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

NCT ID: NCT02523521

Last Updated: 2015-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2015-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Bronchopulmonary Dysplasia Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Bronchopylmonary Dysplasia Control

Nothing

Group Type NO_INTERVENTION

No interventions assigned to this group

Bronchopylmonary Dysplasia Intervention

physical activity program.

Group Type EXPERIMENTAL

Physical activity program

Intervention Type BEHAVIORAL

physical activity program for a bronchopulmonary dysplasia children.

Healthy children

Nothing.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Physical activity program

physical activity program for a bronchopulmonary dysplasia children.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* age between 4 to 6 years old
* Bronchopulmonary Dysplasia diagnostic
* ex-prematurity
* accept to participate.


* age between 4 to 6 years old.

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:


* 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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital de Nens de Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Morales

physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Natalia Morales

Role: PRINCIPAL_INVESTIGATOR

Hospital de Nens de Barcelona

Locations

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Hospital de Nens

Barcelona, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Natalia Morales

Role: CONTACT

+34659181232

Facility Contacts

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Natalia Morales

Role: primary

+34659181232

Other Identifiers

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PIC-140-15

Identifier Type: -

Identifier Source: org_study_id

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