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).
Study summary
This study aims to evaluate the impact of a specifically designed exercise program for hospitalized high-risk pregnant individuals on bed rest. This is a specifically designed physical activiity program, consisting of a resistance and strength exercises intended to be performed even 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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)
Physiological parameters: Rectus femoris area measurement — Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum Loss of rectus femoris area (cm2) in a relaxed state, assessed by ultrasound
Physiological parameters: Time spent in moderate or vigorous activity — Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum Time spent in moderate or vigorous activity (in minutes, summarized as average per day).
Physiological parameters: Total physical activity — Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum Total physical activity (average per day in mG).
Physiological parameters: Handgrip strength test. — Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum Handgrip strength test (in kg, adjusted for gender and age).
Mental health/emotional parameters: GAD-7 — Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum 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) — Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum 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 — Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum 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 — Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery Sleep average per night (in minutes)
Sleep cycle and Quality of life parameters: WHOQOL-BREF score — Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after 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.
Mental health/emotional parameters: SAM: The Self-Assessment Manikin — Daily Visual standardized measure of emotional tone that covers 3 different affective domains (valence, arousal and sense of control). Responses are made by selecting the manikin that best represents the emotional state of the patient. The patient selection is afterwards converted into a numerical result with higher scores indicating more positive affective tone.
Mental health/emotional parameters: RRS: The Ruminative Response Scale — Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum 10-item questionnaire intended to measure rumination, tendency to worriedness and repetitive thinking in front of stressful situations. (score ranking from 10 to 40). Higher scores indicate a higher tendeny to ruminate and a vulnerability trait to psychological distress
Mental health/emotional parameters: BDI-II: — Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum Questionnaire to measuring depression at a cognitive, affective and behavioral level. For the present study only 4 items related to hedonic experience will be selected. Higher scores in each item indicate severity in the loss of hedonic capacity. Reponses are made by using a 4-point Likert scale.
Physiological parameters: Muscle Ultrasound — Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum Muscle ultrasound will be conducted weekly by blinded sonographers using a linear probe (7.5 - 10 MHz). All images will be acquired in triplicate, and the average value will be used for analysis.
Physiological parameters: Maternal Cardiac Ultrasound — Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum Transthoracic echocardiography will be performed using standardised imaging protocols. All measurements will be performed in triplicate when feasible, and averaged for analysis. Standardization of acquisition settings and operator blinding to clinical data will be ensured to reduce measurement bias.
Feasibility evaluation of the implementation of the exercise program: Time needed to recruit sample size — 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 — 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 — 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 — 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 — 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).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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