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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02523521
• Other study ID #: PIC-140-15
• Status: Recruiting
• Phase: N/A
• First received: August 13, 2015
• Last updated: August 13, 2015
• Start date: August 2015
• Est. completion date: November 2015

Study information

• Verified date: August 2015
• Source: Hospital de Nens de Barcelona
• Contact: Natalia Morales
• Phone: +34659181232
• Email: natalimorales3[@]gmail.com
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 6 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Healthy

Intervention

Behavioral:
• Physical activity program
physical activity program for a bronchopulmonary dysplasia children.

Locations

Country	Name	City	State
Spain	Hospital de Nens	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Nens de Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effort tolerance measured by six minute walking test		six minutes	No
Primary	aerobic capacity measured by shuttle run test		15 minutes	No
Secondary	lung function measured by spirometry		5 minutes	No
Secondary	flexibility measured by sit and reach test		2 minutes	No