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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05009433
Other study ID # 1/KS/KF/DS2021
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 24, 2021
Est. completion date August 31, 2031

Study information

Verified date October 2022
Source Gdansk University of Physical Education and Sport
Contact Anna N Szumilewicz, Assoc. Prof.
Phone 601880207
Email anna.szumilewicz@awf.gda.pl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Regular exercise during pregnancy and postpartum leads to health benefits for mother and child. Inactivity during pregnancy and after delivery is now treated as risky behavior. Physically active pregnant women significantly less often suffer from, among others, gestational diabetes, excessive weight gain, lipids disorders, hypertension, preeclampsia, depressive symptoms, functional and structural disorders, including stress urinary incontinence, back pain or diastasis recti abdominis (DRA). Prenatal physical activity reduces the risk of premature delivery and miscarriage, fetal macrosomia, complications in labor or the risk of metabolic disorders in children. High-intensity interval training (HIIT) has become one of the most popular trends in the fitness sector. The effectiveness of HIIT on a number of health indicators has been proven in various populations but limited data are available on HIIT during pregnancy. The first hypothesis is that the HIIT, implemented during pregnancy and after childbirth, as a stronger exercise stimulus, will have a better impact on selected biological and psychological parameters of mothers, as well as on selected health parameters of their children, compared to the MICT (moderate intensity continuous training). Therefore, it promises better preventive effects on pregnancy complications and ailments as well as non-communicable diseases occurring in these populations. In the second hypothesis, it was assumed that HIIT and MICT implemented during pregnancy and after childbirth, tailored to the specific needs of the perinatal period, will not differ in the effectiveness of maintaining normal functional parameters in women, including prevention of urinary incontinence, back pain, DRA, etc. Pregnant women who apply for the study will be divided into three groups: those attending the HIIT, MICT or educational programs. During the study, the participants will be under standard obstetric care. As comparative groups, non-pregnant women will be also recruited. The investigators will collect data on selected biological, functional and psychological parameters in the study women at each trimester of pregnancy, during the puerperium and one year after childbirth. The data from the medical documentation on the course of childbirth and the assessment of the new-born, as well as the results of preventive examinations in the study women's children aged one, two, four and six years will be also analyzed.


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Study Design


Intervention

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Locations

Country Name City State
Poland Laboratory of Physical Effort and Genetics in Sport at Gdansk University of Physical Education and Sport Gdansk Pomorskie

Sponsors (4)

Lead Sponsor Collaborator
Gdansk University of Physical Education and Sport Medical University of Gdansk, Pomeranian Medical University Szczecin, University of Gdansk

Country where clinical trial is conducted

Poland, 

References & Publications (25)

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Outcome

Type Measure Description Time frame Safety issue
Other The level of physical activity based on the International Physical Activity Questionnaire The investigators will use the International Physical Activity Questionnaire to calculate IPAQ score (minimum score: 0; maximum score: not specified; higher scores mean better outcome) to determine the participants' levels of physical activity prior to enrollment in the study and during the study. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Other Ten Item Personality Inventory score The investigators will use the Ten Item Personality Inventory (Gosling et al., 2003; TIPI scores; minimum score: 2; maximum score: 14; the higher the score, the greater the intensity of the personality traits) to analyze the psychosocial determinants of participation in physical activity during the perinatal period. Before starting the intervention.
Other Life Orientation Test - Revised score The investigators will use the optimism versus pessimism scale based on the Life Orientation Test - Revised (Scheier et al., 1994; LOT-R score; minimum score: 6; maximum score: 24; the higher the score, the higher level of optimism) to analyze the psychosocial determinants of participation in physical activity during the perinatal period. Before starting the intervention.
Other The Fat mass and obesity-associated (FTO) gene polymorphism The Fat mass and obesity-associated (FTO) gene polymorphism will be analyzed as a determinant of the incidence of metabolic disorders during pregnancy and postpartum, in relation to different patterns of physical activity and other selected parameters. Before starting the intervention.
Other The Mu-Opioid Receptor Genetic Polymorphism (OPRM1) The Mu-Opioid Receptor Genetic Polymorphism (OPRM1) will be analyzed as a determinant of pain perception during pregnancy, labor and postpartum, in relation to different patterns of physical activity and other selected parameters. Before starting the intervention.
Other The serotonin transporter (5-HTTLPR) polymorphism The serotonin transporter (5-HTTLPR) polymorphism will be analyzed as a determinant of depressive symptoms and anxiety during pregnancy and postpartum, in relation to different patterns of physical activity and other selected parameters. Before starting the intervention.
Primary Changes in maternal oxygen consumption, during and after pregnancy Changes from the baseline maternal oxygen consumption (VO2; ml/min), including the maximal oxygen consumption (VO2max) values in a progressive maximal exercise test on a cycloergometer with electronically regulated load, using stationary respiratory gas analyzer. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Primary Changes in maternal heart rate, during and after pregnancy Changes from the baseline heart rate (HR; beats per minute), including the maximal HR values, in a progressive maximal exercise test on a cycloergometer with electronically regulated load, using heart rate monitor. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Primary Changes in systolic blood pressure, during and after pregnancy Changes from the baseline maternal systolic blood pressure (SBP; mm Hg), in a progressive maximal exercise test on a cycloergometer with electronically regulated load, using electronic blood pressure monitor. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Primary Changes in diastolic blood pressure, during and after pregnancy Changes from the baseline maternal diastolic blood pressure (DBP; mm Hg), in a progressive maximal exercise test on a cycloergometer with electronically regulated load, using electronic blood pressure monitor. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Primary Changes in blood glucose level, during and after pregnancy To assess the changes in glucose levels (mg/dl) the blood samples will be taken on the day of the maximal exercise capacity test before the test (at fasting condition), immediately (approx. 1 min) after completion the test and approx. 40 min. after the test. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially related to metabolism and changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Primary Changes in triglycerides, during and after pregnancy Changes in triglycerides (TG; mg/dl) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially related to metabolism and changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Primary Changes in high-density lipoproteins, during and after pregnancy Changes in high-density lipoproteins (HDL; mg/dl) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially related to metabolism and changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Primary Changes in urea, during and after pregnancy To assess the changes in urea levels (ml/dl), the study participants will collect urine samples to standard urine containers on the day of the maximal exercise capacity test before the test (at fasting condition), immediately after completion the test (up to 15 min) and approx. 60 min after the test. The investigators will analyze changes in this parameter in terms of intervention mode and its relationship with other selected parameters, potentially related to renal function and changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Primary Changes in creatinine, during and after pregnancy To assess the changes in creatinine levels (ml/dl), the study participants will collect urine samples to standard urine containers on the day of the maximal exercise capacity test before the test (at fasting condition), immediately after completion the test (up to 15 min) and approx. 60 min after the test. The investigators will analyze the changes in this parameter in terms of intervention mode and its relationship with other selected parameters, potentially related to renal function and changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Primary Changes in maternal weight, during and after pregnancy Changes in maternal weight will be expressed in kilograms (kg). The investigators will analyze the changes in this parameter in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Primary Changes in maternal Body Mass Index during and after pregnancy Changes in Body Mass Index (BMI, kg/m2) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Primary Changes in maternal neuromuscular activity of pelvic floor muscles, during and after pregnancy The neuromuscular activity of pelvic floor muscles (µV) will be evaluated with surface electromyography with a vaginal probe, in the condition of synergistic muscle relaxation. The investigators will analyze the changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially related to pelvic floor function and changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Primary Changes in the Incontinence Impact Questionnaire score, during and after pregnancy The urinary incontinence symptoms will be assessed using the scale of incontinence impact on the quality of life based on the Incontinence Impact Questionnaire - short form (Uebersax et al., 1995; IIQ-7 score; minimum score: 0; maximum score: 100; higher scores mean worse outcome). The investigators will analyze the changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially related to pelvic floor function and changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Primary Changes in the Urogenital Distress Inventory score, during and after pregnancy The pelvic floor disorders will be assessed using the scale based on the Urogenital Distress Inventory - short form questionnaire (Uebersax et al., 1995; UDI - 6 score; minimum score: 0; maximum score: 100; higher scores mean worse outcome). The investigators will analyze the changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially related to pelvic floor function and changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Primary Changes in the inter-rectus distance, during and after pregnancy The changes in the inter-rectus distance (IRD, mm) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Primary Changes in the center of pressure excursions (static balance), during and after pregnancy The changes in the excursions of the center of pressure (COP; mm) will be measured in standing position using a specialized force platform. The changes in the static balance will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Primary Changes in lumbar spine mobility, during and after pregnancy The changes in the lumbar spine mobility (°) will be measured in standing position using specialized motion detectors and software. The changes lumbar spine mobility will be analyzed in terms of intervention mode and in relation to other selected parameters, potentially changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Primary Changes in cervical spine mobility, during and after pregnancy The changes in the cervical spine mobility (°) will be measured in sitting position using specialized motion detectors and software. The changes lumbar spine mobility will be analyzed in terms of intervention mode and in relation to other selected parameters, potentially changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Primary Changes in foot loading, during and after pregnancy The changes in foot loading (kPa) will be measured in standing position using plantar pressure measurements platform and software. This outcome will be analyzed in terms of intervention mode and in relation to other selected parameters, potentially changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Primary Changes in spatiotemporal gait parameters: step length, during and after pregnancy The changes in the step length (m) will be measured in walking using plantar pressure measurements platform and software. This outcome will be analyzed in terms of intervention mode and in relation to other selected parameters, potentially changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Primary Changes in spatiotemporal gait parameters: step width, during and after pregnancy The changes in the step width (m) will be measured in walking using plantar pressure measurements platform and software. This outcome will be analyzed in terms of intervention mode and in relation to other selected parameters, potentially changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Primary Changes in the hand grip strength, during and after pregnancy The hand muscle strength (kg) will be assessed using the electronic hand grip dynamometer. The participant will perform the test separately for the right and left hands. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Primary Changes in the pressure pain tolerance in the hand area, during and after pregnancy The pressure pain tolerance (PTOL) will be assessed using a computerized pressure algometer in the hand area. The PTOL will be expressed in the value of applied pressure (kPa). The pain test will be performed before and immediately (up to 15 minutes) after the maximal exercise test on a cycloergometer.
The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Primary Changes in the pressure pain tolerance in the forearm area, during and after pregnancy The pressure pain tolerance (PTOL) will be assessed using a computerized pressure algometer in the forearm area. The PTOL will be expressed in the value of applied pressure (kPa). The pain test will be performed before and immediately (up to 15 minutes) after the maximal exercise test on a cycloergometer. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Primary Changes in number of errors in the Stroop Interference test (version S8: congruent/incongruent), during and after pregnancy The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Primary Changes in reaction time based on the Stroop Interference test (version S8: congruent/incongruent), during and after pregnancy The time spent to complete each task, as well as the total time (s) to complete the Stroop Interference test will be assessed. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Primary Changes in the Beck Depression Inventory - II score, during and after pregnancy The occurrence and severity of depression symptoms using the scale of the Beck Depression Inventory - II (Beck et al., BDI -II score; minimum score: 0; maximum score: 63; higher scores mean worse outcome).The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Primary Changes in the Fear of Childbirth questionnaire scores, during and after pregnancy The fear of childbirth will be assessed using a scale based on the Fear of Childbirth scale questionnaire (Areskog et al., 1992; minimum score: 0; maximum score: 63; higher scores mean worse outcome). The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Primary Changes in cortisol level in hair, during and after pregnancy The cortisol level (pg/mg) will be determined from a hair sample as a marker of permanent stress. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Primary Complications of pregnancy: gestational diabetes mellitus The incidence of gestational diabetes mellitus (GDM; % of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. The data will be collected from the pregnant women groups before starting the intervention and after the completion of each training or educational cycle (each training or education cycle lasts 8 weeks) until childbirth.
Primary Complications of pregnancy: gestational hypertension The incidence of gestational hypertension (GH; % of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. The data will be collected from the pregnant women groups before starting the intervention and after the completion of each training or educational cycle (each training or education cycle lasts 8 weeks) until childbirth.
Primary Complications of pregnancy: preeclampsia The incidence of preeclampsia (PE; % of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. The data will be collected from the pregnant women groups before starting the intervention and after the completion of each training or educational cycle (each training or education cycle lasts 8 weeks) until childbirth.
Primary Complications of fetal development: fetal growth restriction The incidence of fetal growth restriction (FGR; % of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. The data will be collected from the pregnant women groups before starting the intervention and after the completion of each training or educational cycle (each training or education cycle lasts 8 weeks) until childbirth.
Primary Complications of fetal development: fetal macrosomia The incidence of fetal macrosomia (FM; % of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. The data will be collected from the pregnant women groups before starting the intervention and after the completion of each training or educational cycle (each training or education cycle lasts 8 weeks) until childbirth.
Primary Childbirth parameters: type of delivery The type of delivery (vaginal delivery, cesarean section, instrumental delivery; % of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. The data will be collected from the pregnant women groups in the first two months after their childbirth.
Primary Childbirth parameters: new-born's birth weight The new-born's birth weight (g) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. The data will be collected from the pregnant women groups in the first two months after their childbirth.
Primary Childbirth parameters: new-born's length The new-born's length (cm) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. The data will be collected from the pregnant women groups in the first two months after their childbirth.
Primary Childbirth parameters: APGAR score The APGAR score (the newborn's appearance, pulse, grimace, activity, and respiration score; minimum score: 0; maximum score: 10; higher scores mean better outcome) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. The data will be collected from the pregnant women groups in the first two months after their childbirth.
Primary Childhood outcomes: changes in body weight The changes in children's body weight (kg) will be analyzed in terms of pre- and postnatal physical activity patterns of their mothers and in relation to other selected parameters. The data will be collected from the offsprings at one, two, four and six years of age.
Primary Childhood outcomes: changes in body height The changes in children's body height (cm) will be analyzed in terms of pre- and postnatal physical activity patterns of their mothers and in relation to other selected parameters. The data will be collected from the offsprings at one, two, four and six years of age.
Primary Childhood outcomes: changes in Body Mass Index The changes in children's Body Mass Index (BMI; kg/m2) will be analyzed in terms of pre- and postnatal physical activity patterns of their mothers and in relation to other selected parameters. The data will be collected from the offsprings at one, two, four and six years of age.
Primary Childhood outcomes: changes in systolic blood pressure The changes in systolic blood pressure (SBP; mm Hg) in children will be analyzed in terms of pre- and postnatal physical activity patterns of their mothers and in relation to other selected parameters. The data will be collected from the offsprings at one, two, four and six years of age.
Primary Childhood outcomes: changes in diastolic blood pressure The changes in diastolic blood pressure (DBP; mm Hg) in children will be analyzed in terms of pre- and postnatal physical activity patterns of their mothers and in relation to other selected parameters. The data will be collected from the offsprings at one, two, four and six years of age.
Secondary Changes in maternal carbon dioxide production, during and after pregnancy Changes from the baseline carbon dioxide production (VCO2; ml/min) in a progressive maximal exercise test on a cycloergometer with electronically regulated load, using stationary respiratory gas analyzer. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Changes in maternal minute ventilation, during and after pregnancy Changes from the baseline maternal minute ventilation (VE; l/min), including the maximal minute ventilation (VEmax) values in a progressive maximal exercise test on a cycloergometer with electronically regulated load, using stationary respiratory gas analyzer. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Changes in maternal respiratory rate, during and after pregnancy Changes from the baseline maternal respiratory rate (RR; breaths per min) in a progressive maximal exercise test on a cycloergometer with electronically regulated load, using stationary respiratory gas analyzer. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Changes in maternal exercise capacity, expressed in administered load, during and after pregnancy Changes in administered load (W) in a progressive maximal exercise test on a cycloergometer with electronically regulated load. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Changes in total cholesterol, during and after pregnancy Changes in total cholesterol (TC; mg/dl) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially related to metabolism and changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Changes in low-density lipoproteins, during and after pregnancy Changes in low-density lipoproteins (LDL; mg/dl) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially related to metabolism and changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Changes in insulin concentration, during and after pregnancy To assess the changes in insulin concentration (ng/ml), the samples will be taken on the day of the maximal exercise capacity test before the test (at fasting condition), immediately (approx. 1 min) after completion the test and approx. 40 min. after the test. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially related to metabolism and changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Changes in irisin concentration, during and after pregnancy To assess the changes in irisin concentration (ng/ml); the samples will be taken on the day of the maximal exercise capacity test before the test (at fasting condition), immediately (approx. 1 min) after completion the test and approx. 40 min. after the test. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially related to metabolism and changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Changes in leptin concentration, during and after pregnancy To assess the changes in leptin concentration (ng/ml); the samples will be taken on the day of the maximal exercise capacity test before the test (at fasting condition), immediately (approx. 1 min) after completion the test and approx. 40 min. after the test. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameter, potentially related to metabolism and changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Changes in adiponectin concentration, during and after pregnancy To assess the changes in adiponectin concentration (ng/ml); the samples will be taken on the day of the maximal exercise capacity test before the test (at fasting condition), immediately (approx. 1 min) after completion the test and approx. 40 min. after the test. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameter, potentially related to metabolism and changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Changes in albumin, during and after pregnancy To assess the changes in albumin levels (mg/l), the study participants will collect urine samples to standard urine containers on the day of the maximal exercise capacity test before the test (at fasting condition), immediately after completion the test (up to 15 min) and approx. 60 min after the test. The serum albumin levels will be also determined. The investigators will analyze changes in this parameter in terms of intervention mode and its relationship with other selected parameters, potentially related to renal function and changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Changes in sodium, during and after pregnancy To assess the changes in sodium levels (mmol/l), the study participants will collect urine samples to standard urine containers on the day of the maximal exercise capacity test before the test (at fasting condition), immediately after completion the test (up to 15 min) and approx. 60 min after the test. The serum sodium levels will be also determined. The investigators will analyze changes in this parameter in terms of intervention mode and its relationship with other selected parameters, potentially related to renal function and changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Changes in potassium, during and after pregnancy To assess the changes in potassium levels (mmol/l), the study participants will collect urine samples to standard urine containers on the day of the maximal exercise capacity test before the test (at fasting condition), immediately after completion the test (up to 15 min) and approx. 60 min after the test. The serum sodium levels will be also determined. The investigators will analyze changes in this parameter in terms of intervention mode and its relationship with other selected parameters, potentially related to renal function and changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Changes in maternal amount of body fat, during and after pregnancy Changes in maternal amount of body fat (%) will be assessed using the electrical bioimpedance method. The investigators will analyze changes in this parameter in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Changes in maternal lean body mass, during and after pregnancy Changes in maternal lean body mass (%) will be assessed using the electrical bioimpedance method. The investigators will analyze changes in this parameter in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Changes in maternal skeletal muscle mass, during and after pregnancy Changes in maternal skeletal muscle mass (%) will be assessed using the electrical bioimpedance method. The investigators will analyze changes in this parameters in terms of intervention mode and its relationship with other selected parameter, potentially changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Changes in maternal body water, during and after pregnancy Changes in maternal skeletal body water (%) will be assessed using the electrical bioimpedance method. The investigators will analyze changes in this parameter in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Changes in the technique of voluntary pelvic floor muscle contraction, during and after pregnancy The technique of voluntary pelvic floor muscle contraction (Szumilewicz et al. 2019; technique scores using 1-4 scale; minimum score: 1; maximum score: 4; higher scores mean better outcome) will be evaluated using surface electromyography with a vaginal probe. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially related to pelvic floor function and changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Changes in maternal neuromuscular activity of pelvic floor muscles in contractions combining pelvic floor and synergistic muscles, during and after pregnancy The neuromuscular activity of pelvic floor muscles (µV) will be evaluated with surface electromyography with a vaginal probe, in the condition of synergistic muscle activation.The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially related to pelvic floor function and changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Changes in the Oswestry Disability Index, during and after pregnancy The investigators will assess the occurrence and severity of back pain and its impact of the everyday life using the scale of the Oswestry Disability Index (Fairbank and Pynsent, 2000; ODI score; minimum score: 0; maximum score: 50; higher scores mean worse outcome). This outcome will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Changes in spatiotemporal gait parameters: gait speed, during and after pregnancy The changes in the gait speed (m/s) will be measured in walking using plantar pressure measurements platform and software. This outcome will be analyzed in terms of intervention mode and in relation to other selected parameters, potentially changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Changes in spatiotemporal gait parameters: stride duration, during and after pregnancy The changes in the stride duration (s) will be measured in walking using plantar pressure measurements platform and software. This outcome will be analyzed in terms of intervention mode and in relation to other selected parameters, potentially changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Changes in spatiotemporal gait parameters: stance duration, during and after pregnancy The changes in the stance duration (s) will be measured in walking using plantar pressure measurements platform and software. This outcome will be analyzed in terms of intervention mode and in relation to other selected parameters, potentially changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Changes in the SF-12 Physical Score, during and after pregnancy The investigators will use the scale of Physical and Mental Health Status based on the Short Form-12 (SF-12) questionnaire (Gandek et al., 1998; PCS-12; minimum score: 24; maximum score: 57; higher scores mean better outcome). The Physical Score will be analyzed in relation to various intervention modes during the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Changes in the SF-12 Mental Score, during and after pregnancy The investigators will use the scale of Physical and Mental Health Status based on the Short Form-12 (SF-12) questionnaire (Gandek et al., 1998; MCS-12; minimum score: 19; maximum score: 61; higher scores mean better outcome). The Mental Score will be analyzed in relation to various intervention modes during the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Changes in the Flourishing Scale score, during and after pregnancy The investigators will use The Flourishing Scale (Diener et al., 2009; SF score; minimum score: 8; maximum score: 56; higher scores mean better outcome) to analyze the psychosocial aspects of participation in physical activity during the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Changes in the Fear of COVID-19 Scale score during and after pregnancy The investigators will use The Fear of COVID-19 Scale (Ahorsu et al., 2020; FCV-19S score; minimum score: 7; maximum score: 35; higher scores mean worse outcome)) will be assessed. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Changes in the pressure pain threshold in the hand area, during and after pregnancy The pressure pain tolerance (PPT) will be assessed using a computerized pressure algometer in the hand area. The PPT will be expressed in the value of applied pressure (kPa). The pain test will be performed before and immediately (up to 15 minutes) after the maximal exercise test on a cycloergometer. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Changes in the pressure pain threshold in the forearm area, during and after pregnancy The pressure pain tolerance (PPT) will be assessed using a computerized pressure algometer in the forearm area. The PPT will be expressed in the value of applied pressure (kPa). The pain test will be performed before and immediately (up to 15 minutes) after the maximal exercise test on a cycloergometer.
The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.
Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Changes in serum cortisol level, during and after pregnancy The investigators will analyze the changes in serum cortisol level (ng/ml) induced by the maximal exercise test and the intervention mode, and its relationship with other selected parameters, potentially related to depression, anxiety and stress levels and changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Changes in serum oxytocin level, during and after pregnancy The investigators will analyze the changes in serum oxytocin level (ng/ml) induced by the maximal exercise test and the intervention mode, and its relationship with other selected parameters, potentially related to depression, anxiety and stress levels and changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Changes in serum dopamine level, during and after pregnancy The investigators will analyze the changes in serum dopamine level (ng/ml) induced by the maximal exercise test and the intervention mode, and its relationship with other selected parameters, potentially related to depression, anxiety and stress levels and changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Changes in serum adrenaline level, during and after pregnancy The investigators will analyze the changes in serum adrenaline level (ng/ml) induced by the maximal exercise test and the intervention mode, and its relationship with other selected parameters, potentially related to depression, anxiety and stress levels and changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Changes in serum serotonin level, during and after pregnancy The investigators will analyze the changes in serum serotonin level (ng/ml) induced by the maximal exercise test and the intervention mode, and its relationship with other selected parameters, potentially related to depression, anxiety and stress levels and changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
Secondary Childbirth parameters: gestational age at birth The gestational age at birth (weeks) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. The data will be collected from the pregnant women groups in the first two months after their childbirth.
Secondary Childbirth parameters: length of labor The length of labor (hours and minutes) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. The data will be collected from the pregnant women groups in the first two months after their childbirth.
Secondary Childbirth parameters: induction of labor The rate of induction of labor (% of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. The data will be collected from the pregnant women groups in the first two months after their childbirth.
Secondary Childbirth parameters: episiotomy The rate of episiotomy (% of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. The data will be collected from the pregnant women groups in the first two months after their childbirth.
Secondary Childbirth parameters: perineal lacerations The incidence of perineal lacerations (% of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. The data will be collected from the pregnant women groups in the first two months after their childbirth.
Secondary Childbirth parameters: the use of anesthetics The rate of anesthetics use (% of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. The data will be collected from the pregnant women groups in the first two months after their childbirth.
Secondary Childbirth parameters: labor complications The incidence of labor complications (% of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. The data will be collected from the pregnant women groups in the first two months after their childbirth.
Secondary Childbirth parameters: neonatal intensive care unit The incidence of neonatal intensive care unit (NICU; % of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. The data will be collected from the pregnant women groups in the first two months after their childbirth.
Secondary Childhood outcomes: changes in percentage of body fat The changes in amount of body fat in children (%) will be analyzed in terms of pre- and postnatal physical activity patterns of their mothers and in relation to other selected parameters. The data will be collected from the offsprings at one, two, four and six years of age.
Secondary Covid-19 disease The incidence of Covid-19 disease (% of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).
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