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CompletedNCT05001906GineVeiwUpdated Jan 6, 2023

Pregnant Women With Physical Activity

An interventional study of Exercise group in Pregnancy, sponsored by University of Banja Luka. Completed at 1 site in Bosnia and Herzegovina. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-06.

Sponsored by University of Banja Luka · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Dec 2020, registered Jul 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study 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.

Read the detailed description

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 incidence of a sedentary lifestyle during pregnancy ranges from 64.5 to 91.5% and tends to increase in the third trimester. This has a negative impact on the quality of life and contributes to the obesity epidemic in pregnant women. Physical inactivity and excessive weight gain during pregnancy increase the risk of gestational diabetes and pregnancy-induced hypertension. In pregnancy, the circulatory system adapts to adequately supply the needs of the mother and fetus. Physical activity is considered a preventive measure for the diseases of the cardiovascular system in pregnancy.

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.

In the first phase of the study, an experimental and control group will be formed. The prenatal exercise program will be conducted with the experimental group for 8 weeks. The control group will not exercise, will have standard prenatal care, and attend classes of theoretical classes on childbirth. Respondents in both groups will fill out a questionnaire from which the data will be obtained: age, height, bodyweight before pregnancy. Data on the week of pregnancy will be obtained from the medical documentation.

The prenatal exercise program was made according to the recommendations of the American College of Obstetricians and Gynecologists (ACOG recommendations) and the guidelines of the Croatian Association of Physiotherapists for Women's Health.

The exercise program is presented with: 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 breathing and relaxation techniques.

Bodyweight will be measured at the beginning of the test, at the end of the exercise program, and at the end of the pregnancy.

Blood pressure data will be obtained by measuring blood pressure with a mercury manometer with a mercury column, in both groups: at the beginning of the study and the end of the study.

The shape of capillary loops and the number of capillary loops of the nail skin fold will be analyzed with nailfold capillaroscopy in both groups of subjects: at the beginning of the study and after 8 weeks.

In the second phase of the work, the collected data will be processed by methods of descriptive and parametric statistics.

The obtained results will be presented at the third phase of the work.

02

Conditions studied

  • Pregnancy

Keywords

  • Pregnancy
  • Physical exercise
  • Cardiovascular system
  • Gestational weight gain
03

In context

Lead sponsor

University of Banja Luka is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • No intervention
    Control group

    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.

  • Experimental
    Exercise group

    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

  • BehavioralExercise group

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 20-32 weeks of gestation

  2. 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).

    Time frame: 28-40 weeks of gestation

Secondary outcomes

  1. Gestational weigh gain

    Weight gain during pregnancy measured in kilograms would be determined.

    Time frame: 38 weeks pregnancy

  2. Shape of nailfold capillary loops

    The shape of capillary loops of the nail skin fold would be assessed with nailfold capillaroscopy at the beginning of prenatal exercises, between 20 and 32 weeks of gestation, and at the end of prenatal exercises, between 28 and 40 weeks of gestation.

    Time frame: 20-32 weeks and 28-40 weeks gestation

  3. Nailfold capillary density

    The density of capillary loops of the nail skin fold would be assessed as the number of capillary loops per 1 mm of the distal row of capillary in nailfold (capillary/mm). The measurements will be realized at the beginning of prenatal exercises, between 20 and 32 weeks of gestation, and at the end of prenatal exercises, between 28 and 40 weeks of gestation.

    Time frame: 20-32 weeks and 28-40 weeks gestation

07

Study locations

1 site
  • University of Banja Luka, Faculty of Medicine
    Banja Luka, 78000, Bosnia and Herzegovina
08

References and documents

Individual participant data

Plan to share: Yes — Data that will be shared are individual participant data that underlie the results reported in the article (text, tables, figures)

Supporting information: Study protocol, Icf, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05001906
Lead sponsor
University of Banja Luka
Responsible party
Sponsor
First posted
Aug 12, 2021
Start date
Dec 1, 2020
Primary completion
Jan 4, 2023
Completion
Jan 4, 2023
Last update
Jan 6, 2023

Study contacts

Vesna Ljubojevic, MD PhD
study chair · Faculty of Medicine, University of Banja Luka
Vlatka Bojanic, MSN
principal investigator · Faculty of Medicine, University of Banja Luka

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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