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

ConditionsPregnancy 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

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18-45

SponsorGdansk University of Physical Education and Sport

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

contraindications to increased physical effort or to any of the diagnostic or control tests;

allergies to materials used during diagnostic and control tests (e.g. nickel present in steel plates of vaginal electrodes, disinfectants);

other conditions that, according to the researchers, will threaten the health or safety of the participants or will significantly affect the quality of the collected data.

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.
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.
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.
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.
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.

Treatment groups

600 Participants

are divided into 6 treatment groups

Treatment groups

See each treatment group below.

Group A: Pregnant HIIT groupExperimental treatment 1 intervention

Group B: Pregnant MICT groupActive comparator 1 intervention

Group C: Pregnant standard care groupSham comparator 1 intervention

Group D: Nonpregnant HIIT groupExperimental treatment 1 intervention

Group E: Nonpregnant MICT groupActive comparator 1 intervention

Group F: Nonpregnant standard care groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

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.

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 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.

Time frame

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.

Time frame

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.

Time frame

Secondary outcomes

Changes in maternal carbon dioxide production, during and after pregnancy

Changes from the baseline carbon dioxide production (VCO2; ml/min) in a progressive maximal exercise test on a cycloergometer with electronically regulated load, using stationary respiratory gas analyzer. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters.

Time frame

Changes in maternal minute ventilation, during and after pregnancy

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

Time frame

Changes in maternal respiratory rate, during and after pregnancy

Changes from the baseline maternal respiratory rate (RR; breaths per min) in a progressive maximal exercise test on a cycloergometer with electronically regulated load, using stationary respiratory gas analyzer. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters.

Time frame

Changes in maternal exercise capacity, expressed in administered load, during and after pregnancy

Changes in administered load (W) in a progressive maximal exercise test on a cycloergometer with electronically regulated load. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters.

Time frame

Other outcomes

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

The investigators will use the International Physical Activity Questionnaire to calculate IPAQ score (minimum score: 0; maximum score: not specified; higher scores mean better outcome) to determine the participants' levels of physical activity prior to enrollment in the study and during the study.

Time frame

Ten Item Personality Inventory score

The investigators will use the Ten Item Personality Inventory (Gosling et al., 2003; TIPI scores; minimum score: 2; maximum score: 14; the higher the score, the greater the intensity of the personality traits) to analyze the psychosocial determinants of participation in physical activity during the perinatal period.

Time frame

Before starting the intervention.

Life Orientation Test - Revised score

The investigators will use the optimism versus pessimism scale based on the Life Orientation Test - Revised (Scheier et al., 1994; LOT-R score; minimum score: 6; maximum score: 24; the higher the score, the higher level of optimism) to analyze the psychosocial determinants of participation in physical activity during the perinatal period.

Time frame

Before starting the intervention.

The Fat mass and obesity-associated (FTO) gene polymorphism

The Fat mass and obesity-associated (FTO) gene polymorphism will be analyzed as a determinant of the incidence of metabolic disorders during pregnancy and postpartum, in relation to different patterns of physical activity and other selected parameters.

Time frame

Before starting the intervention.