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

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
aerobic exercise
Sponsored by
Instituto Materno Infantil Prof. Fernando Figueira
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma, aerobic exercise, child, cytokines

Eligibility Criteria

8 Years - 19 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Integral Medicine Institute Professor. Fernando Figueira-IMIP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

aerobic exercise

control

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Distance walked during the 6-minute walk
Before and after 6 weeks of intervention
Changes in lung function
Assessed by spirometry (forced expiratory volume in one second, forced vital capacity and the relationship of these. Besides, peak expiratory flow.
Days free of asthma
Measured through a journal that will be recorded days without asthma symptoms such as cough, dyspnea, chest tightness, and use of extra medication.
Respiratory pressures maxima
Through the evaluation of the maximum inspiratory and expiratory pressure by manuvacuometro
Analysis of cytokines
Measured in blood plasma samples and analyzed by flow cytometry

Full Information

First Posted
May 13, 2013
Last Updated
August 8, 2013
Sponsor
Instituto Materno Infantil Prof. Fernando Figueira
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1. Study Identification

Unique Protocol Identification Number
NCT01920529
Brief Title
Aerobic Exercise in Children With Moderate and Severe Asthma
Acronym
AECA
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

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Materno Infantil Prof. Fernando Figueira

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 ).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, aerobic exercise, child, cytokines

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aerobic exercise
Arm Type
Experimental
Arm 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.
Arm Title
control
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
aerobic exercise
Other Intervention Name(s)
physical exercise, physical training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Inflammatory mediators by analyzing cytokines by flow cytometry
Description
Was carried collection of peripheral blood cells separated and analyzed for cytokine flow cytometry method. We evaluated Th1 and Th2 cytokines.
Time Frame
six weeks
Secondary Outcome Measure Information:
Title
Distance walked during the 6-minute walk
Description
Before and after 6 weeks of intervention
Time Frame
6 weeks
Title
Changes in lung function
Description
Assessed by spirometry (forced expiratory volume in one second, forced vital capacity and the relationship of these. Besides, peak expiratory flow.
Time Frame
Before and after 6 weeks of intervention
Title
Days free of asthma
Description
Measured through a journal that will be recorded days without asthma symptoms such as cough, dyspnea, chest tightness, and use of extra medication.
Time Frame
After six weeks
Title
Respiratory pressures maxima
Description
Through the evaluation of the maximum inspiratory and expiratory pressure by manuvacuometro
Time Frame
Before and after 6 weeks
Title
Analysis of cytokines
Description
Measured in blood plasma samples and analyzed by flow cytometry
Time Frame
Before and after 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Livia B Andrade, PhD student
Organizational Affiliation
Professor of Pediatric Physical Therapy Specialization of integral medicine institute Prof. Fernando Figueira
Official's Role
Principal Investigator
Facility Information:
Facility Name
Integral Medicine Institute Professor. Fernando Figueira-IMIP
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50070550
Country
Brazil

12. IPD Sharing Statement

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Aerobic Exercise in Children With Moderate and Severe Asthma

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