Clinical trial NCT04412720: Aerobic and Respiratory Exercises on Asthma
Official title: Effects of Aerobic and Respiratory Exercises on Asthma Clinical Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Aerobic exercises
Respiratory exercises
Asthma clinical control
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many studies have reported the benefits of aerobic and breathing exercises such as, reduction of symptoms and reduced the use of medications, the number of crises, exercise induced bronchoconstriction (EIB), and improvement in health-related quality of life (HRQoL). This study will be a randomized and controlled trial (RCT) with 2 parallel arms and blinded assessment. Fifty-four moderate or severe patients with asthma under optimized medication will be randomly assigned (computer-generated) into either aerobic+breathing exercises (AB) or aerobic+stretching exercises (AS). All patients will receive the same educational session and will perform the physical exercise proposed for the group for 12 weeks, 2 times/week, 60-minute sessions; however, the AB group will perform Buteyko breathing technique and AS will perform muscle stretching exercise. All patients will be assessed to clinical control, quality of life, psychosocial symptoms, pulmonary function, functional capacity, physical activity levels, sleep quality, thoracoabdominal mechanics, hyperventilation symptoms, and asthma exacerbation. The data normality will be analyzed by Kolmogorov-Smirnov. The variables obtained before interventions will be compared using the t-test or Mann-Whitney U-test. Comparisons of the outcomes initial and final data will be analyzed with repeated measures ANOVA with appropriate post hoc test. The significance level will be set to 5% for all tests.

Detailed description: Many studies have reported the benefits of aerobic and breathing exercises such as, reduction of symptoms and reduced the use of medications, the number of crises, exercise induced bronchoconstriction (EIB), and improvement in health-related quality of life (HRQoL). This study will be a randomized and controlled trial (RCT) with 2 parallel arms and blinded assessment. Fifty-four moderate or severe patients with asthma under optimized medication will be randomly assigned (computer-generated) into either aerobic+breathing exercises (AB) or aerobic+stretching exercises (AS). All patients will receive the same educational session and will perform the physical exercise proposed for the group for 12 weeks, 2 times/week, 60-minute sessions; however, the AB group will perform Buteyko breathing technique and AS will perform muscle stretching exercise. All patients will be assessed to clinical control, quality of life, psychosocial symptoms, pulmonary function, functional capacity, physical activity levels, sleep quality, thoracoabdominal mechanics, hyperventilation symptoms, and asthma exacerbation. The data normality will be analyzed by Kolmogorov-Smirnov. The variables obtained before interventions will be compared using the t-test or Mann-Whitney U-test. Comparisons of the outcomes initial and final data will be analyzed with repeated measures ANOVA with appropriate post hoc test. The significance level will be set to 5% for all tests.

Eligibility criteria: Inclusion Criteria:

* Asthma moderate and severe with diagnosed according to the Global Initiative for Asthma (GINA) 2020
* Sedentary (\< 150 min of moderate to vigorous physical activity/week)
* Body Mass Index ≥18.5 kg/m2 and \<35 kg/m2
* Medical treatment, for at least 6 months
* Clinically stable (i.e., no exacerbation or changes in medication for at least 30 days)

Exclusion Criteria:

* Cardiovascular, musculoskeletal or other chronic lung diseases
* Active Cancer
* Pregnant
* Uncontrolled hypertension or diabetes
* Current smoker or ex smoker (\>10 pack-years)
* Psychiatric disease or cognitive deficit

Primary outcomes:
measure: Change in asthma clinical control
timeFrame: Change from baseline to 10 weeks of intervention
Secondary outcomes:
measure: Change in health related quality of life
timeFrame: Change from baseline to 10 weeks of intervention
measure: Change in psychosocial symptoms
timeFrame: Change from baseline to 10 weeks of intervention
measure: Change in pulmonary function in absolute values
timeFrame: Change from baseline to 10 weeks of intervention
measure: Change in pulmonary function in predict values
timeFrame: Change from baseline to 10 weeks of intervention
measure: Change in functional capacity
timeFrame: Change from baseline to 10 weeks of intervention
measure: Change in physical activity levels
timeFrame: Change from baseline to 10 weeks of intervention
measure: Change in sleep quality
timeFrame: Change from baseline to 10 weeks of intervention
measure: Change in thoracoabdominal mechanics
timeFrame: Change from baseline to 10 weeks of intervention
measure: Change in hyperventilation symptoms
timeFrame: Change from baseline to 10 weeks of intervention
measure: Change in asthma exacerbation
timeFrame: Change from baseline to 10 weeks of intervention
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Celso Ricardo Fernandes de Carvalho
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Celso RF Carvalho, PhD
role: STUDY_DIRECTOR
References: