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Active Pregnancy Against COVID-19 (ACPREGCOV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04563065
Recruitment Status : Recruiting
First Posted : September 24, 2020
Last Update Posted : September 28, 2020
Sponsor:
Collaborators:
Hospital Severo Ochoa
Puerta de Hierro University Hospital
Hospital Vall d'Hebron
Hospital Universitario de Torrejón de Ardoz
Clínica Zuatzu de San Sebastián
Information provided by (Responsible Party):
Rubén Barakat Carballo, Universidad Politecnica de Madrid

Brief Summary:

Historically and traditionally, the recommendations related to physical exercise during pregnancy have been based more on moral or cultural issues than on scientific evidence. During some phases of history, pregnancy has meant a period of seclusion for women (not only physical). One of the adverse consequences has been the common recommendation of rest as a general rule for pregnant women.

Scientific evidence from recent years has achieved a better understanding of the process of pregnancy and childbirth as well as maternal and fetal responses to exercise. Currently, both from a scientific and clinical/obstetric point of view, there is no doubt about the benefits of an active pregnancy for entire body of pregnant woman, and even her child. In fact, risks of a sedentary lifestyle are applicable to the pregnancy situation, even more with important associated complications during pregnancy and postpartum period.

Unfortunately, the impact of COVID-19 has caused an unprecedented global crisis, in this sense the necessary measures taken by the different administrations, especially in terms of confinement causes (from now on) a large number of complications affecting different populations. In summary a complex situation without established prevention strategies exists.

The pregnant population is, due to the nature of the gestation and delivery process, one of the population groups with the highest risk of adverse outcomes and associated complications and whose consequences include the mother, fetus, newborn and even children. According to an important body of scientific literature and based on an epigenetic effect, the intrauterine environment can be a determining factor for the future human being to evolve regardless of complications and pathologies (cardiovascular, metabolic, psychic, emotional). This is demonstrated by numerous recent scientific evidences that confirm the unfortunate association between an adverse intrauterine environment (due to various factors) and observable postnatal pathologies in infants.

In addition, current publications report the large number and variety of alterations that the COVID-19 situation causes in pregnant women and that includes the entire female organism. This complex situation does not only affect aspects of a physical or physiological nature, but also psychic and emotional factors. In summary, a new state of confinement or similar situations in the near future (impossibility of groupings, distance between people), avoid during the daily life of pregnant women one of the important and recent recommendations made by the international scientific community: a pregnancy physically active.

This is especially relevant, due to the dangerous association between complications of a psychological or emotional nature during pregnancy with pre, peri and postnatal disorders (low birth weights, perinatal complications, altered and prolonged deliveries, etc.), which affect not only to the mother and can determine the health of the future human being. According to the scientific literature and based on an epigenetic effect, the intrauterine environment can be a determining aspect in the health of the future human being and the prevention of complications and pathologies (cardiovascular, metabolic, psychic, emotional). This is demonstrated by numerous and recent scientific evidences that confirm the unfortunate association between an adverse intrauterine environment (due to various factors) and different pathologies during and after pregnancy.

It is evident the change that COVID-19 and its effects will generate in the lifestyle of the pregnant population and the increased probability of suffering associated pathologies in the next 24-36 months. No preventive actions have yet been planned in Spain and its public hospitals against the impact of COVID-19 on the quality of life of pregnant women. It is urgent to design and perform an adequate strategy of intervention for its possible prevention. From the scientific point of view, the recommendations are clear and concrete, an aerobic exercise program, designed and supervised by professionals from the Sciences of Physical Activity and Sports, is the best option for pregnant women.

In this sense, in the last 30 years, physical exercise has proven to have many benefits for pregnant women, without causing risks or adverse effects on maternal-fetal well-being. This is confirmed by an important body of scientific literature on gestational physical exercise and its effects on pregnancy outcomes.


Condition or disease Intervention/treatment Phase
Pregnancy Complications Pregnancy, High Risk Pregnancy Induced Hypertension Newborn Morbidity Fetal Growth Retardation Fetus Disorder Weight Gain, Maternal Maternal-Fetal Relations Other: Exercise program Other: Healthy lifestyle advise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Active Pregnancy, Prevention Against the Effects of COVID-19
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise group

The design of the physical exercise program will be supported by the Canadian and Spanish Guidelines for exercise throughout pregnancy (11,13) and published by Barakat model (10).

