Mental Health WellnessGESTACTIVENCT05295264
Active Pregnancy. Mental and Emotional Health Care to Pregnant Woman During and After Coronavirus (COVID-19)
A study testing Moderate exercise program in people with Mental Health Wellness and Emotional Problem, run by Universidad Politecnica de Madrid at 1 site in Spain.
Trial summary
The complex process of pregnancy and childbirth can determine the future health of mother and child. It is the only vital process that involves the modification of practically all of a woman's body systems in order to sustain fetal life. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness, Emotional Problem
- What is being tested?
- Moderate exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSpain
- Study dates
- 17 Mar 2022to 30 Dec 2025
- 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 45 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 providers prior to participation:
- Absolute contraindications to exercise:
- Ruptured membranes.
- Premature labor.
- Unexplained persistent vaginal bleeding.
- Placenta praevia after 28 weeks gestation.
Show all 25Show fewer
- Pre-eclampsia.
- Incompetent cervix.
- Intrauterine growth restriction.
- High-order multiple pregnancies (eg, triplets).
- Uncontrolled type I diabetes.
- Uncontrolled hypertension.
- Uncontrolled thyroid disease.
- Other serious cardiovascular, respiratory, or systemic disorders.
- Relative contraindications to exercise:
- Recurrent pregnancy loss.
- Gestational hypertension.
- A history of spontaneous preterm birth.
- Mild/moderate cardiovascular or respiratory disease.
- Symptomatic anemia.
- Malnutrition.
- Eating disorder.
- Twin pregnancy after the 28th week.
- Other significant medical conditions.
- Women in the CG were asked about their exercise once each trimester using a "Decision Algorithm" and those who are excessively actives were excluded.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- 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. Mental and Emotional Health Care to Pregnant Woman During and After COVID-19
The complex process of pregnancy and childbirth can determine the future health of mother and child. It is the only vital process that involves the modification of practically all of a woman's body systems in order to sustain fetal life. In this sense, it is essential to ensure adequate functioning of all maternal physiological, mental and emotional mechanisms that facilitate fetal growth and development. Complications in any of these health domains and functions may contribute to pathologies and complications that have a detrimental impact on maternal and newborn health.
Pregnancy could be a vulnerable period for women, especially regarding mental and emotional illnesses, which are more likely to manifest during this time compared to other periods of their life. In this sense, a high prevalence of prenatal stress, anxiety and depression exists, which are associated with downstream newborn complications as well.
Read more
Depressive symptoms such as sadness, decreased interest in everyday activities, reduced energy and concentration are generated by the aforementioned gestational lability, these symptoms would appear (mostly) at the beginning of the pregnancy. Feelings of being overwhelmed, uneasiness, threat or imminent danger, uncertainty, difficulty in making decisions, obsessive thoughts could be caused by prenatal anxiety.
According to scientific literature, the consequences of mental and emotional disturbances during pregnancy go beyond the gestational period and affect mother, fetus, newborn, and even child development, including complications such as preterm delivery, prolonged and more instrumental labor, low birth weight, pre-term birth, infant's physical and cognitive developmental delay, and the poor mother-infant relationship.
Read the detailed description
COVID-19. Risks associated with an inactive pregnancy:
The impact of COVID-19 has generated a global crisis never before experienced, which affects physiological, emotional, mental, and social factors for all population groups, including those who are pregnant with important related risks.
The complications associated with confinement (no group support, reduced mobility, the distance between people, etc.), significantly affects the lifestyle of pregnant individuals and potentially remove one of the basic recommendations established by the international scientific community: a physically active lifestyle.
Scientific evidence confirms that engaging in an unhealthy lifestyle during pregnancy, including inactivity, enhances the risk of chronic disease for both mother and fetus. In fact, the growing epidemic of sedentary behavior affects pregnancy and childbirth with adverse pre, peri, and postnatal outcomes. Unfortunately, the situation caused by COVID-19 could further exacerbate sedentary behavior and its associated complications for pregnant women.
Current Status:
Before the COVID-19 pandemic, the range of prenatal mental and emotional alterations was close to 15-30%, the prevalence being particularly high in low- and middle-income countries. However, the new social and economic situation generated by the COVID-19 pandemic has raised these values significantly, in this sense 37% reported clinically relevant symptoms of depression and 57% of pregnant women experienced symptoms of anxiety.
This means that the pandemic has negatively affected the mental and emotional health of pregnant women, and consequently of future generations. It is necessary (urgent) to intervene right now with preventive policies and alternatives.
The difficulty and associated (maternal/fetal) risks of pharmacological treatment of mental and emotional illnesses during pregnancy, requires the scientific search for new alternatives, especially aimed at the prevention of these pathologies.
There are important lifestyle recommendations promoted by the scientific community about establishing elements that ensure a healthy pregnancy. However, a small percentage of pregnant women meet global healthy lifestyle guidelines. In fact, the scientific literature reports an increase of perinatal disorders, for example, a high percentage of women continue to gain excessive weight during pregnancy in spite of mentioned health recommendations, and this in turn also increases the risk for other complications.
There are no official estimates of healthcare costs that these complications generate but obviously, we speculate significant amounts.
Worldwide, 80% of pregnant women or (or maybe more) don´t achieve the minimum weekly amount of 150 minutes of moderate physical activity intensity. In Spain, this inactivity is similar to other countries, with approximately 19.7% of women achieving the American College of Obstetricians and Gynecologists (ACOG) recommendations to be active weekly during pregnancy.
Physical exercise as a preventive factor:
Given this complex problem, it is necessary (urgent) to find non-invasive prevention mechanisms to benefit the wellbeing of the mother and her child, taking into account that pregnancy predisposes the woman to a significant change in lifestyle.
As substantiated by scientific evidence, physical exercise during pregnancy does not cause adverse effects on the mother and fetus. Indeed, physical exercise during pregnancy may prevent chronic disease risk in the mother and fetus.
Although the scientific literature is not entirely conclusive, many studies show the positive influence of a physical activity program during pregnancy on maternal mental and emotional status (even with better benefits if it´s supervised); this could be a good approach to maintain healthy mental wellbeing.
GESTACTIVE will examine the effects of a supervised moderate exercise program during pregnancy as a preventive tool for mental and emotional distress, as well as associated complications. The results of this proposal will contribute to the improvement of the quality of life of pregnant women and thus the promotion of health of future generations.
Hypothesis Aerobic, moderate, and supervised exercise during pregnancy can be an efficient element of the prevention of mental and emotional 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, in non-face-to-face and face-to-face ways, on the prevention of maternal mental and emotional health, fetal, newborn, and infant outcomes 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:
a, All the activities 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. Relaxing 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
- Mental Health Wellness, Emotional Problem
- Being tested
- Moderate exercise program
- Keywords
- pregnancy, exercise, lifestyle, physical activity, fetal-maternal health
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate exercise programOther
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 guidelines 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 and published by Barakat model.
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: Moderate exercise program |
| 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.
Prenatal depression (CES-D)
analyze with a questionnaire the variability during pregnancy (Likert scale 0-3)
Measured: 9 months
Prenatal anxiety, 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
Prenatal stress, Perceived Stress Scale (PSS)
analyze with a questionnaire the value and its interrelationship with physical exercise patterns(Likert scale 0-3)
Measured: 9 months
Postnatal depression, Edinburgh Postnatal Depression Scale (EPDS).
analyze with a questionnaire the value and its interrelationship with physical exercise during pregnancy(Likert scale 0-5)
Measured: 6 months
Postnatal anxiety, State-Trait Anxiety Inventory (STAI)
analyze with a questionnaire the value and its interrelationship with physical exercise patterns (Likert scale 0-3)
Measured: 6 months
Postnatal stress, PSS (Perceived Stress Scale)
analyze with a questionnaire the value and its interrelationship with physical exercise patterns(Likert scale 0-5; higher scores mean a worse outcome)
Measured: 6 months
Secondary outcomes (33)
Maternal weight gain
analyze the increase during pregnancy
Measured: 9 months
Blood pressure
analyze how it varies during pregnancy
Measured: 9 months
O'Sullivan test (OGTT)
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)(Likert scale 0-5; higher scores mean a worse outcome)
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
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 (1 to 10)
Measured: 1 month
Birth length
analyze the value and its interrelationship with physical exercise patterns
Measured: 1 month
Head circumference
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 pattern
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
Umbilical cord Ph
analyze the value and its interrelationship with physical exercise patterns
Measured: 1 month
Fetal development
analyze variables (estimated fetal weight, Fetal cardiac function, fetal measures, 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 cardiovascular disease (CVD) risk.
Measured: 9 months
Maternal sleep habits
analyze with Pittsburgh´s sleep quality index (Likert scale 0-5; higher scores mean a worse outcome)
Measured: 9 months
Maternal body self-perception
analyze using Ben-Toby Walker Body Attitude Questionnaire (Likert scale 0-5; higher scores mean a worse outcome)
Measured: 9 months
Newborn sleep habits
analyze using Brief Infant Sleep Questionnaire (Likert scale 0-5; higher scores mean a worse outcome)
Measured: 24 months
Perception of health status - Short Form 36 health scale
analyze the value and its interrelationship with physical exercise patterns (Likert scale 0-5; higher scores mean a better outcome)
Measured: 9 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 posted25 Mar 2022
- Study start17 Mar 2022
- Primary completion1 Jan 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Mental Health WellnessStudies 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 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 Universitario de Torrejón, Madrid, Hospital Clinic of Barcelona, Hospital Vall d'Hebron, Clinica Zuatzu
- Responsible party
- Principal investigator, Rubén Barakat Carballo, Universidad Politecnica de Madrid
- Investigators
- Rubén Barakat, PhD, Study director, Universidad Politécnica de Madrid (UPM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295264
- Sponsor's protocol ID
- Gestactive2022
- Acronym
- GESTACTIVE
- Status last verified
- Jun 2022
- First submitted
- 24 Mar 2022
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khaire A, Wadhwani N, Madiwale S, Joshi S. Maternal fats and pregnancy complications: Implications for long-term health. Prostaglandins Leukot Essent Fatty Acids. 2020 Jun;157:102098. doi: 10.1016/j.plefa.2020.102098. Epub 2020 Apr 21.
PubMed 32380367Abbasi H, Puusepp-Benazzouz H. Pregnancy Stress, Anxiety, and Depression Sequela on Neonatal Brain Development. JAMA Pediatr. 2020 Sep 1;174(9):908. doi: 10.1001/jamapediatrics.2020.1073. No abstract available.
PubMed 32568372Wenzel ES, Gibbons RD, O'Hara MW, Duffecy J, Maki PM. Depression and anxiety symptoms across pregnancy and the postpartum in low-income Black and Latina women. Arch Womens Ment Health. 2021 Dec;24(6):979-986. doi: 10.1007/s00737-021-01139-y. Epub 2021 May 10.
PubMed 33970310Li H, Bowen A, Bowen R, Muhajarine N, Balbuena L. Mood instability, depression, and anxiety in pregnancy and adverse neonatal outcomes. BMC Pregnancy Childbirth. 2021 Aug 25;21(1):583. doi: 10.1186/s12884-021-04021-y.
PubMed 34429072Graham RM, Jiang L, McCorkle G, Bellando BJ, Sorensen ST, Glasier CM, Ramakrishnaiah RH, Rowell AC, Coker JL, Ou X. Maternal Anxiety and Depression during Late Pregnancy and Newborn Brain White Matter Development. AJNR Am J Neuroradiol. 2020 Oct;41(10):1908-1915. doi: 10.3174/ajnr.A6759. Epub 2020 Sep 10.
PubMed 32912873Hunter SK, Freedman R, Law AJ, Christians U, Holzman JBW, Johnson Z, Hoffman MC. Maternal corticosteroids and depression during gestation and decreased fetal heart rate variability. Neuroreport. 2021 Oct 6;32(14):1170-1174. doi: 10.1097/WNR.0000000000001711.
PubMed 34284445Ullah R, Hasan TN, Rahman MU, Naqvi SS, Sharif N, Ahmad I, Ullah B, Khan I, Ammad M, Arshad N. Coronavirus Family: Responsible Agents for Stress, Depression, and Anxiety during Pregnancy. Psychiatr Danub. 2021 Fall;33(3):425-426. No abstract available.
PubMed 34795194Bivia-Roig G, La Rosa VL, Gomez-Tebar M, Serrano-Raya L, Amer-Cuenca JJ, Caruso S, Commodari E, Barrasa-Shaw A, Lison JF. Analysis of the Impact of the Confinement Resulting from COVID-19 on the Lifestyle and Psychological Wellbeing of Spanish Pregnant Women: An Internet-Based Cross-Sectional Survey. Int J Environ Res Public Health. 2020 Aug 15;17(16):5933. doi: 10.3390/ijerph17165933.
PubMed 32824191Mottola 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 30337460Physical 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 32217980Meander L, Lindqvist M, Mogren I, Sandlund J, West CE, Domellof M. Physical activity and sedentary time during pregnancy and associations with maternal and fetal health outcomes: an epidemiological study. BMC Pregnancy Childbirth. 2021 Feb 27;21(1):166. doi: 10.1186/s12884-021-03627-6.
PubMed 33639879Jones MA, Catov JM, Jeyabalan A, Whitaker KM, Barone Gibbs B. Sedentary behaviour and physical activity across pregnancy and birth outcomes. Paediatr Perinat Epidemiol. 2021 May;35(3):341-349. doi: 10.1111/ppe.12731. Epub 2020 Oct 30.
PubMed 33124060Atkinson L, De Vivo M, Hayes L, Hesketh KR, Mills H, Newham JJ, Olander EK, Smith DM. Encouraging Physical Activity during and after Pregnancy in the COVID-19 Era, and beyond. Int J Environ Res Public Health. 2020 Oct 7;17(19):7304. doi: 10.3390/ijerph17197304.
PubMed 33036326Dadi AF, Miller ER, Bisetegn TA, Mwanri L. Global burden of antenatal depression and its association with adverse birth outcomes: an umbrella review. BMC Public Health. 2020 Feb 4;20(1):173. doi: 10.1186/s12889-020-8293-9.
PubMed 32019560Lebel C, MacKinnon A, Bagshawe M, Tomfohr-Madsen L, Giesbrecht G. Elevated depression and anxiety symptoms among pregnant individuals during the COVID-19 pandemic. J Affect Disord. 2020 Dec 1;277:5-13. doi: 10.1016/j.jad.2020.07.126. Epub 2020 Aug 1.
PubMed 32777604
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. Mental and Emotional Health Care to Pregnant Woman During and After COVID-19
- ClinicalTrials.gov ID
- NCT05295264
- Acronym / sponsor ID
- GESTACTIVE / Gestactive2022
- Conditions
- Mental Health Wellness, Emotional Problem
- Keywords
- pregnancy, exercise, lifestyle, physical activity, fetal-maternal health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Universidad Politecnica de MadridUniversity, hospital or other
- Collaborators
- Hospital Severo Ochoa, Puerta de Hierro University Hospital, Hospital Universitario de Torrejón, Madrid, Hospital Clinic of Barcelona, Hospital Vall d'Hebron, Clinica Zuatzu
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 25 Mar 2022 (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.
The complex process of pregnancy and childbirth can determine the future health of mother and child. It is the only vital process that involves the modification of practically all of a woman's body systems in order to sustain fetal life. In this sense, it is essential to ensure adequate functioning of all maternal physiological, mental and emotional mechanisms that facilitate fetal growth and development. Complications in any of these health domains and functions may contribute to pathologies and complications that have a detrimental impact on maternal and newborn health.
Pregnancy could be a vulnerable period for women, especially regarding mental and emotional illnesses, which are more likely to manifest during this time compared to other periods of their life. In this sense, a high prevalence of prenatal stress, anxiety and depression exists, which are associated with downstream newborn complications as well.
Depressive symptoms such as sadness, decreased interest in everyday activities, reduced energy and concentration are generated by the aforementioned gestational lability, these symptoms would appear (mostly) at the beginning of the pregnancy. Feelings of being overwhelmed, uneasiness, threat or imminent danger, uncertainty, difficulty in making decisions, obsessive thoughts could be caused by prenatal anxiety.
According to scientific literature, the consequences of mental and emotional disturbances during pregnancy go beyond the gestational period and affect mother, fetus, newborn, and even child development, including complications such as preterm delivery, prolonged and more instrumental labor, low birth weight, pre-term birth, infant's physical and cognitive developmental delay, and the poor mother-infant relationship.
Detailed description
COVID-19. Risks associated with an inactive pregnancy:
The impact of COVID-19 has generated a global crisis never before experienced, which affects physiological, emotional, mental, and social factors for all population groups, including those who are pregnant with important related risks.
The complications associated with confinement (no group support, reduced mobility, the distance between people, etc.), significantly affects the lifestyle of pregnant individuals and potentially remove one of the basic recommendations established by the international scientific community: a physically active lifestyle.
Scientific evidence confirms that engaging in an unhealthy lifestyle during pregnancy, including inactivity, enhances the risk of chronic disease for both mother and fetus. In fact, the growing epidemic of sedentary behavior affects pregnancy and childbirth with adverse pre, peri, and postnatal outcomes. Unfortunately, the situation caused by COVID-19 could further exacerbate sedentary behavior and its associated complications for pregnant women.
Current Status:
Before the COVID-19 pandemic, the range of prenatal mental and emotional alterations was close to 15-30%, the prevalence being particularly high in low- and middle-income countries. However, the new social and economic situation generated by the COVID-19 pandemic has raised these values significantly, in this sense 37% reported clinically relevant symptoms of depression and 57% of pregnant women experienced symptoms of anxiety.
This means that the pandemic has negatively affected the mental and emotional health of pregnant women, and consequently of future generations. It is necessary (urgent) to intervene right now with preventive policies and alternatives.
The difficulty and associated (maternal/fetal) risks of pharmacological treatment of mental and emotional illnesses during pregnancy, requires the scientific search for new alternatives, especially aimed at the prevention of these pathologies.
There are important lifestyle recommendations promoted by the scientific community about establishing elements that ensure a healthy pregnancy. However, a small percentage of pregnant women meet global healthy lifestyle guidelines. In fact, the scientific literature reports an increase of perinatal disorders, for example, a high percentage of women continue to gain excessive weight during pregnancy in spite of mentioned health recommendations, and this in turn also increases the risk for other complications.
There are no official estimates of healthcare costs that these complications generate but obviously, we speculate significant amounts.
Worldwide, 80% of pregnant women or (or maybe more) don´t achieve the minimum weekly amount of 150 minutes of moderate physical activity intensity. In Spain, this inactivity is similar to other countries, with approximately 19.7% of women achieving the American College of Obstetricians and Gynecologists (ACOG) recommendations to be active weekly during pregnancy.
Physical exercise as a preventive factor:
Given this complex problem, it is necessary (urgent) to find non-invasive prevention mechanisms to benefit the wellbeing of the mother and her child, taking into account that pregnancy predisposes the woman to a significant change in lifestyle.
As substantiated by scientific evidence, physical exercise during pregnancy does not cause adverse effects on the mother and fetus. Indeed, physical exercise during pregnancy may prevent chronic disease risk in the mother and fetus.
Although the scientific literature is not entirely conclusive, many studies show the positive influence of a physical activity program during pregnancy on maternal mental and emotional status (even with better benefits if it´s supervised); this could be a good approach to maintain healthy mental wellbeing.
GESTACTIVE will examine the effects of a supervised moderate exercise program during pregnancy as a preventive tool for mental and emotional distress, as well as associated complications. The results of this proposal will contribute to the improvement of the quality of life of pregnant women and thus the promotion of health of future generations.
Hypothesis Aerobic, moderate, and supervised exercise during pregnancy can be an efficient element of the prevention of mental and emotional 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, in non-face-to-face and face-to-face ways, on the prevention of maternal mental and emotional health, fetal, newborn, and infant outcomes 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:
a, All the activities 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. Relaxing 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
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Moderate exercise programThe design of the physical exercise program will be supported by the Canadian and Spanish Guidelines for exercise throughout pregnancy and published by Barakat model. 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 45 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 (25 listed)
- Women with absolute contraindications. Women with relative contraindications need permission from obstetric care providers prior to participation:
- Ruptured membranes.
- Premature labor.
- 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 |
|---|---|---|
| Moderate exercise programExercise 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 guidelines 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
Prenatal depression (CES-D)
Time frame: 9 months
analyze with a questionnaire the variability during pregnancy (Likert scale 0-3)
Prenatal anxiety, 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)
Prenatal stress, Perceived Stress Scale (PSS)
Time frame: 9 months
analyze with a questionnaire the value and its interrelationship with physical exercise patterns(Likert scale 0-3)
Postnatal depression, Edinburgh Postnatal Depression Scale (EPDS).
Time frame: 6 months
analyze with a questionnaire the value and its interrelationship with physical exercise during pregnancy(Likert scale 0-5)
Postnatal anxiety, State-Trait Anxiety Inventory (STAI)
Time frame: 6 months
analyze with a questionnaire the value and its interrelationship with physical exercise patterns (Likert scale 0-3)
Postnatal stress, PSS (Perceived Stress Scale)
Time frame: 6 months
analyze with a questionnaire the value and its interrelationship with physical exercise patterns(Likert scale 0-5; higher scores mean a worse outcome)
33 secondary outcomes
Maternal weight gain
Time frame: 9 months
Blood pressure
Time frame: 9 months
O'Sullivan test (OGTT)
Time frame: 1 month
Urinary Incontinence Questionnaire (ICIQ-SF)
Time frame: 9 months
Behavior of Fetal Heart Rate
Time frame: 3 months
Gestational age
Time frame: 9 months
Type of delivery (Vaginal, instrumental or cesarean)
Time frame: 1 month
Duration of labor
Time frame: 1 month
Birthweight
Time frame: 1 month
Child's weight
Time frame: 24 months
Child's height
Time frame: 24 months
Mental assessment of the child (depression questionnaire adapted to childhood)
Time frame: 24 months
Psychomotor behavior of the child
Time frame: 24 months
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
Birth length
Time frame: 1 month
Head circumference
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
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
Perception of health status - Short Form 36 health scale
Time frame: 9 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 32380367Khaire A, Wadhwani N, Madiwale S, Joshi S. Maternal fats and pregnancy complications: Implications for long-term health. Prostaglandins Leukot Essent Fatty Acids. 2020 Jun;157:102098. doi: 10.1016/j.plefa.2020.102098. Epub 2020 Apr 21.
- Background: PubMed 32568372Abbasi H, Puusepp-Benazzouz H. Pregnancy Stress, Anxiety, and Depression Sequela on Neonatal Brain Development. JAMA Pediatr. 2020 Sep 1;174(9):908. doi: 10.1001/jamapediatrics.2020.1073. No abstract available.
- Background: PubMed 33970310Wenzel ES, Gibbons RD, O'Hara MW, Duffecy J, Maki PM. Depression and anxiety symptoms across pregnancy and the postpartum in low-income Black and Latina women. Arch Womens Ment Health. 2021 Dec;24(6):979-986. doi: 10.1007/s00737-021-01139-y. Epub 2021 May 10.
- Background: PubMed 34429072Li H, Bowen A, Bowen R, Muhajarine N, Balbuena L. Mood instability, depression, and anxiety in pregnancy and adverse neonatal outcomes. BMC Pregnancy Childbirth. 2021 Aug 25;21(1):583. doi: 10.1186/s12884-021-04021-y.
- Background: PubMed 32912873Graham RM, Jiang L, McCorkle G, Bellando BJ, Sorensen ST, Glasier CM, Ramakrishnaiah RH, Rowell AC, Coker JL, Ou X. Maternal Anxiety and Depression during Late Pregnancy and Newborn Brain White Matter Development. AJNR Am J Neuroradiol. 2020 Oct;41(10):1908-1915. doi: 10.3174/ajnr.A6759. Epub 2020 Sep 10.
- Background: PubMed 34284445Hunter SK, Freedman R, Law AJ, Christians U, Holzman JBW, Johnson Z, Hoffman MC. Maternal corticosteroids and depression during gestation and decreased fetal heart rate variability. Neuroreport. 2021 Oct 6;32(14):1170-1174. doi: 10.1097/WNR.0000000000001711.
- Background: PubMed 34795194Ullah R, Hasan TN, Rahman MU, Naqvi SS, Sharif N, Ahmad I, Ullah B, Khan I, Ammad M, Arshad N. Coronavirus Family: Responsible Agents for Stress, Depression, and Anxiety during Pregnancy. Psychiatr Danub. 2021 Fall;33(3):425-426. No abstract available.
- Background: PubMed 32824191Bivia-Roig G, La Rosa VL, Gomez-Tebar M, Serrano-Raya L, Amer-Cuenca JJ, Caruso S, Commodari E, Barrasa-Shaw A, Lison JF. Analysis of the Impact of the Confinement Resulting from COVID-19 on the Lifestyle and Psychological Wellbeing of Spanish Pregnant Women: An Internet-Based Cross-Sectional Survey. Int J Environ Res Public Health. 2020 Aug 15;17(16):5933. doi: 10.3390/ijerph17165933.
- 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 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 33639879Meander L, Lindqvist M, Mogren I, Sandlund J, West CE, Domellof M. Physical activity and sedentary time during pregnancy and associations with maternal and fetal health outcomes: an epidemiological study. BMC Pregnancy Childbirth. 2021 Feb 27;21(1):166. doi: 10.1186/s12884-021-03627-6.
- Background: PubMed 33124060Jones MA, Catov JM, Jeyabalan A, Whitaker KM, Barone Gibbs B. Sedentary behaviour and physical activity across pregnancy and birth outcomes. Paediatr Perinat Epidemiol. 2021 May;35(3):341-349. doi: 10.1111/ppe.12731. Epub 2020 Oct 30.
- Individual participant dataSharing planned: No
Related trials for Mental Health Wellness
RecruitingPhase 2/3
Food-Body-Mind Intervention (16 Weeks)
Mental Health Wellness, Emotional Problem
Recruiting
Connecting Families to Improve Parental Self-efficacy and Parent Psychosocial and Infant Health Outcomes in the NICU
Self Efficacy, Infant Development
Active, not recruiting
The IGNITE Study on Concentrated Investment in Black Neighborhoods
Financial Stress, Economic Problems
RecruitingPhase 2
Parenting in 2 Worlds Multisite Trial
Parenting, Mental Health Wellness 1
Recruiting
Future Leaders Program: Testing a Youth Leadership, Engagement, and Mindfulness Program
Adolescent Behavior Problem, Mental Health Wellness 1
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, PhD study director
Universidad Politécnica de Madrid (UPM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate exercise program in people with Mental Health Wellness and Emotional Problem, run by Universidad Politecnica de Madrid at 1 site 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 25 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 1 site 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 (662556019 ext. +34, 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?
Prenatal depression (CES-D) (time frame: 9 months). The study lists 6 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 NCT05295264, which also lists 28 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; AzTrials last refreshed its copy on 8 Nov 2026.