Pregnancy ComplicationsACPREGCOVNCT04563065
Active Pregnancy Against COVID-19
A study testing Exercise program and Healthy lifestyle advise in people with Pregnancy Complications and Pregnancy, High Risk, run by Universidad Politecnica de Madrid at 2 sites in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Complications, Pregnancy, High Risk, Pregnancy Induced Hypertension
- What is being tested?
- Exercise program and Healthy lifestyle advise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Aug 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 27Show fewer
- 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:
- 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.
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Facultad de Ciencias de la Actividad Física y el Deporte (INEF)
Madrid, 28040
Cristina Silva-José, MsC, +34662556019, cristina.silva.jose@upm.es
Rubén Barakat, +34910677811, barakatruben@gmail.com
- Recruiting
Facultad de Ciencias de la Actividad Física y el Deporte - INEF
Madrid, 28040
Rubén Barakat, Dr, 910677811 ext. +34, barakatruben@gmail.com
Rubén Barakat, Dr
About this study
Official title: Active Pregnancy, Prevention Against the Effects of COVID-19
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.
Read more
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.
Read the detailed description
Hypothesis Aerobic, moderate, and supervised exercise during pregnancy can be an efficient element of prevention of alterations that the situation generated by COVID-19 causes to the healthy pregnant population and their children.
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:
- All the activity carried out will be aerobic.
- Avoid working positions in which areas normally overloaded by pregnancy are further affected.
- 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.
- An adequate fluid intake will be maintained before and after the activity.
- 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:
- 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.
- 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
- Pregnancy Complications, Pregnancy, High Risk, Pregnancy Induced Hypertension, Newborn Morbidity, Fetal Growth Retardation, Fetus Disorder
- Being tested
- Exercise program, Healthy lifestyle advise
- Medical subject headings
- Pregnancy Complications, Hypertension, Pregnancy-Induced, Fetal Growth Retardation, Fetal Diseases, Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programOther
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 adviseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal weight gain
analyze the increase during pregnancy
Measured: 9 months
blood pressure
analyze how it varies during pregnancy
Measured: 9 months
OGTT-O'Sullivan test
analyze the value and its interrelationship with physical exercise patterns
Measured: 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)
Measured: 9 months
State-Trait Anxiety Inventory (STAI)
analyze with a questionnaire the value and its interrelationship with physical exercise patterns (Likert scale 0-3)
Measured: 9 months
depression scale (CES-D)
analyze with a questionnaire the variability during pregnancy (Likert scale 0-3)
Measured: 9 months
Behavior of Fetal Heart Rate
analyze variability during pregnancy
Measured: 3 months
gestational age
analyze the value and its interrelationship with physical exercise patterns
Measured: 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
Measured: 1 month
duration of labor
analyze the value and its interrelationship with physical exercise patterns
Measured: 1 month
birthweight
analyze the value and its interrelationship with physical exercise patterns
Measured: 1 month
child's weight
analyze the value and its interrelationship with physical exercise patterns during pregnancy
Measured: 24 months
child's height
analyze the value and its interrelationship with physical exercise patterns during pregnancy
Measured: 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)
Measured: 24 months
psychomotor behavior of the child
analyze some variables (sitting, crawling, standing, walking, holding objects...) and its relationship with maternal exercise
Measured: 24 months
Secondary outcomes (20)
Maternal pains during pregnancy (headache, back pain, pelvic pain, paravertebral, scapular, etc.)
analyze the value and its interrelationship with physical exercise patterns
Measured: 9 months
fetal growth and development
analyze the value and its interrelationship with physical exercise patterns
Measured: 9 months
Delivery tears
analyze the value and its interrelationship with physical exercise patterns
Measured: 1 month
performing episiotomy during childbirth
analyze the appearance (descriptive: yes/no) and its interrelationship with physical exercise patterns
Measured: 1 month
Apgar Score
analyze the value and its interrelationship with physical exercise patterns
Measured: 1 month
length
analyze the value and its interrelationship with physical exercise patterns
Measured: 1 month
cranial perimeter
analyze the value and its interrelationship with physical exercise patterns
Measured: 1 month
Landau reflexes test
analyze the value and its interrelationship with physical exercise patterns
Measured: 1 month
neonatal intensive care unit (NICU)
analyze the number of admissions and its interrelationship with physical exercise patterns
Measured: 1 month
Postpartum recovery of pre-pregnancy weight
analyze how it varies during postpartum period
Measured: 12 months
Edinburgh Postpartum Depression Scale (EPDS)
analyze with a questionnaire how it varies during postpartum period (Likert scale 0-3)
Measured: 12 months
umbilical cord Ph
analyze the value and its interrelationship with physical exercise patterns
Measured: 1 month
Fetal development
analyze variables (estimated fetal weight, FCF, DBT, CRL, SNT, uterine arteries...) by ultrasound
Measured: 9 months, once a trimester
Carotid intima-media thickness (CIMT)
Measurement of carotid intima-media thickness (CIMT) with B-mode ultrasound is a noninvasive, sensitive, and reproducible technique for identifying and quantifying subclinical vascular disease and for evaluating CVD risk.
Measured: 9 months
Maternal sleep habits
analyze with Pittsburgh´s sleep quality index
Measured: 9 months
maternal body self-perception
analyze using Ben-Tobim Walker Body Attitude Questionnaire
Measured: 9 months
Newborn sleep habits
analyze using Brief Infant Sleep Questionnaire
Measured: 24 months
Placental angiogenic factors
placental growth factor (PIGF)
Measured: measured at 24-25 weeks and at 34-35 weeks
Placental angiogenic factors
soluble fms-like tyrosinekinase-1(sFlt1)
Measured: measured at 24-25 weeks and at 34-35 weeks
Lipidic profile
Total Cholesterol, LDL-Cholesterol, HDL- Cholesterol, Tryglicerids
Measured: measured at 24-25 weeks and at 34-35 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start1 Aug 2020
- Primary completion30 Nov 2020
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Politecnica de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Severo Ochoa, Puerta de Hierro University Hospital, Hospital Vall d'Hebron, Hospital Universitario de Torrejón, Madrid, Clínica Zuatzu de San Sebastián
- Responsible party
- Principal investigator, Rubén Barakat Carballo, Universidad Politecnica de Madrid
- Investigators
- Rubén Barakat, Dr, Study director, Universidad Politécnica de Madrid (UPM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563065
- Sponsor's protocol ID
- UPM-2020-32/33
- Acronym
- ACPREGCOV
- Status last verified
- Jun 2022
- First submitted
- 19 Sep 2020
- Last updated
- 1 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26704894Barakat 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.
PubMed 29529475Barakat 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.
PubMed 30470666Vargas-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.
PubMed 30527949Fernandez-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.
PubMed 32160968Mourtakos 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.
PubMed 25885759Contreras 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.
PubMed 27613707Badon 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.
PubMed 30324807Shrestha 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.
PubMed 31179827Physical 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.
PubMed 32217980Mottola 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.
PubMed 30337460Barakat 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.
PubMed 32613735Yang 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.
PubMed 32354293Della 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.
PubMed 32311350Novakovic 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.
PubMed 23102655
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Pregnancy, Prevention Against the Effects of COVID-19
- ClinicalTrials.gov ID
- NCT04563065
- Acronym / sponsor ID
- ACPREGCOV / UPM-2020-32/33
- Conditions
- Pregnancy Complications, Pregnancy, High Risk, Pregnancy Induced Hypertension, Newborn Morbidity, Fetal Growth Retardation, Fetus Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Universidad Politecnica de MadridUniversity, hospital or other
- Collaborators
- Hospital Severo Ochoa, Puerta de Hierro University Hospital, Hospital Vall d'Hebron, Hospital Universitario de Torrejón, Madrid, Clínica Zuatzu de San Sebastián
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 24 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hypothesis Aerobic, moderate, and supervised exercise during pregnancy can be an efficient element of prevention of alterations that the situation generated by COVID-19 causes to the healthy pregnant population and their children.
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:
- All the activity carried out will be aerobic.
- Avoid working positions in which areas normally overloaded by pregnancy are further affected.
- 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.
- An adequate fluid intake will be maintained before and after the activity.
- 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:
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Exercise program, Other: Healthy lifestyle adviseThe 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). |
| 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). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (27 listed)
- Women with absolute contraindications. Women with relative contraindications need permission from obstetric care provider prior to participation(1,2):
- Ruptured membranes.
- Premature labour.
- Unexplained persistent vaginal bleeding.
- Placenta praevia after 28 weeks' gestation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise programAll 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). | Other | Exercise group |
| Healthy lifestyle adviseThis 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. | Other | Exercise group |
Primary outcome
Maternal weight gain
Time frame: 9 months
analyze the increase during pregnancy
blood pressure
Time frame: 9 months
analyze how it varies during pregnancy
OGTT-O'Sullivan test
Time frame: 1 month
analyze the value and its interrelationship with physical exercise patterns
Urinary Incontinence Questionnaire (ICIQ-SF)
Time frame: 9 months
analyze with a questionnaire the value and its interrelationship with physical exercise patterns (different measures in the questionnaire)
State-Trait Anxiety Inventory (STAI)
Time frame: 9 months
analyze with a questionnaire the value and its interrelationship with physical exercise patterns (Likert scale 0-3)
depression scale (CES-D)
Time frame: 9 months
analyze with a questionnaire the variability during pregnancy (Likert scale 0-3)
Behavior of Fetal Heart Rate
Time frame: 3 months
analyze variability during pregnancy
gestational age
Time frame: 9 months
analyze the value and its interrelationship with physical exercise patterns
type of delivery (Vaginal, instrumental or cesarean)
Time frame: 1 month
analyze whether women have had a vaginal, instrumental or cesarean delivery and its interrelationship with physical exercise patterns
duration of labor
Time frame: 1 month
analyze the value and its interrelationship with physical exercise patterns
birthweight
Time frame: 1 month
analyze the value and its interrelationship with physical exercise patterns
child's weight
Time frame: 24 months
analyze the value and its interrelationship with physical exercise patterns during pregnancy
child's height
Time frame: 24 months
analyze the value and its interrelationship with physical exercise patterns during pregnancy
mental assessment of the child (depression questionnaire adapted to childhood)
Time frame: 24 months
analyze the value and its interrelationship with physical exercise patterns during pregnancy (Likert scale 0-3)
psychomotor behavior of the child
Time frame: 24 months
analyze some variables (sitting, crawling, standing, walking, holding objects...) and its relationship with maternal exercise
20 secondary outcomes
Maternal pains during pregnancy (headache, back pain, pelvic pain, paravertebral, scapular, etc.)
Time frame: 9 months
fetal growth and development
Time frame: 9 months
Delivery tears
Time frame: 1 month
performing episiotomy during childbirth
Time frame: 1 month
Apgar Score
Time frame: 1 month
length
Time frame: 1 month
cranial perimeter
Time frame: 1 month
Landau reflexes test
Time frame: 1 month
neonatal intensive care unit (NICU)
Time frame: 1 month
Postpartum recovery of pre-pregnancy weight
Time frame: 12 months
Edinburgh Postpartum Depression Scale (EPDS)
Time frame: 12 months
umbilical cord Ph
Time frame: 1 month
Fetal development
Time frame: 9 months, once a trimester
Carotid intima-media thickness (CIMT)
Time frame: 9 months
Maternal sleep habits
Time frame: 9 months
maternal body self-perception
Time frame: 9 months
Newborn sleep habits
Time frame: 24 months
Placental angiogenic factors
Time frame: measured at 24-25 weeks and at 34-35 weeks
Placental angiogenic factors
Time frame: measured at 24-25 weeks and at 34-35 weeks
Lipidic profile
Time frame: measured at 24-25 weeks and at 34-35 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
- Background: PubMed 26704894Barakat 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.
- Background: PubMed 29529475Barakat 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.
- Background: PubMed 30470666Barakat 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.
- Background: PubMed 30527949Vargas-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.
- Background: PubMed 32160968Fernandez-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.
- Background: PubMed 25885759Mourtakos 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.
- Background: PubMed 27613707Contreras 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.
- Background: PubMed 30324807Badon 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.
- Background: PubMed 31179827Shrestha 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.
- Background: PubMed 32217980Physical 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.
- Background: PubMed 30337460Mottola 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.
- Background: PubMed 32613735Barakat 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.
- Reference of the Spanish clinical guidelines of physical exercise for pregnancyLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Pregnancy Complications
Active, not recruitingObservational study
A Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns and Outcomes in Atypical Hemolytic Uremic Syndrome Patients
Atypical Hemolytic Uremic Syndrome(aHUS)
Recruiting
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Neonatal Respiratory Distress Related Conditions, Meconium
Recruiting
Feasibility of the "One-Finger Technique" for Identifying the Upper Left Ureter During Para-Aortic Lymphadenectomy
Ovary Cancer, Cervical Cancer
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Active, not recruitingObservational study
Predictive Biomarkers for Precision Management of Pre-cancerous Cervical Neoplasia
HSIL, High Grade Squamous Intraepithelial Lesion, DNA Methylation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rubén Barakat, Dr study director
Universidad Politécnica de Madrid (UPM)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise program and Healthy lifestyle advise in people with Pregnancy Complications and Pregnancy, High Risk, run by Universidad Politecnica de Madrid at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cristina Silva-Jose, Msc (+34662556019, cristina.silva.jose@upm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal weight gain (time frame: 9 months). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04563065, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2022.