Frequency: The program will consist of three weekly sessions. The duration of every session will be 55-60 minutes. The intensity of the workload will be 55-60% of the maximum maternal Heart Rate, and controlled by Polar monitor (FT60). Likewise, once a week, the Borg Scale of Perceived Effort will be administered to participants, in order to have a more reliable assessment of the intensity of the activities, 12-14 (moderate; out of a 20 point scale) will be the level used.

The minimum adherence required for the participants will be 80% of the total sessions (approximately 80 sessions).

Other: 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).

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

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).



Primary Outcome Measures :
  1. Maternal weight gain [ Time Frame: 9 months ]
    analyze the increase during pregnancy

  2. blood pressure [ Time Frame: 9 months ]
    analyze how it varies during pregnancy

  3. OGTT-O'Sullivan test [ Time Frame: 1 month ]
    analyze the value and its interrelationship with physical exercise patterns

  4. 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)

  5. 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)

  6. depression scale (CES-D) [ Time Frame: 9 months ]
    analyze with a questionnaire the variability during pregnancy (Likert scale 0-3)

  7. Behavior of Fetal Heart Rate [ Time Frame: 3 months ]
    analyze variability during pregnancy

  8. gestational age [ Time Frame: 9 months ]
    analyze the value and its interrelationship with physical exercise patterns

  9. 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

  10. duration of labor [ Time Frame: 1 month ]
    analyze the value and its interrelationship with physical exercise patterns

  11. birthweight [ Time Frame: 1 month ]
    analyze the value and its interrelationship with physical exercise patterns

  12. child's weight [ Time Frame: 24 months ]
    analyze the value and its interrelationship with physical exercise patterns during pregnancy

  13. child's height [ Time Frame: 24 months ]
    analyze the value and its interrelationship with physical exercise patterns during pregnancy

  14. 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)


Secondary Outcome Measures :
  1. Maternal pains during pregnancy (headache, back pain, pelvic pain, paravertebral, scapular, etc.) [ Time Frame: 9 months ]
    analyze the value and its interrelationship with physical exercise patterns

  2. fetal growth and development [ Time Frame: 9 months ]
    analyze the value and its interrelationship with physical exercise patterns

  3. Delivery tears [ Time Frame: 1 month ]
    analyze the value and its interrelationship with physical exercise patterns

  4. performing episiotomy during childbirth [ Time Frame: 1 month ]
    analyze the appearance (descriptive: yes/no) and its interrelationship with physical exercise patterns

  5. Apgar Score [ Time Frame: 1 month ]
    analyze the value and its interrelationship with physical exercise patterns

  6. length [ Time Frame: 1 month ]
    analyze the value and its interrelationship with physical exercise patterns

  7. cranial perimeter [ Time Frame: 1 month ]
    analyze the value and its interrelationship with physical exercise patterns

  8. Landau reflexes test [ Time Frame: 1 month ]
    analyze the value and its interrelationship with physical exercise patterns

  9. neonatal intensive care unit (NICU) [ Time Frame: 1 month ]
    analyze the number of admissions and its interrelationship with physical exercise patterns

  10. Postpartum recovery of pre-pregnancy weight [ Time Frame: 12 months ]
    analyze how it varies during postpartum period

  11. Edinburgh Postpartum Depression Scale (EPDS) [ Time Frame: 12 months ]
    analyze with a questionnaire how it varies during postpartum period (Likert scale 0-3)


Other Outcome Measures:
  1. Perception of health status - SF36 health scale [ Time Frame: 24 months ]
    analyze the value and its interrelationship with physical exercise patterns (Likert scale)

  2. Recovery of pelvic floor muscles ultrasound [ Time Frame: 6 months ]
    analyze the diameter and thickness of muscles in the perineal area and its interrelationship with physical exercise patterns

  3. Maternal habits of physical activity - Pregnancy Physical Activity Questionnaire (PPAQ) [ Time Frame: 12 months ]
    analyzewith a questionnaire how it varies during and after pregnancy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • Women with absolute contraindications. Women with relative contraindications need permission from obstetric care provider prior to participation(1,2):

Absolute contraindications to exercise:

  • Ruptured membranes.
  • Premature labour.
  • Unexplained persistent vaginal bleeding.
  • Placenta praevia after 28 weeks' gestation.
  • Pre-eclampsia.
  • Incompetent cervix.
  • Intrauterine growth restriction.
  • High-order multiple pregnancy (eg, triplets).
  • Uncontrolled type I diabetes.
  • Uncontrolled hypertension.
  • Uncontrolled thyroid disease.
  • Other serious cardiovascular, respiratory or systemic disorder.

Relative contraindications to exercise:

  • Recurrent pregnancy loss.
  • Gestational hypertension.
  • A history of spontaneous preterm birth.
  • Mild/moderate cardiovascular or respiratory disease.
  • Symptomatic anaemia.
  • Malnutrition.
  • Eating disorder.
  • Twin pregnancy after the 28th week.
  • Other significant medical conditions.

References:

  1. Mottola, M. F., Davenport, M. H., Ruchat, S. M., Davies, G. A., Poitras, V. J., Gray, C. E., … Zehr, L. 2019 Canadian guideline for physical activity throughout pregnancy. British Journal of Sports Medicine, 2018; 52(21), 1339-1346. https://doi.org/10.1136/bjsports-2018-100056.
  2. Barakat R, Díaz-Blanco A, Franco E, Rollán-Malmierca A, Brik M, Vargas M, et al. Guías clínicas para el ejercicio físico durante el embarazo/Clinical guidelines for physical exercise during pregnancy. Prog Obstet Ginecol 2019;62(5):464-471. DOI: 10.20960/j.pog.00231.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04563065


Contacts
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Contact: Cristina Silva-Jose, Msc +34662556019 cristina.silva.jose@upm.es

Locations
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Spain
Facultad de Ciencias de la Actividad Física y el Deporte (INEF) Recruiting
Madrid, Spain, 28040
Contact: Cristina Silva-José, MsC    +34662556019    cristina.silva.jose@upm.es   
Contact: Rubén Barakat    +34910677811    barakatruben@gmail.com   
Principal Investigator: Rubén Barakat, Dr         
Sub-Investigator: Cristina Silva-Jose, Msc         
Sub-Investigator: Ángeles Blanco, Dr         
Sub-Investigator: Irune Alzola, Dr         
Sub-Investigator: Ignacio Refoyo, Dr         
Sub-Investigator: Miguel Sanchez-Polan, Msc         
Facultad de Ciencias de la Actividad Física y el Deporte - INEF Recruiting
Madrid, Spain, 28040
Contact: Rubén Barakat, Dr    910677811 ext +34    barakatruben@gmail.com   
Principal Investigator: Rubén Barakat, Dr         
Sub-Investigator: Cristina Silva-Jose, Msc         
Sub-Investigator: Ángeles Blanco, Dr         
Sub-Investigator: Miguel Sanchez-Polan, Msc         
Sub-Investigator: Ignacio Refoyo, Dr         
Sub-Investigator: Irune Alzola, Dr         
Sub-Investigator: Maia Brik, Dr         
Sub-Investigator: Irene Buhigas, Dr         
Sub-Investigator: Aranzazu Martin, Dr         
Sub-Investigator: Mar Gil, Dr         
Sub-Investigator: Tirso Perez, Dr         
Sub-Investigator: Vanessa Carrero, Dr         
Sub-Investigator: Javier Coterón, Dr         
Sub-Investigator: Javier Gil, Dr         
Sponsors and Collaborators
Universidad Politecnica de Madrid
Hospital Severo Ochoa
Puerta de Hierro University Hospital
Hospital Vall d'Hebron
Hospital Universitario de Torrejón de Ardoz
Clínica Zuatzu de San Sebastián
Investigators
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Study Director: Rubén Barakat, Dr Universidad Politécnica de Madrid (UPM)
Additional Information:
Publications:

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Responsible Party: Rubén Barakat Carballo, Dr, Universidad Politecnica de Madrid
ClinicalTrials.gov Identifier: NCT04563065    
Other Study ID Numbers: UPM-2020-32/33
First Posted: September 24, 2020    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pregnancy Complications
Fetal Growth Retardation
Hypertension, Pregnancy-Induced
Weight Gain
Gestational Weight Gain
Hypertension
Vascular Diseases
Cardiovascular Diseases
Body Weight Changes
Body Weight
Fetal Diseases
Growth Disorders
Pathologic Processes