NCT03153839

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
145

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
unknown

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, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 15, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

May 15, 2017

Status Verified

May 1, 2017

Enrollment Period

9 months

First QC Date

December 13, 2016

Last Update Submit

May 12, 2017

Conditions

Infant BehaviorGestational Age Over 30 Weeks

Keywords

ChildrenBabiesInfantSwimming poolAquatic physical activityMotor developmentNeurodevelopment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Evaluation of the development of affectivity

    12 months

  • Gestational age

    37- 42 Weeks

  • Labour alterations

    3 months

  • Apgar at birth

    3 months

  • Newborn data

    3 months

  • +5 more secondary outcomes

Study Arms (2)

Study group

EXPERIMENTAL

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

Control group

NO INTERVENTION

71 infants who will not practice the programme. They only will be evaluated.

Interventions

Aquatic physical activity in babiesBEHAVIORAL

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.

Study group

Eligibility Criteria

Age3 Months - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Granda

Granada, 18071, Spain

RECRUITING

MeSH Terms

Conditions

Infant Behavior

Condition Hierarchy (Ancestors)

Child BehaviorBehavior

Central Study Contacts

María José Aguilar Cordero, Professor

CONTACT

657841751mariajaguilar@telefonica.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 13, 2016

First Posted

May 15, 2017

Study Start

October 1, 2016

Primary Completion

July 1, 2017

Study Completion

November 1, 2017

Last Updated

May 15, 2017

Record last verified: 2017-05

Locations

ES(1)