- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02523521
Impact of an Exercise Program for Children Aged 4 to 6 Years With Bronchopulmonary Dysplasia
Impacte d'un Programa d'Exercici Per Nens d'Entre 4 a 6 Anys Amb Displàsia Broncopulmonar
Study Overview
Status
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Natalia Morales
- Phone Number: +34659181232
- Email: natalimorales3@gmail.com
Study Locations
-
-
-
Barcelona, Spain, 08009
- Recruiting
- Hospital de Nens
-
Contact:
- Natalia Morales
- Phone Number: +34659181232
- Email: natalimorales3@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
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
Sponsor
Investigators
- Principal Investigator: Natalia Morales, Hospital de Nens de Barcelona
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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