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

Study Overview
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Brief Summary
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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.

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

Conditions
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Infant Behavior, Gestational Age Over 30 Weeks

Intervention / Treatment
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* Behavioral: Aquatic physical activity in babies


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>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<br>* 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.<br>|
| No Intervention: Control group<br>71 infants who will not practice the programme. They only will be evaluated. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Babies, Infant, Swimming pool, Aquatic physical activity, Motor development, Neurodevelopment