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

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ClinicalTrials.gov Identifier: NCT01920529
Recruitment Status : Completed
First Posted : August 12, 2013
Last Update Posted : August 12, 2013
Sponsor:
Information provided by (Responsible Party):
Livia Barboza de Andrade, Instituto Materno Infantil Prof. Fernando Figueira

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

Condition or disease Intervention/treatment Phase
Asthma Other: aerobic exercise Not Applicable

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 ).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of a Physical Training Program on Inflammatory Response, Functional Capacity and Quality Life in Children With Moderate and Severe Asthma.
Study Start Date : August 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: aerobic exercise
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.
Other: aerobic 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.
Other Name: physical exercise, physical training

Placebo Comparator: control
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.
Other: aerobic 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.
Other Name: physical exercise, physical training




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   8 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920529


Locations
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Brazil
Integral Medicine Institute Professor. Fernando Figueira-IMIP
Recife, Pernambuco, Brazil, 50070550
Sponsors and Collaborators
Instituto Materno Infantil Prof. Fernando Figueira
Investigators
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Principal Investigator: Livia B Andrade, PhD student Professor of Pediatric Physical Therapy Specialization of integral medicine institute Prof. Fernando Figueira

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Responsible Party: Livia Barboza de Andrade, PhD Student, Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier: NCT01920529     History of Changes
Other Study ID Numbers: livia1971
EASMADOC2013 ( Other Identifier: University Hospital )
First Posted: August 12, 2013    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: August 2013

Keywords provided by Livia Barboza de Andrade, Instituto Materno Infantil Prof. Fernando Figueira:
asthma, aerobic exercise, child, cytokines

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases