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

Effectiveness of a Physical Training Program on Inflammatory Response, Functional Capacity and Quality Life 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

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Other: aerobic exercise

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 ).

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50070550
      • Integral Medicine Institute Professor. Fernando Figueira-IMIP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: physical exercise, physical training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	six weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance walked during the 6-minute walk	Before and after 6 weeks of intervention	6 weeks
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.	Before and after 6 weeks of intervention
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.	After six weeks
Respiratory pressures maxima	Through the evaluation of the maximum inspiratory and expiratory pressure by manuvacuometro	Before and after 6 weeks
Analysis of cytokines	Measured in blood plasma samples and analyzed by flow cytometry	Before and after 6 weeks

Collaborators and Investigators

• Sponsor: Instituto Materno Infantil Prof. Fernando Figueira
• Investigators: Principal Investigator: Livia B Andrade, PhD student, Professor of Pediatric Physical Therapy Specialization of integral medicine institute Prof. Fernando Figueira

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: May 13, 2013
• First Submitted That Met QC Criteria: August 8, 2013
• First Posted (Estimate): August 12, 2013

Study Record Updates

• Last Update Posted (Estimate): August 12, 2013
• Last Update Submitted That Met QC Criteria: August 8, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: asthma, aerobic exercise, child, cytokines
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: livia1971; EASMADOC2013 (Other Identifier: University Hospital)