Comparing high-intensity and moderate-intensity exercise during pregnancy and its effects on health and birth outcomes
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
NA · Gdansk University of Physical Education and Sport · NCT05009433
This study tests whether high-intensity or moderate-intensity exercise during pregnancy can improve health and birth outcomes for moms and their babies.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Gdansk University of Physical Education and Sport (other) |
| Locations | 1 site (Gdansk, Pomeranian Voivodeship) |
| Trial ID | NCT05009433 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of high-intensity interval training (HIIT) versus moderate-intensity continuous training (MICT) on health and birth outcomes for pregnant women. It aims to determine how these different exercise regimens impact maternal and child health, including risks associated with pregnancy complications. Participants will engage in structured exercise programs while receiving standard obstetric care and education on healthy lifestyles. The study will assess various biological, functional, and psychological parameters throughout pregnancy and postpartum.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women who have a healthy pregnancy course and can participate in physical activities.
Not a fit: Patients who are unable to engage in physical activities due to medical complications or contraindications during pregnancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence for effective exercise recommendations during pregnancy, improving health outcomes for mothers and their children.
How similar studies have performed: While HIIT has shown effectiveness in various populations, limited data exists on its application during pregnancy, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Gdansk, Pomeranian Voivodeship
- Laboratory of Physical Effort and Genetics in Sport at Gdansk University of Physical Education and Sport — Gdansk, Pomeranian Voivodeship, Poland (RECRUITING)
Study contacts
- Principal investigator: Anna N Szumilewicz, Assoc. Prof. — Gdansk University of Physical Activity and Sport
- Study coordinator: Anna N Szumilewicz, Assoc. Prof.
- Email: anna.szumilewicz@awf.gda.pl
- Phone: 601880207
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pregnancy, Postpartum, Childbirth, Health Status, Physical Fitness, Noncommunicable Diseases, Metabolism, Diabetes Mellitus, Gestational