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

Not Applicable

• Conditions: Bronchopulmonary Dysplasia; Healthy
• Interventions: Behavioral: Physical activity program

• Registration Number: NCT02523521
• Lead Sponsor: Hospital de Nens de Barcelona

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.

Study Timeline

• Status Verified: 2015-08
• Study Start: 2015-08
• Study First Submitted: 2015-08-13
• Study First Submitted QC: 2015-08-13
• Last Update Submitted: 2015-08-13
• Study First Posted: 2015-08-14
• Last Update Posted: 2015-08-14
• Primary Completion: 2015-10
• Study Completion: 2015-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bronchopylmonary Dysplasia Intervention	Physical activity program	physical activity program.

Primary Outcome Measures

Name	Time	Method
aerobic capacity measured by shuttle run test	15 minutes
effort tolerance measured by six minute walking test	six minutes

Secondary Outcome Measures

Name	Time	Method
lung function measured by spirometry	5 minutes
flexibility measured by sit and reach test	2 minutes

Trial Locations

Locations (1)

Hospital de Nens; 🇪🇸 Barcelona, Spain