Active Pregnancy Against COVID-19 (ACPREGCOV)
Pregnancy Complications, Pregnancy, High Risk, Pregnancy Induced Hypertension
About this trial
This is an interventional prevention trial for Pregnancy Complications
Eligibility 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:
- Mottola, M. F., Davenport, M. H., Ruchat, S. M., Davies, G. A., Poitras, V. J., Gray, C. E., … Zehr, L. 2019 Canadian guideline for physical activity throughout pregnancy. British Journal of Sports Medicine, 2018; 52(21), 1339-1346. https://doi.org/10.1136/bjsports-2018-100056.
- Barakat R, Díaz-Blanco A, Franco E, Rollán-Malmierca A, Brik M, Vargas M, et al. Guías clínicas para el ejercicio físico durante el embarazo/Clinical guidelines for physical exercise during pregnancy. Prog Obstet Ginecol 2019;62(5):464-471. DOI: 10.20960/j.pog.00231.
Sites / Locations
- Facultad de Ciencias de la Actividad Física y el Deporte (INEF)Recruiting
- Facultad de Ciencias de la Actividad Física y el Deporte - INEFRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Exercise group
Control 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).
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).