Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women

NCT ID: NCT06713083

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-26
• Study Completion Date: 2025-12-31

Brief 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 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.

Conditions

Bed Rest; Pregnancy; Pregnancy Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Exercise group

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.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: 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).

Non-exercise group

Pregnant women admitted in the Maternal Intermediate Care Unit who will follow the standard management for its complication

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Montse Palacio

OTHER

Sponsor Role: lead

Responsible Party

Montse Palacio

Head of Maternal Medicine Department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Montse Palacio, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Head of Maternal Medicine Department

Locations

Hospital Clínic de Barcelona

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Montse Palacio, MD, PhD

Role: CONTACT

secmmf@clinic.cat

+34932275400 ext. 9946

Federico Migliorelli, MD, PhD

Role: CONTACT

secmmf@clinic.cat

+34932275400 ext. 9946

Facility Contacts

Montse Palacio, MD, PhD

Role: primary

secmmf@clinic.cat

+34932275400 ext. 9946

Federico Migliorelli, MD, PhD

Role: backup

secmmf@clinic.cat

+34932275400 ext. 9946

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Bed RestPregnancy

Identifier Type: -

Identifier Source: org_study_id