Health TrialsbyHealthPanel

Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women

ConditionsBed RestPregnancyPregnancy Complications
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMontse Palacio

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Maternal age of 18 or more

Delivery not expected within 1 week after recruitment.

Language ability to understand the study.

Informed consent signed.

Disqualifiers

Fetal death

Severe mental health disorders and substance abuse disorders.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise

    Other intervention

    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).

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Exercise groupExperimental treatment 1 intervention
Group B: Non-exercise groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Physiological parameters: Time spent in moderate or vigorous activity

Time spent in moderate or vigorous activity (in minutes, summarized as average per day).

Time frame
At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum
2

Physiological parameters: Total physical activity

Total physical activity (average per day in mG).

Time frame
At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum
3

Physiological parameters: Handgrip strength test.

Handgrip strength test (in kg, adjusted for gender and age).

Time frame
At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum
4

Physiological parameters: Calf Circumference measurement

Calf Circumference measurement (in cm, adjusted for gender and age).

Time frame
At enrollment, weeks 1 to 6 (if not delivered), at delivery, 6 weeks post-partum

Secondary outcomes

1

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.

Time frame
At enrollment
2

Baseline Maternal and fetal characteristics: Maternal age

Maternal age (in years)

Time frame
At enrollment
3

Baseline Maternal and fetal characteristics: Maternal weight

Maternal weight (in kg)

Time frame
At enrollment
4

Baseline Maternal and fetal characteristics: Ethnic group

Ethnic group classified as: * White/European * Hispanic/latin American * Black/African Americans * Arabic * Asian

Time frame
At enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Montse Palacio

Lead sponsor

Hospital Clinic of Barcelona

Sponsor institution

Source ClinicalTrials.gov
Apply now