Study Results
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Basic Information
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UNKNOWN
NA
280 participants
INTERVENTIONAL
2020-08-01
2023-12-31
Brief Summary
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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.
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Detailed Description
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Objective Examine the influence of a supervised aerobic exercise program during pregnancy, by non-face-to-face and face-to-face ways, on the prevention of maternal, fetal, newborn and infant alterations during the pandemic state and in the near future.
Material and Methods
\- Study design.
A randomized clinical trial (RCT) will be carried out, not masked with healthy pregnant women, giving rise to two study groups: exercise group (EG), pregnant women participating in a regular program of supervised physical exercise and control group ( CG), pregnant women who receive normal obstetric monitoring of their pregnancy, including recommendations regarding dietary-nutritional factors, as well as the benefits of an active pregnancy.
All selected pregnant women will sign an Informed Consent before participating in the study.
Women randomly assigned to the 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).
Intervention
General characteristics of the physical exercise program:
* The minimum adherence required will be 80% of the total sessions.
* Onset: gestational week 9-11, immediately after the first prenatal ultrasound, in order to rule out Obstetric Contraindications for physical exercise.
* End: gestational week 38-39.
* Frequency: 3 weekly sessions, various possibilities will be offered at different times from which the pregnant woman can choose, in order to promote work and family conciliation.
Basic Considerations:
1. All the activity carried out will be aerobic.
2. Avoid working positions in which areas normally overloaded by pregnancy are further affected.
3. The work corresponding to flexibility will be carried out always bearing in mind that these are pregnant women, this forces us once again not to include forced operating positions in the exercises or to excessively maintain the stretching times in each area.
4. An adequate fluid intake will be maintained before and after the activity.
5. Also as a general rule and to eliminate potential risks, the following will be avoided:
* Activities that include the Valsalva maneuver.
* High ambient temperatures or very humid environments in order to avoid hyperthermia (body temperature higher than 38º C).
* Sudden movements.
* Positions of extreme muscular tension.
Structure:
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).
Below we offer a greater detail of each part:
I. Warm-up-General activation. Displacements varied without impact activities (avoiding jumps, falls). Mild work of mobility of the main joints.
II. Aerobic section. Exercise to increase intensity up to moderate activities, play with sports equipment (balls, ropes, pikes) or choreographies of different musical styles.
III. Muscle strengthening, general toning exercises of the whole body: lower part (calf, quadriceps, hamstrings, adductors, abductors), upper part (abdominal, pectoral, shoulders, paravertebral musculature). Also exercises for the most weakened and needy muscle groups during pregnancy, the aim is to avoid muscular decompensation.
IV. Coordination and balance exercises: simple tasks of eye-hand and eye-foot coordination with sports equipment, as well as body axis balance exercises.
V. Strengthening the pelvic floor muscles, Kegel exercises will be applied and is basically composed of contractions (slow and fast) of the different structures of the pelvic floor musculature.
VI. Cool down section during 7-8 minutes, aiming to gradually lower the intensity of work with flexibility-stretching and relaxation exercises.
VII. Final Talk. This part is intended for pregnant women to express clearly and openly the sensations and perceptions experienced during the session. The reflection of each participant on the effect of physical practice is sought, not only in the physical or physiological aspect, but also in the psychic and emotional section. The exchange of impressions between the pregnant women, enhances the role of a correctly designed and conducted physical exercise program, as a social mobile of maintenance and improvement of the quality of life of the pregnant woman.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Exercise group
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).
Exercise program
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).
Healthy lifestyle advise
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.
Control group
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).
No interventions assigned to this group
Interventions
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Exercise program
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).
Healthy lifestyle advise
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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:
* Recurrent pregnancy loss.
* Gestational hypertension.
* A history of spontaneous preterm birth.
* Mild/moderate cardiovascular or respiratory disease.
* Symptomatic anaemia.
* Malnutrition.
* Eating disorder.
* Twin pregnancy after the 28th week.
* Other significant medical conditions.
References:
1. Mottola, M. F., Davenport, M. H., Ruchat, S. M., Davies, G. A., Poitras, V. J., Gray, C. E., … Zehr, L. 2019 Canadian guideline for physical activity throughout pregnancy. British Journal of Sports Medicine, 2018; 52(21), 1339-1346. https://doi.org/10.1136/bjsports-2018-100056.
2. Barakat R, Díaz-Blanco A, Franco E, Rollán-Malmierca A, Brik M, Vargas M, et al. Guías clínicas para el ejercicio físico durante el embarazo/Clinical guidelines for physical exercise during pregnancy. Prog Obstet Ginecol 2019;62(5):464-471. DOI: 10.20960/j.pog.00231.
18 Years
50 Years
FEMALE
Yes
Sponsors
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Hospital Severo Ochoa
OTHER
Puerta de Hierro University Hospital
OTHER
Hospital Vall d'Hebron
OTHER
Hospital Universitario de Torrejón,Madrid
OTHER
Clínica Zuatzu de San Sebastián
UNKNOWN
Universidad Politecnica de Madrid
OTHER
Responsible Party
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Rubén Barakat Carballo
Dr
Principal Investigators
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Rubén Barakat, Dr
Role: STUDY_DIRECTOR
Universidad Politécnica de Madrid (UPM)
Locations
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Facultad de Ciencias de la Actividad Física y el Deporte (INEF)
Madrid, , Spain
Facultad de Ciencias de la Actividad Física y el Deporte - INEF
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Reference of the Spanish clinical guidelines of physical exercise for pregnancy
Other Identifiers
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UPM-2020-32/33
Identifier Type: -
Identifier Source: org_study_id
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