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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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24 August 2015 |
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Main ID: |
NCT02523521 |
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Date of registration:
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13/08/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Impact of an Exercise Program for Children Aged 4 to 6 Years With Bronchopulmonary Dysplasia
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Scientific title:
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Impacte d'un Programa d'Exercici Per Nens d'Entre 4 a 6 Anys Amb Displa`sia Broncopulmonar |
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Date of first enrolment:
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August 2015 |
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Target sample size:
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52 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02523521 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
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Phase:
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N/A
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Countries of recruitment
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Spain
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Contacts
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Name:
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Natalia Morales |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital de Nens de Barcelona |
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Name:
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Natalia Morales |
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Address:
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Telephone:
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+34659181232 |
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Email:
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natalimorales3@gmail.com |
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Affiliation:
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Name:
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Natalia Morales |
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Address:
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Telephone:
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+34659181232 |
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Email:
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natalimorales3@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
4 Years
Age maximum:
6 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bronchopulmonary Dysplasia
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Healthy
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Intervention(s)
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Behavioral: Physical activity program
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Primary Outcome(s)
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aerobic capacity measured by shuttle run test
[Time Frame: 15 minutes]
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effort tolerance measured by six minute walking test
[Time Frame: six minutes]
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Secondary Outcome(s)
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flexibility measured by sit and reach test
[Time Frame: 2 minutes]
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lung function measured by spirometry
[Time Frame: 5 minutes]
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Secondary ID(s)
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PIC-140-15
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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