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

HM Children's Hospital

Status: Unknown

Conditions: Healthy; Bronchopulmonary Dysplasia

Treatments: Behavioral: Physical activity program

Study type: Interventional

Funder types: Other

Identifiers

NCT02523521

PIC-140-15

Details and patient eligibility

About

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

Full 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.

Enrollment: 52 estimated patients

Sex: All

Ages: 4 to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 3 patient groups

Bronchopylmonary Dysplasia Control

No Intervention group

Description:

Nothing

Bronchopylmonary Dysplasia Intervention

Experimental group

Description:

physical activity program.

Treatment:

Behavioral: Physical activity program

Healthy children

No Intervention group

Description:

Nothing.