NCT04563065: ACPREGCOV

Active Pregnancy Against COVID-19

Status unknown NA Last updated 1 July 2022

What this trial tests

NA trial testing Exercise program in Pregnancy Complications in 280 participants. Status unknown.

Timeline

1 August 2020

Primary endpoint
30 November 2020

31 December 2023

Quick facts

Lead sponsor	Universidad Politecnica de Madrid
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	280
Start date	1 August 2020
Primary completion	30 November 2020
Estimated completion	31 December 2023
Sites	2 locations across Spain

Drugs / interventions tested

• Exercise program
• Healthy lifestyle advise

Conditions studied

• Pregnancy Complications — all drugs for Pregnancy Complications →
• Pregnancy, High Risk — all drugs for Pregnancy, High Risk →
• Pregnancy Induced Hypertension — all drugs for Pregnancy Induced Hypertension →
• Newborn Morbidity — all drugs for Newborn Morbidity →

Sponsor

Universidad Politecnica de Madrid

Who can join

Adults 18 to 50, female only, with Pregnancy Complications or Pregnancy, High Risk. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Historically and traditionally, the recommendations related to physical exercise during pregnancy have been based more on moral or cultural issues than on scientific evidence. During some phases of history, pregnancy has meant a period of seclusion for women (not only physical). One of the adverse consequences has been the common recommendation of rest as a general rule for pregnant women.

Scientific evidence from recent years has achieved a better understanding of the process of pregnancy and childbirth as well as maternal and fetal responses to exercise. Currently, both from a scientific and clinical/obstetric point of view, there is no doubt about the benefits of an active pregnancy for entire body of pregnant woman, and even her child. In fact, risks of a sedentary lifestyle are applicable to the pregnancy situation, even more with important associated complications during pregnancy and postpartum period.

Unfortunately, the impact of COVID-19 has caused an unprecedented global crisis, in this sense the necessary measures taken by the different administrations, especially in terms of confinement causes (from now on) a large number of complications affecting different populations. In summary a complex situation without established prevention strategies exists.

The pregnant population is, due to the nature of the gestation and delivery process, one of the population groups with the highest risk of adverse outcomes and associated complications and whose consequences include the mother, fetus, newborn and even children. According to an important body of scientific literature and based on an epigenetic effect, the intrauterine environment can be a determining factor for the future human being to evolve regardless of complications and pathologies (cardiovascular, metabolic, psychic, emotional). This is demonstrated by numerous recent scientific evidences that confirm the unfortunate association between an adverse intrauterine environment (due to various factors) and observable postnatal pathologies in infants.

In addition, current publications report the large number and variety of alterations that the COVID-19 situation causes in pregnant women and that includes the entire female organism. This complex situation does not only affect aspects of a physical or physiological nature, but also psychic and emotional factors. In summary, a new state of confinement or similar situations in the near future (impossibility of groupings, distance between people), avoid during the daily life of pregnant women one of the important and recent recommendations made by the international scientific community: a pregnancy physically active.

This is especially relevant, due to the dangerous association between complications of a psychological or emotional nature during pregnancy with pre, peri and postnatal disorders (low birth weights, perinatal complications, altered and prolonged deliveries, etc.), which affect not only to the mother and can determine the health of the future human being. According to the scientific literature and based on an epigenetic effect, the intrauterine environment can be a determining aspect in the health of the future human being and the prevention of complications and pathologies (cardiovascular, metabolic, psychic, emotional). This is demonstrated by numerous and recent scientific evidences that confirm the unfortunate association between an adverse intrauterine environment (due to various factors) and different pathologies during and after pregnancy.

It is evident the change that COVID-19 and its effects will generate in the lifestyle of the pregnant population and the increased probability of suffering associated pathologies in the next 24-36 months. No preventive actions have yet been planned in Spain and its public hospitals against the impact of COVID-19 on the quality of life of pregnant women. It is urgent to design and perform an adequate strategy of intervention for its possible prevention. From the scientific point of view, the recommendations are clear and concrete, an aerobic exercise program, designed and supervised by professionals from the Sciences of Physical Activity and Sports, is the best option for pregnant women.

In this sense, in the last 30 years, physical exercise has proven to have many benefits for pregnant women, without causing risks or adverse effects on maternal-fetal well-being. This is confirmed by an important body of scientific literature on gestational physical exercise and its effects on pregnancy outcomes.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The 'new normal' includes online prenatal exercise: exploring pregnant women's experiences during the pandemic and the role of virtual group fitness on maternal mental health.
   Silva-Jose C, Nagpal TS, Coterón J, Barakat R, et al · · 2022 · cited 18× · PMID 35337280 · DOI 10.1186/s12884-022-04587-1
2. Effectiveness of a Virtual Exercise Program During COVID-19 Confinement on Blood Pressure Control in Healthy Pregnant Women.
   Silva-Jose C, Sánchez-Polán M, Diaz-Blanco Á, Coterón J, et al · · 2021 · cited 13× · PMID 33776798 · DOI 10.3389/fphys.2021.645136
3. The Effect of Online Supervised Exercise throughout Pregnancy on the Prevention of Gestational Diabetes in Healthy Pregnant Women during COVID-19 Pandemic: A Randomized Clinical Trial.
   Uria-Minguito A, Silva-José C, Sánchez-Polán M, Díaz-Blanco Á, et al · · 2022 · cited 12× · PMID 36360995 · DOI 10.3390/ijerph192114104
4. A Virtual Exercise Program throughout Pregnancy during the COVID-19 Pandemic Modifies Maternal Weight Gain, Smoking Habits and Birth Weight-Randomized Clinical Trial.
   Silva-Jose C, Sánchez-Polán M, Barakat R, Díaz-Blanco Á, et al · · 2022 · cited 12× · PMID 35887809 · DOI 10.3390/jcm11144045
5. Exercise throughout Pregnancy Prevents Excessive Maternal Weight Gain during the COVID-19 Pandemic: A Randomized Clinical Trial.
   Silva-Jose C, Sánchez-Polán M, Barakat R, Díaz-Blanco Á, et al · · 2022 · cited 8× · PMID 35743466 · DOI 10.3390/jcm11123392
6. Influence of a Virtual Exercise Program throughout Pregnancy during the COVID-19 Pandemic on Perineal Tears and Episiotomy Rates: A Randomized Clinical Trial.
   Silva-Jose C, Sánchez-Polán M, Díaz-Blanco Á, Pérez-Medina T, et al · · 2021 · cited 7× · PMID 34830530 · DOI 10.3390/jcm10225250
7. Prenatal Exercise Decreases Urinary Incontinence in Late Pregnancy and 3 Months Postpartum: A Randomized Controlled Trial.
   Zhang D, Sánchez-Polán M, Silva-Jose C, Díaz-Blanco Á, et al · · 2025 · cited 1× · PMID 39809234 · DOI 10.1249/mss.0000000000003597
8. A Supervised Hybrid Prenatal Exercise Program Reduces the Incidence of Macrosomia: A Randomized Controlled Trial.
   Zhang D, Sánchez-Polán M, Díaz-Blanco Á, Brik M, et al · · 2026 · PMID 42118948 · DOI 10.1249/mss.0000000000004035