery and 6 weeks postpartum
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)	Whitin 24h after delivery and 6 weeks postpartum
Perinatal outcomes: Breastfeeding rates	Breastfeeding rates	Whitin 24h after delivery and 6 weeks postpartum

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Investigators: Principal Investigator: Federico Migliorelli, MD, PhD, Gynecologist especialist on Maternal fetal medicine

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: June 4, 2026
• First Submitted That Met QC Criteria: June 17, 2026
• First Posted (Actual): June 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Exercise; Pregnancy; Pregnancy complications; Hospitalization; Bed rest; Exercise adaptations
• 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: BedRest Pregnancy Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

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