Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women

NCT06713083 | Recruiting

• 1 other identifier: Bed RestPregnancy
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Bed Rest; Pregnancy; Pregnancy Complications

Keywords

Bed rest; Pregnancy complications; Pregnancy; Hospitalization; Exercise

Outcome Measures

Primary Outcomes (15)

• Physiological parameters: Time spent in moderate or vigorous activity

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

  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).

  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).

  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).

  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.

  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.

  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.

  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)

  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.

  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.

  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)

  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)

  At enrollment

• Baseline Maternal and fetal characteristics: Maternal age

  At enrollment

• Baseline Maternal and fetal characteristics: Maternal weight

  At enrollment

• Baseline Maternal and fetal characteristics: Ethnic group

  At enrollment

• Baseline Maternal and fetal characteristics: Gestational age at recruitment

  At enrollment

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 follow a specific designed exercise program.

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

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

• Montse Palacio: lead

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, 08028, Spain

RECRUITING

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

• Montse Palacio, MD, PhD

  Head of Maternal Medicine Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Montse Palacio, MD, PhD

CONTACT

+34932275400; secmmf@clinic.cat

Federico Migliorelli, 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 INVESTIGATOR
• PI Title: Head of Maternal Medicine Department

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: November 22, 2024
• First Posted: December 3, 2024
• Study Start: February 26, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)