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

Primary Purpose

Bronchopulmonary Dysplasia, Healthy

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Physical activity program

About this trial

This is an interventional supportive care trial for Bronchopulmonary Dysplasia

Eligibility Criteria

4 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Hospital de NensRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

No Intervention

Arm Label

Bronchopylmonary Dysplasia Control

Bronchopylmonary Dysplasia Intervention

Healthy children

Arm Description

Nothing

physical activity program.

Nothing.

Outcomes

Primary Outcome Measures

effort tolerance measured by six minute walking test

aerobic capacity measured by shuttle run test

Secondary Outcome Measures

lung function measured by spirometry

flexibility measured by sit and reach test

Full Information

NCT ID

NCT02523521

First Posted

August 13, 2015

Last Updated

August 13, 2015

Sponsor

Hospital de Nens de Barcelona

1. Study Identification

Unique Protocol Identification Number

NCT02523521

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Unknown status

Study Start Date

August 2015 (undefined)

Primary Completion Date

October 2015 (Anticipated)

Study Completion Date

November 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital de Nens de Barcelona

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bronchopulmonary Dysplasia, Healthy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Bronchopylmonary Dysplasia Control

Arm Type

No Intervention

Arm Description

Nothing

Arm Title

Bronchopylmonary Dysplasia Intervention

Arm Type

Experimental

Arm Description

physical activity program.

Arm Title

Healthy children

Arm Type

No Intervention

Arm Description

Nothing.

Intervention Type

Behavioral

Intervention Name(s)

Physical activity program

Intervention Description

physical activity program for a bronchopulmonary dysplasia children.

Primary Outcome Measure Information:

Title

effort tolerance measured by six minute walking test

Time Frame

six minutes

Title

aerobic capacity measured by shuttle run test

Time Frame

15 minutes

Secondary Outcome Measure Information:

Title

lung function measured by spirometry

Time Frame

5 minutes

Title

flexibility measured by sit and reach test

Time Frame

2 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Natalia Morales

Phone

+34659181232

natalimorales3@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Natalia Morales

Organizational Affiliation

Hospital de Nens de Barcelona

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital de Nens

City

Barcelona

ZIP/Postal Code

08009

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Natalia Morales

Phone

+34659181232

natalimorales3@gmail.com

12. IPD Sharing Statement

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

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