AsthmaAECANCT01920529
Aerobic Exercise in Children With Moderate and Severe Asthma
A study testing aerobic exercise in people with Asthma, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
Trial summary
Regular aerobic physical activity in short-term moderate asthma and severe: Reduce the levels of inflammatory mediators Improves functional capacity Improves Quality of Life Improved lung function Reduces the sensation of dyspnea Improves symptoms scores and medication use Read more about this study
- Who is it for?
- Ages 8 to 19 years
- Conditions the study is for
- Asthma
- What is being tested?
- aerobic exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2011to Mar 2013
- 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 8 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age greater than eight and less than nineteen years
- Diagnosis of moderate to severe persistent asthma according to criteria of GINA
- forced expiratory volume in one minute (FEV1) below 80% of predicts
- Initiation of treatment with inhaled corticosteroids for at least eight weeks before the start of collection.
Who cannot join
- associated disease that limits physical activity, such as neuromuscular disease, congenital or acquired, severe cor pulmonate, severe congenital malformation
- associated with chronic lung disease (cystic fibrosis, bronchiectasis, bronchopulmonary dysplasia, interstitial lung diseases
- significant cognitive deficit, which makes the participant to respond adequately to the questionnaire and / or failure to meet the commands
- exacerbation of crisis (This will be a temporary exclusion criterion, as having taken action as directed by medical routine, the participant can return to training)
- mental deficit.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Integral Medicine Institute Professor. Fernando Figueira-IMIP
Recife, Pernambuco, 50070550
About this study
Official title: Effectiveness of a Physical Training Program on Inflammatory Response, Functional Capacity and Quality Life in Children With Moderate and Severe Asthma.
Regular aerobic physical activity in short-term moderate asthma and severe:
- Reduce the levels of inflammatory mediators
- Improves functional capacity
- Improves Quality of Life
- Improved lung function
- Reduces the sensation of dyspnea
- Improves symptoms scores and medication use
Read the detailed description
Methods: Is designed a randomized clinical trial, efficacy, outpatient physical therapy developed in the Institute of Integrative Medicine Teacher Fernando Figueira (IMIP). A pilot study with 20 participants will be made initially to obtain a sample calculation. Subjectively estimated it will take about 50 participants, with possible losses. Will include children older than eight years, diagnosis of moderate and severe persistent asthma according to criteria of Global Initiative National Asthma (GINA) and forced expiratory volume in one minute (FEV1) below 80% predicted. Will be excluded from the study associated with disease that limits physical activity, such as neuromuscular diseases, congenital or acquired heart disease, chronic lung disease associated exacerbation of the crisis and significant cognitive deficit, which makes the participant to respond adequately to the questionnaire and / or inability to meet the commands. Eligible patients will be randomized into two groups: control group, which is not subjected to any kind of exercise and the intervention group, which will be submitted to aerobic exercise for 30 minutes three times a week for six weeks. The two groups will be evaluated before and at the end of six weeks by testing for 6-minute walk, analysis of dyspnea, questionnaire of quality of life, pulmonary function test (FEV1, FVC), inflammatory markers (cytokine ).
- Conditions
- Asthma
- Being tested
- aerobic exercise
- Keywords
- asthma, aerobic exercise, child, cytokines
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exerciseOther
Also called physical exercise, physical training
Performed aerobic exercise on a treadmill with cardiac predetermined frequency within 6 weeks and frequency of three times per week. All patients were monitored during training.
| Study group | Role | What they receive |
|---|---|---|
| aerobic exercise | Experimental | The study will consist of two groups: Group Comparison (GC) will be submitted to two evaluations at the beginning of a week and end of 6 weeks, without receiving any kind of physical training intervention. Group Training (GT) will undergo two assessments at the beginning of the end of the 1st and 6th week, however will be submitted to aerobic training for six weeks. Supervised aerobic training will be held three times a week for six weeks,treadmill in four consecutive steps each (05 minutes stretching, 05 minutes heating, 20 training minutes (1 st and 2 nd week) and 30 minutes (3 rd to 6 weeks) and cool down 05 minutes). The exercise intensity will be maintained through a desired percentage of heart rate for training (x%) from 70% to 80%, obtaining then the optimal heart rate training. Receives: Other: aerobic exercise |
| control | Placebo comparator | Investigators evaluated the distance walked during the 6-minute walk test and recorded variables such as heart rate, respiratory frequency, pulse oxygen saturation and a scale of perceived exertion (Borg) in the moments before and after the test. There was only evaluation without intervention. Receives: Other: aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory mediators by analyzing cytokines by flow cytometry
Was carried collection of peripheral blood cells separated and analyzed for cytokine flow cytometry method. We evaluated Th1 and Th2 cytokines.
Measured: six weeks
Secondary outcomes (5)
Distance walked during the 6-minute walk
Before and after 6 weeks of intervention
Measured: 6 weeks
Changes in lung function
Assessed by spirometry (forced expiratory volume in one second, forced vital capacity and the relationship of these. Besides, peak expiratory flow.
Measured: Before and after 6 weeks of intervention
Days free of asthma
Measured through a journal that will be recorded days without asthma symptoms such as cough, dyspnea, chest tightness, and use of extra medication.
Measured: After six weeks
Respiratory pressures maxima
Through the evaluation of the maximum inspiratory and expiratory pressure by manuvacuometro
Measured: Before and after 6 weeks
Analysis of cytokines
Measured in blood plasma samples and analyzed by flow cytometry
Measured: Before and after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2013 (estimated)
- Study startAug 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Livia Barboza de Andrade, Instituto Materno Infantil Prof. Fernando Figueira
- Investigators
- Livia B Andrade, PhD student, Principal investigator, Professor of Pediatric Physical Therapy Specialization of integral medicine institute Prof. Fernando Figueira
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920529
- Sponsor's protocol ID
- livia1971
- Other IDs
- EASMADOC2013
- Acronym
- AECA
- Status last verified
- Aug 2013
- First submitted
- 13 May 2013
- Last updated
- 12 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Physical Training Program on Inflammatory Response, Functional Capacity and Quality Life in Children With Moderate and Severe Asthma.
- ClinicalTrials.gov ID
- NCT01920529
- Acronym / sponsor ID
- AECA / livia1971
- Conditions
- Asthma
- Keywords
- asthma, aerobic exercise, child, cytokines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando FigueiraUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 12 Aug 2013 (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.
Regular aerobic physical activity in short-term moderate asthma and severe:
- Reduce the levels of inflammatory mediators
- Improves functional capacity
- Improves Quality of Life
- Improved lung function
- Reduces the sensation of dyspnea
- Improves symptoms scores and medication use
Detailed description
Methods: Is designed a randomized clinical trial, efficacy, outpatient physical therapy developed in the Institute of Integrative Medicine Teacher Fernando Figueira (IMIP). A pilot study with 20 participants will be made initially to obtain a sample calculation. Subjectively estimated it will take about 50 participants, with possible losses. Will include children older than eight years, diagnosis of moderate and severe persistent asthma according to criteria of Global Initiative National Asthma (GINA) and forced expiratory volume in one minute (FEV1) below 80% predicted. Will be excluded from the study associated with disease that limits physical activity, such as neuromuscular diseases, congenital or acquired heart disease, chronic lung disease associated exacerbation of the crisis and significant cognitive deficit, which makes the participant to respond adequately to the questionnaire and / or inability to meet the commands. Eligible patients will be randomized into two groups: control group, which is not subjected to any kind of exercise and the intervention group, which will be submitted to aerobic exercise for 30 minutes three times a week for six weeks. The two groups will be evaluated before and at the end of six weeks by testing for 6-minute walk, analysis of dyspnea, questionnaire of quality of life, pulmonary function test (FEV1, FVC), inflammatory markers (cytokine ).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aerobic exercise | Experimental | Other: aerobic exerciseThe study will consist of two groups: Group Comparison (GC) will be submitted to two evaluations at the beginning of a week and end of 6 weeks, without receiving any kind of physical training intervention. Group Training (GT) will undergo two assessments at the beginning of the end of the 1st and 6th week, however will be submitted to aerobic training for six weeks. Supervised aerobic training will be held three times a week for six weeks,treadmill in four consecutive steps each (05 minutes stretching, 05 minutes heating, 20 training minutes (1 st and 2 nd week) and 30 minutes (3 rd to 6 weeks) and cool down 05 minutes). The exercise intensity will be maintained through a desired percentage of heart rate for training (x%) from 70% to 80%, obtaining then the optimal heart rate training. |
| control | Placebo comparator | Other: aerobic exerciseInvestigators evaluated the distance walked during the 6-minute walk test and recorded variables such as heart rate, respiratory frequency, pulse oxygen saturation and a scale of perceived exertion (Borg) in the moments before and after the test. There was only evaluation without intervention. |
Who may qualify
- Ages
- 8 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age greater than eight and less than nineteen years
- Diagnosis of moderate to severe persistent asthma according to criteria of GINA
- forced expiratory volume in one minute (FEV1) below 80% of predicts
- Initiation of treatment with inhaled corticosteroids for at least eight weeks before the start of collection.
Key exclusion criteria (5 listed)
- associated disease that limits physical activity, such as neuromuscular disease, congenital or acquired, severe cor pulmonate, severe congenital malformation
- associated with chronic lung disease (cystic fibrosis, bronchiectasis, bronchopulmonary dysplasia, interstitial lung diseases
- significant cognitive deficit, which makes the participant to respond adequately to the questionnaire and / or failure to meet the commands
- exacerbation of crisis (This will be a temporary exclusion criterion, as having taken action as directed by medical routine, the participant can return to training)
- mental deficit.
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 |
|---|---|---|
| aerobic exerciseAlso: physical exercise, physical trainingPerformed aerobic exercise on a treadmill with cardiac predetermined frequency within 6 weeks and frequency of three times per week. All patients were monitored during training. | Other | aerobic exercise, control |
Primary outcome
Inflammatory mediators by analyzing cytokines by flow cytometry
Time frame: six weeks
Was carried collection of peripheral blood cells separated and analyzed for cytokine flow cytometry method. We evaluated Th1 and Th2 cytokines.
5 secondary outcomes
Distance walked during the 6-minute walk
Time frame: 6 weeks
Changes in lung function
Time frame: Before and after 6 weeks of intervention
Days free of asthma
Time frame: After six weeks
Respiratory pressures maxima
Time frame: Before and after 6 weeks
Analysis of cytokines
Time frame: Before and after 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
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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.
Livia B Andrade, PhD student principal investigator
Professor of Pediatric Physical Therapy Specialization of integral medicine institute Prof. Fernando Figueira
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise in people with Asthma, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 12 Aug 2013. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory mediators by analyzing cytokines by flow cytometry (time frame: six weeks). 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 12 Aug 2013.