Aerobic Exercise in Children With Moderate and Severe Asthma (AECA)

Instituto Materno Infantil Prof. Fernando Figueira

Status: Completed

Conditions: Asthma

Treatments: Other: aerobic exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT01920529

EASMADOC2013 (Other Identifier)

livia1971

Details and patient eligibility

About

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

Full 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 ).

Enrollment: 50 patients

Sex: All

Ages: 8 to 19 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

aerobic exercise

Experimental group

Description:

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.

Treatment:

Other: aerobic exercise

control

Placebo Comparator group

Description:

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.

Treatment:

Other: aerobic exercise