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Status unknownNCT05295264GESTACTIVEUpdated Jul 1, 2022

Active Pregnancy. Mental and Emotional Health Care to Pregnant Woman During and After Coronavirus (COVID-19)

An interventional study of Moderate exercise program in Mental Health Wellness and Emotional Problem, sponsored by Universidad Politecnica de Madrid. Status unknown at 1 site in Spain. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-01.

Sponsored by Universidad Politecnica de Madrid · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Recruiting — may be out of date.

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Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 596 studies in Motor Activity with a site in Spain — 149 open to participants now, 185 under way, 1 of them phase 3. Motor Activity · Spain.

Planned enrollment
37th of 538
500 · median 80
Started
2022
with 44 others
No phase
514 of 596
126 open now
Registered
291st of 596
by date

Among the 596 studies in Motor Activity with a site in Spain, this one is the 37th largest by planned enrollment of the 538 interventional ones that give a count, is one of 45 that started in 2022, is one of 514 with no phase, and was the 291st registered.

Motor Activity

9,809 studies on the registry are indexed under Motor Activity; 1,915 are open to participants now.

Browse Motor Activity studies →

Open to participants now

149 of the 596 studies in Motor Activity with a site in Spain are open now. Recruiting first, the newest first:

144 more — sign in →

All 149 open studies →

A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →

Who these studies take

Of the 1,203 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 538 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: 18 Years to 45 Years · female · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 596 studies in Motor Activity with a site in Spain, or all of them as a file.
02

Study 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. 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.

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.

b. Avoid working positions in which areas normally overloaded by pregnancy are further affected.

c. 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.

d. An adequate fluid intake will be maintained before and after the activity.

e. Also as a general rule and to eliminate potential risks, the following will be avoided:

  • Activities that include the Valsalva maneuver.
  • High ambient temperatures or very humid environments in order to avoid hyperthermia (body temperature higher than 38º C).
  • Sudden movements.
  • Positions of extreme muscular tension.

Structure:

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

Below we offer a greater detail of each part:

I. Warm-up-General activation. Displacements varied without impact activities (avoiding jumps, falls). Mild work of mobility of the main joints.

II. Aerobic section. Exercise to increase intensity up to moderate activities, play with sports equipment (balls, ropes, pikes), or choreographies of different musical styles.

III. Muscle strengthening, general toning exercises of the whole body: lower part (calf, quadriceps, hamstrings, adductors, abductors), upper part (abdominal, pectoral, shoulders, paravertebral musculature). Also exercises for the most weakened and needy muscle groups during pregnancy, the aim is to avoid muscular decompensation.

IV. Coordination and balance exercises: simple tasks of eye-hand and eye-foot coordination with sports equipment, as well as body axis balance exercises.

V. Strengthening the pelvic floor muscles, Kegel exercises will be applied and is basically composed of contractions (slow and fast) of the different structures of the pelvic floor musculature.

VI. 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.

03

Conditions studied

  • Mental Health Wellness
  • Emotional Problem

Browse trials for

Keywords

  • pregnancy
  • exercise
  • lifestyle
  • physical activity
  • fetal-maternal health
04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

- 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.

Exclusion criteria

Exclusion Criteria:

Women with absolute . 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.
  • 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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
500 participants (estimated)

Study arms

  • Experimental
    Exercise group

    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).

    Other: Moderate exercise program

  • No intervention
    Control group

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

Interventions

  • OtherModerate exercise program

    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.

06

What researchers measure

Primary outcomes

  1. Prenatal depression (CES-D)

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

    Time frame: 9 months

  2. Prenatal anxiety, State-Trait Anxiety Inventory (STAI)

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

    Time frame: 9 months

  3. Prenatal stress, Perceived Stress Scale (PSS)

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

    Time frame: 9 months

  4. 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)

    Time frame: 6 months

  5. Postnatal anxiety, State-Trait Anxiety Inventory (STAI)

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

    Time frame: 6 months

  6. 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)

    Time frame: 6 months

Secondary outcomes

  1. Maternal weight gain

    analyze the increase during pregnancy

    Time frame: 9 months

  2. Blood pressure

    analyze how it varies during pregnancy

    Time frame: 9 months

  3. O'Sullivan test (OGTT)

    analyze the value and its interrelationship with physical exercise patterns

    Time frame: 1 month

  4. 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)

    Time frame: 9 months

  5. Behavior of Fetal Heart Rate

    analyze variability during pregnancy

    Time frame: 3 months

  6. Gestational age

    analyze the value and its interrelationship with physical exercise patterns

    Time frame: 9 months

  7. 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

    Time frame: 1 month

  8. Duration of labor

    analyze the value and its interrelationship with physical exercise patterns

    Time frame: 1 month

  9. Birthweight

    analyze the value and its interrelationship with physical exercise patterns

    Time frame: 1 month

  10. Child's weight

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

    Time frame: 24 months

  11. Child's height

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

    Time frame: 24 months

  12. 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)

    Time frame: 24 months

  13. Psychomotor behavior of the child

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

    Time frame: 24 months

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

    analyze the value and its interrelationship with physical exercise patterns

    Time frame: 9 months

  15. Fetal growth and development

    analyze the value and its interrelationship with physical exercise patterns

    Time frame: 9 months

  16. Delivery tears

    analyze the value and its interrelationship with physical exercise patterns

    Time frame: 1 month

  17. Performing episiotomy during childbirth

    analyze the appearance (descriptive: yes/no) and its interrelationship with physical exercise patterns

    Time frame: 1 month

  18. Apgar Score

    analyze the value and its interrelationship with physical exercise patterns (1 to 10)

    Time frame: 1 month

  19. Birth length

    analyze the value and its interrelationship with physical exercise patterns

    Time frame: 1 month

  20. Head circumference

    analyze the value and its interrelationship with physical exercise patterns

    Time frame: 1 month

  21. Landau reflexes test

    analyze the value and its interrelationship with physical exercise pattern

    Time frame: 1 month

  22. Neonatal intensive care unit (NICU)

    analyze the number of admissions and its interrelationship with physical exercise patterns

    Time frame: 1 month

  23. Postpartum recovery of pre-pregnancy weight

    analyze how it varies during postpartum period

    Time frame: 12 months

  24. Umbilical cord Ph

    analyze the value and its interrelationship with physical exercise patterns

    Time frame: 1 month

  25. Fetal development

    analyze variables (estimated fetal weight, Fetal cardiac function, fetal measures, uterine arteries...) by ultrasound

    Time frame: 9 months, once a trimester

  26. 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.

    Time frame: 9 months

  27. Maternal sleep habits

    analyze with Pittsburgh´s sleep quality index (Likert scale 0-5; higher scores mean a worse outcome)

    Time frame: 9 months

  28. Maternal body self-perception

    analyze using Ben-Toby Walker Body Attitude Questionnaire (Likert scale 0-5; higher scores mean a worse outcome)

    Time frame: 9 months

  29. Newborn sleep habits

    analyze using Brief Infant Sleep Questionnaire (Likert scale 0-5; higher scores mean a worse outcome)

    Time frame: 24 months

  30. 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)

    Time frame: 9 months

  31. Placental angiogenic factors

    placental growth factor (PIGF)

    Time frame: measured at 24-25 weeks and at 34-35 weeks

  32. Placental angiogenic factors

    soluble fms-like tyrosinekinase-1 (sFlt1)

    Time frame: measured at 24-25 weeks and at 34-35 weeks

  33. Lipidic profile

    ( Total Cholesterol, LDL-Cholesterol, HDL- Cholesterol, Tryglicerids)

    Time frame: measured at 24-25 weeks and at 34-35 weeks

Other outcomes

  1. Recovery of pelvic floor muscles ultrasound

    analyze the diameter and thickness of muscles in the perineal area and their interrelationship with physical exercise patterns

    Time frame: 6 months

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

    analyze with a questionnaire how it varies during and after pregnancy

    Time frame: 12 months

  3. Pregestational maternal patterns

    analyze sociodemographic and behavioral habits like (smoking, alcoholism, previous illness, COVID-19, parity, occupation, previous miscarriage...)

    Time frame: 9 months

  4. Coronavirus disease

    analyze the coronavirus condition during pregnancy and its interrelationship with other variables

    Time frame: 9 months

07

Study locations

1 of 1 sites recruiting
  • Facultad de Ciencias de la Actividad Física y el Deporte - INEF
    Madrid, 28040, Spain
    Recruiting
    • Rubén Barakat, Dr · Contactbarakatruben@gmail.com · 910677811
    • Rubén Barakat, Dr · Principal investigator
    • Cristina Silva-Jose, Msc · Sub investigator
    • Miguel Sanchez-Polan, Msc · Sub investigator
    • Ignacio Refoyo, Dr · Sub investigator
    • Tirso Perez, Dr · Sub investigator
    • Javier Coterón, Dr · Sub investigator
    • Vanessa Carrero Martinez, Dr · Sub investigator
    • Laura de Mingo Romanillos, Dr · Sub investigator
    • Irene Fernandez Buhigas, Dr · Sub investigator
    • Fatima Garcia Benasach, Dr · Sub investigator
    • Carmen Orizales Lago, Dr · Sub investigator
    • Montse Palacio, Dr · Sub investigator
    • Adriana Aquise Pino, Dr · Sub investigator
    • Mar Gil Mira, Dr · Sub investigator
    • Ángeles Blanco, Dr · Sub investigator
    • Maia Brik, Dr · Sub investigator
    • Aranzazu Martin Arias, Dr · Sub investigator
08

References and documents

Publications

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  • Wenzel 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 33970310 ↗
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  • Hunter 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 34284445 ↗
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  • Bivia-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 32824191 ↗
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  • Jones 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 33124060 ↗
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  • Wolgast E, Lindh-Astrand L, Lilliecreutz C. Women's perceptions of medication use during pregnancy and breastfeeding-A Swedish cross-sectional questionnaire study. Acta Obstet Gynecol Scand. 2019 Jul;98(7):856-864. doi: 10.1111/aogs.13570. Epub 2019 Mar 20. PubMed 30739330 ↗
  • Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955. PubMed 33239350 ↗
  • Reichetzeder C. Overweight and obesity in pregnancy: their impact on epigenetics. Eur J Clin Nutr. 2021 Dec;75(12):1710-1722. doi: 10.1038/s41430-021-00905-6. Epub 2021 Jul 6. PubMed 34230629 ↗
  • Goldstein RF, Abell SK, Ranasinha S, Misso M, Boyle JA, Black MH, Li N, Hu G, Corrado F, Rode L, Kim YJ, Haugen M, Song WO, Kim MH, Bogaerts A, Devlieger R, Chung JH, Teede HJ. Association of Gestational Weight Gain With Maternal and Infant Outcomes: A Systematic Review and Meta-analysis. JAMA. 2017 Jun 6;317(21):2207-2225. doi: 10.1001/jama.2017.3635. PubMed 28586887 ↗
  • Amezcua-Prieto C, Olmedo-Requena R, Jimenez-Mejias E, Hurtado-Sanchez F, Mozas-Moreno J, Lardelli-Claret P, Jimenez-Moleon JJ. Changes in leisure time physical activity during pregnancy compared to the prior year. Matern Child Health J. 2013 May;17(4):632-8. doi: 10.1007/s10995-012-1038-3. PubMed 22569946 ↗
  • Ribeiro MM, Andrade A, Nunes I. Physical exercise in pregnancy: benefits, risks and prescription. J Perinat Med. 2021 Sep 6;50(1):4-17. doi: 10.1515/jpm-2021-0315. Print 2022 Jan 27. PubMed 34478617 ↗
  • Sanchez-Polan M, Franco E, Silva-Jose C, Gil-Ares J, Perez-Tejero J, Barakat R, Refoyo I. Exercise During Pregnancy and Prenatal Depression: A Systematic Review and Meta-Analysis. Front Physiol. 2021 Jun 28;12:640024. doi: 10.3389/fphys.2021.640024. eCollection 2021. PubMed 34262468 ↗
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Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2022 (actual). Primary completion is estimated for Jan 2024, 21 months after the start.

Of 5,155 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 21 months is above that.

Counting every sponsor, half of 5,215 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 24, 2022
First posted
Mar 25, 2022
StartActual
Mar 17, 2022
Primary completionEst.
Jan 1, 2024
CompletionEst.
Dec 30, 2025
Last update
Jul 1, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05295264
Lead sponsor
Universidad Politecnica de Madrid
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
Rubén Barakat Carballo (Doctor, Universidad Politecnica de Madrid) — Principal investigator
First posted
Mar 25, 2022
Start date
Mar 17, 2022
Primary completion
Jan 1, 2024 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Jul 1, 2022

Study contacts

Cristina Silva-Jose, Msc
Contact
cristina.silva.jose@upm.es
662556019 ext. +34
Rubén Barakat, PhD
study director · Universidad Politécnica de Madrid (UPM)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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