Reducing Exercise-induced Bronchoconstriction in Children With Asthma and Obesity
Condition: Asthma in Children; Obesity, Childhood; Exercise Induced Bronchospasm
MeSH terms: Asthma; Bronchial Spasm; Asthma, Exercise-Induced; Obesity; Pediatric Obesity
Intervention: Albuterol Sulfate; Interval Warm-up exercise
Intervention description: Participants will inhale 2 puffs of albuterol (90mcg per actuation). After 15 minutes, participants will undergo an exercise induced bronchoconstriction test; Participants will undergo eight 30 sec bouts of high intensity exercise with 45 second recovery between bouts. After 15 minutes, participants will undergo an exercise induced bronchoconstriction test
Intervention MeSH terms: Albuterol
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 2x3 mixed ANOVA. 2 between groups: children with and without obesity. 3 within groups: control, interval warm-up, pretreatment with bronchodilator
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 8 Years
Maximum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: pediatric; bronchoconstriction

Summary:

      Guidelines from the American Thoracic Society strongly recommend interval warm-up exercise
      before planned exercise to reduce exercise-induced bronchoconstriction severity. However, no
      empirical data on the effects of interval warm-up exercise on exercise-induced
      bronchoconstriction severity are available in obese asthmatic children, where excess fat
      exerts such an unfavorable burden on the respiratory system, particularly during exercise.
      The objective of this study is to investigate the effects of interval warm-up exercise on
      exercise-induced bronchoconstriction severity in obese and nonobese asthmatic children. Our
      approach will be to investigate exercise tolerance, respiratory function, and
      exercise-induced bronchoconstriction severity and the effects of (1) 8x30sec interval warm-up
      & (2) pretreatment with a bronchodilator compared with a no-treatment control on
      exercise-induced bronchoconstriction severity in 8-12 yr, prepubescent, obese and nonobese
      asthmatic children.

      [Aim]: To investigate the effects of interval warm-up exercise on exercise-induced
      bronchoconstriction severity. [Hypothesis]: Interval warm-up exercise will reduce
      exercise-induced bronchoconstriction severity after an exercise challenge test to a similar
      extent as bronchodilator and better than control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  no history of smoking, no history or evidence of heart disease, no history of
             uncontrolled hypertension, no documented and/or diagnosed sleep disorders, no
             diagnosed diabetes, no metabolic disorders, no history of significant mental illness,
             no dietary restrictions, no serious health conditions, or no musculoskeletal
             abnormality that would preclude exercise.

          -  Normal weight children with a body mass index between the 16th and 84th percentile

          -  Obese children with a body mass index > 95th percentile but less than 170% above the
             95th percentile and less than an absolute body mass index of 40 kg·m2

          -  Pulmonary function criteria 1) forced vital capacity ≥ 80% predicted, 2) forced
             expiratory volume in the first second (FEV1) ≥ 75% predicted, and total lung capacity
             ≥ 80% predicted

        Exclusion Criteria:

          -  Children with significant diseases other than obesity and mild asthma will be
             excluded. A significant disease is defined as either a disease that in the opinion of
             the PI or medical consultant Dr. Craig Nakamura may put the participant at risk
             because of participation in the study or a disease that may influence the results of
             the study or the patient's ability to participate in the study.

          -  Children who cannot follow directions (e.g., eating before testing), adequately
             perform procedures (e.g., pulmonary function tests), or keep appointments (e.g., no
             shows for testing), will be excluded from study participation.

          -  Because the risk of severe exercise induced bronchoconstriction increases in children
             with moderate or severe obstructive airway disease, children with FEV1 < 75% predicted
             will be excluded from the study. Diagnosis of asthma (i.e., airway responsiveness with
             reversible obstruction) will be established by spirometry (i.e., improvement of FEV1
             of ≥8% after administration of bronchodilator).

          -  Children without reversible airway obstruction will also be excluded from the study.

          -  Children who have been hospitalized for an asthma exacerbation or who have taken oral
             glucocorticoids for asthma in the past year, and children who have been admitted to an
             intensive care unit or been intubated because of their asthma in the past five years,
             will be excluded to reduce the risk of exacerbation during the study.