Aerobic Exercise in Children With Moderate and Severe Asthma

Asthma Clinical Trial

— AECA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01920529
• Other study ID #: livia1971
• Secondary ID: EASMADOC2013
• Status: Completed
• Phase: N/A
• First received: May 13, 2013
• Last updated: August 8, 2013
• Start date: August 2011
• Est. completion date: March 2013

Study information

• Verified date: August 2013
• Source: Instituto Materno Infantil Prof. Fernando Figueira
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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 ).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 19 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

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.

Locations

Country	Name	City	State
Brazil	Integral Medicine Institute Professor. Fernando Figueira-IMIP	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Materno Infantil Prof. Fernando Figueira

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Distance walked during the 6-minute walk	Before and after 6 weeks of intervention	6 weeks	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Respiratory pressures maxima	Through the evaluation of the maximum inspiratory and expiratory pressure by manuvacuometro	Before and after 6 weeks	Yes
Secondary	Analysis of cytokines	Measured in blood plasma samples and analyzed by flow cytometry	Before and after 6 weeks	Yes