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Bed RestBedRestNCT06713083

Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women

A study testing Exercise in people with Bed Rest and Pregnancy, run by Montse Palacio at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Bed Rest, Pregnancy, Pregnancy Complications
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSpain
Study dates
26 Feb 2025to Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Maternal age of 18 or more
  • Delivery not expected within 1 week after recruitment.
  • Language ability to understand the study.
  • Informed consent signed.

Who cannot join

  • Fetal death
  • Severe mental health disorders and substance abuse disorders.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Montse Palacio, MD, PhD contact

+34932275400 ext. 9946

secmmf@clinic.cat

Federico Migliorelli, MD, PhD contact

+34932275400 ext. 9946

secmmf@clinic.cat

Spain1 site, 1 recruiting
  • Hospital Clínic de Barcelona

    Barcelona, 08028

    Montse Palacio, MD, PhD, +34932275400 ext. 9946, secmmf@clinic.cat

    Federico Migliorelli, MD, PhD, +34932275400 ext. 9946, secmmf@clinic.cat

    Recruiting

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
Exercise
Keywords
Bed rest, Pregnancy complications, Pregnancy, Hospitalization, Exercise
Medical subject headings
Pregnancy Complications, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseOther

    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).

Study groups in NCT06713083
Study groupRoleWhat they receive
Exercise groupExperimentalPregnant women admitted in the Maternal Intermediate Care Unit who will follow the standard management for its complication and will follow a specific designed exercise program.
Receives: Other: Exercise
Non-exercise groupNo interventionPregnant women admitted in the Maternal Intermediate Care Unit who will follow the standard management for its complication

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Time spent in moderate or vigorous activity (in minutes, summarized as average per day).

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

  2. Physiological parameters: Total physical activity

    Total physical activity (average per day in mG).

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

  3. Physiological parameters: Handgrip strength test.

    Handgrip strength test (in kg, adjusted for gender and age).

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

  4. Physiological parameters: Calf Circumference measurement

    Calf Circumference measurement (in cm, adjusted for gender and age).

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

  5. 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.

    Measured: At enrollment, weeks 2, 4 and 6 (if not delivered), at delivery, 6 weeks post-partum

  6. 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.

    Measured: At enrollment, weeks 2, 4 and 6 (if not delivered), at delivery, 6 weeks post-partum

  7. 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.

    Measured: At enrollment, weeks 2, 4 and 6 (if not delivered), at delivery, 6 weeks post-partum

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

    Sleep average per night (in minutes)

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

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

    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.

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

  10. 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.

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

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

    Time needed to recruit sample size (in days)

    Measured: Through study completion, an average of 6 months

  12. 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

    Measured: Through study completion, an average of 6 months

  13. 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

    Measured: Through study completion, an average of 6 months

  14. 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)

    Measured: Through study completion, an average of 6 months

  15. 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).

    Measured: At delivery

Secondary outcomes (23)
  1. Baseline Maternal and fetal characteristics: Evaluation of physical activity (GAQ-P questionnaire)

    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.

    Measured: At enrollment

  2. Baseline Maternal and fetal characteristics: Maternal age

    Maternal age (in years)

    Measured: At enrollment

  3. Baseline Maternal and fetal characteristics: Maternal weight

    Maternal weight (in kg)

    Measured: At enrollment

  4. Baseline Maternal and fetal characteristics: Ethnic group

    Ethnic group classified as:

    • White/European
    • Hispanic/latin American
    • Black/African Americans
    • Arabic
    • Asian

    Measured: At enrollment

  5. Baseline Maternal and fetal characteristics: Gestational age at recruitment

    Gestational age at recruitment (in weeks + days)

    Measured: At enrollment

  6. Baseline Maternal and fetal characteristics: Twin pregnancy

    Twin pregnancy (yes/no)

    Measured: At enrollment

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

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

    Measured: At enrollment

  8. 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)

    Measured: At enrollment

  9. Baseline Maternal and fetal characteristics: Musculoskeletal limitations

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

    Measured: At enrollment

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

    Medication while admitted (antihypertensive treatment, tocolysis, magnesium sulphate, antibiotics, corticosteroids, others)

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

  11. 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)

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

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

    Length of hospital admission (in days)

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

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

    Fetal CTG description

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

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

    Diet during the admission (in Kcal and special needs)

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

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

    Daily fluid intake (in mL)

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

  16. Perinatal outcomes: Gestational age at delivery

    Gestational age at delivery (in weeks + days)

    Measured: At delivery and 6 weeks post-partum

  17. Perinatal outcomes: Birthweight

    Birthweight (in grams) and percentile

    Measured: At delivery and 6 weeks post-partum

  18. Perinatal outcomes: SGA/growth restriction

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

    Measured: At delivery and 6 weeks post-partum

  19. Perinatal outcomes: Mode of delivery

    Mode of delivery (spontaneous, assisted, cesarean section)

    Measured: At delivery and 6 weeks post-partum

  20. 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)

    Measured: At delivery and 6 weeks post-partum

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

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

    Measured: At delivery and 6 weeks post-partum

  22. 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)

    Measured: At delivery and 6 weeks post-partum

  23. Perinatal outcomes: Breastfeeding rates

    Breastfeeding rates

    Measured: At delivery and 6 weeks post-partum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2024
  2. Study start26 Feb 2025
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06713083
Sponsor's protocol ID
Bed RestPregnancy
Acronym
BedRest
Status last verified
Sep 2025
First submitted
22 Nov 2024
Last updated
9 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This is a pilot study designed to evaluate the feasibility and preliminary outcomes of the intervention. As such, no data-sharing plan has been developed. The focus of this study is to generate initial findings to inform the design of future larger-scale studies, where a detailed data-sharing plan may be established.

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Bed Rest and Pregnancy, run by Montse Palacio at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Montse Palacio, MD, PhD (+34932275400 ext. 9946, secmmf@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.

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