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Completed

NCT Number: NCT05001906

Pregnant Women With Physical Activity

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Banja Luka, Faculty of Medicine

Banja Luka, 78000, Bosnia and Herzegovina

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Systolic and diastolic blood pressure at time point 1

    Time frame: 20-32 weeks of gestation

    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.

  2. Systolic and diastolic blood pressure at time point 2

    Time frame: 28-40 weeks of gestation

    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).

Secondary outcomes

  1. Gestational weigh gain

    Time frame: 38 weeks pregnancy

    Weight gain during pregnancy measured in kilograms would be determined.

  2. Shape of nailfold capillary loops

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

    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.

  3. Nailfold capillary density

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

    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.

Sponsors and collaborators

Lead sponsor

University of Banja Luka

Other

Registry information

Official study title

Research on the Influence of Prenatal Exercise on Circulatory Function and Structure of Pregnant Women

Acronym: GineVeiw

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 12, 2021
Registry last updated
Jan 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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