ACPREGCOV: Active Pregnancy Against COVID-19

Sponsor

Universidad Politecnica de Madrid (Other)

Overall Status

Recruiting

CT.gov ID

NCT04563065

Collaborator

Hospital Severo Ochoa (Other), Puerta de Hierro University Hospital (Other), Hospital Vall d'Hebron (Other), Hospital Universitario de Torrejón de Ardoz (Other), Clínica Zuatzu de San Sebastián (Other)

280

Enrollment

Locations

Arms

Anticipated Duration (Months)

140

Patients Per Site

3.4

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Detailed Description

Hypothesis Aerobic, moderate, and supervised exercise during pregnancy can be an efficient element of prevention of alterations that the situation generated by COVID-19 causes to the healthy pregnant population and their children.

Objective Examine the influence of a supervised aerobic exercise program during pregnancy, by non-face-to-face and face-to-face ways, on the prevention of maternal, fetal, newborn and infant alterations during the pandemic state and in the near future.

Material and Methods

Study design.

A randomized clinical trial (RCT) will be carried out, not masked with healthy pregnant women, giving rise to two study groups: exercise group (EG), pregnant women participating in a regular program of supervised physical exercise and control group ( CG), pregnant women who receive normal obstetric monitoring of their pregnancy, including recommendations regarding dietary-nutritional factors, as well as the benefits of an active pregnancy.

All selected pregnant women will sign an Informed Consent before participating in the study.

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

Intervention

General characteristics of the physical exercise program:

The minimum adherence required will be 80% of the total sessions.
Onset: gestational week 9-11, immediately after the first prenatal ultrasound, in order to rule out Obstetric Contraindications for physical exercise.
End: gestational week 38-39.
Frequency: 3 weekly sessions, various possibilities will be offered at different times from which the pregnant woman can choose, in order to promote work and family conciliation.

Basic Considerations:

All the activity carried out will be aerobic.
Avoid working positions in which areas normally overloaded by pregnancy are further affected.
The work corresponding to flexibility will be carried out always bearing in mind that these are pregnant women, this forces us once again not to include forced operating positions in the exercises or to excessively maintain the stretching times in each area.
An adequate fluid intake will be maintained before and after the activity.
Also as a general rule and to eliminate potential risks, the following will be avoided:

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

Structure:

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

Below we offer a greater detail of each part:

Warm-up-General activation. Displacements varied without impact activities (avoiding jumps, falls). Mild work of mobility of the main joints.
Aerobic section. Exercise to increase intensity up to moderate activities, play with sports equipment (balls, ropes, pikes) or choreographies of different musical styles.
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.
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.
Cool down section during 7-8 minutes, aiming to gradually lower the intensity of work with flexibility-stretching and relaxation exercises.
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

Study Type:

Interventional

Anticipated 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 :

Aug 1, 2020

Actual Primary Completion Date :

Nov 30, 2020

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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).

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

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).

Outcome Measures

Primary Outcome Measures

Maternal weight gain [9 months]
analyze the increase during pregnancy
blood pressure [9 months]
analyze how it varies during pregnancy
OGTT-O'Sullivan test [1 month]
analyze the value and its interrelationship with physical exercise patterns
Urinary Incontinence Questionnaire (ICIQ-SF) [9 months]
analyze with a questionnaire the value and its interrelationship with physical exercise patterns (different measures in the questionnaire)
State-Trait Anxiety Inventory (STAI) [9 months]
analyze with a questionnaire the value and its interrelationship with physical exercise patterns (Likert scale 0-3)
depression scale (CES-D) [9 months]
analyze with a questionnaire the variability during pregnancy (Likert scale 0-3)
Behavior of Fetal Heart Rate [3 months]
analyze variability during pregnancy
gestational age [9 months]
analyze the value and its interrelationship with physical exercise patterns
type of delivery (Vaginal, instrumental or cesarean) [1 month]
analyze whether women have had a vaginal, instrumental or cesarean delivery and its interrelationship with physical exercise patterns
duration of labor [1 month]
analyze the value and its interrelationship with physical exercise patterns
birthweight [1 month]
analyze the value and its interrelationship with physical exercise patterns
child's weight [24 months]
analyze the value and its interrelationship with physical exercise patterns during pregnancy
child's height [24 months]
analyze the value and its interrelationship with physical exercise patterns during pregnancy
mental assessment of the child (depression questionnaire adapted to childhood) [24 months]
analyze the value and its interrelationship with physical exercise patterns during pregnancy (Likert scale 0-3)
psychomotor behavior of the child [24 months]
analyze some variables (sitting, crawling, standing, walking, holding objects...) and its relationship with maternal exercise

