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.
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.
Spain1 site, 1 recruiting
- 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
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.
- Conditions
- Bed Rest, Pregnancy, Pregnancy Complications
- 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 group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Pregnant 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 group | No intervention | Pregnant 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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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)
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
Baseline Maternal and fetal characteristics: Maternal age
Maternal age (in years)
Measured: At enrollment
Baseline Maternal and fetal characteristics: Maternal weight
Maternal weight (in kg)
Measured: At enrollment
Baseline Maternal and fetal characteristics: Ethnic group
Ethnic group classified as:
- White/European
- Hispanic/latin American
- Black/African Americans
- Arabic
- Asian
Measured: At enrollment
Baseline Maternal and fetal characteristics: Gestational age at recruitment
Gestational age at recruitment (in weeks + days)
Measured: At enrollment
Baseline Maternal and fetal characteristics: Twin pregnancy
Twin pregnancy (yes/no)
Measured: At enrollment
Baseline Maternal and fetal characteristics: Fetal growth percentile at admission
Fetal growth percentile at admission (customized for gender and multiplicity)
Measured: At enrollment
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
Baseline Maternal and fetal characteristics: Musculoskeletal limitations
Musculoskeletal limitations (injuries or pathologies) (yes/no and description)
Measured: At enrollment
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
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
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
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
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
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
Perinatal outcomes: Gestational age at delivery
Gestational age at delivery (in weeks + days)
Measured: At delivery and 6 weeks post-partum
Perinatal outcomes: Birthweight
Birthweight (in grams) and percentile
Measured: At delivery and 6 weeks post-partum
Perinatal outcomes: SGA/growth restriction
SGA/growth restriction (yes/no) and classification, if any
Measured: At delivery and 6 weeks post-partum
Perinatal outcomes: Mode of delivery
Mode of delivery (spontaneous, assisted, cesarean section)
Measured: At delivery and 6 weeks post-partum
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
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
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
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.
- First posted3 Dec 2024
- Study start26 Feb 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bed RestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Montse Palacio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Montse Palacio, Hospital Clinic of Barcelona
- Investigators
- Montse Palacio, MD, PhD, Principal investigator, Head of Maternal Medicine Department
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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women. A Pilot Study
- ClinicalTrials.gov ID
- NCT06713083
- Acronym / sponsor ID
- BedRest / Bed RestPregnancy
- Conditions
- Bed Rest, Pregnancy, Pregnancy Complications
- Keywords
- Bed rest, Pregnancy complications, Pregnancy, Hospitalization, Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Montse PalacioUniversity, hospital or other
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: ExercisePregnant 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. |
| Non-exercise group | No intervention | –Pregnant women admitted in the Maternal Intermediate Care Unit who will follow the standard management for its complication |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Maternal age of 18 or more
- Delivery not expected within 1 week after recruitment.
- Language ability to understand the study.
- Informed consent signed.
Key exclusion criteria (2 listed)
- Fetal death
- Severe mental health disorders and substance abuse disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseSpecifically 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). | Other | Exercise group |
Primary outcome
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).
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).
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).
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).
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.
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.
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.
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)
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.
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.
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)
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
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
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)
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).
23 secondary outcomes
Baseline Maternal and fetal characteristics: Evaluation of physical activity (GAQ-P questionnaire)
Time frame: At enrollment
Baseline Maternal and fetal characteristics: Maternal age
Time frame: At enrollment
Baseline Maternal and fetal characteristics: Maternal weight
Time frame: At enrollment
Baseline Maternal and fetal characteristics: Ethnic group
Time frame: At enrollment
Baseline Maternal and fetal characteristics: Gestational age at recruitment
Time frame: At enrollment
Baseline Maternal and fetal characteristics: Twin pregnancy
Time frame: At enrollment
Baseline Maternal and fetal characteristics: Fetal growth percentile at admission
Time frame: At enrollment
Baseline Maternal and fetal characteristics: Medical condition that justifies hospital admission
Time frame: At enrollment
Baseline Maternal and fetal characteristics: Musculoskeletal limitations
Time frame: At enrollment
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
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
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
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
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
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
Perinatal outcomes: Gestational age at delivery
Time frame: At delivery and 6 weeks post-partum
Perinatal outcomes: Birthweight
Time frame: At delivery and 6 weeks post-partum
Perinatal outcomes: SGA/growth restriction
Time frame: At delivery and 6 weeks post-partum
Perinatal outcomes: Mode of delivery
Time frame: At delivery and 6 weeks post-partum
Perinatal outcomes: Composite adverse maternal outcome
Time frame: At delivery and 6 weeks post-partum
Perinatal outcomes: Neonatal admission to neonatal intensive care unit
Time frame: At delivery and 6 weeks post-partum
Perinatal outcomes: Composite adverse neonatal outcome
Time frame: At delivery and 6 weeks post-partum
Perinatal outcomes: Breastfeeding rates
Time frame: At delivery and 6 weeks post-partum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Montse Palacio, MD, PhD principal investigator
Head of Maternal Medicine Department
1 site in 1 country: see every site and its status.
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.