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Clinical Trials/NCT05001906
NCT05001906CompletedNot Applicable

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

University of Banja Luka2 sites in 1 country70 target enrollmentStarted: December 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
70
Locations
2
Primary Endpoint
Systolic and diastolic blood pressure at time point 2

Study Overview

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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
20 Years to 40 Years (Adult)
Sex
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

  • 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,
  • not being regular in the physical exercise program
  • at the pregnant woman's own request.

Outcomes

Primary Outcomes

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).

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.

Secondary Outcomes

  • Nailfold capillary density(20-32 weeks and 28-40 weeks gestation)
  • Gestational weigh gain(38 weeks pregnancy)
  • Shape of nailfold capillary loops(20-32 weeks and 28-40 weeks gestation)

Investigators

Sponsor
University of Banja Luka
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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