Pregnant Women With Physical Activity

NCT ID: NCT05001906

Last Updated: 2023-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2023-01-04

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.

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.

Conditions

Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Exercise group

Intervention Type: 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.

Interventions

Exercise 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Banja Luka

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vesna Ljubojevic, MD PhD

Role: STUDY_CHAIR

Faculty of Medicine, University of Banja Luka

Vlatka Bojanic, MSN

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, University of Banja Luka

Locations

University of Banja Luka, Faculty of Medicine

Banja Luka, , Bosnia and Herzegovina

Countries

Bosnia and Herzegovina

Other Identifiers

EO2619

Identifier Type: -

Identifier Source: org_study_id