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

Infant Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03153839
• Other study ID #: 25/11/2016 UGR
• Status: Recruiting
• Phase: N/A
• First received: December 13, 2016
• Last updated: May 12, 2017
• Start date: October 2016
• Est. completion date: November 2017

Study information

• Verified date: May 2017
• Source: Universidad de Granada
• Contact: María José Aguilar Cordero, Professor
• Phone: 657841751
• Email: mariajaguilar[@]telefonica.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 145
• Est. completion date: November 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 12 Months

Eligibility

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.

Related Conditions & MeSH terms

• Gestational Age Over 30 Weeks
• Infant Behavior

Intervention

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.

Locations

Country	Name	City	State
Spain	Universidad de Granda	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

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