Impact of an Exercise Program for Children Aged 4 to 6 Years With Bronchopulmonary Dysplasia

August 13, 2015 updated by: Morales, Hospital de Nens de Barcelona

Impacte d'un Programa d'Exercici Per Nens d'Entre 4 a 6 Anys Amb Displàsia Broncopulmonar

The purpose of this study is to determine the effects of a physical activity program for children with Bronchopulmonary Dysplasia.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Primary objectives is: to compare exercise tolerance and aerobic capacity between healthy children with Bronchopulmonary Dysplasia children Only Bronchopulmonary Dysplasia children will realise the physical activity program.

Secondary objectives are: to analyse lung function and to evaluate flexibility.

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 6 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Bronchopulmonary Dysplasia Children

Inclusion Criteria:

  • age between 4 to 6 years old
  • Bronchopulmonary Dysplasia diagnostic
  • ex-prematurity
  • accept to participate.

Exclusion Criteria:

  • congenital malformations
  • neuromuscular disorders
  • gait alterations
  • difficulties for communication and understanding
  • wheezing or pulmonary disease two weeks before to start the program
  • hemodynamic changes (heart rate > 130bpm, systolic blood pressure > 130bpm, diastolic blood pressure > 80bpm).
  • heart and/or lung transplantation.

Healthy children Criteria:

Inclusion Criteria:

  • age between 4 to 6 years old.

Exclusion Criteria:

  • antecedents of pulmonary or cardiac chronic disease
  • congenital malformations
  • neuromuscular disorders
  • gait alterations
  • difficulties for communication and understanding
  • wheezing or pulmonary disease two weeks before to start the program
  • hemodynamic changes (heart rate > 130bpm, systolic blood pressure > 130bpm, diastolic blood pressure > 80bpm).
  • heart and/or lung transplantation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Bronchopylmonary Dysplasia Control
Nothing
Experimental: Bronchopylmonary Dysplasia Intervention
physical activity program.
Behavioral: Physical activity program
physical activity program for a bronchopulmonary dysplasia children.
No Intervention: Healthy children
Nothing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
effort tolerance measured by six minute walking test
Time Frame: six minutes
six minutes
aerobic capacity measured by shuttle run test
Time Frame: 15 minutes
15 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
lung function measured by spirometry
Time Frame: 5 minutes
5 minutes
flexibility measured by sit and reach test
Time Frame: 2 minutes
2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Nens de Barcelona

Investigators

  • Principal Investigator: Natalia Morales, Hospital de Nens de Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)

November 1, 2015

Study Registration Dates

First Submitted

August 13, 2015

First Submitted That Met QC Criteria

August 13, 2015

First Posted (Estimate)

August 14, 2015

Study Record Updates

Last Update Posted (Estimate)

August 14, 2015

Last Update Submitted That Met QC Criteria

August 13, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIC-140-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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