Bed Rest, Pregnancy, Pregnancy Complications
Conditions
Keywords
Bed rest, Pregnancy, Pregnancy complications, Hospitalization, Exercise, Exercise adaptations
Brief summary
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
OTHERExercise
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).
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This study follows a parallel assignment model, where participants are randomized into two distinct groups. One group will follow a specifically designed exercise program tailored for individuals on bed rest during high-risk pregnancy, while the other group will receive standard care without structured physical activity. The intervention group will perform daily resistance and strength exercises adapted for execution while in bed. The control group will serve as a comparison to evaluate the impact of the exercise program on physical and emotional health, quality of life, and sleep during hospitalization. Randomization ensures unbiased allocation, and both groups will be monitored simultaneously throughout the study duration.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physiological parameters: Rectus femoris area measurement | Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum | Loss of rectus femoris area (cm2) in a relaxed state, assessed by ultrasound |
| Physiological parameters: Time spent in moderate or vigorous activity | Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum | Time spent in moderate or vigorous activity (in minutes, summarized as average per day). |
| Physiological parameters: Total physical activity | Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum | Total physical activity (average per day in mG). |
| Physiological parameters: Handgrip strength test. | Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum | Handgrip strength test (in kg, adjusted for gender and age). |
| Mental health/emotional parameters: GAD-7 | Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum | GAD-7: Generalized Anxiety Disorder assessment scale (score ranging from 0 to 21). The higher the results, higher is the severity of anxiety. |
| Mental health/emotional parameters: Perceived Stress Scale (PSS-10) | Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum | Perceived Stress Scale (PSS-10) (score ranging from 0 to 40). The higher the results, higher is the perception of stress. |
| Mental health/emotional parameters: Edinburg Postpartum Depression Scale | Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum | 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. |
| Sleep cycle and Quality of life parameters: Sleep average per night | Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery | Sleep average per night (in minutes) |
| Sleep cycle and Quality of life parameters: WHOQOL-BREF score | 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. |
| Mental health/emotional parameters: SAM: The Self-Assessment Manikin | 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. |
| Mental health/emotional parameters: RRS: The Ruminative Response Scale | 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 |
| Mental health/emotional parameters: BDI-II: | 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. |
| Physiological parameters: Muscle Ultrasound | 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. |
| Physiological parameters: Maternal Cardiac Ultrasound | 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. |
| Feasibility evaluation of the implementation of the exercise program: Time needed to recruit sample size | Through study completion, an average of 6 months | Time needed to recruit sample size (in days) |
| Feasibility evaluation of the implementation of the exercise program: Number of women who declined to participate in the study | Through study completion, an average of 6 months | Number of women who declined to participate in the study |
| Feasibility evaluation of the implementation of the exercise program: Number of women who give up participation in the study | Through study completion, an average of 6 months | Number of women who give up participation in the study |
| Feasibility evaluation of the implementation of the exercise program: Adherence to the program | Through study completion, an average of 6 months | Adherence to the program (number of days of actual performance of the exercise program while admitted) |
| Satisfaction evaluation | At delivery | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Maternal and fetal characteristics: Evaluation of physical activity (GAQ-P questionnaire) | 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. |
| Baseline Maternal and fetal characteristics: Maternal age | Baseline | Maternal age (In years) |
| Baseline Maternal and fetal characteristics: Maternal weight | Baseline | Maternal weight (In kg) |
| Baseline Maternal and fetal characteristics: Ethnic group | Baseline | Ethnic group classified as: - White/European - Hispanic/latin American - Black/African Americans - Arabic - Asian |
| Baseline Maternal and fetal characteristics: Gestational age at recruitment | Baseline | Gestational age at recruitment (in weeks + days) |
| Baseline Maternal and fetal characteristics: Twin pregnancy | Baseline | Twin pregnancy (yes/no) |
| Baseline Maternal and fetal characteristics: Fetal growth percentile at admission | Baseline | Fetal growth percentile at admission (customized for gender and multiplicity) |
| Baseline Maternal and fetal characteristics: Medical condition that justifies hospital admission | Baseline | Medical condition that justifies hospital admission (hypertensive disorders, preterm labor, rupture of membranes, antepartum bleeding, others) |
| Baseline Maternal and fetal characteristics: Musculoskeletal limitations | Baseline | Musculoskeletal limitations (injuries or pathologies) (yes/no and description) |
| Maternal and fetal characteristics during hospital admission: Medication while admitted | 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) |
| Maternal and fetal characteristics during hospital admission: Length of stay in the intermediate care unit | 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) |
| Maternal and fetal characteristics during hospital admission: Length of hospital admission | 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) |
| Maternal and fetal characteristics during hospital admission: Fetal CTG | Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum | Fetal CTG description |
| Maternal and fetal characteristics during hospital admission: Diet during the admission | 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) |
| Maternal and fetal characteristics during hospital admission: Daily fluid intake | Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum | Daily fluid intake (in mL) |
| Perinatal outcomes: Gestational age at delivery | Whitin 24h after delivery and 6 weeks postpartum | Gestational age at delivery (in weeks + days |
| Perinatal outcomes: Birthweight | Whitin 24h after delivery and 6 weeks postpartum | Birthweight (in grams) and percentile |
| Perinatal outcomes: SGA/growth restriction | Whitin 24h after delivery and 6 weeks postpartum | SGA/growth restriction (yes/no) and classification, if any |
| Perinatal outcomes: Mode of delivery | Whitin 24h after delivery and 6 weeks postpartum | Mode of delivery (spontaneous, assisted, cesarean section) |
| Perinatal outcomes: Composite adverse maternal outcome | 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) |
| Perinatal outcomes: Neonatal admission to neonatal intensive care unit | Whitin 24h after delivery and 6 weeks postpartum | Neonatal admission to neonatal intensive care unit (yes/no) |
| Perinatal outcomes: Composite adverse neonatal outcome | 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) |
| Perinatal outcomes: Breastfeeding rates | Whitin 24h after delivery and 6 weeks postpartum | Breastfeeding rates |
Countries
Spain
Contacts
CONTACTFederico Migliorelli, Migliorelli, MD, PhD
CONTACTMontse Palacio, MD, PhD
PRINCIPAL_INVESTIGATORFederico Migliorelli, MD, PhD
Gynecologist especialist on Maternal fetal medicine
Outcome results
None listed