Clinical trial NCT06713083: Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women
Official title: Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women. A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bed Rest
Pregnancy
Pregnancy Complications
Keywords: Bed rest
Pregnancy complications
Pregnancy
Hospitalization
Exercise
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Physiological parameters: Time spent in moderate or vigorous activity
timeFrame: At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum
measure: Physiological parameters: Total physical activity
timeFrame: At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum
measure: Physiological parameters: Handgrip strength test.
timeFrame: At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum
measure: Physiological parameters: Calf Circumference measurement
timeFrame: At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum
measure: Mental health/emotional parameters: GAD-7
timeFrame: At enrollment, weeks 2, 4 and 6 (if not delivered), at delivery, 6 weeks post-partum
measure: Mental health/emotional parameters: Perceived Stress Scale (PSS-10)
timeFrame: At enrollment, weeks 2, 4 and 6 (if not delivered), at delivery, 6 weeks post-partum
measure: Mental health/emotional parameters: Edinburg Postpartum Depression Scale
timeFrame: At enrollment, weeks 2, 4 and 6 (if not delivered), at delivery, 6 weeks post-partum
measure: Sleep cycle and Quality of life parameters: Sleep average per night
timeFrame: At enrollment, weeks 2, 4 and 6 (if not delivered), at delivery
measure: Sleep cycle and Quality of life parameters: Insomnia Severity Index (ISI)
timeFrame: At enrollment, weeks 2, 4 and 6 (if not delivered), at delivery
measure: Sleep cycle and Quality of life parameters: WHOQOL-BREF score
timeFrame: At enrollment, weeks 2, 4 and 6 (if not delivered), at delivery
measure: Feasibility evaluation of the implementation of the exercise program: Time needed to recruit sample size
timeFrame: Through study completion, an average of 6 months
measure: Feasibility evaluation of the implementation of the exercise program: Number of women who declined to participate in the study
timeFrame: Through study completion, an average of 6 months
measure: Feasibility evaluation of the implementation of the exercise program: Number of women who give up participation in the study
timeFrame: Through study completion, an average of 6 months
measure: Feasibility evaluation of the implementation of the exercise program: Adherence to the program
timeFrame: Through study completion, an average of 6 months
measure: Satisfaction evaluation
timeFrame: At delivery
Secondary outcomes:
measure: Baseline Maternal and fetal characteristics: Evaluation of physical activity (GAQ-P questionnaire)
timeFrame: At enrollment
measure: Baseline Maternal and fetal characteristics: Maternal age
timeFrame: At enrollment
measure: Baseline Maternal and fetal characteristics: Maternal weight
timeFrame: At enrollment
measure: Baseline Maternal and fetal characteristics: Ethnic group
timeFrame: At enrollment
measure: Baseline Maternal and fetal characteristics: Gestational age at recruitment
timeFrame: At enrollment
measure: Baseline Maternal and fetal characteristics: Twin pregnancy
timeFrame: At enrollment
measure: Baseline Maternal and fetal characteristics: Fetal growth percentile at admission
timeFrame: At enrollment
measure: Baseline Maternal and fetal characteristics: Medical condition that justifies hospital admission
timeFrame: At enrollment
measure: Baseline Maternal and fetal characteristics: Musculoskeletal limitations
timeFrame: At enrollment
measure: Maternal and fetal characteristics during hospital admission: Medication while admitted
timeFrame: At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum
measure: Maternal and fetal characteristics during hospital admission: Length of stay in the intermediate care unit
timeFrame: At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum
measure: Maternal and fetal characteristics during hospital admission: Length of hospital admission
timeFrame: At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum
measure: Maternal and fetal characteristics during hospital admission: Fetal CTG
timeFrame: At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum
measure: Maternal and fetal characteristics during hospital admission: Diet during the admission
timeFrame: At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum
measure: Maternal and fetal characteristics during hospital admission: Daily fluid intake
timeFrame: At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum
measure: Perinatal outcomes: Gestational age at delivery
timeFrame: At delivery and 6 weeks post-partum
measure: Perinatal outcomes: Birthweight
timeFrame: At delivery and 6 weeks post-partum
measure: Perinatal outcomes: SGA/growth restriction
timeFrame: At delivery and 6 weeks post-partum
measure: Perinatal outcomes: Mode of delivery
timeFrame: At delivery and 6 weeks post-partum
measure: Perinatal outcomes: Composite adverse maternal outcome
timeFrame: At delivery and 6 weeks post-partum
measure: Perinatal outcomes: Neonatal admission to neonatal intensive care unit
timeFrame: At delivery and 6 weeks post-partum
measure: Perinatal outcomes: Composite adverse neonatal outcome
timeFrame: At delivery and 6 weeks post-partum
measure: Perinatal outcomes: Breastfeeding rates
timeFrame: At delivery and 6 weeks post-partum
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
Study officials:
affiliation: Head of Maternal Medicine Department
name: Montse Palacio, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: