Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women

Not Applicable

Recruiting

• Conditions: Bed Rest; Pregnancy; Pregnancy Complications

• Registration Number: NCT06713083
• Lead Sponsor: Montse Palacio

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-11-22
• Study First Submitted QC: 2024-11-30
• Study First Posted: 2024-12-03
• Status Verified: 2025-02
• Study Start: 2025-02-26
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-27
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Physiological parameters: Handgrip strength test.	At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum	Handgrip strength test (in kg, adjusted for gender and age).
Physiological parameters: Time spent in moderate or vigorous activity	At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum	Time spent in moderate or vigorous activity (in minutes, summarized as average per day).
Physiological parameters: Total physical activity	At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum	Total physical activity (average per day in mG).
Physiological parameters: Calf Circumference measurement	At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum	Calf Circumference measurement (in cm, adjusted for gender and age).
Mental health/emotional parameters: GAD-7	At enrollment, weeks 2, 4 and 6 (if not delivered), at delivery, 6 weeks post-partum	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)	At enrollment, weeks 2, 4 and 6 (if not delivered), at delivery, 6 weeks post-partum	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	At enrollment, weeks 2, 4 and 6 (if not delivered), at delivery, 6 weeks post-partum	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	At enrollment, weeks 2, 4 and 6 (if not delivered), at delivery	Sleep average per night (in minutes)
Sleep cycle and Quality of life parameters: Insomnia Severity Index (ISI)	At enrollment, weeks 2, 4 and 6 (if not delivered), at delivery	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.
Sleep cycle and Quality of life parameters: WHOQOL-BREF score	At enrollment, weeks 2, 4 and 6 (if not delivered), at 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.
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 Outcome Measures

Name	Time	Method
Baseline Maternal and fetal characteristics: Evaluation of physical activity (GAQ-P questionnaire)	At enrollment	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.
Baseline Maternal and fetal characteristics: Maternal age	At enrollment	Maternal age (in years)
Baseline Maternal and fetal characteristics: Maternal weight	At enrollment	Maternal weight (in kg)
Baseline Maternal and fetal characteristics: Ethnic group	At enrollment	Ethnic group classified as: * White/European; * Hispanic/latin American; * Black/African Americans; * Arabic; * Asian
Baseline Maternal and fetal characteristics: Gestational age at recruitment	At enrollment	Gestational age at recruitment (in weeks + days)
Baseline Maternal and fetal characteristics: Twin pregnancy	At enrollment	Twin pregnancy (yes/no)
Baseline Maternal and fetal characteristics: Fetal growth percentile at admission	At enrollment	Fetal growth percentile at admission (customized for gender and multiplicity)
Baseline Maternal and fetal characteristics: Medical condition that justifies hospital admission	At enrollment	Medical condition that justifies hospital admission (hypertensive disorders, preterm labor, rupture of membranes, antepartum bleeding, others)
Baseline Maternal and fetal characteristics: Musculoskeletal limitations	At enrollment	Musculoskeletal limitations (injuries or pathologies) (yes/no and description)
Maternal and fetal characteristics during hospital admission: Medication while admitted	At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum	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	At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum	Length of stay in the intermediate care unit (in days)
Maternal and fetal characteristics during hospital admission: Length of hospital admission	At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum	Length of hospital admission (in days)
Maternal and fetal characteristics during hospital admission: Fetal CTG	At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum	Fetal CTG description
Maternal and fetal characteristics during hospital admission: Diet during the admission	At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum	Diet during the admission (in Kcal and special needs)
Maternal and fetal characteristics during hospital admission: Daily fluid intake	At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum	Daily fluid intake (in mL)
Perinatal outcomes: Gestational age at delivery	At delivery and 6 weeks post-partum	Gestational age at delivery (in weeks + days)
Perinatal outcomes: Birthweight	At delivery and 6 weeks post-partum	Birthweight (in grams) and percentile
Perinatal outcomes: SGA/growth restriction	At delivery and 6 weeks post-partum	SGA/growth restriction (yes/no) and classification, if any
Perinatal outcomes: Mode of delivery	At delivery and 6 weeks post-partum	Mode of delivery (spontaneous, assisted, cesarean section)
Perinatal outcomes: Composite adverse maternal outcome	At delivery and 6 weeks post-partum	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	At delivery and 6 weeks post-partum	Neonatal admission to neonatal intensive care unit (yes/no)
Perinatal outcomes: Composite adverse neonatal outcome	At delivery and 6 weeks post-partum	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	At delivery and 6 weeks post-partum	Breastfeeding rates

Trial Locations

Locations (1)

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain