Aerobic and Respiratory Exercises on Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Aerobic and Breathing Exercises
Aerobic and Stretching Exercises
Sponsored by

About this trial
This is an interventional treatment trial for Asthma focused on measuring Aerobic exercises, Respiratory exercises, Asthma clinical control
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
Sites / Locations
- Celso Ricardo Fernandes de Carvalho
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Aerobic and Breathing Exercises
Aerobic and Stretching Exercises
Arm Description
The experimental intervention will be aerobic and breathing exercises.
The active comparative intervention will be aerobic and stretching exercises.
Outcomes
Primary Outcome Measures
Change in asthma clinical control
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.
Secondary Outcome Measures
Change in health related quality of life
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.
Change in psychosocial symptoms
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.
Change in pulmonary function in absolute values
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.
Change in pulmonary function in predict values
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 in functional capacity
The functional capacity will be assessed by the Incremental Shuttle Walking Test (ISWT)
Change in physical activity levels
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 in sleep quality
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.
Change in thoracoabdominal mechanics
The thoracoabdominal mechanics will be assessed by optoelectronic plethysmography
Change in hyperventilation symptoms
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 in asthma exacerbation
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.
Full Information
NCT ID
NCT04412720
First Posted
May 21, 2020
Last Updated
August 22, 2023
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04412720
Brief Title
Aerobic and Respiratory Exercises on Asthma
Official Title
Effects of Aerobic and Respiratory Exercises on Asthma Clinical Control
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 5, 2020 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Aerobic exercises, Respiratory exercises, Asthma clinical control
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
All the measurements will be performed by a professional blinded to the groups. The same assessor will be maintained to perform the evaluations before and after the intervention. The professionals involved with the evaluations will be different from the professionals involved on the intervention.
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aerobic and Breathing Exercises
Arm Type
Experimental
Arm Description
The experimental intervention will be aerobic and breathing exercises.
Arm Title
Aerobic and Stretching Exercises
Arm Type
Active Comparator
Arm Description
The active comparative intervention will be aerobic and stretching exercises.
Intervention Type
Other
Intervention Name(s)
Aerobic and Breathing Exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Aerobic and Stretching Exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in asthma clinical control
Description
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.
Time Frame
Change from baseline to 10 weeks of intervention
Secondary Outcome Measure Information:
Title
Change in health related quality of life
Description
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.
Time Frame
Change from baseline to 10 weeks of intervention
Title
Change in psychosocial symptoms
Description
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.
Time Frame
Change from baseline to 10 weeks of intervention
Title
Change in pulmonary function in absolute values
Description
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.
Time Frame
Change from baseline to 10 weeks of intervention
Title
Change in pulmonary function in predict values
Description
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.
Time Frame
Change from baseline to 10 weeks of intervention
Title
Change in functional capacity
Description
The functional capacity will be assessed by the Incremental Shuttle Walking Test (ISWT)
Time Frame
Change from baseline to 10 weeks of intervention
Title
Change in physical activity levels
Description
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).
Time Frame
Change from baseline to 10 weeks of intervention
Title
Change in sleep quality
Description
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.
Time Frame
Change from baseline to 10 weeks of intervention
Title
Change in thoracoabdominal mechanics
Description
The thoracoabdominal mechanics will be assessed by optoelectronic plethysmography
Time Frame
Change from baseline to 10 weeks of intervention
Title
Change in hyperventilation symptoms
Description
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.
Time Frame
Change from baseline to 10 weeks of intervention
Title
Change in asthma exacerbation
Description
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.
Time Frame
Change from baseline to 10 weeks of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Celso RF Carvalho, PhD
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Celso Ricardo Fernandes de Carvalho
City
São Paulo
ZIP/Postal Code
01246903
Country
Brazil
12. IPD Sharing Statement
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Aerobic and Respiratory Exercises on Asthma
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