Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women.
- Sponsor
- Hospital Clinic of Barcelona
- Study ID
- NCT07657000
- Status
- Not Yet Recruiting
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Conditions
- Bed Rest
- Pregnancy
- Pregnancy Complications
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Exercise — OTHERSpecifically 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 Details
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.
Key Dates
- First listed
- Jun 18, 2026
- Start date
- Sep 30, 2026
- Status verified
- May 2026
- Primary completion
- Sep 30, 2027
- Completion
- Sep 30, 2029
Study Design
- Enrollment
- 140 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Exercise groupPregnant women admitted in the Maternal Intermediate Care Unit who will follow the standard management for its complication and will receiving the intervention and monitored according to study procedures
- No Intervention: Non-exercise groupPregnant women admitted in the Maternal Intermediate Care Unit who will follow the standard management for its complication without any specific instructions to engage in physical activity, also monitored according to study procedures.
Primary Outcome Measure
Physiological parameters: Rectus femoris area measurement [ Time Frame: Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum ]
Central Contacts
- Federico Migliorelli, Migliorelli, MD, PhD+34932275400
- Montse Palacio, MD, PhD+34932275400
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