Impact of an Exercise Program for Children Aged 4 to 6 Ye... | NCT02523521

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

NCT02523521

Sponsor

Hospital de Nens de Barcelona

Status

Unknown status

Last Update Posted

Aug 14, 2015Estimated

Enrollment

52Estimated

Phase

Not Applicable

Conditions

Bronchopulmonary Dysplasia
Healthy

Interventions

Physical activity program

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

Oct 2015Estimated

Completion Date

Nov 2015Estimated

First Submitted Date

Aug 13, 2015

First Submission Date that Met QC Criteria

Aug 13, 2015

First Posted Date

Aug 14, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2015

Last Update Posted Date

Aug 14, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bronchopylmonary Dysplasia Control	No Intervention	Nothing
Bronchopylmonary Dysplasia Intervention	Experimental	physical activity program.	Behavioral: Physical activity program
Healthy children	No Intervention	Nothing.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Physical activity program	Behavioral	physical activity program for a bronchopulmonary dysplasia children.	Bronchopylmonary Dysplasia Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
effort tolerance measured by six minute walking test		six minutes
aerobic capacity measured by shuttle run test		15 minutes

Secondary Outcomes

Measure	Description	Time Frame
lung function measured by spirometry		5 minutes
flexibility measured by sit and reach test		2 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Natalia Morales	Contact	+34659181232		natalimorales3@gmail.com

Overall Officials

Name	Affiliation	Role
Natalia Morales	Hospital de Nens de Barcelona	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Nens	Recruiting	Barcelona	Barcelona	08009	Spain

Condition Browse Module

MeSH Terms

ID	Term
D001997	Bronchopulmonary Dysplasia

Ancestor Terms

ID	Term
D055397	Ventilator-Induced Lung Injury
D055370	Lung Injury
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided