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
1 other identifier
interventional
52
1 country
1
Brief Summary
The purpose of this study is to determine the effects of a physical activity program for children with Bronchopulmonary Dysplasia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 13, 2015
CompletedFirst Posted
Study publicly available on registry
August 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedAugust 14, 2015
August 1, 2015
2 months
August 13, 2015
August 13, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
effort tolerance measured by six minute walking test
six minutes
aerobic capacity measured by shuttle run test
15 minutes
Secondary Outcomes (2)
lung function measured by spirometry
5 minutes
flexibility measured by sit and reach test
2 minutes
Study Arms (3)
Bronchopylmonary Dysplasia Control
NO INTERVENTIONNothing
Bronchopylmonary Dysplasia Intervention
EXPERIMENTALphysical activity program.
Healthy children
NO INTERVENTIONNothing.
Interventions
physical activity program for a bronchopulmonary dysplasia children.
Eligibility Criteria
You may qualify if:
- age between 4 to 6 years old
- Bronchopulmonary Dysplasia diagnostic
- ex-prematurity
- accept to participate.
You may not qualify if:
- 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:
- age between 4 to 6 years old.
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Nens
Barcelona, Barcelona, 08009, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Natalia Morales
Hospital de Nens de Barcelona
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- physiotherapist
Study Record Dates
First Submitted
August 13, 2015
First Posted
August 14, 2015
Study Start
August 1, 2015
Primary Completion
October 1, 2015
Study Completion
November 1, 2015
Last Updated
August 14, 2015
Record last verified: 2015-08