Influence of the Aquatic Physical Activity for the Neurologic Development of the Babies

Introduction: physical activity in infants through aquatic therapy is widely known for the later development of sensory ,cognitive and motor areas. In this way, babies will have a greater sense of freedom, pleasure and memory of the maternal uterus. In addition, the margin therapeutic safety in the water is very broad, which allows an optimal development of aquatic early stimulation programs.

Objective: To determine the relationship between aquatic physical activity in infants and the development of their psychomotor skills in their first year.

Methods: A prospective case-control study will take place for 12 months. Participating infants will be divided in two groups: an experimental group, which will be integrated by 74 babies who will participate with their parents in the aquatic physical activity programme in a heated pool (34-35ºC) and a control group with 71 babies who will not participate in the activities. The aquatic activity will consist on 20 minutes sessions twice a week.

Study Overview

• Status: Unknown
• Conditions: Infant Behavior; Gestational Age Over 30 Weeks
• Intervention / Treatment: Behavioral: Aquatic physical activity in babies

• Study Type: Interventional
• Enrollment (Anticipated): 145
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: María José Aguilar Cordero, Professor; Phone Number: +34 657841751; Email: mariajaguilar@telefonica.net

Study Locations

• Spain
  • Granada, Spain, 18071
    • Recruiting
    • Universidad de Granda
    • Contact: María José Aguilar Cordero, Professor; Phone Number: +34 657841751; Email: mariajaguilar@telefonica.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Commitment to participate voluntarily.
• Signing informed consent to participate in the research, according to the Helsinki Declaration, updated at the 64th General Assembly, Fortaleza, Brazil, October 2013.

Exclusion Criteria:

• Babies who are born with a gestational age of less than 30 weeks.
• Baby changes that prevent physical activity.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; 74 infants who will practice with their parents a programme of aquatic physical activity in a swimming pool for one year. They will be evaluated before and after the programme.	Behavioral: Aquatic physical activity in babies; A programme based on four different types exercises realized in a swimming pool for twelve months. Before the beginning of the aquatic physical activity, the infants will be evaluated. Afther that, the study group will practise the exercises with their parents in 20 minutes sessions twice a week and when they finish the programme they will be evaluated again.
No Intervention: Control group; 71 infants who will not practice the programme. They only will be evaluated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of baby development	According to the Brunet-Lezine test summarized, evaluating 5 items: motor characteristics, adaptation, language, personal and social behavior and warning signs	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the development of affectivity	Test Q-Sort	12 months
Gestational age	Weeks of Gestation at birth	37- 42 Weeks
Labour alterations	Compiled from clinical history	3 months
Apgar at birth	Apgar test	3 months
Newborn data	Compiled from clinical history	3 months
Type of childbirth	Compiled from clinical history	3 months
Nutrition of the baby.	Lactation, formula or complementary feeding	12 months
Family demographic variables	Compiled from clinical history	3 months
Family history of illness.	Compiled from clinical history	3 months
Toxic habits of parents	Compiled from clinical history	3 months

Collaborators and Investigators

• Sponsor: Universidad de Granada

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: December 13, 2016
• First Submitted That Met QC Criteria: May 12, 2017
• First Posted (Actual): May 15, 2017

Study Record Updates

• Last Update Posted (Actual): May 15, 2017
• Last Update Submitted That Met QC Criteria: May 12, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Children; Infant; Babies; Swimming pool; Aquatic physical activity; Motor development; Neurodevelopment
• Other Study ID Numbers: 25/11/2016 UGR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No