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Aerobic Exercise in Children With Moderate and Severe Asthma

Effectiveness of a Physical Training Program on Inflammatory Response, Functional Capacity and Quality Life in Children With Moderate and Severe Asthma.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01920529
Acronym
AECA
Enrollment
50
Registered
2013-08-12
Start date
2011-08-31
Completion date
2013-03-31
Last updated
2013-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

asthma, aerobic exercise, child, cytokines

Brief 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

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 ).

Interventions

OTHERaerobic exercise

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.

Sponsors

Instituto Materno Infantil Prof. Fernando Figueira
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
8 Years to 19 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Inflammatory mediators by analyzing cytokines by flow cytometrysix weeksWas carried collection of peripheral blood cells separated and analyzed for cytokine flow cytometry method. We evaluated Th1 and Th2 cytokines.

Secondary

MeasureTime frameDescription
Distance walked during the 6-minute walk6 weeksBefore and after 6 weeks of intervention
Changes in lung functionBefore and after 6 weeks of interventionAssessed by spirometry (forced expiratory volume in one second, forced vital capacity and the relationship of these. Besides, peak expiratory flow.
Days free of asthmaAfter six weeksMeasured through a journal that will be recorded days without asthma symptoms such as cough, dyspnea, chest tightness, and use of extra medication.
Respiratory pressures maximaBefore and after 6 weeksThrough the evaluation of the maximum inspiratory and expiratory pressure by manuvacuometro
Analysis of cytokinesBefore and after 6 weeksMeasured in blood plasma samples and analyzed by flow cytometry

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026