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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Non-exercise group | No Intervention | Pregnant women admitted in the Maternal Intermediate Care Unit who will follow the standard management for its complication |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Maternal and fetal characteristics: Evaluation of physical activity (GAQ-P questionnaire) | Evaluation of physical activity using the Get Active Questionnaire for Pregnancy. The questionnaire self-classifies how often and for how long she is engaged in physical activity of a light, moderate or vigorous intensity. Also, it addresses the question whether the woman should speak to her Obstetric Health Care Provider before beginning or continue to be physically active. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Montse Palacio, MD, PhD | Contact | +34932275400 | 9946 | secmmf@clinic.cat |
| Federico Migliorelli, MD, PhD | Contact | +34932275400 | 9946 | secmmf@clinic.cat |
| Name | Affiliation | Role |
|---|---|---|
| Montse Palacio, MD, PhD | Head of Maternal Medicine Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínic de Barcelona | Recruiting | Barcelona | 08028 | Spain |
This is a pilot study designed to evaluate the feasibility and preliminary outcomes of the intervention. As such, no data-sharing plan has been developed. The focus of this study is to generate initial findings to inform the design of future larger-scale studies, where a detailed data-sharing plan may be established.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 31, 2024 | Nov 25, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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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.
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| 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 |
| At enrollment |
| Baseline Maternal and fetal characteristics: Maternal age | Maternal age (in years) | At enrollment |
| Baseline Maternal and fetal characteristics: Maternal weight | Maternal weight (in kg) | At enrollment |
| Baseline Maternal and fetal characteristics: Ethnic group | Ethnic group classified as:
| At enrollment |
| Baseline Maternal and fetal characteristics: Gestational age at recruitment | Gestational age at recruitment (in weeks + days) | At enrollment |
| Baseline Maternal and fetal characteristics: Twin pregnancy | Twin pregnancy (yes/no) | At enrollment |
| Baseline Maternal and fetal characteristics: Fetal growth percentile at admission | Fetal growth percentile at admission (customized for gender and multiplicity) | At enrollment |
| Baseline Maternal and fetal characteristics: Medical condition that justifies hospital admission | Medical condition that justifies hospital admission (hypertensive disorders, preterm labor, rupture of membranes, antepartum bleeding, others) | At enrollment |
| Baseline Maternal and fetal characteristics: Musculoskeletal limitations | Musculoskeletal limitations (injuries or pathologies) (yes/no and description) | At enrollment |
| Maternal and fetal characteristics during hospital admission: Medication while admitted | Medication while admitted (antihypertensive treatment, tocolysis, magnesium sulphate, antibiotics, corticosteroids, others) | 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 | Length of stay in the intermediate care unit (in days) | 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 | Length of hospital admission (in days) | At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum |
| Maternal and fetal characteristics during hospital admission: Fetal CTG | Fetal CTG description | 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 | Diet during the admission (in Kcal and special needs) | 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 | Daily fluid intake (in mL) | At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum |
| Perinatal outcomes: Gestational age at delivery | Gestational age at delivery (in weeks + days) | At delivery and 6 weeks post-partum |
| Perinatal outcomes: Birthweight | Birthweight (in grams) and percentile | At delivery and 6 weeks post-partum |
| Perinatal outcomes: SGA/growth restriction | SGA/growth restriction (yes/no) and classification, if any | At delivery and 6 weeks post-partum |
| Perinatal outcomes: Mode of delivery | Mode of delivery (spontaneous, assisted, cesarean section) | At delivery and 6 weeks post-partum |
| Perinatal outcomes: Composite adverse maternal outcome | Composite adverse maternal outcome (yes/no considering any of the following: re-intervention, endometritis, infection of surgical wound, curettage, admission to intensive care unit, hysterectomy, need for transfusion, postpartum hemorrhage requiring medication other than oxytocin or ergometrine, maternal sepsis, death) | At delivery and 6 weeks post-partum |
| Perinatal outcomes: Neonatal admission to neonatal intensive care unit | Neonatal admission to neonatal intensive care unit (yes/no) | At delivery and 6 weeks post-partum |
| Perinatal outcomes: Composite adverse neonatal outcome | Composite adverse neonatal outcome: (yes/no considering any of the following: respiratory morbidity - respiratory distress syndrome or transient tachypnea - requiring intubation, moderate-severe bronchopulmonary dysplasia, intraventricular hemorrhage grade III-IV, early-onset sepsis, periventricular leukomalacia, necrotizing enterocolitis, retinopathy requiring laser, fetal or neonatal death) | At delivery and 6 weeks post-partum |
| Perinatal outcomes: Breastfeeding rates | Breastfeeding rates | At delivery and 6 weeks post-partum |