Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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).

Первичные конечные точки

• Physiological parameters: Time spent in moderate or vigorous activity [Срок оценки: At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum]
• Physiological parameters: Total physical activity [Срок оценки: At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum]
• Physiological parameters: Handgrip strength test. [Срок оценки: At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum]
• Physiological parameters: Calf Circumference measurement [Срок оценки: At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum]
• Mental health/emotional parameters: GAD-7 [Срок оценки: 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) [Срок оценки: At enrollment, weeks 2, 4 and 6 (if not delivered), at delivery, 6 weeks post-partum]
• Mental health/emotional parameters: Edinburg Postpartum Depression Scale [Срок оценки: 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 [Срок оценки: At enrollment, weeks 2, 4 and 6 (if not delivered), at delivery]
• Sleep cycle and Quality of life parameters: Insomnia Severity Index (ISI) [Срок оценки: At enrollment, weeks 2, 4 and 6 (if not delivered), at delivery]
• Sleep cycle and Quality of life parameters: WHOQOL-BREF score [Срок оценки: At enrollment, weeks 2, 4 and 6 (if not delivered), at delivery]

Вторичные конечные точки (12)

• Baseline Maternal and fetal characteristics: Evaluation of physical activity (GAQ-P questionnaire) [Срок оценки: At enrollment]
• Baseline Maternal and fetal characteristics: Maternal age [Срок оценки: At enrollment]
• Baseline Maternal and fetal characteristics: Maternal weight [Срок оценки: At enrollment]
• Baseline Maternal and fetal characteristics: Ethnic group [Срок оценки: At enrollment]
• Baseline Maternal and fetal characteristics: Gestational age at recruitment [Срок оценки: At enrollment]
• Baseline Maternal and fetal characteristics: Twin pregnancy [Срок оценки: At enrollment]
• Baseline Maternal and fetal characteristics: Fetal growth percentile at admission [Срок оценки: At enrollment]
• Baseline Maternal and fetal characteristics: Medical condition that justifies hospital admission [Срок оценки: At enrollment]
• Baseline Maternal and fetal characteristics: Musculoskeletal limitations [Срок оценки: At enrollment]
• Maternal and fetal characteristics during hospital admission: Medication while admitted [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Испания · 1 центр

• Hospital Clínic de Barcelona — Barcelona

Идентификаторы

NCT: NCT06713083 · Bed RestPregnancy

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