Clinical trial NCT01920529: Aerobic Exercise in Children With Moderate and Severe Asthma
Official title: Effectiveness of a Physical Training Program on Inflammatory Response, Functional Capacity and Quality Life in Children With Moderate and Severe Asthma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: asthma, aerobic exercise, child, cytokines
Lead sponsor: Instituto Materno Infantil Prof. Fernando Figueira
Sponsor class: OTHER
First posted: 2013-08-12
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 ).

Eligibility criteria: 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.

Primary outcomes:
measure: Inflammatory mediators by analyzing cytokines by flow cytometry
timeFrame: six weeks
Secondary outcomes:
measure: Distance walked during the 6-minute walk
timeFrame: 6 weeks
measure: Changes in lung function
timeFrame: Before and after 6 weeks of intervention
measure: Days free of asthma
timeFrame: After six weeks
measure: Respiratory pressures maxima
timeFrame: Before and after 6 weeks
measure: Analysis of cytokines
timeFrame: Before and after 6 weeks
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Integral Medicine Institute Professor. Fernando Figueira-IMIP
state: Pernambuco
Study officials:
affiliation: Professor of Pediatric Physical Therapy Specialization of integral medicine institute Prof. Fernando Figueira
name: Livia B Andrade, PhD student
role: PRINCIPAL_INVESTIGATOR
References: