Pregnant Women With Physical Activity

NCT05001906 | Completed

• 1 other identifier: EO2619
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Physical activity, defined as any movement of the body produced by the contraction of skeletal muscles in all phases of life, maintains and improves cardiorespiratory capacity, reduces the risk of obesity and associated comorbidities. The study will analyze the effect of prenatal exercise on circulatory functional and structural parameters and gestational weight gain in pregnant women who exercised regularly, compared to pregnant women who did not exercise regularly.

Conditions

Pregnancy

Keywords

Pregnancy; Physical exercise; Cardiovascular system; Gestational weight gain

Outcome Measures

Primary Outcomes (2)

• Systolic and diastolic blood pressure at time point 1

  The blood pressure of pregnant women would be measured using a standard mercury manometer and compared in between study groups. In the experimental group, blood pressure would be measured at the beginning of prenatal exercises, between 20 and 32 weeks of gestation. In the control group, blood pressure would be measured at the beginning of theoretical classes, between 20 and 32 weeks of gestation.

  20-32 weeks of gestation

• Systolic and diastolic blood pressure at time point 2

  Using a standard mercury manometer blood pressure would be measured in the experimental group after eight weeks of prenatal exercises (between 28 and 40 weeks of gestation) and in the control group after eight weeks of theoretical classes (between 28 and 40 weeks of gestation).

  28-40 weeks of gestation

Secondary Outcomes (3)

• Gestational weigh gain

  38 weeks pregnancy

• Shape of nailfold capillary loops

  20-32 weeks and 28-40 weeks gestation

• Nailfold capillary density

  20-32 weeks and 28-40 weeks gestation

Study Arms (2)

Control group

NO INTERVENTION

The control group (CG) will consist of pregnant women with standard prenatal care, who attending theoretical classes on childbirth (CG, n = 35). The control group will not exercise. The sedentary participants will continue their regular daily activities and life habits.

Exercise group

EXPERIMENTAL

The exercise group (EG) will consist of pregnant women who will attend theoretical classes and prenatal exercises in the program of psychophysical preparation for childbirth (EG, n = 35). The experimental group will exercise for 45 minutes, three times a week.

Behavioral: Exercise group

Interventions

Exercise group BEHAVIORAL

The exercise program comprises static and dynamic breathing exercises, muscle stretching exercises and muscle strength exercises, exercises to strengthen the abdominal wall muscles, exercises to strengthen the thigh muscles - quadriceps femoris (lat. musculus quadriceps femoris), to strengthen gluteal muscles, exercises to increase pelvic mobility, exercise to improve circulation, as well as pelvic floor muscle training with relaxation techniques.

Exercise group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age of pregnant women from 20 to 40 years
• a normal pregnancy confirmed by a gynecologist
• duration of pregnancy from the 20th to the 32nd gestational week
• body mass index (BMI) before pregnancy \<25 kg/m2
• single pregnancy.

You may not qualify if:

• bleeding in the second or third trimester
• premature birth in the current pregnancy,
• rupture of the amniotic sac,
• preeclampsia or pregnancy-induced hypertension,
• intrauterine growth restriction (IUGR) in the current pregnancy,
• anemia
• not being regular in the physical exercise program
• at the pregnant woman's own request.

Sponsors & Collaborators

• University of Banja Luka: lead

Study Sites (1)

University of Banja Luka, Faculty of Medicine

Banja Luka, 78000, Bosnia and Herzegovina

Location

MeSH Terms

Conditions

Motor Activity; Gestational Weight Gain

Condition Hierarchy (Ancestors)

Behavior; Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vesna Ljubojevic, MD PhD

  Faculty of Medicine, University of Banja Luka

  STUDY CHAIR

• Vlatka Bojanic, MSN

  Faculty of Medicine, University of Banja Luka

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: August 12, 2021
• Study Start: December 1, 2020
• Primary Completion: January 4, 2023
• Study Completion: January 4, 2023
• Last Updated: January 6, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data will be available 3 months following publication and ending 36 months following article publication.
• Access Criteria: Proposals should be directed to vesna.ljubojevic@med.unibl.org.The proposal may be submitted up to 36 months following article publication.

Locations

BO (1)