Clinical trial NCT06572943: The Effect of Long-Term Moderate Intensity Exercise During Pregnancy on Maternal and Fetal Cardiovascular System
Official title: The Effect of Long-Term Moderate Intensity Exercise During Pregnancy on Maternal and Fetal Cardiovascular System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Related
Keywords: pregnancy
physical activity
exercise
Maternal cardiovascular system
Fetal cardiovascular system
Lead sponsor: University Hospital, Ioannina
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The investigators aim to evaluate the effect of long-term moderate intensity physical activity during pregnancy in maternal and fetal cardiovascular system. A randomized clinical trial was designed with two groups (Study group and Control Group).

Detailed description: Physical activity (PA) enhances not only physical but also mental health.PA contributes to the prevention of a variety of diseases in general population including hypertension, diabetes mellitus, stress, and depression. Nevertheless, pregnancy is a time period that various changes take place in a woman's body. Those alterations might be either facilitators or barriers for conducting PA during pregnancy.

When it comes to pregnancy several benefits have been associated with PA for both mother and fetus; such as low gestational weight gain, lower incidence of gestational diabetes mellitus (GDM), better management of Pre-eclampsia and post-partum weight retention. Moreover, PA improves mental health in pregnant women, while recent studies have revealed that physical exercise during pregnancy can improve oxidative stress, inflammation and endothelial function. The vast majority of Obstetricians \& Gynecologists recommend that pregnant women should be urged to start or continue doing physical activity in the absence of contraindications. To be more specific, pregnant women should do at least 150 minutes of moderate intensity PA weekly. However, several studies support that pregnant women all over the world does not meet those recommendations. Relevant evidence of published literature are scarce regarding the alterations on maternal and fetal cardiovascular system due to chronic exercise .

Thus, investigators aim to evaluate the effect of long-term moderate intensity PA in maternal and fetal cardiovascular system. Thus, a randomized clinical trial with two groups (study group-control group) was designed. The study group includes pregnant women during the 1st trimester that will undergo moderate intensity PA, while the control group includes pregnant women that will receive the routine antenatal care. Participants will be followed up until 6 months postpartum.

To be more specific, all participants will receive a pedometer to record their daily steps from the first trimester until the postpartum period. The intervention group will additional receive detailed recommendations for 30 minutes of moderate intensity exercise at least 4-5 times per week (if not daily) and brochures with relevant information will be administrated as well. Moreover, brochures with dietary recommendations during pregnancy will be given to all participants.

Three routine antenatal ultrasound scans at 11-13+6 , 20-24, and 32-36 gestational weeks will be performed. Maternal Uterine Dopplers will be assessed at every scan, while fetal Dopplers will be done at 2nd and 3rd trimester. Maternal cardiovascular assessment will take place at 1st trimester, 3rd trimester and postpartum with transthoracic echocardiography, ophthalmic artery Doppler, Flow Mediated Dilatation and Arterial Stiffness . Fetal heart function will be assessed at 2nd and 3rd trimester. Evaluation of the infants' heart will also be performed at 6 months postpartum. A questionnaire evaluating mental health known as Depression-Anxiety and Stress Scale 21 (DASS-21) in pregnant women will be administered during the 1st and 3rd trimester. Maternal body fat measurements will take place at each trimester and postpartum. In addition fat composition of both the fetus will be evaluated by ultrasound before the delivery and the newborn within 48 hours following birth. Maternal blood sample will be collected during 1st trimester, 3rd trimester and postpartum and blood sample from the umbilical cord during labour, to assess several parameters.

All participants will be fully informed about the purpose of the study and will be included only after signing the Informed Consent Form. All data collected will be confidential and only accessible to members of the research team. These data will be coded according to GDPR. The clinical implementation of this study will be according to the International Code of Medical Ethics of the World Medical Association (Declaration of Helsinki), and all participants submitted a written informed consent since a detailed description of all aspects and the objectives of the study are explained and fully understood. The ethical committee of the University Hospital of Ioannina approved this study (decision number: 3/30-01-2024; date of approval; 30 January 2024).

Eligibility criteria: Inclusion Criteria:

* Pregnant women during 1st trimester, who had the routine dating scan at 11-13+6 gestational weeks \[also known as Nuchal translucency (NT) scan\] and the uterine arteries (UtA) PI assessment

Exclusion Criteria:

* Diabetes Mellitus (Type I or II)
* Maternal age \< 18 years old
* Body Mass Index (BMI) \> 40
* Contraindications for PA: Multiple Pregnancies, Vaginal Bleeding, Hypertension or Gestational Hypertension, Uncontrolled Thyroid Diseases, Cardiovascular Diseases (e.g. valvular diseases, congenital heart diseases, cardiomyopathies, atrial fibrillation, coronary heart disease) or respiratory system diseases (asthma, chronic obstructive pulmonary disease) or systemic disease (cancer, autoimmune diseases) or several other diseases considered to be barriers for PA during pregnancy.

Primary outcomes:
measure: Uterine Arteries Pulsatility Index at each trimester
timeFrame: 11-13+6, 20-24, and 32-36 gestational weeks
Secondary outcomes:
measure: Umbilical artery Pulsatility Index during the 2nd and 3rd trimester
timeFrame: 20-24, and 32-36 gestational weeks
measure: Middle Cerebral Artery Pulsatility Index during the 2nd and 3rd trimester
timeFrame: 20-24, and 32-36 gestational weeks
measure: Incidence of Gestational Diabetes
timeFrame: 26-29 weeks gestation
measure: Incidence Pre-eclampsia
timeFrame: >20 weeks until 4-6 weeks postpartum
measure: Maternal body fat measurements
timeFrame: 11-13+6., 20-24, and 32-36 gestational weeks, 8-12 weeks postpartum
measure: Gestational weight Change
timeFrame: Between 36-40 weeks gestation
measure: Gestational age at labor
timeFrame: Delivery
measure: Maternal mental health
timeFrame: 11-13+6. and 32-36 gestational weeks
measure: Maternal cardiovascular adaptations during pregnancy and postpartum
timeFrame: 11-13+6, 32-36 gestational weeks and 8-12 weeks postpartum
measure: Arterial stiffness and FMD adaptations thorough pregnancy
timeFrame: 11-13+6. and 32-36 gestational weeks and 8-12 weeks postpartum
measure: Maternal Blood Samples' findings
timeFrame: 11-13+6, 32-36 gestational weeks and 8-12 weeks postpartum
measure: Umbilical cord blood samples; findings
timeFrame: Delivery
measure: Fetus and Neonatal Fat Composition
timeFrame: Before delivery and within 48 hours following delivery
measure: Fetal heart adaptations and cardiovascular changes of the infant
timeFrame: 20-24, 32-36 gestational weeks and 5-7 months postpartum.
Other outcomes:
Locations:
city: Ioannina
country: Greece
facility: Department of Obstetrics and Gynecology, University Hospital of Ioannina
Study officials:
affiliation: University Hospital, Ioannina
name: George Makrydimas, Professor
role: STUDY_DIRECTOR
References:
citation: Martland R, Mondelli V, Gaughran F, Stubbs B. Can high-intensity interval training improve physical and mental health outcomes? A meta-review of 33 systematic reviews across the lifespan. J Sports Sci. 2020 Feb;38(4):430-469. doi: 10.1080/02640414.2019.1706829. Epub 2019 Dec 31.
citation: Zschucke E, Gaudlitz K, Strohle A. Exercise and physical activity in mental disorders: clinical and experimental evidence. J Prev Med Public Health. 2013 Jan;46 Suppl 1(Suppl 1):S12-21. doi: 10.3961/jpmph.2013.46.S.S12. Epub 2013 Jan 30.
citation: Davies G, Artal R. It's time to treat exercise in pregnancy as therapy. Br J Sports Med. 2019 Jan;53(2):81. doi: 10.1136/bjsports-2018-100360. Epub 2018 Dec 15. No abstract available.
citation: Michalek IM, Comte C, Desseauve D. Impact of maternal physical activity during an uncomplicated pregnancy on fetal and neonatal well-being parameters: a systematic review of the literature. Eur J Obstet Gynecol Reprod Biol. 2020 Sep;252:265-272. doi: 10.1016/j.ejogrb.2020.06.061. Epub 2020 Jun 29.
citation: 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.
citation: Mottola MF, Davenport MH, Ruchat SM, Davies GA, Poitras VJ, Gray CE, Jaramillo Garcia A, Barrowman N, Adamo KB, Duggan M, Barakat R, Chilibeck P, Fleming K, Forte M, Korolnek J, Nagpal T, Slater LG, Stirling D, Zehr L. 2019 Canadian guideline for physical activity throughout pregnancy. Br J Sports Med. 2018 Nov;52(21):1339-1346. doi: 10.1136/bjsports-2018-100056.
citation: Evenson KR, Wen F. Prevalence and correlates of objectively measured physical activity and sedentary behavior among US pregnant women. Prev Med. 2011 Jul-Aug;53(1-2):39-43. doi: 10.1016/j.ypmed.2011.04.014. Epub 2011 May 4.
citation: Hesketh KR, Evenson KR. Prevalence of U.S. Pregnant Women Meeting 2015 ACOG Physical Activity Guidelines. Am J Prev Med. 2016 Sep;51(3):e87-9. doi: 10.1016/j.amepre.2016.05.023. No abstract available.
citation: Fernandez-Buhigas I, Martin Arias A, Vargas-Terrones M, Brik M, Rolle V, Barakat R, Munoz-Gonzalez MD, Refoyo I, Gil MM, Santacruz B. Fetal and maternal Doppler adaptation to maternal exercise during pregnancy: a randomized controlled trial. J Matern Fetal Neonatal Med. 2023 Dec;36(1):2183759. doi: 10.1080/14767058.2023.2183759.
citation: Chatzakis C, Sotiriadis A, Fatouros IG, Jamurtas AZ, Deli CK, Papagianni M, Dinas K, Mastorakos G. The Effect of Physical Exercise on Oxidation Capacity and Utero-Placental Circulation in Pregnancies with Gestational Diabetes Mellitus and Uncomplicated Pregnancies, a Pilot Study. Diagnostics (Basel). 2022 Jul 16;12(7):1732. doi: 10.3390/diagnostics12071732.