Health TrialsbyHealthPanel

Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women.

ConditionsBed RestPregnancyPregnancy Complications
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHospital Clinic of Barcelona

About this trial

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 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

140 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: Rectus femoris area measurement

Loss of rectus femoris area (cm2) in a relaxed state, assessed by ultrasound

Time frame
Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
2

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
Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
3

Physiological parameters: Total physical activity

Total physical activity (average per day in mG).

Time frame
Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
4

Physiological parameters: Handgrip strength test.

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

Time frame
Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum

Secondary outcomes

1

Baseline Maternal and fetal characteristics: Evaluation of physical activity (GAQ-P questionnaire)

The questionnarie self-clasisfies how often and for how long the participant engages in light-, moderate-, or vigorous-intensity physical activity. It also assesses whether the participant should consult her obstetric health care provider before beginning or continuing physical activity during pregnancy. The GAQP is a screening and classification tool and does not generate a numerical summary score. Therefore, no minimun or maximum applies, and higher or lower scores do not indicate a better or worse outcome.

Time frame
Baseline
2

Baseline Maternal and fetal characteristics: Maternal age

Maternal age (In years)

Time frame
Baseline
3

Baseline Maternal and fetal characteristics: Maternal weight

Maternal weight (In kg)

Time frame
Baseline
4

Baseline Maternal and fetal characteristics: Ethnic group

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

Time frame
Baseline

Other outcomes

Sponsors and contacts

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

Hospital Clinic of Barcelona

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: