Active Pregnancy Against COVID-19

NCT04563065 | Unknown

• 1 other identifier: UPM-2020-32/33
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pregnancy Complications; Pregnancy, High Risk; Pregnancy Induced Hypertension; Newborn Morbidity; Fetal Growth Retardation; Fetus Disorder; Weight Gain, Maternal; Maternal-Fetal Relations

Outcome Measures

Primary Outcomes (15)

• Maternal weight gain

  analyze the increase during pregnancy

  9 months

• blood pressure

  analyze how it varies during pregnancy

  9 months

• OGTT-O'Sullivan test

  analyze the value and its interrelationship with physical exercise patterns

  1 month

• Urinary Incontinence Questionnaire (ICIQ-SF)

  analyze with a questionnaire the value and its interrelationship with physical exercise patterns (different measures in the questionnaire)

  9 months

• State-Trait Anxiety Inventory (STAI)

  analyze with a questionnaire the value and its interrelationship with physical exercise patterns (Likert scale 0-3)

  9 months

• depression scale (CES-D)

  analyze with a questionnaire the variability during pregnancy (Likert scale 0-3)

  9 months

• Behavior of Fetal Heart Rate

  analyze variability during pregnancy

  3 months

• gestational age

  analyze the value and its interrelationship with physical exercise patterns

  9 months

• type of delivery (Vaginal, instrumental or cesarean)

  analyze whether women have had a vaginal, instrumental or cesarean delivery and its interrelationship with physical exercise patterns

  1 month

• duration of labor

  analyze the value and its interrelationship with physical exercise patterns

  1 month

• birthweight

  analyze the value and its interrelationship with physical exercise patterns

  1 month

• child's weight

  analyze the value and its interrelationship with physical exercise patterns during pregnancy

  24 months

• child's height

  analyze the value and its interrelationship with physical exercise patterns during pregnancy

  24 months

• mental assessment of the child (depression questionnaire adapted to childhood)

  analyze the value and its interrelationship with physical exercise patterns during pregnancy (Likert scale 0-3)

  24 months

• psychomotor behavior of the child

  analyze some variables (sitting, crawling, standing, walking, holding objects...) and its relationship with maternal exercise

  24 months

Secondary Outcomes (20)

• Maternal pains during pregnancy (headache, back pain, pelvic pain, paravertebral, scapular, etc.)

  9 months

• fetal growth and development

  9 months

• Delivery tears

  1 month

• performing episiotomy during childbirth

  1 month

• Apgar Score

  1 month

Other Outcomes (6)

• Perception of health status - SF36 health scale

  24 months

• Recovery of pelvic floor muscles ultrasound

  6 months

• Maternal habits of physical activity - Pregnancy Physical Activity Questionnaire (PPAQ)

  12 months

Study Arms (2)

Exercise group

EXPERIMENTAL

The design of the physical exercise program will be supported by the Canadian and Spanish Guidelines for exercise throughout pregnancy (11,13) and published by Barakat model (10). Frequency: The program will consist of three weekly sessions. The duration of every session will be 55-60 minutes. The intensity of the workload will be 55-60% of the maximum maternal Heart Rate, and controlled by Polar monitor (FT60). Likewise, once a week, the Borg Scale of Perceived Effort will be administered to participants, in order to have a more reliable assessment of the intensity of the activities, 12-14 (moderate; out of a 20 point scale) will be the level used. The minimum adherence required for the participants will be 80% of the total sessions (approximately 80 sessions).

Other: Exercise program; Other: Healthy lifestyle advise

Control group

NO INTERVENTION

Women randomly assigned to the control group (CG) received general advice from their health care provider about the positive effects of physical activity. Participants in the CG had their usual visits with health care providers during pregnancy, which were equal to the exercise group. Women were not discouraged from exercising on their own. However, women in the CG were asked about their exercise once each trimester using a "Decision Algorithm" (by telephone).

Interventions

Exercise program OTHER

All sessions will begin with a warm-up of 7-8 minutes composed of mild movements and joint mobility of upper and lower limbs exercises. Then a central part of 35-40 minutes, four types of activities will be included (aerobic work, muscle strengthening, coordination/balance tasks, pelvic floor exercises), finally a section of flexibility, relaxation and final talk (comments and sharing) will be performed (12-15 minutes).

Exercise group

Healthy lifestyle advise OTHER

This intervention consists of providing infographics and videos with advice on healthy habits throughout the pregnancy process. This type of content will be related to daily physical activity, food recommendations and fundamental exercises to perform during pregnancy.

Exercise group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women fulfilling the following criteria: \>18 years old, singleton pregnancies and planning management and delivery at the research hospitals and also do not participate in any other program of supervised physical exercise.

You may not qualify if:

• Women with absolute contraindications. Women with relative contraindications need permission from obstetric care provider prior to participation(1,2):
• Absolute contraindications to exercise:
• Ruptured membranes.
• Premature labour.
• Unexplained persistent vaginal bleeding.
• Placenta praevia after 28 weeks' gestation.
• Pre-eclampsia.
• Incompetent cervix.
• Intrauterine growth restriction.
• High-order multiple pregnancy (eg, triplets).
• Uncontrolled type I diabetes.
• Uncontrolled hypertension.
• Uncontrolled thyroid disease.
• Other serious cardiovascular, respiratory or systemic disorder.
• Relative contraindications to exercise:

Sponsors & Collaborators

• Universidad Politecnica de Madrid: lead
• Hospital Severo Ochoa: collaborator
• Puerta de Hierro University Hospital: collaborator
• Hospital Vall d'Hebron: collaborator
• Hospital Universitario de Torrejón,Madrid: collaborator
• Clínica Zuatzu de San Sebastián: collaborator

Study Sites (2)

Facultad de Ciencias de la Actividad Física y el Deporte (INEF)

Madrid, 28040, Spain

RECRUITING

Facultad de Ciencias de la Actividad Física y el Deporte - INEF

Madrid, 28040, Spain

RECRUITING

Related Publications (23)

• Barakat R, Pelaez M, Cordero Y, Perales M, Lopez C, Coteron J, Mottola MF. Exercise during pregnancy protects against hypertension and macrosomia: randomized clinical trial. Am J Obstet Gynecol. 2016 May;214(5):649.e1-8. doi: 10.1016/j.ajog.2015.11.039. Epub 2015 Dec 15.

  PMID: 26704894 BACKGROUND

• Barakat R, Franco E, Perales M, Lopez C, Mottola MF. Exercise during pregnancy is associated with a shorter duration of labor. A randomized clinical trial. Eur J Obstet Gynecol Reprod Biol. 2018 May;224:33-40. doi: 10.1016/j.ejogrb.2018.03.009. Epub 2018 Mar 6.

  PMID: 29529475 BACKGROUND

• Barakat R, Refoyo I, Coteron J, Franco E. Exercise during pregnancy has a preventative effect on excessive maternal weight gain and gestational diabetes. A randomized controlled trial. Braz J Phys Ther. 2019 Mar-Apr;23(2):148-155. doi: 10.1016/j.bjpt.2018.11.005. Epub 2018 Nov 17.

  PMID: 30470666 BACKGROUND

• Vargas-Terrones M, Nagpal TS, Barakat R. Impact of exercise during pregnancy on gestational weight gain and birth weight: an overview. Braz J Phys Ther. 2019 Mar-Apr;23(2):164-169. doi: 10.1016/j.bjpt.2018.11.012. Epub 2018 Nov 22.

  PMID: 30527949 BACKGROUND

• Fernandez-Buhigas I, Brik M, Martin-Arias A, Vargas-Terrones M, Varillas D, Barakat R, Santacruz B. Maternal physiological changes at rest induced by exercise during pregnancy: A randomized controlled trial. Physiol Behav. 2020 Jun 1;220:112863. doi: 10.1016/j.physbeh.2020.112863. Epub 2020 Mar 8.

  PMID: 32160968 BACKGROUND

• Mourtakos SP, Tambalis KD, Panagiotakos DB, Antonogeorgos G, Arnaoutis G, Karteroliotis K, Sidossis LS. Maternal lifestyle characteristics during pregnancy, and the risk of obesity in the offspring: a study of 5,125 children. BMC Pregnancy Childbirth. 2015 Mar 21;15:66. doi: 10.1186/s12884-015-0498-z.

  PMID: 25885759 BACKGROUND

• Contreras ZA, Ritz B, Virk J, Cockburn M, Heck JE. Maternal pre-pregnancy and gestational diabetes, obesity, gestational weight gain, and risk of cancer in young children: a population-based study in California. Cancer Causes Control. 2016 Oct;27(10):1273-85. doi: 10.1007/s10552-016-0807-5. Epub 2016 Sep 9.

  PMID: 27613707 BACKGROUND

• Badon SE, Littman AJ, Chan KCG, Tadesse MG, Stapleton PL, Bammler TK, Sorensen TK, Williams MA, Enquobahrie DA. Physical activity and epigenetic biomarkers in maternal blood during pregnancy. Epigenomics. 2018 Nov;10(11):1383-1395. doi: 10.2217/epi-2017-0169. Epub 2018 Oct 16.

  PMID: 30324807 BACKGROUND

• Shrestha D, Workalemahu T, Tekola-Ayele F. Maternal dyslipidemia during early pregnancy and epigenetic ageing of the placenta. Epigenetics. 2019 Oct;14(10):1030-1039. doi: 10.1080/15592294.2019.1629234. Epub 2019 Jun 14.

  PMID: 31179827 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

• Barakat R. An exercise program throughout pregnancy: Barakat model. Birth Defects Res. 2021 Feb 1;113(3):218-226. doi: 10.1002/bdr2.1747. Epub 2020 Jul 2.

  PMID: 32613735 BACKGROUND

• Yang Z, Wang M, Zhu Z, Liu Y. Coronavirus disease 2019 (COVID-19) and pregnancy: a systematic review. J Matern Fetal Neonatal Med. 2022 Apr;35(8):1619-1622. doi: 10.1080/14767058.2020.1759541. Epub 2020 Apr 30.

  PMID: 32354293 BACKGROUND

• Della Gatta AN, Rizzo R, Pilu G, Simonazzi G. Coronavirus disease 2019 during pregnancy: a systematic review of reported cases. Am J Obstet Gynecol. 2020 Jul;223(1):36-41. doi: 10.1016/j.ajog.2020.04.013. Epub 2020 Apr 18.

  PMID: 32311350 BACKGROUND

• Novakovic B, Saffery R. The ever growing complexity of placental epigenetics - role in adverse pregnancy outcomes and fetal programming. Placenta. 2012 Dec;33(12):959-70. doi: 10.1016/j.placenta.2012.10.003. Epub 2012 Oct 24.

  PMID: 23102655 BACKGROUND

• Khan S, Jun L, Nawsherwan, Siddique R, Li Y, Han G, Xue M, Nabi G, Liu J. Association of COVID-19 with pregnancy outcomes in health-care workers and general women. Clin Microbiol Infect. 2020 Jun;26(6):788-790. doi: 10.1016/j.cmi.2020.03.034. Epub 2020 Apr 8. No abstract available.

  PMID: 32278081 BACKGROUND

• Perales M, Valenzuela PL, Barakat R, Cordero Y, Pelaez M, Lopez C, Ruilope LM, Santos-Lozano A, Lucia A. Gestational Exercise and Maternal and Child Health: Effects until Delivery and at Post-Natal Follow-up. J Clin Med. 2020 Jan 31;9(2):379. doi: 10.3390/jcm9020379.

  PMID: 32023833 BACKGROUND

• Pelaez M, Gonzalez-Cerron S, Montejo R, Barakat R. Protective Effect of Exercise in Pregnant Women Including Those Who Exceed Weight Gain Recommendations: A Randomized Controlled Trial. Mayo Clin Proc. 2019 Oct;94(10):1951-1959. doi: 10.1016/j.mayocp.2019.01.050.

  PMID: 31585579 BACKGROUND

• Perales M, Refoyo I, Coteron J, Bacchi M, Barakat R. Exercise during pregnancy attenuates prenatal depression: a randomized controlled trial. Eval Health Prof. 2015 Mar;38(1):59-72. doi: 10.1177/0163278714533566. Epub 2014 May 28.

  PMID: 24872442 BACKGROUND

• Barakat R, Perales M, Garatachea N, Ruiz JR, Lucia A. Exercise during pregnancy. A narrative review asking: what do we know? Br J Sports Med. 2015 Nov;49(21):1377-81. doi: 10.1136/bjsports-2015-094756. Epub 2015 Jul 1.

  PMID: 26135742 BACKGROUND

• Martin-Arias A, Fernandez-Buhigas I, Aramburu-Anglada C, Pino AA, Saez RB, Rolle V, Sanchez-Polan M, Silva-Jose C, Gil MM, Santacruz B. The Effect of a Supervised Exercise Program Throughout Pregnancy on Longitudinal Lipid Profile Changes: A Randomized Clinical Trial. Matern Fetal Med. 2026 Jan;8(1):40-47. doi: 10.1097/FM9.0000000000000318. Epub 2025 Sep 26.

  PMID: 41624594 DERIVED

• Zhang D, Sanchez-Polan M, Silva-Jose C, Diaz-Blanco A, Brik M, Arias AM, Hernando P, Barakat R. Prenatal Exercise Decreases Urinary Incontinence in Late Pregnancy and 3 Months Postpartum: A Randomized Controlled Trial. Med Sci Sports Exerc. 2025 Mar 1;57(3):555-562. doi: 10.1249/MSS.0000000000003597. Epub 2024 Nov 18.

  PMID: 39809234 DERIVED

• Uria-Minguito A, Silva-Jose C, Sanchez-Polan M, Diaz-Blanco A, Garcia-Benasach F, Carrero Martinez V, Alzola I, Barakat R. 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. Int J Environ Res Public Health. 2022 Oct 28;19(21):14104. doi: 10.3390/ijerph192114104.

  PMID: 36360995 DERIVED

Related Links

• Reference of the Spanish clinical guidelines of physical exercise for pregnancy

MeSH Terms

Conditions

Pregnancy Complications; Hypertension, Pregnancy-Induced; Fetal Growth Retardation; Fetal Diseases; Gestational Weight Gain

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Rubén Barakat, Dr

  Universidad Politécnica de Madrid (UPM)

  STUDY DIRECTOR

Central Study Contacts

Cristina Silva-Jose, Msc

CONTACT

+34662556019; cristina.silva.jose@upm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 19, 2020
• First Posted: September 24, 2020
• Study Start: August 1, 2020
• Primary Completion: November 30, 2020
• Study Completion: December 31, 2023
• Last Updated: July 1, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)