<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04412720</url>
  </required_header>
  <id_info>
    <org_study_id>2491900</org_study_id>
    <nct_id>NCT04412720</nct_id>
  </id_info>
  <brief_title>Aerobic and Respiratory Exercises on Asthma</brief_title>
  <official_title>Effects of Aerobic and Respiratory Exercises on Asthma Clinical Control</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Many studies have reported the benefits of aerobic and breathing exercises such as, reduction&#xD;
      of symptoms and reduced the use of medications, the number of crises, exercise induced&#xD;
      bronchoconstriction (EIB), and improvement in health-related quality of life (HRQoL). This&#xD;
      study will be a randomized and controlled trial (RCT) with 2 parallel arms and blinded&#xD;
      assessment. Fifty-four moderate or severe patients with asthma under optimized medication&#xD;
      will be randomly assigned (computer-generated) into either aerobic+breathing exercises (AB)&#xD;
      or aerobic+stretching exercises (AS). All patients will receive the same educational session&#xD;
      and will perform the physical exercise proposed for the group for 12 weeks, 2 times/week,&#xD;
      60-minute sessions; however, the AB group will perform Buteyko breathing technique and AS&#xD;
      will perform muscle stretching exercise. All patients will be assessed to clinical control,&#xD;
      quality of life, psychosocial symptoms, pulmonary function, functional capacity, physical&#xD;
      activity levels, sleep quality, thoracoabdominal mechanics, hyperventilation symptoms, and&#xD;
      asthma exacerbation. The data normality will be analyzed by Kolmogorov-Smirnov. The variables&#xD;
      obtained before interventions will be compared using the t-test or Mann-Whitney U-test.&#xD;
      Comparisons of the outcomes initial and final data will be analyzed with repeated measures&#xD;
      ANOVA with appropriate post hoc test. The significance level will be set to 5% for all tests.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Many studies have reported the benefits of aerobic and breathing exercises such as, reduction&#xD;
      of symptoms and reduced the use of medications, the number of crises, exercise induced&#xD;
      bronchoconstriction (EIB), and improvement in health-related quality of life (HRQoL). This&#xD;
      study will be a randomized and controlled trial (RCT) with 2 parallel arms and blinded&#xD;
      assessment. Fifty-four moderate or severe patients with asthma under optimized medication&#xD;
      will be randomly assigned (computer-generated) into either aerobic+breathing exercises (AB)&#xD;
      or aerobic+stretching exercises (AS). All patients will receive the same educational session&#xD;
      and will perform the physical exercise proposed for the group for 12 weeks, 2 times/week,&#xD;
      60-minute sessions; however, the AB group will perform Buteyko breathing technique and AS&#xD;
      will perform muscle stretching exercise. All patients will be assessed to clinical control,&#xD;
      quality of life, psychosocial symptoms, pulmonary function, functional capacity, physical&#xD;
      activity levels, sleep quality, thoracoabdominal mechanics, hyperventilation symptoms, and&#xD;
      asthma exacerbation. The data normality will be analyzed by Kolmogorov-Smirnov. The variables&#xD;
      obtained before interventions will be compared using the t-test or Mann-Whitney U-test.&#xD;
      Comparisons of the outcomes initial and final data will be analyzed with repeated measures&#xD;
      ANOVA with appropriate post hoc test. The significance level will be set to 5% for all tests.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 5, 2020</start_date>
  <completion_date type="Actual">July 31, 2021</completion_date>
  <primary_completion_date type="Actual">January 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in asthma clinical control</measure>
    <time_frame>Change from baseline to 10 weeks of intervention</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in health related quality of life</measure>
    <time_frame>Change from baseline to 10 weeks of intervention</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in psychosocial symptoms</measure>
    <time_frame>Change from baseline to 10 weeks of intervention</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pulmonary function in absolute values</measure>
    <time_frame>Change from baseline to 10 weeks of intervention</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pulmonary function in predict values</measure>
    <time_frame>Change from baseline to 10 weeks of intervention</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in functional capacity</measure>
    <time_frame>Change from baseline to 10 weeks of intervention</time_frame>
    <description>The functional capacity will be assessed by the Incremental Shuttle Walking Test (ISWT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physical activity levels</measure>
    <time_frame>Change from baseline to 10 weeks of intervention</time_frame>
    <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 (&lt; 100 counts/min).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sleep quality</measure>
    <time_frame>Change from baseline to 10 weeks of intervention</time_frame>
    <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 &quot;5&quot;or greater indicates a &quot;poor&quot; sleeper.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in thoracoabdominal mechanics</measure>
    <time_frame>Change from baseline to 10 weeks of intervention</time_frame>
    <description>The thoracoabdominal mechanics will be assessed by optoelectronic plethysmography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hyperventilation symptoms</measure>
    <time_frame>Change from baseline to 10 weeks of intervention</time_frame>
    <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.&#xD;
syndrome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in asthma exacerbation</measure>
    <time_frame>Change from baseline to 10 weeks of intervention</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Aerobic and Breathing Exercises</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental intervention will be aerobic and breathing exercises.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aerobic and Stretching Exercises</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The active comparative intervention will be aerobic and stretching exercises.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aerobic and Breathing Exercises</intervention_name>
    <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.</description>
    <arm_group_label>Aerobic and Breathing Exercises</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aerobic and Stretching Exercises</intervention_name>
    <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.</description>
    <arm_group_label>Aerobic and Stretching Exercises</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Asthma moderate and severe with diagnosed according to the Global Initiative for&#xD;
             Asthma (GINA) 2020&#xD;
&#xD;
          -  Sedentary (&lt; 150 min of moderate to vigorous physical activity/week)&#xD;
&#xD;
          -  Body Mass Index ≥18.5 kg/m2 and &lt;35 kg/m2&#xD;
&#xD;
          -  Medical treatment, for at least 6 months&#xD;
&#xD;
          -  Clinically stable (i.e., no exacerbation or changes in medication for at least 30&#xD;
             days)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiovascular, musculoskeletal or other chronic lung diseases&#xD;
&#xD;
          -  Active Cancer&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Uncontrolled hypertension or diabetes&#xD;
&#xD;
          -  Current smoker or ex smoker (&gt;10 pack-years)&#xD;
&#xD;
          -  Psychiatric disease or cognitive deficit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Celso RF Carvalho, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Sao Paulo General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Celso Ricardo Fernandes de Carvalho</name>
      <address>
        <city>São Paulo</city>
        <zip>01246903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>August 22, 2023</last_update_submitted>
  <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Aerobic exercises</keyword>
  <keyword>Respiratory exercises</keyword>
  <keyword>Asthma clinical control</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04412720
org study id: 2491900
nct id: NCT04412720
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (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.
measure: Change in asthma clinical control
time frame: Change from baseline to 10 weeks of intervention
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.
measure: Change in health related quality of life
time frame: Change from baseline to 10 weeks of intervention
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.
measure: Change in psychosocial symptoms
time frame: Change from baseline to 10 weeks of intervention
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.
measure: Change in pulmonary function in absolute values
time frame: Change from baseline to 10 weeks of intervention
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.
measure: Change in pulmonary function in predict values
time frame: Change from baseline to 10 weeks of intervention
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.
measure: Change in functional capacity
time frame: Change from baseline to 10 weeks of intervention
description: The functional capacity will be assessed by the Incremental Shuttle Walking Test (ISWT)
measure: Change in physical activity levels
time frame: Change from baseline to 10 weeks of intervention
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).
measure: Change in sleep quality
time frame: Change from baseline to 10 weeks of intervention
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.
measure: Change in thoracoabdominal mechanics
time frame: Change from baseline to 10 weeks of intervention
description: The thoracoabdominal mechanics will be assessed by optoelectronic plethysmography
measure: Change in hyperventilation symptoms
time frame: Change from baseline to 10 weeks of intervention
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.
measure: Change in asthma exacerbation
time frame: Change from baseline to 10 weeks of intervention
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.
arm group label: Aerobic and Breathing Exercises
arm group type: Experimental
description: The experimental intervention will be aerobic and breathing exercises.
arm group label: Aerobic and Stretching Exercises
arm group type: Active Comparator
description: The active comparative intervention will be aerobic and stretching exercises.
intervention type: Other
intervention name: Aerobic and Breathing Exercises
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.
arm group label: Aerobic and Breathing Exercises
intervention type: Other
intervention name: Aerobic and Stretching Exercises
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.
arm group label: Aerobic and Stretching Exercises
criteria: 
gender: All
minimum age: 18 Years
maximum age: 59 Years
healthy volunteers: No
last name: Celso RF Carvalho, PhD
role: Study Director
affiliation: University of Sao Paulo General Hospital
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Asthma