Secondary Outcome Measures

Maternal pains during pregnancy (headache, back pain, pelvic pain, paravertebral, scapular, etc.) [9 months]
analyze the value and its interrelationship with physical exercise patterns
fetal growth and development [9 months]
analyze the value and its interrelationship with physical exercise patterns
Delivery tears [1 month]
analyze the value and its interrelationship with physical exercise patterns
performing episiotomy during childbirth [1 month]
analyze the appearance (descriptive: yes/no) and its interrelationship with physical exercise patterns
Apgar Score [1 month]
analyze the value and its interrelationship with physical exercise patterns
length [1 month]
analyze the value and its interrelationship with physical exercise patterns
cranial perimeter [1 month]
analyze the value and its interrelationship with physical exercise patterns
Landau reflexes test [1 month]
analyze the value and its interrelationship with physical exercise patterns
neonatal intensive care unit (NICU) [1 month]
analyze the number of admissions and its interrelationship with physical exercise patterns
Postpartum recovery of pre-pregnancy weight [12 months]
analyze how it varies during postpartum period
Edinburgh Postpartum Depression Scale (EPDS) [12 months]
analyze with a questionnaire how it varies during postpartum period (Likert scale 0-3)
umbilical cord Ph [1 month]
analyze the value and its interrelationship with physical exercise patterns
Fetal development [9 months, once a trimester]
analyze variables (estimated fetal weight, FCF, DBT, CRL, SNT, uterine arteries...) by ultrasound
Carotid intima-media thickness (CIMT) [9 months]
Measurement of carotid intima-media thickness (CIMT) with B-mode ultrasound is a noninvasive, sensitive, and reproducible technique for identifying and quantifying subclinical vascular disease and for evaluating CVD risk.
Maternal sleep habits [9 months]
analyze with Pittsburgh´s sleep quality index
maternal body self-perception [9 months]
analyze using Ben-Tobim Walker Body Attitude Questionnaire
Newborn sleep habits [24 months]
analyze using Brief Infant Sleep Questionnaire
Placental angiogenic factors [measured at 24-25 weeks and at 34-35 weeks]
placental growth factor (PIGF)
Placental angiogenic factors [measured at 24-25 weeks and at 34-35 weeks]
soluble fms-like tyrosinekinase-1(sFlt1)
Lipidic profile [measured at 24-25 weeks and at 34-35 weeks]
Total Cholesterol, LDL-Cholesterol, HDL- Cholesterol, Tryglicerids

Other Outcome Measures

Perception of health status - SF36 health scale [24 months]
analyze the value and its interrelationship with physical exercise patterns (Likert scale)
Recovery of pelvic floor muscles ultrasound [6 months]
analyze the diameter and thickness of muscles in the perineal area and its interrelationship with physical exercise patterns
Maternal habits of physical activity - Pregnancy Physical Activity Questionnaire (PPAQ) [12 months]
analyze with a questionnaire how it varies during and after pregnancy
Pregestational maternal patterns [9 months]
analyze sociodemographic and behavioural habits like (smoking, alcoholism, pervious illness, COVID-19, parity, occupation, previous miscarriage...)
Edimburgh postpartum depression scale [6 months]
analyze with a questionnaire the variability in the postpartum
Covid-19 disease [9 months]
analyze the covid-19 condition durign pregnancy and its interrelationship with other variables

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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:

Mottola, M. F., Davenport, M. H., Ruchat, S. M., Davies, G. A., Poitras, V. J., Gray,

E., … Zehr, L. 2019 Canadian guideline for physical activity throughout pregnancy. British Journal of Sports Medicine, 2018; 52(21), 1339-1346. https://doi.org/10.1136/bjsports-2018-100056.

Barakat R, Díaz-Blanco A, Franco E, Rollán-Malmierca A, Brik M, Vargas M, et al. Guías clínicas para el ejercicio físico durante el embarazo/Clinical guidelines for physical exercise during pregnancy. Prog Obstet Ginecol 2019;62(5):464-471. DOI: 10.20960/j.pog.00231.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Facultad de Ciencias de la Actividad Física y el Deporte (INEF)	Madrid		Spain	28040
2	Facultad de Ciencias de la Actividad Física y el Deporte - INEF	Madrid		Spain	28040