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

NCT07657000 | Not Yet Recruiting

• 1 other identifier: BedRest Pregnancy Study
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bed Rest; Pregnancy; Pregnancy Complications

Keywords

Bed rest; Pregnancy; Pregnancy complications; Hospitalization; Exercise; Exercise adaptations

Outcome Measures

Primary Outcomes (19)

• Physiological parameters: Rectus femoris area measurement

  Loss of rectus femoris area (cm2) in a relaxed state, assessed by ultrasound

  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).

  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).

  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).

  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.

  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.

  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.

  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)

  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.

  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.

  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

  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.

  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.

  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.

  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)

  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

  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

  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)

  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).

  At delivery

Secondary Outcomes (23)

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

  Baseline

• Baseline Maternal and fetal characteristics: Maternal age

  Baseline

• Baseline Maternal and fetal characteristics: Maternal weight

  Baseline

• Baseline Maternal and fetal characteristics: Ethnic group

  Baseline

• Baseline Maternal and fetal characteristics: Gestational age at recruitment

  Baseline

Study Arms (2)

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

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.

Interventions

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).

Exercise group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, Barcelona, 08028, Spain

Location

MeSH Terms

Conditions

Pregnancy Complications; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Federico Migliorelli, MD, PhD

  Gynecologist especialist on Maternal fetal medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federico Migliorelli, Migliorelli, MD, PhD

CONTACT

+34932275400; secmmf@clinic.cat

Montse Palacio, MD, PhD

CONTACT

+34932275400; secmmf@clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 18, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2029
• Last Updated: June 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)