[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100439987":3},{"organization":4,"armGroups":7,"interventions":41,"overallOfficials":76,"centralContacts":81,"locations":91,"responsibleParty":112,"collaborators":114,"id":121,"slug":122,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":129,"sex":130,"minAge":131,"maxAge":132,"enrollmentInfo":133,"targetDuration":59,"studyType":136,"phases":137,"briefSummary":139,"conditions":140,"keywords":159,"overallStatus":94,"whyStopped":59,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":184},{"fullName":5,"class":6},"Gdansk University of Physical Education and Sport","OTHER",[8,14,20,26,31,36],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Behavioral: High intensity interval training program for pregnant women",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Behavioral: Moderate intensity continuous training program for pregnant women",{"label":21,"type":22,"description":23,"interventionNames":24},"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.",[25],"Behavioral: Standard obstetric care with extended education on healthy lifestyle",{"label":27,"type":10,"description":28,"interventionNames":29},"Nonpregnant HIIT group","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).\n\nDuring 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.",[30],"Behavioral: High intensity interval training program for nonpregnant women",{"label":32,"type":16,"description":33,"interventionNames":34},"Nonpregnant MICT group","The moderate intensity continuous training program will be implemented according to the World Health Organization guidelines on physical activity and sedentary behavior (2020).\n\nDuring 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.",[35],"Behavioral: Moderate intensity continuous training program for nonpregnant women",{"label":37,"type":22,"description":38,"interventionNames":39},"Nonpregnant standard care group","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.",[40],"Behavioral: Standard health care with extended education on healthy lifestyle",[42,49,55,60,66,72],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"BEHAVIORAL","High intensity interval training program for pregnant 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.\n\nAfter 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.",[9],[48],"HIIT during pregnancy",{"type":43,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"Moderate intensity continuous training program for pregnant women","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.\n\nAfter 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.",[15],[54],"MICT during pregnancy",{"type":43,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"Standard obstetric care with extended education on healthy lifestyle","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.",[21],null,{"type":43,"name":61,"description":62,"armGroupLabels":63,"otherNames":64},"High intensity interval training program for nonpregnant women","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.\n\nFor 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.",[27],[65],"Lifetime HIIT",{"type":43,"name":67,"description":68,"armGroupLabels":69,"otherNames":70},"Moderate intensity continuous training program for nonpregnant women","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.\n\nFor 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.",[32],[71],"Lifetime MICT",{"type":43,"name":73,"description":74,"armGroupLabels":75,"otherNames":59},"Standard health care with extended education on healthy lifestyle","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.",[37],[77],{"name":78,"affiliation":79,"role":80},"Anna N Szumilewicz, Assoc. Prof.","Gdansk University of Physical Activity and Sport","PRINCIPAL_INVESTIGATOR",[82,87],{"name":78,"role":83,"phone":84,"phoneExt":85,"email":86},"CONTACT","601880207","+48","anna.szumilewicz@awf.gda.pl",{"name":88,"role":83,"phone":89,"phoneExt":85,"email":90},"Żaneta Wojdakowska","58 55 47 101","nauka@awf.gda.pl",[92],{"facility":93,"status":94,"city":95,"state":96,"zip":97,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":105,"contacts":106},"Laboratory of Physical Effort and Genetics in Sport at Gdansk University of Physical Education and Sport","RECRUITING","Gdansk","Pomeranian Voivodeship","80-336","Poland","PL",{"type":101,"coordinates":102},"Point",[103,104],18.64912,54.35227,{"lat":104,"lon":103},[107,108],{"name":78,"role":83,"phone":84,"phoneExt":85,"email":86},{"name":109,"role":83,"phone":110,"phoneExt":85,"email":111},"Robert Urbański, PhD","58 554 74 15","lab.sport@awf.gda.pl",{"type":113,"investigatorFullName":59,"investigatorTitle":59,"investigatorAffiliation":59,"oldNameTitle":59,"oldOrganization":59},"SPONSOR",[115,117,119],{"name":116,"class":6},"Medical University of Gdansk",{"name":118,"class":6},"University of Gdansk",{"name":120,"class":6},"Pomeranian Medical University Szczecin","100439987","hiit-vs-mict-during-pregnancy-and-health-and-birth-outcomes-in-mothers-and-children-100439987",false,"NCT05009433","HIIT vs MICT During Pregnancy and Health and Birth Outcomes in Mothers and Children","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","HIIT MAMA","Inclusion Criteria:\n\nCriteria: Inclusion Criteria:\n\nFor pregnant women:\n\n1. course of pregnancy allowing participation in physical activities adapted to pregnant women\n2. consent of the obstetric care provider to participate in the study tests and exercise classes;\n3. 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;\n4. 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;\n5. availability to participate in classes three times a week until the day of delivery;\n6. 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;\n7. 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).\n\nFor nonpregnant women:\n\n1. nulliparous;\n2. lack of diagnosed infertility and other disorders of the reproductive system;\n3. 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\n4. 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);\n5. 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;\n6. 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).\n\nExclusion Criteria for Pregnant and Nonpregnant Women:\n\n1. contraindications to increased physical effort or to any of the diagnostic or control tests;\n2. allergies to materials used during diagnostic and control tests (e.g. nickel present in steel plates of vaginal electrodes, disinfectants);\n3. 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.",true,"FEMALE","18 Years","45 Years",{"count":134,"type":135},600,"ESTIMATED","INTERVENTIONAL",[138],"NA","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.\n\nHigh-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.\n\nThe 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.\n\nPregnant 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.\n\nThe 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.",[141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158],"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",[160,161,162,163,164,165,166,167,168,169,170,144,171,143,172,173,174],"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","Physical fitness","Birth outcomes","Infant","Child","2022-11-30",{"date":177,"type":178},"2022-12-02","ACTUAL",{"date":180,"type":178},"2021-06-24",{"date":182,"type":135},"2031-08-31",{"name":5,"class":6},1]