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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
140
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).
Hospital Clínic de Barcelona
Barcelona, Barcelona, Spain
Physiological parameters: Rectus femoris area measurement
Loss of rectus femoris area (cm2) in a relaxed state, assessed by ultrasound
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 spent in moderate or vigorous activity (in minutes, summarized as average per day).
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
Total physical activity (average per day in mG).
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.
Handgrip strength test (in kg, adjusted for gender and age).
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
GAD-7: Generalized Anxiety Disorder assessment scale (score ranging from 0 to 21). The higher the results, higher is the severity of anxiety.
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)
Perceived Stress Scale (PSS-10) (score ranging from 0 to 40). The higher the results, higher is the perception of stress.
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
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.
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
Sleep average per night (in minutes)
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Feasibility evaluation of the implementation of the exercise program: Time needed to recruit sample size
Time needed to recruit sample size (in days)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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).
Time frame: At delivery
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.
Time frame: Baseline
Baseline Maternal and fetal characteristics: Maternal age
Maternal age (In years)
Time frame: Baseline
Baseline Maternal and fetal characteristics: Maternal weight
Maternal weight (In kg)
Time frame: Baseline
Baseline Maternal and fetal characteristics: Ethnic group
Ethnic group classified as: - White/European - Hispanic/latin American - Black/African Americans - Arabic - Asian
Time frame: Baseline
Baseline Maternal and fetal characteristics: Gestational age at recruitment
Gestational age at recruitment (in weeks + days)
Time frame: Baseline
Baseline Maternal and fetal characteristics: Twin pregnancy
Twin pregnancy (yes/no)
Time frame: Baseline
Baseline Maternal and fetal characteristics: Fetal growth percentile at admission
Fetal growth percentile at admission (customized for gender and multiplicity)
Time frame: Baseline
Baseline Maternal and fetal characteristics: Medical condition that justifies hospital admission
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Medical condition that justifies hospital admission (hypertensive disorders, preterm labor, rupture of membranes, antepartum bleeding, others)
Time frame: Baseline
Baseline Maternal and fetal characteristics: Musculoskeletal limitations
Musculoskeletal limitations (injuries or pathologies) (yes/no and description)
Time frame: Baseline
Maternal and fetal characteristics during hospital admission: Medication while admitted
Medication while admitted (antihypertensive treatment, tocolysis, magnesium sulphate, antibiotics, corticosteroids, others)
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
Length of stay in the intermediate care unit (in days)
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
Length of hospital admission (in days)
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: Fetal CTG
Fetal CTG description
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: Diet during the admission
Diet during the admission (in Kcal and special needs)
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: Daily fluid intake
Daily fluid intake (in mL)
Time frame: 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
Time frame: Whitin 24h after delivery and 6 weeks postpartum
Perinatal outcomes: Birthweight
Birthweight (in grams) and percentile
Time frame: Whitin 24h after delivery and 6 weeks postpartum
Perinatal outcomes: SGA/growth restriction
SGA/growth restriction (yes/no) and classification, if any
Time frame: Whitin 24h after delivery and 6 weeks postpartum
Perinatal outcomes: Mode of delivery
Mode of delivery (spontaneous, assisted, cesarean section)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Whitin 24h after delivery and 6 weeks postpartum
Perinatal outcomes: Breastfeeding rates
Breastfeeding rates
Time frame: Whitin 24h after delivery and 6 weeks postpartum