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

NCT05009433 | Recruiting

• 1 other identifier: 1/KS/KF/DS2021
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pregnancy; Postpartum; Childbirth; Health Status; Physical Fitness; Noncommunicable Diseases; Metabolism; Diabetes Mellitus, Gestational; Pregnancy Induced Hypertension; Body Composition; Back Pain; Pain Threshold; Biomechanics; Pelvic Floor Disorders; Urinary Incontinence; Cognitive Function; Depression; Anxiety

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

Outcome Measures

Primary Outcomes (43)

• Changes in maternal oxygen consumption, during and after pregnancy

  Changes from the baseline maternal oxygen consumption (VO2; ml/min), including the maximal oxygen consumption (VO2max) values in a progressive maximal exercise test on a cycloergometer with electronically regulated load, using stationary respiratory gas analyzer. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters.

  Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).

• Changes in maternal heart rate, during and after pregnancy

  Changes from the baseline heart rate (HR; beats per minute), including the maximal HR values, in a progressive maximal exercise test on a cycloergometer with electronically regulated load, using heart rate monitor. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters.

  Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).

• Changes in systolic blood pressure, during and after pregnancy

  Changes from the baseline maternal systolic blood pressure (SBP; mm Hg), in a progressive maximal exercise test on a cycloergometer with electronically regulated load, using electronic blood pressure monitor. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters.

  Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).

• Changes in diastolic blood pressure, during and after pregnancy

  Changes from the baseline maternal diastolic blood pressure (DBP; mm Hg), in a progressive maximal exercise test on a cycloergometer with electronically regulated load, using electronic blood pressure monitor. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters.

  Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).

• Changes in blood glucose level, during and after pregnancy

  To assess the changes in glucose levels (mg/dl) the blood samples will be taken on the day of the maximal exercise capacity test before the test (at fasting condition), immediately (approx. 1 min) after completion the test and approx. 40 min. after the test. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially related to metabolism and changing with regular exercise in the perinatal period.

  Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).

• Changes in triglycerides, during and after pregnancy

  Changes in triglycerides (TG; mg/dl) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially related to metabolism and changing with regular exercise in the perinatal period.

  Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).

• Changes in high-density lipoproteins, during and after pregnancy

  Changes in high-density lipoproteins (HDL; mg/dl) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially related to metabolism and changing with regular exercise in the perinatal period.

  Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).

• Changes in urea, during and after pregnancy

  To assess the changes in urea levels (ml/dl), the study participants will collect urine samples to standard urine containers on the day of the maximal exercise capacity test before the test (at fasting condition), immediately after completion the test (up to 15 min) and approx. 60 min after the test. The investigators will analyze changes in this parameter in terms of intervention mode and its relationship with other selected parameters, potentially related to renal function and changing with regular exercise in the perinatal period.

  Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).

• Changes in creatinine, during and after pregnancy

  To assess the changes in creatinine levels (ml/dl), the study participants will collect urine samples to standard urine containers on the day of the maximal exercise capacity test before the test (at fasting condition), immediately after completion the test (up to 15 min) and approx. 60 min after the test. The investigators will analyze the changes in this parameter in terms of intervention mode and its relationship with other selected parameters, potentially related to renal function and changing with regular exercise in the perinatal period.

  Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).

• Changes in maternal weight, during and after pregnancy

  Changes in maternal weight will be expressed in kilograms (kg). The investigators will analyze the changes in this parameter in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.

  Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).

• Changes in maternal Body Mass Index during and after pregnancy

  Changes in Body Mass Index (BMI, kg/m2) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.

  Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).

• Changes in maternal neuromuscular activity of pelvic floor muscles, during and after pregnancy

  The neuromuscular activity of pelvic floor muscles (µV) will be evaluated with surface electromyography with a vaginal probe, in the condition of synergistic muscle relaxation. The investigators will analyze the changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially related to pelvic floor function and changing with regular exercise in the perinatal period.

  Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).

• Changes in the Incontinence Impact Questionnaire score, during and after pregnancy

  The urinary incontinence symptoms will be assessed using the scale of incontinence impact on the quality of life based on the Incontinence Impact Questionnaire - short form (Uebersax et al., 1995; IIQ-7 score; minimum score: 0; maximum score: 100; higher scores mean worse outcome). The investigators will analyze the changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially related to pelvic floor function and changing with regular exercise in the perinatal period.

  Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).

• Changes in the Urogenital Distress Inventory score, during and after pregnancy

  The pelvic floor disorders will be assessed using the scale based on the Urogenital Distress Inventory - short form questionnaire (Uebersax et al., 1995; UDI - 6 score; minimum score: 0; maximum score: 100; higher scores mean worse outcome). The investigators will analyze the changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially related to pelvic floor function and changing with regular exercise in the perinatal period.

  Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).

• Changes in the inter-rectus distance, during and after pregnancy

  The changes in the inter-rectus distance (IRD, mm) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.

  Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).

• Changes in the center of pressure excursions (static balance), during and after pregnancy

  The changes in the excursions of the center of pressure (COP; mm) will be measured in standing position using a specialized force platform. The changes in the static balance will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.

  Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).

• Changes in lumbar spine mobility, during and after pregnancy

  The changes in the lumbar spine mobility (°) will be measured in standing position using specialized motion detectors and software. The changes lumbar spine mobility will be analyzed in terms of intervention mode and in relation to other selected parameters, potentially changing with regular exercise in the perinatal period.

  Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).

• Changes in cervical spine mobility, during and after pregnancy

  The changes in the cervical spine mobility (°) will be measured in sitting position using specialized motion detectors and software. The changes lumbar spine mobility will be analyzed in terms of intervention mode and in relation to other selected parameters, potentially changing with regular exercise in the perinatal period.

  Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).

• Changes in foot loading, during and after pregnancy

  The changes in foot loading (kPa) will be measured in standing position using plantar pressure measurements platform and software. This outcome will be analyzed in terms of intervention mode and in relation to other selected parameters, potentially changing with regular exercise in the perinatal period.

  Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).

• Changes in spatiotemporal gait parameters: step length, during and after pregnancy

  The changes in the step length (m) will be measured in walking using plantar pressure measurements platform and software. This outcome will be analyzed in terms of intervention mode and in relation to other selected parameters, potentially changing with regular exercise in the perinatal period.

  Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).

• Changes in spatiotemporal gait parameters: step width, during and after pregnancy

  The changes in the step width (m) will be measured in walking using plantar pressure measurements platform and software. This outcome will be analyzed in terms of intervention mode and in relation to other selected parameters, potentially changing with regular exercise in the perinatal period.

  Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).

• Changes in the hand grip strength, during and after pregnancy

  The hand muscle strength (kg) will be assessed using the electronic hand grip dynamometer. The participant will perform the test separately for the right and left hands.

  Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).

• Changes in the pressure pain tolerance in the hand area, during and after pregnancy

  The pressure pain tolerance (PTOL) will be assessed using a computerized pressure algometer in the hand area. The PTOL will be expressed in the value of applied pressure (kPa). The pain test will be performed before and immediately (up to 15 minutes) after the maximal exercise test on a cycloergometer. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.

  Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).

• Changes in the pressure pain tolerance in the forearm area, during and after pregnancy

  The pressure pain tolerance (PTOL) will be assessed using a computerized pressure algometer in the forearm area. The PTOL will be expressed in the value of applied pressure (kPa). The pain test will be performed before and immediately (up to 15 minutes) after the maximal exercise test on a cycloergometer. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.

  Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).

• Changes in number of errors in the Stroop Interference test (version S8: congruent/incongruent), during and after pregnancy

  The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.

  Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).

• Changes in reaction time based on the Stroop Interference test (version S8: congruent/incongruent), during and after pregnancy

  The time spent to complete each task, as well as the total time (s) to complete the Stroop Interference test will be assessed. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.

  Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).

• Changes in the Beck Depression Inventory - II score, during and after pregnancy

  The occurrence and severity of depression symptoms using the scale of the Beck Depression Inventory - II (Beck et al., BDI -II score; minimum score: 0; maximum score: 63; higher scores mean worse outcome).The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.

  Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).

• Changes in the Fear of Childbirth questionnaire scores, during and after pregnancy

  The fear of childbirth will be assessed using a scale based on the Fear of Childbirth scale questionnaire (Areskog et al., 1992; minimum score: 0; maximum score: 63; higher scores mean worse outcome). The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.

  Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).

• Changes in cortisol level in hair, during and after pregnancy

  The cortisol level (pg/mg) will be determined from a hair sample as a marker of permanent stress. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.

  Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).

• Complications of pregnancy: gestational diabetes mellitus

  The incidence of gestational diabetes mellitus (GDM; % of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.

  The data will be collected from the pregnant women groups before starting the intervention and after the completion of each training or educational cycle (each training or education cycle lasts 8 weeks) until childbirth.

• Complications of pregnancy: gestational hypertension

  The incidence of gestational hypertension (GH; % of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.

  The data will be collected from the pregnant women groups before starting the intervention and after the completion of each training or educational cycle (each training or education cycle lasts 8 weeks) until childbirth.

• Complications of pregnancy: preeclampsia

  The incidence of preeclampsia (PE; % of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.

  The data will be collected from the pregnant women groups before starting the intervention and after the completion of each training or educational cycle (each training or education cycle lasts 8 weeks) until childbirth.

• Complications of fetal development: fetal growth restriction

  The incidence of fetal growth restriction (FGR; % of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.

  The data will be collected from the pregnant women groups before starting the intervention and after the completion of each training or educational cycle (each training or education cycle lasts 8 weeks) until childbirth.

• Complications of fetal development: fetal macrosomia

  The incidence of fetal macrosomia (FM; % of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.

  The data will be collected from the pregnant women groups before starting the intervention and after the completion of each training or educational cycle (each training or education cycle lasts 8 weeks) until childbirth.

• Childbirth parameters: type of delivery

  The type of delivery (vaginal delivery, cesarean section, instrumental delivery; % of the study group) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.

  The data will be collected from the pregnant women groups in the first two months after their childbirth.

• Childbirth parameters: new-born's birth weight

  The new-born's birth weight (g) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.

  The data will be collected from the pregnant women groups in the first two months after their childbirth.

• Childbirth parameters: new-born's length

  The new-born's length (cm) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.

  The data will be collected from the pregnant women groups in the first two months after their childbirth.

• Childbirth parameters: APGAR score

  The APGAR score (the newborn's appearance, pulse, grimace, activity, and respiration score; minimum score: 0; maximum score: 10; higher scores mean better outcome) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period.

  The data will be collected from the pregnant women groups in the first two months after their childbirth.

• Childhood outcomes: changes in body weight

  The changes in children's body weight (kg) will be analyzed in terms of pre- and postnatal physical activity patterns of their mothers and in relation to other selected parameters.

  The data will be collected from the offsprings at one, two, four and six years of age.

• Childhood outcomes: changes in body height

  The changes in children's body height (cm) will be analyzed in terms of pre- and postnatal physical activity patterns of their mothers and in relation to other selected parameters.

  The data will be collected from the offsprings at one, two, four and six years of age.

• Childhood outcomes: changes in Body Mass Index

  The changes in children's Body Mass Index (BMI; kg/m2) will be analyzed in terms of pre- and postnatal physical activity patterns of their mothers and in relation to other selected parameters.

  The data will be collected from the offsprings at one, two, four and six years of age.

• Childhood outcomes: changes in systolic blood pressure

  The changes in systolic blood pressure (SBP; mm Hg) in children will be analyzed in terms of pre- and postnatal physical activity patterns of their mothers and in relation to other selected parameters.

  The data will be collected from the offsprings at one, two, four and six years of age.

• Childhood outcomes: changes in diastolic blood pressure

  The changes in diastolic blood pressure (DBP; mm Hg) in children will be analyzed in terms of pre- and postnatal physical activity patterns of their mothers and in relation to other selected parameters.

  The data will be collected from the offsprings at one, two, four and six years of age.

Secondary Outcomes (44)

• Changes in maternal carbon dioxide production, during and after pregnancy

  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

  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

  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

  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

  Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).

Other Outcomes (6)

• The level of physical activity based on the International Physical Activity Questionnaire

  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).

• Ten Item Personality Inventory score

  Before starting the intervention.

• Life Orientation Test - Revised score

  Before starting the intervention.

Study Arms (6)

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.

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.

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.

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.

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.

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.

Behavioral: Standard health care with extended education on healthy lifestyle

Interventions

High intensity interval training program for pregnant women BEHAVIORAL

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.

Also known as: HIIT during pregnancy

Pregnant HIIT group

Moderate intensity continuous training program for pregnant women BEHAVIORAL

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.

Also known as: MICT during pregnancy

Pregnant MICT group

Standard obstetric care with extended education on healthy lifestyle BEHAVIORAL

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.

Pregnant standard care group

High intensity interval training program for nonpregnant women BEHAVIORAL

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.

Also known as: Lifetime HIIT

Nonpregnant HIIT group

Moderate intensity continuous training program for nonpregnant women BEHAVIORAL

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.

Also known as: Lifetime MICT

Nonpregnant MICT group

Standard health care with extended education on healthy lifestyle BEHAVIORAL

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.

Nonpregnant standard care group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gdansk University of Physical Education and Sport: lead
• Medical University of Gdansk: collaborator
• University of Gdansk: collaborator
• Pomeranian Medical University Szczecin: collaborator

Study Sites (1)

Laboratory of Physical Effort and Genetics in Sport at Gdansk University of Physical Education and Sport

Gdansk, Pomeranian Voivodeship, 80-336, Poland

RECRUITING

Related Publications (27)

• 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.

  PMID: 27127296 BACKGROUND

• 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.

  PMID: 27733352 BACKGROUND

• 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.

  PMID: 28642221 BACKGROUND

• 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.

  PMID: 30337463 BACKGROUND

• 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.

  PMID: 30337466 BACKGROUND

• 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.

  PMID: 30337349 BACKGROUND

• 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.

  PMID: 30337464 BACKGROUND

• 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.

  PMID: 32023833 BACKGROUND

• 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.

  PMID: 32217980 BACKGROUND

• 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.

  PMID: 33239350 BACKGROUND

• Batrakoulis A. European survey of fitness trends for 2020. ACSM's Health & Fitness Journal. 2019;23(6):28-35. PubMed PMID: 141012112.

  BACKGROUND

• Campbell WW, Kraus WE, Powell KE, Haskell WL, Janz KF, Jakicic JM, Troiano RP, Sprow K, Torres A, Piercy KL, Bartlett DB; 2018 PHYSICAL ACTIVITY GUIDELINES ADVISORY COMMITTEE*. High-Intensity Interval Training for Cardiometabolic Disease Prevention. Med Sci Sports Exerc. 2019 Jun;51(6):1220-1226. doi: 10.1249/MSS.0000000000001934.

  PMID: 31095079 BACKGROUND

• Yeh SW, Lin LF, Chen HC, Huang LK, Hu CJ, Tam KW, Kuan YC, Hong CH. High-intensity functional exercise in older adults with dementia: A systematic review and meta-analysis. Clin Rehabil. 2021 Feb;35(2):169-181. doi: 10.1177/0269215520961637. Epub 2020 Oct 11.

  PMID: 33040592 BACKGROUND

• Lavin-Perez AM, Collado-Mateo D, Mayo X, Humphreys L, Liguori G, James Copeland R, Del Villar Alvarez F, Jimenez A. High-intensity exercise to improve cardiorespiratory fitness in cancer patients and survivors: A systematic review and meta-analysis. Scand J Med Sci Sports. 2021 Feb;31(2):265-294. doi: 10.1111/sms.13861. Epub 2020 Nov 5.

  PMID: 33098219 BACKGROUND

• Songstad NT, Kaspersen KH, Hafstad AD, Basnet P, Ytrehus K, Acharya G. Effects of High Intensity Interval Training on Pregnant Rats, and the Placenta, Heart and Liver of Their Fetuses. PLoS One. 2015 Nov 13;10(11):e0143095. doi: 10.1371/journal.pone.0143095. eCollection 2015.

  PMID: 26566220 BACKGROUND

• Ong MJ, Wallman KE, Fournier PA, Newnham JP, Guelfi KJ. Enhancing energy expenditure and enjoyment of exercise during pregnancy through the addition of brief higher intensity intervals to traditional continuous moderate intensity cycling. BMC Pregnancy Childbirth. 2016 Jul 15;16(1):161. doi: 10.1186/s12884-016-0947-3.

  PMID: 27417194 BACKGROUND

• Szumilewicz A, Worska A, Santos-Rocha R, Oviedo-Caro M. Evidence-based and practice-oriented guidelines for exercising during pregnancy. In: Santos-Rocha R, editor. Exercise and sporting activity during pregnancy Evidence-based guidelines. Cham: Springer International Publishing; 2019. p. 157-81.

  BACKGROUND

• Santos-Rocha R, Gutiérrez I, Szumilewicz A, Pajaujiene S. Exercise testing and prescription for pregnant women. In: Santos-Rocha R, editor. Exercise and sporting activity during pregnancy: evidence-based guidelines. Cham: Springer International Publishing; 2019. p. 183-230.

  BACKGROUND

• Szumilewicz A, Santos-Rocha R. Exercise selection and adaptation during pregnancy. In: Santos-Rocha R, editor. Exercise and sporting activity during pregnancy Evidence-based guidelines. Cham: Springer International Publishing; 2019. p. 231-308.

  BACKGROUND

• Szumilewicz A, Worska A, Piernicka M, Kuchta A, Kortas J, Jastrzebski Z, Radziminski L, Jaworska J, Micielska K, Ziemann E. The Exercise-Induced Irisin Is Associated with Improved Levels of Glucose Homeostasis Markers in Pregnant Women Participating in 8-Week Prenatal Group Fitness Program: A Pilot Study. Biomed Res Int. 2017;2017:9414525. doi: 10.1155/2017/9414525. Epub 2017 Oct 31.

  PMID: 29226153 BACKGROUND

• Szumilewicz A, Worska A, Piernicka M, Kuchta A, Jastrzebski Z, Radziminski L, Kozlowska M, Micielska K, Ziemann E. Acute Postexercise Change in Circulating Irisin Is Related to More Favorable Lipid Profile in Pregnant Women Attending a Structured Exercise Program and to Less Favorable Lipid Profile in Controls: An Experimental Study with Two Groups. Int J Endocrinol. 2019 Feb 28;2019:1932503. doi: 10.1155/2019/1932503. eCollection 2019.

  PMID: 30944566 BACKGROUND

• Szumilewicz A, Dornowski M, Piernicka M, Worska A, Kuchta A, Kortas J, Bludnicka M, Radziminski L, Jastrzebski Z. High-Low Impact Exercise Program Including Pelvic Floor Muscle Exercises Improves Pelvic Floor Muscle Function in Healthy Pregnant Women - A Randomized Control Trial. Front Physiol. 2019 Jan 30;9:1867. doi: 10.3389/fphys.2018.01867. eCollection 2018.

  PMID: 30761019 BACKGROUND

• Szumilewicz A, Kuchta A, Kranich M, Dornowski M, Jastrzebski Z. Prenatal high-low impact exercise program supported by pelvic floor muscle education and training decreases the life impact of postnatal urinary incontinence: A quasiexperimental trial. Medicine (Baltimore). 2020 Feb;99(6):e18874. doi: 10.1097/MD.0000000000018874.

  PMID: 32028397 BACKGROUND

• Budnik-Przybylska D, Laskowski R, Pawlicka P, Anikiej-Wiczenbach P, Lada-Masko A, Szumilewicz A, Makurat F, Przybylski J, Soya H, Kazmierczak M. Do Physical Activity and Personality Matter for Hair Cortisol Concentration and Self-Reported Stress in Pregnancy? A Pilot Cross-Sectional Study. Int J Environ Res Public Health. 2020 Nov 1;17(21):8050. doi: 10.3390/ijerph17218050.

  PMID: 33139602 BACKGROUND

• Santos-Rocha R, Szumilewicz A, Perales M, Pajaujiene S. EuropeActive Standards EQF Level 5 - Pregnancy and Postnatal Exercise Specialist. Brussels: EuropeActive; 2016.

  BACKGROUND

• Sun J, Radziminski L, Santos-Rocha R, Szumilewicz A. High-intensity interval training is an effective exercise mode to maintain normal blood pressure during pregnancy: a randomized control trial. Sci Rep. 2024 Nov 14;14(1):27975. doi: 10.1038/s41598-024-79552-3.

  PMID: 39543304 DERIVED

• Wilczynska D, Walczak-Kozlowska T, Radziminski L, Oviedo-Caro MA, Santos-Rocha R, Szumilewicz A. Can we hit prenatal depression and anxiety through HIIT? The effectiveness of online high intensity interval training in pregnant women during the COVID-19 pandemic: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2022 Dec 22;14(1):215. doi: 10.1186/s13102-022-00610-2.

  PMID: 36550564 DERIVED

MeSH Terms

Conditions

Noncommunicable Diseases; Diabetes, Gestational; Hypertension, Pregnancy-Induced; Back Pain; Pelvic Floor Disorders; Urinary Incontinence; Depression; Anxiety Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Female Urogenital Diseases; Male Urogenital Diseases; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Anna N Szumilewicz, Assoc. Prof.

  Gdansk University of Physical Activity and Sport

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna N Szumilewicz, Assoc. Prof.

CONTACT

601880207; anna.szumilewicz@awf.gda.pl

Żaneta Wojdakowska

CONTACT

58 55 47 101; nauka@awf.gda.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Due to the trial design and specificity of the interventions it is not possible to blind the study participants in terms of the allocation to the study groups. The HIIT and MICT groups will attend exercise sessions of high or moderate intesity, 3 times a week, while the comparative groups will not be subjected to any exercise intervention. However the data collectors and assessors will be blinded to the group allocation.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: August 17, 2021
• Study Start: June 24, 2021
• Primary Completion (Estimated): March 31, 2031
• Study Completion (Estimated): August 31, 2031
• Last Updated: December 2, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will become available 6 months after publication, for a period of 10 years.
• Access Criteria: All data published in peer-reviewed scientific journals will be made available to all interested researchers and preserved long-term. Data will be made available via open-access repository following the acceptance of the scientific journal, publishing the study reports. The process for gaining access to non-publicly accessible data will be straightforward and involve email communication to the Principal Investigator. We expect no embargo periods for political/commercial/patent or publishing process reasons. The URL for the data repository will be shared as soon as it is ready.

Locations

PL (1)