NCT04619394

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2018

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 6, 2020

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2020

Enrollment Period

6 months

First QC Date

November 2, 2020

Last Update Submit

November 2, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Balance

    Balance analysis by force platform

    24 weeks

Study Arms (3)

Control Group (CG)

NO INTERVENTION

Control Group (CG): Formed by those pregnant women who do not perform any physical exercise, only the basic and instrumental activities of daily life (ABVD and AIVD respectively) and intensity of the physical labor load of very light to moderate. The period from 10-12 SG to 37-41 SG.

Experimental Group 1 (GE1)

ACTIVE COMPARATOR

Experimental Group 1 (GE1): Created for pregnant women who carry out their own program of each monitor in the different sports centers and public and private swimming pools in the South of the Autonomous Community of Galicia. These own programs will all have the same format: initial warm-up phase, main part of indicated and personalized exercises for pregnancies and final phase with a return to calm.

Other: Aquatic exercise - own monitors program

Experimental Group 2 (GE2)

ACTIVE COMPARATOR

Experimental Group 2 (GE2): In this third and last group, we incorporated the AIPAP program into the exclusive programs of each monitor in the various public and private sports centers and swimming pools in the South of the Autonomous Community of Galicia. The researcher trained in this method, together with the monitors who voluntarily wish to do so, will translate said format and program into their sessions.

Other: Aquatic exercise - AIPAP program

Interventions

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.

Experimental Group 1 (GE1)

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.

Experimental Group 2 (GE2)

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Vigo

Pontevedra, 36005, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
BENIGNA BLANCO NUÑEZ

Study Record Dates

First Submitted

November 2, 2020

First Posted

November 6, 2020

Study Start

October 1, 2017

Primary Completion

April 3, 2018

Study Completion

April 22, 2020

Last Updated

November 6, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations