Breathing Versus Aerobic Exercises on Asthma Control

Not Applicable

• Conditions: Asthma

• Registration Number: NCT02065258
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

Background: Asthma is a chronic inflammatory airway disease characterized by reversible obstruction, inflammation and hyperresponsiveness to different stimulus. Aerobic and breathing exercises have been demonstrated to benefit asthmatic patients; however, there is no evidence comparing the effectiveness of the treatments. Objective: To compare the effects of aerobic and breathing exercises on clinical control (primary outcome), psychosocial morbidity and daily life physical activity (secondary outcome) in patients with moderate-to-severe persistent asthma. In addition, thoracoabdominal kinematics, heart rate variability and airway and systemic inflammation will be evaluated. The initial hypothesis will be that both exercises present improved clinical control of asthma. Methods: Forty-eight asthmatic adults will be randomly divided into 2 groups: aerobic (AG) and breathing exercises (BG). All treatments will be performed twice a week for 3 months, totalizing 24 sessions of 40 minutes each. Both groups will complete an educational program consisting of 2 classes at the beginning of the interventions. Before and after interventions, the following parameters will be quantified: clinical control, health related quality of life, levels of anxiety and depression, maximal exercise capacity, autonomic nervous imbalance, daily living physical activity, thoracoabdominal kinematics, inflammatory cells in the sputum, fraction of exhaled nitric oxide (FENO) and systemic inflammatory cytokines. Asthma symptoms will be quantified monthly using diaries. Kolmogorov-Smirnov test will be used to analyze the data normality, and a two-way ANOVA with repeated measures with appropriate post hoc test (Student Newman Keuls) will be used to compare the inter and intra-groups differences

Detailed Description

Both groups completed an educational program that consisted of two classes held once a week, each lasting 2 hours. Presentations and group discussions were done, including information about asthma pathophysiology, medication skills, self-monitoring techniques, and environmental control and avoidance strategies.

Study Timeline

• Study Start: 2013-02
• Status Verified: 2013-12
• Primary Completion: 2014-02
• Study First Submitted: 2014-02-03
• Study First Submitted QC: 2014-02-14
• Last Update Submitted: 2014-02-14
• Study First Posted: 2014-02-17
• Last Update Posted: 2014-02-17
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Asthma moderate and severe
• Asthma will diagnosed (Global Initiative for Asthma -GINA)
• Body Mass Index <35 kg/ m2
• Sedentary
• Medical treatment, for at least 6 months
• Clinically stable

Exclusion Criteria

• Smokers
• Cardiac disease
• Chronic Obstructive Pulmonary Disease
• Active Cancer
• Pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from Clinical Control	After 3 months of intervetion	Clinical control will be evaluated by Asthma Control Questionnaire (ACQ)

Secondary Outcome Measures

Name	Time	Method
Change from psychosocial morbidity	After 3 months of intervetion	The psychosocial morbidity will be quantified by health factors related to quality of life (Asthma quality of life questionnaire- AQLQ) and depression and anxiety levels (HAD score)
Change from Daily life physical activity (DLPA)	After 3 months of intervetion	Daily life physical activity will be assessed using an accelerometer (power Walker SW 610, Japan) that records the total daily number of steps and those performed at moderate intensity ( \>110 steps per minute)

Trial Locations

Locations (1)

Hospital das Clínicas da FMUSP; 🇧🇷 Sao Paulo, SP, Brazil