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NCT Number: NCT06713083

Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínic de Barcelona

Barcelona, 08028, Spain

Location status: Recruiting

Location contact

Federico Migliorelli, MD, PhD

CONTACT

[email protected]

+34932275400 ext. 9946

Montse Palacio, MD, PhD

CONTACT

[email protected]

+34932275400 ext. 9946

Montse Palacio, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Other

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).

Primary outcomes

  1. Physiological parameters: Time spent in moderate or vigorous activity

    Time frame: 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).

  2. Physiological parameters: Total physical activity

    Time frame: At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum

    Total physical activity (average per day in mG).

  3. Physiological parameters: Handgrip strength test.

    Time frame: 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).

  4. Physiological parameters: Calf Circumference measurement

    Time frame: 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).

  5. Mental health/emotional parameters: GAD-7

    Time frame: 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.

  6. Mental health/emotional parameters: Perceived Stress Scale (PSS-10)

    Time frame: 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.

  7. Mental health/emotional parameters: Edinburg Postpartum Depression Scale

    Time frame: 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.

  8. Sleep cycle and Quality of life parameters: Sleep average per night

    Time frame: At enrollment, weeks 2, 4 and 6 (if not delivered), at delivery

    Sleep average per night (in minutes)

  9. Sleep cycle and Quality of life parameters: Insomnia Severity Index (ISI)

    Time frame: 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.

  10. Sleep cycle and Quality of life parameters: WHOQOL-BREF score

    Time frame: 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.

  11. Feasibility evaluation of the implementation of the exercise program: Time needed to recruit sample size

    Time frame: Through study completion, an average of 6 months

    Time needed to recruit sample size (in days)

  12. Feasibility evaluation of the implementation of the exercise program: Number of women who declined to participate in the study

    Time frame: Through study completion, an average of 6 months

    Number of women who declined to participate in the study

  13. Feasibility evaluation of the implementation of the exercise program: Number of women who give up participation in the study

    Time frame: Through study completion, an average of 6 months

    Number of women who give up participation in the study

  14. Feasibility evaluation of the implementation of the exercise program: Adherence to the program

    Time frame: Through study completion, an average of 6 months

    Adherence to the program (number of days of actual performance of the exercise program while admitted)

  15. Satisfaction evaluation

    Time frame: 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 outcomes

  1. Baseline Maternal and fetal characteristics: Evaluation of physical activity (GAQ-P questionnaire)

    Time frame: 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.

  2. Baseline Maternal and fetal characteristics: Maternal age

    Time frame: At enrollment

    Maternal age (in years)

  3. Baseline Maternal and fetal characteristics: Maternal weight

    Time frame: At enrollment

    Maternal weight (in kg)

  4. Baseline Maternal and fetal characteristics: Ethnic group

    Time frame: At enrollment

    Ethnic group classified as:

    • White/European
    • Hispanic/latin American
    • Black/African Americans
    • Arabic
    • Asian
  5. Baseline Maternal and fetal characteristics: Gestational age at recruitment

    Time frame: At enrollment

    Gestational age at recruitment (in weeks + days)

  6. Baseline Maternal and fetal characteristics: Twin pregnancy

    Time frame: At enrollment

    Twin pregnancy (yes/no)

  7. Baseline Maternal and fetal characteristics: Fetal growth percentile at admission

    Time frame: At enrollment

    Fetal growth percentile at admission (customized for gender and multiplicity)

  8. Baseline Maternal and fetal characteristics: Medical condition that justifies hospital admission

    Time frame: At enrollment

    Medical condition that justifies hospital admission (hypertensive disorders, preterm labor, rupture of membranes, antepartum bleeding, others)

  9. Baseline Maternal and fetal characteristics: Musculoskeletal limitations

    Time frame: At enrollment

    Musculoskeletal limitations (injuries or pathologies) (yes/no and description)

  10. Maternal and fetal characteristics during hospital admission: Medication while admitted

    Time frame: 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)

  11. Maternal and fetal characteristics during hospital admission: Length of stay in the intermediate care unit

    Time frame: 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)

  12. Maternal and fetal characteristics during hospital admission: Length of hospital admission

    Time frame: At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum

    Length of hospital admission (in days)

  13. Maternal and fetal characteristics during hospital admission: Fetal CTG

    Time frame: At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum

    Fetal CTG description

  14. Maternal and fetal characteristics during hospital admission: Diet during the admission

    Time frame: At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum

    Diet during the admission (in Kcal and special needs)

  15. Maternal and fetal characteristics during hospital admission: Daily fluid intake

    Time frame: At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum

    Daily fluid intake (in mL)

  16. Perinatal outcomes: Gestational age at delivery

    Time frame: At delivery and 6 weeks post-partum

    Gestational age at delivery (in weeks + days)

  17. Perinatal outcomes: Birthweight

    Time frame: At delivery and 6 weeks post-partum

    Birthweight (in grams) and percentile

  18. Perinatal outcomes: SGA/growth restriction

    Time frame: At delivery and 6 weeks post-partum

    SGA/growth restriction (yes/no) and classification, if any

  19. Perinatal outcomes: Mode of delivery

    Time frame: At delivery and 6 weeks post-partum

    Mode of delivery (spontaneous, assisted, cesarean section)

  20. Perinatal outcomes: Composite adverse maternal outcome

    Time frame: 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)

  21. Perinatal outcomes: Neonatal admission to neonatal intensive care unit

    Time frame: At delivery and 6 weeks post-partum

    Neonatal admission to neonatal intensive care unit (yes/no)

  22. Perinatal outcomes: Composite adverse neonatal outcome

    Time frame: 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)

  23. Perinatal outcomes: Breastfeeding rates

    Time frame: At delivery and 6 weeks post-partum

    Breastfeeding rates

Study contacts

Contact information is provided by the study sponsor or research team.

Federico Migliorelli, MD, PhD

CONTACT

[email protected]

+34932275400 ext. 9946

Montse Palacio, MD, PhD

CONTACT

[email protected]

+34932275400 ext. 9946

Sponsors and collaborators

Lead sponsor

Montse Palacio

Other

Registry information

Official study title

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

Acronym: BedRest

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 3, 2024
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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