Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04619394
Other study ID # EACE01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2017
Est. completion date April 22, 2020

Study information

Verified date November 2020
Source University of Vigo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Research about the balance in pregnant women who perform water exercise and those who do not engage in any type of sporting activity. The initial objectives are to know if there is an improvement in the balance in women who perform aquatic exercise reviewed at the end of pregnancy versus those who do not, through the use of a podiatric platform. This experimental randomized controlled study (RCT) will be carried out in sports centers and / or public or private municipal swimming pools in the south of Galicia The recruitment of passive pregnant women (control group) will be carried out in the health center of Pontevedra Virxe da Peregrina in the first visit to the midwife in the 10th and 12th week of gestation, while the recruitment of the active pregnant women (group experimental 1 and experimental group 2) in the teaching centers of the aquatic exercise sessions in the same weeks of gestation. The women of the three groups will have a low-risk normoevolutive pregnancy and will be studied in the first and third trimesters. The instruments that will be used to obtain data will be through an initial questionnaire, a platform and study of stability through the center of gravity and base of podiatric support. The plan for analyzing the data will be done through SPSS 17.0.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date April 22, 2020
Est. primary completion date April 3, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 35 Years
Eligibility Inclusion Criteria: - The criteria for inclusion of the sample are: 1. Women aged between 20 and 35 years since before 20 years and after 35 years it is associated with a greater maternal and perinatal risk.2. The intensity of the physical workload must be moderate to very light . 3. The gestational age (EG) in which they are captured must be delimited between 10 and 12 weeks of gestation (SG) without any obstetric risk or associated pathology, primiparous or multiparous. Exclusion Criteria: - Exclusion and withdrawal criteria. The exclusion criteria will be: 1. Present any type of absolute / relative obstetric contraindication. 2. Not to have notions of swimming. 3. Multiple pregnancies. 4. Pregnant women with cognitive / physical disability. 5. Present some diagnosed pathology that alters the normal balance as neurological, traumatological or podiatric diseases. The appearance of any warning signs / symptoms such as vaginal bleeding, feeling light-headed or faint, difficulty breathing before doing exercise, chest pain, headache, muscle weakness, pain or swelling in the calves, Regular and painful contractions in the uterus and drip of fluid through the vagina, will imply the abandonment of the physical exercise program that was developing.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Aquatic exercise - own monitors program
Supervision of own exercises by the Monitor with its own program. Two weekly sessions, both aquatic in small glass and large. The activity carried out will be aerobic; They will work with their own body weight and the lightweight floating material they offer in these pools. Exercises will be carried out that favor flexibility, elasticity, resistance and the strengthening of the muscular ligaments. The intensity of the exercises will be moderate and adapted in each month of gestation. We will eliminate positions and exercises that overload the pregnant woman, avoiding possible injuries and obstetric alterations. The start of the program will be established in week 10-12 of the pregnancy and the end in week 37-41. The total number of sessions of the program will be from 25 to 31 (28 sessions of minimum compliance), with a frequency of 2 sessions per week. The duration of these will be 50 minutes and adherence to both experimental groups of =28 classes.
Aquatic exercise - AIPAP program
Supervised by a midwife with AIPAP method. AIPAP method is divided into 10 sessions of 50 minutes that are repeated cyclically with a total of 120 exercises. The sessions are divided into 5 groups with different objectives: 2 sessions of aerobic capacity improvement, 2 sessions of strength improvement, 2 sessions of pelvic elasticity, 2 coordination sessions and the last 4 sessions of the previous ones. The beginning of the program will be established in week 10-12 of pregnancy and the end in week 37-41. The total number of sessions of the program will be 25-31 (28 sessions of minimum compliance), with a frequency of 2 sessions per week. The duration of these will be 50 minutes in both experimental groups. It will be necessary to obtain an adherence to both experimental groups of =28 classes.

Locations

Country Name City State
Spain Universidad de Vigo Pontevedra

Sponsors (1)

Lead Sponsor Collaborator
José M. Cancela

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Balance Balance analysis by force platform 24 weeks
See also
  Status Clinical Trial Phase
Completed NCT03442582 - Afluria Pregnancy Registry
Terminated NCT02161861 - Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study N/A
Not yet recruiting NCT05934318 - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE) N/A
Enrolling by invitation NCT05415371 - Persistent Poverty Counties Pregnant Women With Medicaid N/A
Completed NCT04548102 - Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman N/A
Completed NCT03218956 - Protein Requirement During Lactation N/A
Completed NCT02191605 - Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy N/A
Completed NCT02223637 - Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
Recruiting NCT06049953 - Maternal And Infant Antipsychotic Study
Completed NCT02577536 - PregSource: Crowdsourcing to Understand Pregnancy
Not yet recruiting NCT06336434 - CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy Phase 1/Phase 2
Not yet recruiting NCT05412238 - Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months N/A
Not yet recruiting NCT04786587 - Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
Not yet recruiting NCT05028387 - Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.
Completed NCT02683005 - Study of Hepatitis C Treatment During Pregnancy Phase 1
Completed NCT02783170 - Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women Phase 4
Recruiting NCT02507180 - Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
Recruiting NCT02564250 - Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women N/A
Recruiting NCT02619188 - Nutritional Markers in Normal and Hyperemesis Pregnancies N/A
Completed NCT02523755 - Evaluation of Regional Distribution of Ventilation During Labor With or Without Epidural Analgesia Phase 4