PregnancyHIIT MAMANCT05009433

HIIT vs MICT During Pregnancy and Health and Birth Outcomes in Mothers and Children

A study testing High intensity interval training program for pregnant women, Moderate intensity continuous training program for pregnant women and Standard obstetric care with extended education on healthy lifestyle in people with Pregnancy and Postpartum, run by Gdansk University of Physical Education and Sport at 1 site in Poland.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Pregnancy, Postpartum, Childbirth
What is being tested?: High intensity interval training program for pregnant women, Moderate intensity continuous training program for pregnant women and Standard obstetric care with extended education on healthy lifestyle
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 600 participants
Where: 1 sitePoland
Study dates: 24 Jun 2021to 31 Aug 2031
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Criteria: Inclusion Criteria:
For pregnant women:
course of pregnancy allowing participation in physical activities adapted to pregnant women
consent of the obstetric care provider to participate in the study tests and exercise classes;
taking part in all diagnostic and control tests to assess selected biological, functional and psychological parameters at each trimester of pregnancy, during the puerperium and one year after childbirth;
participant's consent to use 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 children aged one, two, four and six, routinely performed according to the Polish pediatric care system;

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availability to participate in classes three times a week until the day of delivery;
declaration of participation in postpartum classes at least once a week and self-completion of the exercise program according to written instructions prepared by the exercise specialist;
women can participate in the exercise programs regardless of their level of fitness or exercise capacity, as well as the level of motor skills (based on the diagnostic exercise tests, the exercise program will be tailored to the individual needs and capabilities of a woman).
For nonpregnant women:
nulliparous;
lack of diagnosed infertility and other disorders of the reproductive system;
taking part in all diagnostic and control tests to assess selected biological, functional and psychological parameters at indicated time points: before and after each of the 8-week exercise program during the first 8 months of the study and once every 3 months during the following twelve months of the study
declaration of availability to participate in exercise classes three times a week for the first 8 months of the program (attendance at least 80% is required);
declaration of participation in classes at least once a week and self-completion of the exercise program to the required 150 minutes of physical activity per week, according to the written guidelines prepared by the instructor, for the next 12 months of the program;
women can participate in the exercise program regardless of their level of fitness or exercise capacity, as well as the level of motor skills (based on the diagnostic exercise tests, the exercise program will be tailored to the individual needs and capabilities of a woman).

Who cannot join

contraindications to increased physical effort or to any of the diagnostic or control tests;
allergies to materials used during diagnostic and control tests (e.g. nickel present in steel plates of vaginal electrodes, disinfectants);
other conditions that, according to the researchers, will threaten the health or safety of the participants or will significantly affect the quality of the collected data.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Anna N Szumilewicz, Assoc. Prof. contact

601880207 ext. +48

anna.szumilewicz@awf.gda.pl

Żaneta Wojdakowska contact

58 55 47 101 ext. +48

nauka@awf.gda.pl

Poland1 site, 1 recruiting

Laboratory of Physical Effort and Genetics in Sport at Gdansk University of Physical Education and Sport
Gdansk, Pomeranian Voivodeship, 80-336
Anna N Szumilewicz, Assoc. Prof., 601880207 ext. +48, anna.szumilewicz@awf.gda.pl
Robert Urbański, PhD, 58 554 74 15 ext. +48, lab.sport@awf.gda.pl
Recruiting

Other trials in Poland

About this study

Official title: The Effect of Pre- and Postnatal High Intensity Interval Training and Moderate Intensity Continuous Training on Biological, Functional and Psychological Markers of Pregnancy Disorders and Non-communicable Diseases in Mothers and Offsprings

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.

Conditions: Pregnancy, Postpartum, Childbirth, Health Status, Physical Fitness, Noncommunicable Diseases
Being tested: High intensity interval training program for pregnant women, Moderate intensity continuous training program for pregnant women, Standard obstetric care with extended education on healthy lifestyle, High intensity interval training program for nonpregnant women, Moderate intensity continuous training program for nonpregnant women
Keywords: Pregnant women, Prenatal care, Postpartum women, Postnatal care, Exercise, Physical activity, Exercise intervention, Educational intervention, Exercise test, High-intensity interval training, Moderate-intensity continuous training, Health Status, Physical fitness, Childbirth, Birth outcomes, Infant, Child
Medical subject headings: Noncommunicable Diseases, Diabetes, Gestational, Hypertension, Pregnancy-Induced, Back Pain, Pelvic Floor Disorders, Urinary Incontinence, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

High intensity interval training program for pregnant womenBehavioural
Also called HIIT during pregnancy
Pregnant women will participate in 8-week HIIT cycles until the day of delivery, 3 times a week, in a volume of each session of 60 minutes. The main part (15-20 min) will be conducted in a form of high intensity intervals, approx. 85-90% of maximum exercise capacity. The intervals will consist of performing exercises for 30-60 seconds, alternating with a 30-60 second rest break, in the ratio of exercise time to rest 1:2, 1:1 or 2:1, according to the individual possibilities of the participant and taking into account the training progression and stage of pregnancy. The exercise intensity will be monitored with the use of heart rate monitors, the Borg Rating of Perceived Exertion (RPE) and the Talk Test.
After birth, women will participate in 3-month HIIT cycles from the moment of achieving postpartum readiness to training until one year postpartum. Classes will be carried out stationary or online, depending on the pandemic situation and the availability of the woman.
Moderate intensity continuous training program for pregnant womenBehavioural
Also called MICT during pregnancy
Pregnant women will participate in 8-week MICT cycles until the day of delivery, 3 times a week, in a volume of each session of 60 minutes. The main part (20-25 min) will be conducted in a form of moderate intensity continuous exercise, of 70-80% of the maximum exercise capacity, e.g. in the form of high- and low-impact aerobics choreography with music. The sessions will also include resistance, neuromotor, body posture and flexibility exercises (25 min), breathing exercises, relaxation and visualization of pregnancy or childbirth (10 min). The exercise intensity will be monitored with the use of heart rate monitors, the Borg Rating of Perceived Exertion (RPE) and the Talk Test.
After birth, women will participate in 3-month MICT cycles from the moment of achieving postpartum readiness to training until one year postpartum. Classes will be carried out stationary or online, depending on the pandemic situation and the availability of the woman.
Standard obstetric care with extended education on healthy lifestyleBehavioural
Pregnant women will get standard obstetric care according to the national law. They will attend educational sessions on a healthy lifestyle, physical activity in the perinatal period and selected aspects of pregnancy and motherhood. Educational classes will be conducted online in real time, at least once every two weeks, until one year postpartum.
High intensity interval training program for nonpregnant womenBehavioural
Also called Lifetime HIIT
Nonpregnant women will participate in 8-week HIIT cycles for a period of 8 months, 3 times a week, in a volume of each session of 60 minutes. The main part (15-20 min) will be conducted in a form of high intensity intervals, approx. 85-90% of maximum exercise capacity. The intervals will consist of performing exercises for 30-60 seconds, alternating with a 30-60 second rest break, in the ratio of exercise time to rest 1:2, 1:1 or 2:1, according to the individual possibilities of the participant and taking into account the training progression. The exercise intensity will be monitored with the use of heart rate monitors, the Borg Rating of Perceived Exertion (RPE) and the Talk Test.
For the next 12 months of the project, women will participate in 3-month HIIT cycles. Classes will be carried out stationary or online, depending on the pandemic situation and the availability of the woman.
Moderate intensity continuous training program for nonpregnant womenBehavioural
Also called Lifetime MICT
Nonpregnant women will participate in 8-week MICT cycles for a period of 8 months, 3 times a week, in a volume of each session of 60 minutes. The main part (20-25 min) will be conducted in a form of moderate continuous intensity exercise, of 70-80% of the maximum exercise capacity, e.g. in the form of high- and low-impact aerobics choreography with music. The sessions will also include resistance, neuromotor, body posture and flexibility exercises (25 min), breathing exercises and relaxation (10 min). The exercise intensity will be monitored with the use of heart rate monitors, the Borg Rating of Perceived Exertion (RPE) and the Talk Test.
For the next 12 months of the project, women will participate in 3-month MICT cycles. Classes will be carried out stationary or online, depending on the pandemic situation and the availability of the woman.
Standard health care with extended education on healthy lifestyleBehavioural
Nonpregnant women will get standard health care according to the national law. They will attend educational sessions on a healthy lifestyle, physical activity and selected aspects of preparation to pregnancy and motherhood. Classes will be conducted online in real time, at least once every two weeks, for a period of 20 months.

Study groups in NCT05009433
Study group	Role	What they receive
Pregnant HIIT group	Experimental	The high intensity interval training (HIIT) program will be implemented according to the World Health Organization guidelines on physical activity and sedentary behavior (2020) and on the recommendations on physical activity and exercise during pregnancy and postpartum period published by the American College of Obstetricians and Gynecologists (2020). The program will be also based on the "High-Intensity Interval Training for Cardiometabolic Disease Prevention" report by American College of Sports Medicine (2019). During the study, the participant will be under standard obstetric care on her own. She is obliged to inform her obstetric care provider about participation in the HIIT program and to provide feedback to the project coordinator as to possible recommendations of the obstetric care provider regarding the exercise. Receives: Behavioral: High intensity interval training program for pregnant women
Pregnant MICT group	Active comparator	The moderate intensity continuous training (MICT) program will be implemented based on the World Health Organization guidelines on physical activity and sedentary behavior (2020) and on the recommendations on physical activity and exercise during pregnancy and postpartum period published by the American College of Obstetricians and Gynecologists (2020). During the study, the participant will be under standard obstetric care on her own. She is obliged to inform her obstetric care provider about participation in the MICT program and to provide feedback to the project coordinator as to possible recommendations of the obstetric care provider regarding the exercise. Receives: Behavioral: Moderate intensity continuous training program for pregnant women
Pregnant standard care group	Sham comparator	During the study, the participant will be under standard obstetric care on her own. She is obliged to inform her obstetric care provider about participation in the HIIT Mama study and to provide feedback to the project coordinator as to possible contraindications to taking part in the study tests. Receives: Behavioral: Standard obstetric care with extended education on healthy lifestyle
Nonpregnant HIIT group	Experimental	The high intensity interval training (HIIT) program will be implemented according to the World Health Organization guidelines on physical activity and sedentary behavior (2020) and on the "High-Intensity Interval Training for Cardiometabolic Disease Prevention" report by American College of Sports Medicine (2019). During the study, the participant will be under standard health care on her own. She is obliged to inform her health care provider about participation in the HIIT Mama study and to provide feedback to the project coordinator as to possible contraindications to exercise or taking part in the study tests. Receives: Behavioral: High intensity interval training program for nonpregnant women
Nonpregnant MICT group	Active comparator	The moderate intensity continuous training program will be implemented according to the World Health Organization guidelines on physical activity and sedentary behavior (2020). During the study, the participant will be under standard health care on her own. She is obliged to inform her health care provider about participation in the HIIT Mama study and to provide feedback to the project coordinator as to possible contraindications to exercise or taking part in the study tests. Receives: Behavioral: Moderate intensity continuous training program for nonpregnant women
Nonpregnant standard care group	Sham comparator	During the study, the participant will be under standard health care on her own. She is obliged to inform her health care provider about participation in the HIIT Mama study and to provide feedback to the project coordinator as to possible contraindications to exercise or taking part in the study tests. Receives: Behavioral: Standard health care with extended education on healthy lifestyle

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: The data will be collected from the pregnant women groups in the first two months after their childbirth.
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.
Measured: The data will be collected from the pregnant women groups in the first two months after their childbirth.
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.
Measured: The data will be collected from the pregnant women groups in the first two months after their childbirth.
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.
Measured: The data will be collected from the pregnant women groups in the first two months after their childbirth.
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.
Measured: The data will be collected from the offsprings at one, two, four and six years of age.
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.
Measured: The data will be collected from the offsprings at one, two, four and six years of age.
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.
Measured: The data will be collected from the offsprings at one, two, four and six years of age.
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.
Measured: The data will be collected from the offsprings at one, two, four and six years of age.
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.
Measured: The data will be collected from the offsprings at one, two, four and six years of age.

Secondary outcomes (44)

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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: The data will be collected from the pregnant women groups in the first two months after their childbirth.
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.
Measured: The data will be collected from the pregnant women groups in the first two months after their childbirth.
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.
Measured: The data will be collected from the pregnant women groups in the first two months after their childbirth.
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.
Measured: The data will be collected from the pregnant women groups in the first two months after their childbirth.
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.
Measured: The data will be collected from the pregnant women groups in the first two months after their childbirth.
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.
Measured: The data will be collected from the pregnant women groups in the first two months after their childbirth.
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.
Measured: The data will be collected from the pregnant women groups in the first two months after their childbirth.
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.
Measured: The data will be collected from the pregnant women groups in the first two months after their childbirth.
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.
Measured: The data will be collected from the offsprings at one, two, four and six years of age.
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.
Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jun 202131 Aug 2031

First posted17 Aug 2021
Study start24 Jun 2021
Primary completion31 Mar 2031 (estimated)
Study completion31 Aug 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (29)Papers the sponsor has linked to this study.
Other trials for PregnancyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Model description: The study model is parallel in the two subgroups. The first subgroup consists of pregnant women who will be assigned to one of the three interventions: high intensity interval training program, moderate intensity continuous program or educational program on healthy lifestyle. The second subgroup will be age-matched nonpregnant women and they will be also assigned to the above three interventions. The pregnant women will be evaluated both in comparison to other pregnant women intervention groups and to the appropriate control non-pregnant groups.
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 600 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05009433
Sponsor's protocol ID: 1/KS/KF/DS2021
Acronym: HIIT MAMA
Status last verified: Oct 2022
First submitted: 12 Jul 2021
Last updated: 2 Dec 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All IPD that underlie results reported in publications will be available to other researchers. All procedures will be conducted in accordance with the Regulation (2016/679) of the European Parliament and of the Council of 27 April 2016 on the protection of individuals with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46 / EC. Each data set will be linked to a given research task description, the methods used to generate the data, the period of time data were collected and whether the data have been updated. The data will be stored in the standard file formats, such as MS Excel (.xlsx), MS Word (.docx), Comma Separated Values (.csv), Portable Document Format (.pdf), Joint Photographic Experts Group (.jpg), Tagged Image File Format (.tiff). Transformation of the high-resolution images may be necessary prior to data sharing. No further manipulation of these files is necessary.

Publications

Bo K, Artal R, Barakat R, Brown W, Davies GA, Dooley M, Evenson KR, Haakstad LA, Henriksson-Larsen K, Kayser B, Kinnunen TI, Mottola MF, Nygaard I, van Poppel M, Stuge B, Khan KM. Exercise and pregnancy in recreational and elite athletes: 2016 evidence summary from the IOC expert group meeting, Lausanne. Part 1-exercise in women planning pregnancy and those who are pregnant. Br J Sports Med. 2016 May;50(10):571-89. doi: 10.1136/bjsports-2016-096218. No abstract available.
PubMed 27127296
Bo K, Artal R, Barakat R, Brown W, Dooley M, Evenson KR, Haakstad LAH, Larsen K, Kayser B, Kinnunen TI, Mottola MF, Nygaard I, van Poppel M, Stuge B, Davies GAL; IOC Medical Commission. Exercise and pregnancy in recreational and elite athletes: 2016 evidence summary from the IOC expert group meeting, Lausanne. Part 2-the effect of exercise on the fetus, labour and birth. Br J Sports Med. 2016 Nov;50(21):1297-1305. doi: 10.1136/bjsports-2016-096810. Epub 2016 Oct 12.
PubMed 27733352
Bo K, Artal R, Barakat R, Brown WJ, Davies GAL, Dooley M, Evenson KR, Haakstad LAH, Kayser B, Kinnunen TI, Larsen K, Mottola MF, Nygaard I, van Poppel M, Stuge B, Khan KM; IOC Medical Commission. Exercise and pregnancy in recreational and elite athletes: 2016/17 evidence summary from the IOC Expert Group Meeting, Lausanne. Part 3-exercise in the postpartum period. Br J Sports Med. 2017 Nov;51(21):1516-1525. doi: 10.1136/bjsports-2017-097964. Epub 2017 Jun 22. No abstract available.
PubMed 28642221
Davenport MH, Ruchat SM, Poitras VJ, Jaramillo Garcia A, Gray CE, Barrowman N, Skow RJ, Meah VL, Riske L, Sobierajski F, James M, Kathol AJ, Nuspl M, Marchand AA, Nagpal TS, Slater LG, Weeks A, Adamo KB, Davies GA, Barakat R, Mottola MF. Prenatal exercise for the prevention of gestational diabetes mellitus and hypertensive disorders of pregnancy: a systematic review and meta-analysis. Br J Sports Med. 2018 Nov;52(21):1367-1375. doi: 10.1136/bjsports-2018-099355.
PubMed 30337463
Davenport MH, Nagpal TS, Mottola MF, Skow RJ, Riske L, Poitras VJ, Jaramillo Garcia A, Gray CE, Barrowman N, Meah VL, Sobierajski F, James M, Nuspl M, Weeks A, Marchand AA, Slater LG, Adamo KB, Davies GA, Barakat R, Ruchat SM. Prenatal exercise (including but not limited to pelvic floor muscle training) and urinary incontinence during and following pregnancy: a systematic review and meta-analysis. Br J Sports Med. 2018 Nov;52(21):1397-1404. doi: 10.1136/bjsports-2018-099780.
PubMed 30337466
Davenport MH, Ruchat SM, Sobierajski F, Poitras VJ, Gray CE, Yoo C, Skow RJ, Jaramillo Garcia A, Barrowman N, Meah VL, Nagpal TS, Riske L, James M, Nuspl M, Weeks A, Marchand AA, Slater LG, Adamo KB, Davies GA, Barakat R, Mottola MF. Impact of prenatal exercise on maternal harms, labour and delivery outcomes: a systematic review and meta-analysis. Br J Sports Med. 2019 Jan;53(2):99-107. doi: 10.1136/bjsports-2018-099821. Epub 2018 Oct 18.
PubMed 30337349
Davenport MH, McCurdy AP, Mottola MF, Skow RJ, Meah VL, Poitras VJ, Jaramillo Garcia A, Gray CE, Barrowman N, Riske L, Sobierajski F, James M, Nagpal T, Marchand AA, Nuspl M, Slater LG, Barakat R, Adamo KB, Davies GA, Ruchat SM. Impact of prenatal exercise on both prenatal and postnatal anxiety and depressive symptoms: a systematic review and meta-analysis. Br J Sports Med. 2018 Nov;52(21):1376-1385. doi: 10.1136/bjsports-2018-099697.
PubMed 30337464
Perales M, Valenzuela PL, Barakat R, Cordero Y, Pelaez M, Lopez C, Ruilope LM, Santos-Lozano A, Lucia A. Gestational Exercise and Maternal and Child Health: Effects until Delivery and at Post-Natal Follow-up. J Clin Med. 2020 Jan 31;9(2):379. doi: 10.3390/jcm9020379.
PubMed 32023833
Physical Activity and Exercise During Pregnancy and the Postpartum Period: ACOG Committee Opinion, Number 804. Obstet Gynecol. 2020 Apr;135(4):e178-e188. doi: 10.1097/AOG.0000000000003772.
PubMed 32217980
Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955.
PubMed 33239350
Batrakoulis A. European survey of fitness trends for 2020. ACSM's Health & Fitness Journal. 2019;23(6):28-35. PubMed PMID: 141012112.
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Interested in taking part?

Anna N Szumilewicz, Assoc. Prof.

601880207 ext. +48

anna.szumilewicz@awf.gda.pl

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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