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Recruiting NCT05009433

NCT05009433 HIIT vs MICT During Pregnancy and Health and Birth Outcomes in Mothers and Children

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Clinical Trial Summary
NCT ID NCT05009433
Status Recruiting
Phase
Sponsor Gdansk University of Physical Education and Sport
Condition Pregnancy
Study Type INTERVENTIONAL
Enrollment 600 participants
Start Date 2021-06-24
Primary Completion 2031-03-31

Eligibility & Interventions

Sex Female only
Min Age 18 Years
Max Age 45 Years
Study Type INTERVENTIONAL
Interventions
High intensity interval training program for pregnant womenModerate intensity continuous training program for pregnant womenStandard obstetric care with extended education on healthy lifestyle

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 600 participants in total. It began in 2021-06-24 with a primary completion date of 2031-03-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

Inclusion Criteria: Criteria: Inclusion Criteria: For pregnant women: 1. course of pregnancy allowing participation in physical activities adapted to pregnant women 2. consent of the obstetric care provider to participate in the study tests and exercise classes; 3. 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; 4. 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; 5. availability to participate in classes three times a week until the day of delivery; 6. 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; 7. 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: 1. nulliparous; 2. lack of diagnosed infertility and other disorders of the reproductive system; 3. 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 4. 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); 5. 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; 6. 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). Exclusion Criteria for Pregnant and Nonpregnant Women: 1. contraindications to increased physical effort or to any of the diagnostic or control tests; 2. allergies to materials used during diagnostic and control tests (e.g. nickel present in steel plates of vaginal electrodes, disinfectants); 3. 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.

Contact & Investigator

Central Contact

Anna N Szumilewicz, Assoc. Prof.

✉ anna.szumilewicz@awf.gda.pl

📞 601880207

Principal Investigator

Anna N Szumilewicz, Assoc. Prof.

PRINCIPAL INVESTIGATOR

Gdansk University of Physical Activity and Sport

Frequently Asked Questions

Who can join the NCT05009433 clinical trial?

This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05009433 currently recruiting?

Yes, NCT05009433 is actively recruiting participants. Contact the research team at anna.szumilewicz@awf.gda.pl for enrollment information.

Where is the NCT05009433 trial being conducted?

This trial is being conducted at Gdansk, Poland.

Who is sponsoring the NCT05009433 clinical trial?

NCT05009433 is sponsored by Gdansk University of Physical Education and Sport. The principal investigator is Anna N Szumilewicz, Assoc. Prof. at Gdansk University of Physical Activity and Sport. The trial plans to enroll 600 participants.

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