MedPath

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.

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
NameTimeMethod
Change from Clinical ControlAfter 3 months of intervetion

Clinical control will be evaluated by Asthma Control Questionnaire (ACQ)

Secondary Outcome Measures
NameTimeMethod
Change from psychosocial morbidityAfter 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

Hospital das Clínicas da FMUSP
🇧🇷Sao Paulo, SP, Brazil
Celso RF Carvalho, PhD
Principal Investigator
Milene G Saccomani, Msc
Principal Investigator
Karen B Evaristo
Principal Investigator
Milton A Martins, MD
Sub Investigator
Rafael Stelmach, MD
Sub Investigator
Alberto Cukier, MD
Sub Investigator
Regina M Carvalho-Pinto, MD
Sub Investigator
Marcos Rojo, Dr
Sub Investigator
Danilo F Santaella, Dr
Sub Investigator
Beatriz M Saraiva-Romanholo, PhD
Sub Investigator
Denise Paisani, PhD
Sub Investigator

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.