Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
Study NCT ID:
NCT04412720
Status:
COMPLETED
Last Update Posted:
2023-08-24
First Post:
2020-05-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Aerobic and Respiratory Exercises on Asthma
Sponsor:
University of Sao Paulo General Hospital
Organization:
Study Overview
Official Title:
Effects of Aerobic and Respiratory Exercises on Asthma Clinical Control
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: