Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women. A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Physiological parameters: Time spent in moderate or vigorous activity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Maternal age of 18 or more
- •Delivery not expected within 1 week after recruitment.
- •Language ability to understand the study.
- •Informed consent signed.
排除标准
- •Fetal death
- •Severe mental health disorders and substance abuse disorders.
研究组 & 干预措施
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.
干预措施: Exercise (Other)
Non-exercise group
Pregnant women admitted in the Maternal Intermediate Care Unit who will follow the standard management for its complication
结局指标
主要结局
Physiological parameters: Time spent in moderate or vigorous activity
时间窗: At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum
Time spent in moderate or vigorous activity (in minutes, summarized as average per day).
Physiological parameters: Total physical activity
时间窗: At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum
Total physical activity (average per day in mG).
Physiological parameters: Handgrip strength test.
时间窗: At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum
Handgrip strength test (in kg, adjusted for gender and age).
Physiological parameters: Calf Circumference measurement
时间窗: At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum
Calf Circumference measurement (in cm, adjusted for gender and age).
Mental health/emotional parameters: GAD-7
时间窗: At enrollment, weeks 2, 4 and 6 (if not delivered), at delivery, 6 weeks post-partum
GAD-7: Generalized Anxiety Disorder assessment scale (score ranging from 0 to 21). The higher the results, higher is the severity of anxiety.
Mental health/emotional parameters: Perceived Stress Scale (PSS-10)
时间窗: At enrollment, weeks 2, 4 and 6 (if not delivered), at delivery, 6 weeks post-partum
Perceived Stress Scale (PSS-10) (score ranging from 0 to 40). The higher the results, higher is the perception of stress.
Mental health/emotional parameters: Edinburg Postpartum Depression Scale
时间窗: At enrollment, weeks 2, 4 and 6 (if not delivered), at delivery, 6 weeks post-partum
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.
Sleep cycle and Quality of life parameters: Sleep average per night
时间窗: At enrollment, weeks 2, 4 and 6 (if not delivered), at delivery
Sleep average per night (in minutes)
Sleep cycle and Quality of life parameters: Insomnia Severity Index (ISI)
时间窗: At enrollment, weeks 2, 4 and 6 (if not delivered), at delivery
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.
Sleep cycle and Quality of life parameters: WHOQOL-BREF score
时间窗: At enrollment, weeks 2, 4 and 6 (if not delivered), at delivery
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.
Feasibility evaluation of the implementation of the exercise program: Time needed to recruit sample size
时间窗: Through study completion, an average of 6 months
Time needed to recruit sample size (in days)
Feasibility evaluation of the implementation of the exercise program: Number of women who declined to participate in the study
时间窗: Through study completion, an average of 6 months
Number of women who declined to participate in the study
Feasibility evaluation of the implementation of the exercise program: Number of women who give up participation in the study
时间窗: Through study completion, an average of 6 months
Number of women who give up participation in the study
Feasibility evaluation of the implementation of the exercise program: Adherence to the program
时间窗: Through study completion, an average of 6 months
Adherence to the program (number of days of actual performance of the exercise program while admitted)
Satisfaction evaluation
时间窗: At delivery
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).
次要结局
- Perinatal outcomes: Mode of delivery(At delivery and 6 weeks post-partum)
- 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)
- Baseline Maternal and fetal characteristics: Twin pregnancy(At enrollment)
- Baseline Maternal and fetal characteristics: Fetal growth percentile at admission(At enrollment)
- Baseline Maternal and fetal characteristics: Medical condition that justifies hospital admission(At enrollment)
- Baseline Maternal and fetal characteristics: Musculoskeletal limitations(At enrollment)
- Maternal and fetal characteristics during hospital admission: Medication while admitted(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(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(At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum)
- Maternal and fetal characteristics during hospital admission: Fetal CTG(At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum)
- Maternal and fetal characteristics during hospital admission: Diet during the admission(At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum)
- Maternal and fetal characteristics during hospital admission: Daily fluid intake(At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum)
- Perinatal outcomes: Gestational age at delivery(At delivery and 6 weeks post-partum)
- Perinatal outcomes: Birthweight(At delivery and 6 weeks post-partum)
- Perinatal outcomes: SGA/growth restriction(At delivery and 6 weeks post-partum)
- Perinatal outcomes: Composite adverse maternal outcome(At delivery and 6 weeks post-partum)
- Perinatal outcomes: Neonatal admission to neonatal intensive care unit(At delivery and 6 weeks post-partum)
- Perinatal outcomes: Composite adverse neonatal outcome(At delivery and 6 weeks post-partum)
- Perinatal outcomes: Breastfeeding rates(At delivery and 6 weeks post-partum)
研究者
Montse Palacio
Head of Maternal Medicine Department
Hospital Clinic of Barcelona