Hospital Clínic de Barcelona
Barcelona, Barcelona, 08028
Federico Migliorelli, MD, PhD, +34932275400 ext. 9946, secmmf@clinic.cat
Montse Palacio, MD, PhD, +34932275400 ext. 9946, secmmf@clinic.cat

Other trials in Spain

About this study

Official title: Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women

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.

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 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, Pregnancy complications, Hospitalization, Exercise, Exercise adaptations
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 NCT07657000
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 receiving the intervention and monitored according to study procedures 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 without any specific instructions to engage in physical activity, also monitored according to study procedures.

What is being measured

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

Physiological parameters: Rectus femoris area measurement
Loss of rectus femoris area (cm2) in a relaxed state, assessed by ultrasound
Measured: Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
Physiological parameters: Time spent in moderate or vigorous activity
Time spent in moderate or vigorous activity (in minutes, summarized as average per day).
Measured: Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
Physiological parameters: Total physical activity
Total physical activity (average per day in mG).
Measured: Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
Physiological parameters: Handgrip strength test.
Handgrip strength test (in kg, adjusted for gender and age).
Measured: Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
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: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Sleep cycle and Quality of life parameters: Sleep average per night
Sleep average per night (in minutes)
Measured: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after 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: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery
Mental health/emotional parameters: SAM: The Self-Assessment Manikin
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.
Measured: Daily
Mental health/emotional parameters: RRS: The Ruminative Response Scale
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
Measured: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Mental health/emotional parameters: BDI-II:
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.
Measured: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Physiological parameters: Muscle Ultrasound
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.
Measured: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Physiological parameters: Maternal Cardiac Ultrasound
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.
Measured: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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)
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.
Measured: Baseline
Baseline Maternal and fetal characteristics: Maternal age
Maternal age (In years)
Measured: Baseline
Baseline Maternal and fetal characteristics: Maternal weight
Maternal weight (In kg)
Measured: Baseline
Baseline Maternal and fetal characteristics: Ethnic group
Ethnic group classified as: - White/European - Hispanic/latin American - Black/African Americans - Arabic - Asian
Measured: Baseline
Baseline Maternal and fetal characteristics: Gestational age at recruitment
Gestational age at recruitment (in weeks + days)
Measured: Baseline
Baseline Maternal and fetal characteristics: Twin pregnancy
Twin pregnancy (yes/no)
Measured: Baseline
Baseline Maternal and fetal characteristics: Fetal growth percentile at admission
Fetal growth percentile at admission (customized for gender and multiplicity)
Measured: Baseline
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: Baseline
Baseline Maternal and fetal characteristics: Musculoskeletal limitations
Musculoskeletal limitations (injuries or pathologies) (yes/no and description)
Measured: Baseline
Maternal and fetal characteristics during hospital admission: Medication while admitted
Medication while admitted (antihypertensive treatment, tocolysis, magnesium sulphate, antibiotics, corticosteroids, others)
Measured: Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
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: Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Maternal and fetal characteristics during hospital admission: Length of hospital admission
Length of hospital admission (in days)
Measured: Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Maternal and fetal characteristics during hospital admission: Fetal CTG
Fetal CTG description
Measured: Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Maternal and fetal characteristics during hospital admission: Diet during the admission
Diet during the admission (in Kcal and special needs)
Measured: Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Maternal and fetal characteristics during hospital admission: Daily fluid intake
Daily fluid intake (in mL)
Measured: Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Perinatal outcomes: Gestational age at delivery
Gestational age at delivery (in weeks + days
Measured: Whitin 24h after delivery and 6 weeks postpartum
Perinatal outcomes: Birthweight
Birthweight (in grams) and percentile
Measured: Whitin 24h after delivery and 6 weeks postpartum
Perinatal outcomes: SGA/growth restriction
SGA/growth restriction (yes/no) and classification, if any
Measured: Whitin 24h after delivery and 6 weeks postpartum
Perinatal outcomes: Mode of delivery
Mode of delivery (spontaneous, assisted, cesarean section)
Measured: Whitin 24h after delivery and 6 weeks postpartum
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: Whitin 24h after delivery and 6 weeks postpartum
Perinatal outcomes: Neonatal admission to neonatal intensive care unit
Neonatal admission to neonatal intensive care unit (yes/no)
Measured: Whitin 24h after delivery and 6 weeks postpartum
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: Whitin 24h after delivery and 6 weeks postpartum
Perinatal outcomes: Breastfeeding rates
Breastfeeding rates
Measured: Whitin 24h after delivery and 6 weeks postpartum

Timeline

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

Sep 2026Sep 2029

First posted18 Jun 2026
Study startSep 2026 (estimated)
Primary completionSep 2027 (estimated)
Study completionSep 2029 (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.
More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
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: 140 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07657000
Sponsor's protocol ID: BedRest Pregnancy Study
Acronym: BedRest-1
Status last verified: May 2026
First submitted: 4 Jun 2026
Last updated: 18 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual participant data (IPD) will not be shared with esteranl researchers. Study finding will be reported in peer-reviewed scientific journals and presented at scientific meetings in aggregate form, without disclosure of identifiable participant information.

Interested in taking part?

Federico Migliorelli, Migliorelli, MD, PhD

+34932275400 ext. 9946

secmmf@clinic.cat

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Postprocedural Bed-Rest Strategies After Transfemoral Venous Interventions
Venous Access, Endovascular Procedures
Recruiting
DE-RESTRICT: Deimplementing Activity Restriction for Preterm Birth Prevention
Preterm Birth, Activity Restriction
Active, not recruiting
BRAHMS: Bed Rest And HypoMetabolism Study
Microgravity, Caloric Restriction
Not yet recruiting
Bed Rest With a Short Cervix on Preterm Birth
Preterm Birth, Cervical Insufficiency
Not yet recruiting
Bed Rest Duration and Outcomes in Endoscopic Skull Base Reconstruction
Skull Base

All Bed Rest trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2026. 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
ClinicalTrials.gov ID: NCT07657000
Acronym / sponsor ID: BedRest-1 / BedRest Pregnancy Study
Conditions: Bed Rest, Pregnancy, Pregnancy Complications
Keywords: Bed rest, Pregnancy, Pregnancy complications, Hospitalization, Exercise, Exercise adaptations
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 140 participants (estimated)
Lead sponsor: Hospital Clinic of BarcelonaUniversity, hospital or other
Study start: Sep 2026 (estimated)
Primary completion: Sep 2027 (estimated)
Study completion: Sep 2029 (estimated)
First posted: 18 Jun 2026 (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.

Detailed description

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 receiving the intervention and monitored according to study procedures
Non-exercise group	No intervention	–Pregnant women admitted in the Maternal Intermediate Care Unit who will follow the standard management for its complication without any specific instructions to engage in physical activity, also monitored according to study procedures.

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: Rectus femoris area measurement
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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:
Time frame: 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
Time frame: 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
Time frame: 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
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: Baseline
Baseline Maternal and fetal characteristics: Maternal age
Time frame: Baseline
Baseline Maternal and fetal characteristics: Maternal weight
Time frame: Baseline
Baseline Maternal and fetal characteristics: Ethnic group
Time frame: Baseline
Baseline Maternal and fetal characteristics: Gestational age at recruitment
Time frame: Baseline
Baseline Maternal and fetal characteristics: Twin pregnancy
Time frame: Baseline
Baseline Maternal and fetal characteristics: Fetal growth percentile at admission
Time frame: Baseline
Baseline Maternal and fetal characteristics: Medical condition that justifies hospital admission
Time frame: Baseline
Baseline Maternal and fetal characteristics: Musculoskeletal limitations
Time frame: Baseline
Maternal and fetal characteristics during hospital admission: Medication while admitted
Time frame: Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Maternal and fetal characteristics during hospital admission: Length of stay in the intermediate care unit
Time frame: Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Maternal and fetal characteristics during hospital admission: Length of hospital admission
Time frame: Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Maternal and fetal characteristics during hospital admission: Fetal CTG
Time frame: Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Maternal and fetal characteristics during hospital admission: Diet during the admission
Time frame: Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Maternal and fetal characteristics during hospital admission: Daily fluid intake
Time frame: Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Perinatal outcomes: Gestational age at delivery
Time frame: Whitin 24h after delivery and 6 weeks postpartum
Perinatal outcomes: Birthweight
Time frame: Whitin 24h after delivery and 6 weeks postpartum
Perinatal outcomes: SGA/growth restriction
Time frame: Whitin 24h after delivery and 6 weeks postpartum
Perinatal outcomes: Mode of delivery
Time frame: Whitin 24h after delivery and 6 weeks postpartum
Perinatal outcomes: Composite adverse maternal outcome
Time frame: Whitin 24h after delivery and 6 weeks postpartum
Perinatal outcomes: Neonatal admission to neonatal intensive care unit
Time frame: Whitin 24h after delivery and 6 weeks postpartum
Perinatal outcomes: Composite adverse neonatal outcome
Time frame: Whitin 24h after delivery and 6 weeks postpartum
Perinatal outcomes: Breastfeeding rates
Time frame: Whitin 24h after delivery and 6 weeks postpartum

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 18 Jun 2026.
Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with esteranl researchers. Study finding will be reported in peer-reviewed scientific journals and presented at scientific meetings in aggregate form, without disclosure of identifiable participant information.

Related trials for Bed Rest

Not yet recruiting
Postprocedural Bed-Rest Strategies After Transfemoral Venous Interventions
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Recruiting
DE-RESTRICT: Deimplementing Activity Restriction for Preterm Birth Prevention
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Active, not recruiting
BRAHMS: Bed Rest And HypoMetabolism Study
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Not yet recruiting
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Not yet recruiting
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Skull Base

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.

Federico Migliorelli, Migliorelli, MD, PhD contact

+34932275400 ext. 9946

secmmf@clinic.cat

Montse Palacio, MD, PhD contact

+34932275400 ext. 9946

secmmf@clinic.cat

Federico Migliorelli, MD, PhD principal investigator

Gynecologist especialist on Maternal fetal medicine

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 Hospital Clinic of Barcelona 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: opening soon, as of the sponsor's last update on 18 Jun 2026. 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 Federico Migliorelli, Migliorelli, 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: Rectus femoris area measurement (time frame: Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07657000.

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 18 Jun 2026.