<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/NCT02188940</url>
  </required_header>
  <id_info>
    <org_study_id>ETLWOA</org_study_id>
    <secondary_id>2012/16700-9</secondary_id>
    <nct_id>NCT02188940</nct_id>
  </id_info>
  <brief_title>Exercise Training to Lose Weight in Obese Asthmatics</brief_title>
  <official_title>Effects of Exercise Training in a Weight-loss Lifestyle Intervention on Clinical Control and Psychosocial Morbidity in Obese Asthmatics: a Randomized and Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fundação de Amparo à Pesquisa do Estado de São Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Sao Paulo General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obese asthmatics have more severe symptoms, reduced lung function, poorer quality of life and&#xD;
      a reduced response to inhaled corticosteroid medication compared to non-obese asthmatics. In&#xD;
      addition, the impact of a weight-loss program on clinical control and psychological outcomes&#xD;
      has been poorly demonstrated and the effect of exercise training remain unknown. The&#xD;
      investigators aim to investigate the effect of exercise training in a weight-loss program on&#xD;
      asthma clinical control (primary outcome), health factors related to quality of life and&#xD;
      psychosocial symptoms (secondary outcomes) in obese patients with moderate-to-severe&#xD;
      persistent asthma. Physical activity, inflammatory profiles and sleep disorders will also be&#xD;
      evaluated. The investigators' hypothesis is that exercise as part of a weight-loss program is&#xD;
      more effective to lose weight and improve asthma control, quality of life and psychosocial&#xD;
      symptoms in obese asthmatics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, controlled and single blinded trial. Fifty-four asthmatic adults will&#xD;
      be randomly assigned into two groups: DBG (dietary and behavioral support group) or DBE&#xD;
      (similar to DBG + exercise training). Both groups will complete a weight-loss program based&#xD;
      on dietary and behavioral therapy. In addition, DBE will perform a training program based on&#xD;
      aerobic and resistance training whereas DBG will perform a breathing and stretching program.&#xD;
      Interventions will be performed twice a week for 3 months, 60 minutes each. The data&#xD;
      normality will be analyzed by Kolmogorov-Smirnov, the variables obtained before interventions&#xD;
      will be compared with the Student t-test or Mann-whitney U-test. Comparisons of the initial&#xD;
      and final data on outcomes will be analyzed with repeated measures ANOVA with appropriate&#xD;
      post hoc of Bonferroni. The significance level will be set to 5% for all tests.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Control</measure>
    <time_frame>Before and after 3 months of intervention</time_frame>
    <description>Clinical control will be evaluated by asthma control questionnaire (ACQ)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life</measure>
    <time_frame>Before and after 3 months of intervention</time_frame>
    <description>Health related quality of life will be assessed by Asthma Quality Life Questionnaire (AQLQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of depression and anxiety</measure>
    <time_frame>Before and after 3 months of intervention</time_frame>
    <description>the symptoms of depression and anxiety will be assessed by Hospital Anxiety and Depression (HAD)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Airway inflammation</measure>
    <time_frame>Before and after 3 months of intervention</time_frame>
    <description>Airway inflammation will be quantified using the exhaled fraction of nitric oxide (FeNO)</description>
  </other_outcome>
  <other_outcome>
    <measure>serum cytokines and adipokines levels</measure>
    <time_frame>Before and after 3 months of intervention</time_frame>
    <description>The method Cytometric Beat Array (CBA) (BD Biosciences, USA) will be used to analyze the levels of interleukins (IL) IL-4, IL-5, IL-6, IL-8, IL -10,IL-1ra, IL-13,Tumor Necrosis Factor (TNF-α), leptin, adiponectin and C-reactive protein (CRP)</description>
  </other_outcome>
  <other_outcome>
    <measure>Daily life physical activity</measure>
    <time_frame>Before and after 3 months of intervention</time_frame>
    <description>Daily life physical activity will be assessed using an accelerometer (actigraph activity monitor) and physical capacity will be assessed by an incremental cardiopulmonary exercise testing</description>
  </other_outcome>
  <other_outcome>
    <measure>Sleep disorders</measure>
    <time_frame>Before and after 3 months of intervention</time_frame>
    <description>sleep disorders will be assessed by Berlin Questionnaire for Sleep Apnea and Actisleep activity monitor</description>
  </other_outcome>
  <other_outcome>
    <measure>Lung function</measure>
    <time_frame>Before and after 3 months of intervention</time_frame>
    <description>Static and dynamic lung volumes will be assessed by Spirometry and Plethysmograph</description>
  </other_outcome>
  <other_outcome>
    <measure>Physical fitness</measure>
    <time_frame>Before and after 3 months of intervention</time_frame>
    <description>Aerobic potency will be assessed by Cardiopulmonary exercise test</description>
  </other_outcome>
  <other_outcome>
    <measure>Asthma symptoms and exacerbations</measure>
    <time_frame>Before and after 3 months of intervention</time_frame>
    <description>Asthma symptoms will be assessed using a daily diary of symptoms and exacerbation will be defined by an increase in symptoms associated with at least one of the following criteria: use of rescue medication ≥4 puffs per 24 hours during a 48-hour period, need for systemic corticosteroids, unscheduled medical appointment, visit to an emergency room or hospitalization.</description>
  </other_outcome>
  <other_outcome>
    <measure>Body composition</measure>
    <time_frame>Before and after 3 months of intervention</time_frame>
    <description>Body composition will be analyzed by using a tetrapolar 8-point tactile bioelectrical impedance</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Asthma</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Exercise, dietary and behavioral therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The interventions of active comparator will be education program, dietary and behavioral therapy and exercise training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dietary and behavioral therapy</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The intervention in sham comparator will be education program, dietary and behavioral therapy and stretching and breathing exercise.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dietary</intervention_name>
    <description>The dietary therapy will be performed every 15 days, totaling 6 sessions of 60 minutes each by a dietitian. Patients will be advised to follow restricted-calorie diet based on the hypocaloric dietary guidance, multiplying the patient's weight by 20 to 25 calories. The Nutwin ® program will be used to structure the patient's diets, based on 24 hours food record and calories tables. Throughout the program, issues related to food control, the benefits of following a balanced diet and the changing food habits will be discussed.</description>
    <arm_group_label>Dietary and behavioral therapy</arm_group_label>
    <arm_group_label>Exercise, dietary and behavioral therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education Program</intervention_name>
    <description>The education program will consist of 4 classes lasting 6 hours at the beginning of the interventions, in which issues related to asthma and physical activity will be discussed. Presentations and group discussions will be carried out, including information about asthma pathophysiology, medication and peakflowmeter skills, self-monitoring techniques, environmental control, benefits and current recommendations of physical activity.</description>
    <arm_group_label>Dietary and behavioral therapy</arm_group_label>
    <arm_group_label>Exercise, dietary and behavioral therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavioral Therapy</intervention_name>
    <description>The Behavioral therapy will be performed every 15 days, totaling 6 sessions of 60 minutes each by a psychologist. Sessions of group dynamics will be performed to increase the patient adherence in a weight loss program using behavior modification techniques, such as self-management, motivational strategies, positive reinforcement and relapse prevention. Relaxation techniques, experiences and patient's report will also be used.</description>
    <arm_group_label>Dietary and behavioral therapy</arm_group_label>
    <arm_group_label>Exercise, dietary and behavioral therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise Training</intervention_name>
    <description>The aerobic training will be performed on a treadmill and a bike (or an elliptical), twice a week, totaling 24 sessions of 60 minutes each. The initial intensity will be 50% to 60% of VO2 max reaching a maximal 75% of VO2 max and the progression will take place according to the level of effort (Borg) in the last two sessions. Patients will be advised to walk outside at least twice a week for 30 minutes and write down their activity in a diary. Furthermore, they will be given an accelerometer in week 6 to record their daily steps. The resistance training will consist of exercises for the upper and lower limbs. Initially, the patients will perform 2 sets of 10 repetitions with load of 50% to 70% of 1-RM and the progression will take place in the number of repetition, and then in the load.</description>
    <arm_group_label>Exercise, dietary and behavioral therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Stretching and Breathing exercise</intervention_name>
    <description>Breathing exercise will consist of 3 exercises adapted from yoga's breathing technique (kapalabhati, uddhiyana and agnisara) twice a week, totaling 24 sessions of 30 minutes each. Every exercise will be performed in sets of 3 (2 minutes each) with 60 seconds of rest between them. The stretching will consist of stretching exercises for the major muscle groups in 3 sets of 10 seconds each. The program will be performed twice a week, totaling 24 sessions of 30 minutes each.&#xD;
*Both breathing and stretching exercises will be performed as placebo to ensure the same duration of treatment between the two groups.</description>
    <arm_group_label>Dietary and behavioral therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Asthma moderate and severe&#xD;
&#xD;
          -  Asthma will diagnosed (Global Initiative for Asthma -GINA)&#xD;
&#xD;
          -  Body Mass Index between 35 kg/ m2 and 39,9 kg/m2&#xD;
&#xD;
          -  Sedentary&#xD;
&#xD;
          -  Medical treatment, for at least 6 months&#xD;
&#xD;
          -  Clinically stable (i.e., no exacerbation or medication changes for at least 30 days)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiovascular, musculoskeletal or other chronic lung diseases&#xD;
&#xD;
          -  Active Cancer&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Weight loss more than 5 % in the preceding 6 months&#xD;
&#xD;
          -  Using weight-loss medications&#xD;
&#xD;
          -  History of bariatric surgery, uncontrolled hypertension or diabetes&#xD;
&#xD;
          -  Using overnight continuous positive airway pressure&#xD;
&#xD;
          -  Lactating&#xD;
&#xD;
          -  Current or ex-smoker&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Celso RF Carvalho, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sao Paulo General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Hospital of São Paulo University medical school (HCFMUSP)</name>
      <address>
        <city>São Paulo</city>
        <zip>05360-160</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>February 19, 2016</last_update_submitted>
  <last_update_submitted_qc>February 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Asthma</keyword>
  <keyword>Obesity</keyword>
  <keyword>Clinical control</keyword>
  <keyword>Exercise</keyword>
  <keyword>Weight-loss</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02188940
org study id: ETLWOA
secondary id: 2012/16700-9
nct id: NCT02188940
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Obese asthmatics have more severe symptoms, reduced lung function, poorer quality of life and
      a reduced response to inhaled corticosteroid medication compared to non-obese asthmatics. In
      addition, the impact of a weight-loss program on clinical control and psychological outcomes
      has been poorly demonstrated and the effect of exercise training remain unknown. The
      investigators aim to investigate the effect of exercise training in a weight-loss program on
      asthma clinical control (primary outcome), health factors related to quality of life and
      psychosocial symptoms (secondary outcomes) in obese patients with moderate-to-severe
      persistent asthma. Physical activity, inflammatory profiles and sleep disorders will also be
      evaluated. The investigators' hypothesis is that exercise as part of a weight-loss program is
      more effective to lose weight and improve asthma control, quality of life and psychosocial
      symptoms in obese asthmatics.
This is a randomized, controlled and single blinded trial. Fifty-four asthmatic adults will
      be randomly assigned into two groups: DBG (dietary and behavioral support group) or DBE
      (similar to DBG + exercise training). Both groups will complete a weight-loss program based
      on dietary and behavioral therapy. In addition, DBE will perform a training program based on
      aerobic and resistance training whereas DBG will perform a breathing and stretching program.
      Interventions will be performed twice a week for 3 months, 60 minutes each. The data
      normality will be analyzed by Kolmogorov-Smirnov, the variables obtained before interventions
      will be compared with the Student t-test or Mann-whitney U-test. Comparisons of the initial
      and final data on outcomes will be analyzed with repeated measures ANOVA with appropriate
      post hoc of Bonferroni. The significance level will be set to 5% for all tests.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Clinical Control
time frame: Before and after 3 months of intervention
description: Clinical control will be evaluated by asthma control questionnaire (ACQ)
measure: Health related quality of life
time frame: Before and after 3 months of intervention
description: Health related quality of life will be assessed by Asthma Quality Life Questionnaire (AQLQ)
measure: Level of depression and anxiety
time frame: Before and after 3 months of intervention
description: the symptoms of depression and anxiety will be assessed by Hospital Anxiety and Depression (HAD)
measure: Airway inflammation
time frame: Before and after 3 months of intervention
description: Airway inflammation will be quantified using the exhaled fraction of nitric oxide (FeNO)
measure: serum cytokines and adipokines levels
time frame: Before and after 3 months of intervention
description: The method Cytometric Beat Array (CBA) (BD Biosciences, USA) will be used to analyze the levels of interleukins (IL) IL-4, IL-5, IL-6, IL-8, IL -10,IL-1ra, IL-13,Tumor Necrosis Factor (TNF-α), leptin, adiponectin and C-reactive protein (CRP)
measure: Daily life physical activity
time frame: Before and after 3 months of intervention
description: Daily life physical activity will be assessed using an accelerometer (actigraph activity monitor) and physical capacity will be assessed by an incremental cardiopulmonary exercise testing
measure: Sleep disorders
time frame: Before and after 3 months of intervention
description: sleep disorders will be assessed by Berlin Questionnaire for Sleep Apnea and Actisleep activity monitor
measure: Lung function
time frame: Before and after 3 months of intervention
description: Static and dynamic lung volumes will be assessed by Spirometry and Plethysmograph
measure: Physical fitness
time frame: Before and after 3 months of intervention
description: Aerobic potency will be assessed by Cardiopulmonary exercise test
measure: Asthma symptoms and exacerbations
time frame: Before and after 3 months of intervention
description: Asthma symptoms will be assessed using a daily diary of symptoms and exacerbation will be defined by an increase in symptoms associated with at least one of the following criteria: use of rescue medication ≥4 puffs per 24 hours during a 48-hour period, need for systemic corticosteroids, unscheduled medical appointment, visit to an emergency room or hospitalization.
measure: Body composition
time frame: Before and after 3 months of intervention
description: Body composition will be analyzed by using a tetrapolar 8-point tactile bioelectrical impedance
arm group label: Exercise, dietary and behavioral therapy
arm group type: Active Comparator
description: The interventions of active comparator will be education program, dietary and behavioral therapy and exercise training.
arm group label: Dietary and behavioral therapy
arm group type: Sham Comparator
description: The intervention in sham comparator will be education program, dietary and behavioral therapy and stretching and breathing exercise.
intervention type: Behavioral
intervention name: Dietary
description: The dietary therapy will be performed every 15 days, totaling 6 sessions of 60 minutes each by a dietitian. Patients will be advised to follow restricted-calorie diet based on the hypocaloric dietary guidance, multiplying the patient's weight by 20 to 25 calories. The Nutwin ® program will be used to structure the patient's diets, based on 24 hours food record and calories tables. Throughout the program, issues related to food control, the benefits of following a balanced diet and the changing food habits will be discussed.
arm group label: Dietary and behavioral therapy
arm group label: Exercise, dietary and behavioral therapy
intervention type: Behavioral
intervention name: Education Program
description: The education program will consist of 4 classes lasting 6 hours at the beginning of the interventions, in which issues related to asthma and physical activity will be discussed. Presentations and group discussions will be carried out, including information about asthma pathophysiology, medication and peakflowmeter skills, self-monitoring techniques, environmental control, benefits and current recommendations of physical activity.
arm group label: Dietary and behavioral therapy
arm group label: Exercise, dietary and behavioral therapy
intervention type: Behavioral
intervention name: Behavioral Therapy
description: The Behavioral therapy will be performed every 15 days, totaling 6 sessions of 60 minutes each by a psychologist. Sessions of group dynamics will be performed to increase the patient adherence in a weight loss program using behavior modification techniques, such as self-management, motivational strategies, positive reinforcement and relapse prevention. Relaxation techniques, experiences and patient's report will also be used.
arm group label: Dietary and behavioral therapy
arm group label: Exercise, dietary and behavioral therapy
intervention type: Other
intervention name: Exercise Training
description: The aerobic training will be performed on a treadmill and a bike (or an elliptical), twice a week, totaling 24 sessions of 60 minutes each. The initial intensity will be 50% to 60% of VO2 max reaching a maximal 75% of VO2 max and the progression will take place according to the level of effort (Borg) in the last two sessions. Patients will be advised to walk outside at least twice a week for 30 minutes and write down their activity in a diary. Furthermore, they will be given an accelerometer in week 6 to record their daily steps. The resistance training will consist of exercises for the upper and lower limbs. Initially, the patients will perform 2 sets of 10 repetitions with load of 50% to 70% of 1-RM and the progression will take place in the number of repetition, and then in the load.
arm group label: Exercise, dietary and behavioral therapy
intervention type: Other
intervention name: Stretching and Breathing exercise
description: Breathing exercise will consist of 3 exercises adapted from yoga's breathing technique (kapalabhati, uddhiyana and agnisara) twice a week, totaling 24 sessions of 30 minutes each. Every exercise will be performed in sets of 3 (2 minutes each) with 60 seconds of rest between them. The stretching will consist of stretching exercises for the major muscle groups in 3 sets of 10 seconds each. The program will be performed twice a week, totaling 24 sessions of 30 minutes each.
*Both breathing and stretching exercises will be performed as placebo to ensure the same duration of treatment between the two groups.
arm group label: Dietary and behavioral therapy
criteria: 
gender: All
minimum age: 30 Years
maximum age: 60 Years
healthy volunteers: No
last name: Celso RF Carvalho, PhD
role: Principal Investigator
affiliation: University of Sao Paulo General Hospital
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Asthma
mesh term: Obesity
sharing ipd: Yes