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Reducing Exercise-induced Bronchoconstriction in Children With Asthma and Obesity

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ClinicalTrials.gov Identifier: NCT03586544
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Dharini M Bhammar, University of Nevada, Las Vegas

Brief Summary:

In obese children, excess fat exerts an increased mechanical burden on the respiratory system, particularly during exercise. It is unclear whether this burden reduces respiratory function and exercise tolerance and increases severity of exercise-induced bronchoconstriction in obese asthmatic children. The investigators propose that most of the respiratory effects in obese asthmatic children are the result of low lung volume breathing (i.e., reduced functional residual capacity). The first objective of this study is to investigate respiratory function, exercise tolerance, and exercise-induced bronchoconstriction in obese vs. nonobese asthmatic children. 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. Thus, the second 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 1]: To investigate respiratory function and exercise tolerance [Hypothesis]: Obesity in children with asthma will reduce respiratory function and exercise tolerance [Aim 2]: To investigate exercise-induced bronchoconstriction. [Hypothesis]: Obesity in children with asthma will increase exercise-induced bronchoconstriction severity as evidenced by a greater maximum % fall in forced expiratory volume in the first second after an exercise challenge test.

[Aim 3]: 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, although to a greater extent in nonobese asthmatic children.


Condition or disease Intervention/treatment Phase
Asthma in Children Obesity, Childhood Exercise Induced Bronchospasm Behavioral: Interval Warm-up exercise Drug: Albuterol Other: Control Phase 4

Detailed Description:

The investigators will enroll prepubescent, 8 - 12 yr old, obese (body mass index > 95th percentile; N=25) and nonobese (body mass between 16th and 84th percentile; N=25) children with mild asthma. The investigators will investigate the severity of exercise-induced bronchoconstriction during planned exercise performed 15 minutes after the following three conditions performed on separate days in a random order: (1) 8x30sec interval warm-up, (2) short-acting beta agonist or albuterol, & (3) control, in prepubescent, 8 - 12 yr old, obese and nonobese children with mild asthma. The investigators will also investigate differences in pulmonary function, exercise tolerance, and severity of exercise-induced bronchoconstriction between obese and nonobese children.

The investigators will measure the following in all participants:

  1. Pulmonary function: spirometry, lung volumes, diffusing capacity of lung for carbon monoxide, maximum voluntary ventilation, maximal inspiratory and expiratory pressures, airway resistance, and expired nitric oxide
  2. Exercise tolerance during graded cycle ergometry: Gas exchange, ventilation, heart rate, blood pressure, pulse oximetry, electrocardiogram
  3. Ratings of perceived breathlessness and exercise induced bronchoconstriction in response to a 6 minute high-intensity exercise challenge after three conditions performed on three separate days:

Three conditions that will precede the exercise challenge include:

  1. 8x30sec of interval warm-up 15min prior to exercise challenge: This includes eight 30sec bouts of high-intensity interval exercise at 85-95% of HRmax, with 45sec of recovery between.
  2. Two puffs of albuterol 15 min prior to exercise challenge
  3. Control: seated rest for 15min prior to exercise challenge

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group 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)
Primary Purpose: Prevention
Official Title: Asthma and Childhood Obesity: Understanding Potential Mechanisms and Identifying Strategies to Improve Respiratory Symptoms
Actual Study Start Date : September 18, 2018
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : May 30, 2021


Arm Intervention/treatment
Experimental: Experimental
Children will complete an exercise induced bronchoconstriction test preceded by: 1) pretreatment with 'Albuterol' 2) interval warm-up exercise and 3) Control
Behavioral: Interval Warm-up exercise
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
Other Name: High intensity interval training

Drug: Albuterol
Participants will inhale 2 puffs of albuterol (90mcg per actuation). After 15 minutes, participants will undergo an exercise induced bronchoconstriction test
Other Name: Ventolin

Other: Control
This is the control arm. After 15 minutes of seated rest, participants will undergo an exercise induced bronchoconstriction test




Primary Outcome Measures :
  1. Maximum % fall in forced expiratory volume in the first second (FEV1) [ Time Frame: The fall in FEV1 will be assessed for up to 30 minutes after completing the exercise induced bronchoconstriction test ]
    The change in FEV1 from before to after the exercise induced bronchoconstriction test



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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03586544


Contacts
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Contact: Dharini M Bhammar, Ph.D. 7028951453 dharini.bhammar@unlv.edu

Locations
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United States, Nevada
Childrens Lung Specialists Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Manager, Office of Research Compliance    702-784-7840    Janet.Gallegos@hcahealthcare.com   
Principal Investigator: Dharini M Bhammar, Ph.D.         
Sub-Investigator: Craig Nakamura, M.D.         
Sponsors and Collaborators
University of Nevada, Las Vegas
Investigators
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Principal Investigator: Dharini M Bhammar, Ph.D. University of Nevada, Las Vegas

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Responsible Party: Dharini M Bhammar, Assistant Professor, University of Nevada, Las Vegas
ClinicalTrials.gov Identifier: NCT03586544     History of Changes
Other Study ID Numbers: 1131374-2
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: There is no current plan to share individual participant data. However, since the field is moving towards a sharing model, if a determination to share data is made, all individual data that underlie results in a publication will be deidentified before it is shared.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Dharini M Bhammar, University of Nevada, Las Vegas:
pediatric
bronchoconstriction

Additional relevant MeSH terms:
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Asthma
Asthma, Exercise-Induced
Lung Diseases, Obstructive
Lung Diseases
Anti-Asthmatic Agents
Obesity
Bronchial Spasm
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists