NCT Number: NCT05009433
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.
Interested in participating?
Request Info18 year–45 year
Female
Interventional
Not applicable
Gdansk, Pomeranian Voivodeship, 80-336, Poland
Location status: Recruiting
Anna N Szumilewicz, Assoc. Prof.
CONTACT
601880207 ext. +48
Robert Urbański, PhD
CONTACT
58 554 74 15 ext. +48
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Criteria: Inclusion Criteria:
For pregnant women:
For nonpregnant women:
Exclusion criteria
for Pregnant and Nonpregnant Women:
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.
Other names: HIIT 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.
Other names: MICT during pregnancy
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.
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.
Other names: Lifetime HIIT
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.
Other names: Lifetime MICT
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.
Time frame: 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 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.
Time frame: 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 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.
Time frame: 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 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.
Time frame: 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 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.
Time frame: 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).
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.
Time frame: 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 (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.
Time frame: 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 (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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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 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.
Time frame: 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 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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: The data will be collected from the pregnant women groups in the first two months after their childbirth.
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.
Time frame: The data will be collected from the pregnant women groups in the first two months after their childbirth.
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.
Time frame: The data will be collected from the pregnant women groups in the first two months after their childbirth.
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.
Time frame: The data will be collected from the pregnant women groups in the first two months after their childbirth.
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.
Time frame: The data will be collected from the offsprings at one, two, four and six years of age.
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.
Time frame: The data will be collected from the offsprings at one, two, four and six years of age.
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.
Time frame: The data will be collected from the offsprings at one, two, four and six years of age.
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.
Time frame: The data will be collected from the offsprings at one, two, four and six years of age.
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.
Time frame: The data will be collected from the offsprings at one, two, four and six years of age.
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.
Time frame: 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 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.
Time frame: 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 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.
Time frame: 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 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.
Time frame: 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 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.
Time frame: 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 (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.
Time frame: 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 (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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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 (%) 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.
Time frame: 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 (%) 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.
Time frame: 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 (%) 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.
Time frame: 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 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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: The data will be collected from the pregnant women groups in the first two months after their childbirth.
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.
Time frame: The data will be collected from the pregnant women groups in the first two months after their childbirth.
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.
Time frame: The data will be collected from the pregnant women groups in the first two months after their childbirth.
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.
Time frame: The data will be collected from the pregnant women groups in the first two months after their childbirth.
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.
Time frame: The data will be collected from the pregnant women groups in the first two months after their childbirth.
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.
Time frame: The data will be collected from the pregnant women groups in the first two months after their childbirth.
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.
Time frame: The data will be collected from the pregnant women groups in the first two months after their childbirth.
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.
Time frame: The data will be collected from the pregnant women groups in the first two months after their childbirth.
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.
Time frame: The data will be collected from the offsprings at one, two, four and six years of age.
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: Before starting the intervention.
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.
Time frame: Before starting the intervention.
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.
Time frame: Before starting the intervention.
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.
Time frame: Before starting the intervention.
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.
Time frame: Before starting the intervention.
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.
Contact information is provided by the study sponsor or research team.
Anna N Szumilewicz, Assoc. Prof.
CONTACT
601880207 ext. +48
Żaneta Wojdakowska
CONTACT
58 55 47 101 ext. +48
Gdansk University of Physical Education and Sport
Other
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
Acronym: HIIT MAMA
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