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Completed

NCT Number: NCT01920529

Aerobic Exercise 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

Completed

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Key information

Age range

8 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Integral Medicine Institute Professor. Fernando Figueira-IMIP

Recife, Pernambuco, 50070550, Brazil

About this study

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 ).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aerobic Exercise

Other

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.

Other names: physical exercise, physical training

Primary outcomes

  1. 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.

Secondary outcomes

  1. Distance walked during the 6-minute walk

    Time frame: 6 weeks

    Before and after 6 weeks of intervention

  2. Changes in lung function

    Time frame: Before and after 6 weeks of intervention

    Assessed by spirometry (forced expiratory volume in one second, forced vital capacity and the relationship of these. Besides, peak expiratory flow.

  3. Days free of asthma

    Time frame: After six weeks

    Measured through a journal that will be recorded days without asthma symptoms such as cough, dyspnea, chest tightness, and use of extra medication.

  4. Respiratory pressures maxima

    Time frame: Before and after 6 weeks

    Through the evaluation of the maximum inspiratory and expiratory pressure by manuvacuometro

  5. Analysis of cytokines

    Time frame: Before and after 6 weeks

    Measured in blood plasma samples and analyzed by flow cytometry

Sponsors and collaborators

Lead sponsor

Instituto Materno Infantil Prof. Fernando Figueira

Other

Registry information

Official study title

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

Acronym: AECA

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 12, 2013
Registry last updated
Aug 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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