Bronchopulmonary DysplasiaNCT02523521
Impact of an Exercise Program for Children Aged 4 to 6 Years With Bronchopulmonary Dysplasia
A study testing Physical activity program in people with Bronchopulmonary Dysplasia and Healthy, run by Hospital de Nens de Barcelona at 1 site in Spain.
Trial summary
The purpose of this study is to determine the effects of a physical activity program for children with Bronchopulmonary Dysplasia. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchopulmonary Dysplasia, Healthy
- What is being tested?
- Physical activity program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2015to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age between 4 to 6 years old
- Bronchopulmonary Dysplasia diagnostic
- ex-prematurity
- accept to participate.
- age between 4 to 6 years old.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de Nens
Barcelona, Barcelona, 08009
Natalia Morales, +34659181232, natalimorales3@gmail.com
About this study
Official title: Impacte d'un Programa d'Exercici Per Nens d'Entre 4 a 6 Anys Amb Displàsia Broncopulmonar
The purpose of this study is to determine the effects of a physical activity program for children with Bronchopulmonary Dysplasia.
Read the 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.
- Conditions
- Bronchopulmonary Dysplasia, Healthy
- Being tested
- Physical activity program
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity programBehavioural
physical activity program for a bronchopulmonary dysplasia children.
| Study group | Role | What they receive |
|---|---|---|
| Bronchopylmonary Dysplasia Control | No intervention | Nothing |
| Bronchopylmonary Dysplasia Intervention | Experimental | physical activity program. Receives: Behavioral: Physical activity program |
| Healthy children | No intervention | Nothing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
effort tolerance measured by six minute walking test
Measured: six minutes
aerobic capacity measured by shuttle run test
Measured: 15 minutes
Secondary outcomes (2)
lung function measured by spirometry
Measured: 5 minutes
flexibility measured by sit and reach test
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionOct 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Nens de Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morales, Hospital de Nens de Barcelona
- Investigators
- Natalia Morales, Principal investigator, Hospital de Nens de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523521
- Sponsor's protocol ID
- PIC-140-15
- Status last verified
- Aug 2015
- First submitted
- 13 Aug 2015
- Last updated
- 14 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacte d'un Programa d'Exercici Per Nens d'Entre 4 a 6 Anys Amb Displàsia Broncopulmonar
- ClinicalTrials.gov ID
- NCT02523521
- Acronym / sponsor ID
- PIC-140-15
- Conditions
- Bronchopulmonary Dysplasia, Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Hospital de Nens de BarcelonaUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 14 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bronchopylmonary Dysplasia Control | No intervention | –Nothing |
| Bronchopylmonary Dysplasia Intervention | Experimental | Behavioral: Physical activity programphysical activity program. |
| Healthy children | No intervention | –Nothing. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- age between 4 to 6 years old
- Bronchopulmonary Dysplasia diagnostic
- ex-prematurity
- accept to participate.
- age between 4 to 6 years old.
Key exclusion criteria (16 listed)
- congenital malformations
- neuromuscular disorders
- gait alterations
- difficulties for communication and understanding
- wheezing or pulmonary disease two weeks before to start the program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity programphysical activity program for a bronchopulmonary dysplasia children. | Behavioural | Bronchopylmonary Dysplasia Intervention |
Primary outcome
effort tolerance measured by six minute walking test
Time frame: six minutes
aerobic capacity measured by shuttle run test
Time frame: 15 minutes
2 secondary outcomes
lung function measured by spirometry
Time frame: 5 minutes
flexibility measured by sit and reach test
Time frame: 2 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalia Morales principal investigator
Hospital de Nens de Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity program in people with Bronchopulmonary Dysplasia and Healthy, run by Hospital de Nens de Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natalia Morales (+34659181232, natalimorales3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effort tolerance measured by six minute walking test (time frame: six minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2015.