- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04412720
Aerobic and Respiratory Exercises on Asthma
August 22, 2023 updated by: University of Sao Paulo General Hospital
Effects of Aerobic and Respiratory Exercises on Asthma Clinical Control
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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São Paulo, Brazil, 01246903
- Celso Ricardo Fernandes de Carvalho
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 59 years (Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aerobic and Breathing Exercises
The experimental intervention will be aerobic and breathing exercises.
|
Aerobic exercises will be performed on a treadmill, twice a week, totaling 20 sessions of 60 minutes each.
The initial intensity will be 50% to 60% of maximum heart rate and the progression will take place according to the level of effort (Borg) in the last two sessions.
In addition, following the aerobic training, Buteyko Breathing Technique also will be performed during 20 minutes each exercise, in the same treatment session.
During the first two weeks, the patient will learn the technique supervised by a physical therapist.
In addition, the patients will receive a breathing exercise booklet for in-home training.
Before and after each session, patients will be evaluated in relation to blood pressure, heart rate, oxygen saturation and asthma symptoms.
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Active Comparator: Aerobic and Stretching Exercises
The active comparative intervention will be aerobic and stretching exercises.
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Aerobic exercises will be performed on a treadmill, twice a week, totaling 20 sessions of 60 minutes each.
The initial intensity will be 50% to 60% of maximum heart rate and the progression will take place according to the level of effort (Borg) in the last two sessions.
In addition, following the aerobic training, stretching exercises will be performing for major muscle groups, during 30 seconds each one.
The patients will receive a stretching exercise booklet for in-home training.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in asthma clinical control
Time Frame: Change from baseline to 10 weeks of intervention
|
Clinical control will be evaluated by the Asthma Control Questionnaire (ACQ).
The ACQ contains 7 items rated on a 7-point scale (0 = without limitation, 6 = maximum limitation), with a higher score indicating worse control.
Scores lower than 0.75 are associated with good asthma control, whereas scores greater than 1.5 are indicative of poorly controlled asthma, and a change of at least 0.5 points in the ACQ score is regarded as clinically significant.
|
Change from baseline to 10 weeks of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in health related quality of life
Time Frame: Change from baseline to 10 weeks of intervention
|
Health related quality of life will be assessed by Asthma Quality Life Questionnaire (AQLQ).
The AQLQ consists of 32 items rated on a 7-point scale (1 = great deal, 7 = not at all) divided into the following 4 domains: activity limitations, symptoms, emotional function and environmental stimuli.
Higher AQLQ scores indicate a better quality of life, and treatments resulting in a 0.5-point increase in scores following an intervention are considered to be clinically effective.
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Change from baseline to 10 weeks of intervention
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Change in psychosocial symptoms
Time Frame: Change from baseline to 10 weeks of intervention
|
Symptoms of anxiety and depression symptoms will be assessed by the Hospital Anxiety and Depression scale (HADs), which consists of 14 items divided into 2 subscales (7 for anxiety and 7 for depression).
Each item is scored from 0 to 3, with a maximum score of 21 points for each subscale.
A score greater than 8/9 in each subscale suggests a diagnosis of either anxiety and/or depression.
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Change from baseline to 10 weeks of intervention
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Change in pulmonary function in absolute values
Time Frame: Change from baseline to 10 weeks of intervention
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Lung volumes will be assessed by Spirometry.
The variables which will be assessed are Forced Vital Capacity (FVC) and Forced Expiratory Volume in first 1 second (FEV1), all them in liters.
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Change from baseline to 10 weeks of intervention
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Change in pulmonary function in predict values
Time Frame: Change from baseline to 10 weeks of intervention
|
The variables which will be assessed are predicted values for brazilian population of Forced Vital Capacity (FVC), Forced Expiratory Volume in first 1 second (FEV1), and FEV1/FVC ratio.
|
Change from baseline to 10 weeks of intervention
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Change in functional capacity
Time Frame: Change from baseline to 10 weeks of intervention
|
The functional capacity will be assessed by the Incremental Shuttle Walking Test (ISWT)
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Change from baseline to 10 weeks of intervention
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Change in physical activity levels
Time Frame: Change from baseline to 10 weeks of intervention
|
Physical activity and sedentary behaviour will be objectively quantified using a movement sensor (ActiGraph, Pensacola, USA) for 7 consecutive days on the hip using an elastic belt.
Sedentary behaviour will be quantify by the time spent sedentary (< 100 counts/min).
|
Change from baseline to 10 weeks of intervention
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Change in sleep quality
Time Frame: Change from baseline to 10 weeks of intervention
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Sleep quality will be objectively quantified using a movement sensor (ActiGraph, Pensacola, USA) for 7 consecutive nights on the wrist (non-dominant side), and by Pittsburgh Sleep Quality Index (PSQI).
The PSQI consists of 9 items divided into the following 7 domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month.
A global sum of "5"or greater indicates a "poor" sleeper.
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Change from baseline to 10 weeks of intervention
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Change in thoracoabdominal mechanics
Time Frame: Change from baseline to 10 weeks of intervention
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The thoracoabdominal mechanics will be assessed by optoelectronic plethysmography
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Change from baseline to 10 weeks of intervention
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Change in hyperventilation symptoms
Time Frame: Change from baseline to 10 weeks of intervention
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Hyperventilation symptoms will be assessed by the Nijmegen Questionnaire which consists of 16 items. Each item is scored from 0 to 4. A score greater than 23 suggest a positive diagnosis of hyperventilation. syndrome. |
Change from baseline to 10 weeks of intervention
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Change in asthma exacerbation
Time Frame: Change from baseline to 10 weeks of intervention
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Asthma exacerbation will be assessed by the following criteria: the use of ≥4 puffs of rescue medication per 24 hours during a 48-hour period, a need for systemic corticosteroids, an unscheduled medical appointment, and either a visit to an emergency room or hospitalization.
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Change from baseline to 10 weeks of intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Celso RF Carvalho, PhD, University of Sao Paulo General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 5, 2020
Primary Completion (Actual)
January 31, 2021
Study Completion (Actual)
July 31, 2021
Study Registration Dates
First Submitted
May 21, 2020
First Submitted That Met QC Criteria
June 1, 2020
First Posted (Actual)
June 2, 2020
Study Record Updates
Last Update Posted (Actual)
August 24, 2023
Last Update Submitted That Met QC Criteria
August 22, 2023
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2491900
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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