The Effect of Long-Term Moderate Intensity Exercise During Pregnancy on Maternal and Fetal Cardiovascular System

NCT06572943 | Recruiting DMC

• 1 other identifier: 3/30-01-2024 (θ. 6)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Pregnancy Related

Keywords

pregnancy; physical activity; exercise; Maternal cardiovascular system; Fetal cardiovascular system

Outcome Measures

Primary Outcomes (1)

• Uterine Arteries Pulsatility Index at each trimester

  Uterine Arteries Pulsatility Index will be measured with Ultrasound Doppler by the same operator, at each trimester

  11-13+6, 20-24, and 32-36 gestational weeks

Secondary Outcomes (14)

• Umbilical artery Pulsatility Index during the 2nd and 3rd trimester

  20-24, and 32-36 gestational weeks

• Middle Cerebral Artery Pulsatility Index during the 2nd and 3rd trimester

  20-24, and 32-36 gestational weeks

• Incidence of Gestational Diabetes

  26-29 weeks gestation

• Incidence Pre-eclampsia

  >20 weeks until 4-6 weeks postpartum

• Maternal body fat measurements

  11-13+6., 20-24, and 32-36 gestational weeks, 8-12 weeks postpartum

Study Arms (2)

Control

NO INTERVENTION

Routine Antenatal Care. Brochures with dietary recommendations will be given.

Experimental

EXPERIMENTAL

Detailed recommendations and brochures regarding physical activity will be given.Moreover brochures with dietary recommendations will be administrated.

Other: Moderate intensity physical activity

Interventions

Moderate intensity physical activity OTHER

Moderate intensity exercise of 30 minutes for at least 4-5 times per week (if not daily).

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• George Makrydimas: lead

Study Sites (1)

Department of Obstetrics and Gynecology, University Hospital of Ioannina

Ioannina, 45500, Greece

RECRUITING

Related Publications (10)

• 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.

  PMID: 31889469 BACKGROUND

• 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.

  PMID: 23412549 BACKGROUND

• 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.

  PMID: 30554145 BACKGROUND

• 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.

  PMID: 32634674 BACKGROUND

• 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.

  PMID: 32217980 BACKGROUND

• 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.

  PMID: 30337460 BACKGROUND

• 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.

  PMID: 21575654 BACKGROUND

• 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.

  PMID: 27544437 BACKGROUND

• 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.

  PMID: 36889747 BACKGROUND

• 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.

  PMID: 35885635 BACKGROUND

Related Links

• Exercise Holds Even More Heart Health Benefits for People with Stress-Related Conditions. American College of Cardiology
• Exercise in Pregnancy
• Physical activity and pregnancy. RCOG

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• George Makrydimas, Professor

  University Hospital, Ioannina

  STUDY DIRECTOR

Central Study Contacts

George Makrydimas, Professor

CONTACT

+306944542420; grmak@otenet.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynaecology

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 27, 2024
• Study Start: August 26, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-12

Locations

GR (1)