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The study was halted prematurely due to COVID 19.
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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.
Note related to early termination: Although the intent of the study was to compare obese and nonobese children, early termination precluded us from completing this analysis and thus the pooled results are included in the results. The brief summary has been updated to reflect the presented results.
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 measure the following in all participants:
Three conditions that will precede the exercise challenge include:
Control visit was always completed first. The order of the albuterol and interval warm-up exercise visits was randomized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albuterol first | Experimental | Order albuterol and then interval warm up (IWU) |
|
| Interval warm-up first | Experimental | Order is interval warm up (IWU) and then albuterol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albuterol Sulfate | Drug | Participants will inhale 2 puffs of albuterol (90mcg per actuation). After 15 minutes, participants will undergo an exercise induced bronchoconstriction test |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum % Change in Forced Expiratory Volume in the First Second (FEV1) | The change in FEV1 from before to after the exercise induced bronchoconstriction test. For the control condition, the change in FEV1 was measured from before the 6min exercise challenge test to up to 30 min after the exercise challenge test. The control condition was completed before participants were randomized to either albuterol or interval warm-up. This "control" condition is our reference condition because any improvement noted with albuterol or interval warm-up exercise should be compared against the control condition. | The change in FEV1 will be assessed for up to 30 minutes after completing the exercise induced bronchoconstriction test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dharini M Bhammar, Ph.D. | University of Nevada, Las Vegas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Lung Specialists | Las Vegas | Nevada | 89109 | United States |
There is no current plan to share individual participant data.
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18 out of 34 enrolled participants were randomized. Of those not randomized (N=16), 10 did not meet inclusion criteria, 5 declined to participate, and 1 was not randomized because we terminated the study early. Of the 18 participants randomized, 2 did not complete all study visits: 1 because they declined to continue and 1 because of leg pain during exercise.
Dates of recruitment:
34 participants were screened for eligibility between 9/18/2018 - 3/13/2020. Participants were recruited from the Children's Lung Specialists Pediatric Pulmonology clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Order 1: Albuterol First, Interval Warm-up Second | Participants first received albuterol on one day only. After at least 72 h, they completed the interval warm up on one day only. This was an acute study. There is no washout per se. |
| FG001 | Order 2: Interval Warm-up First, Albuterol Second | Participants first completed interval warm up exercise on one day only. After at least 72 h, they recieved the albuterol (180ug) on one day only. This was an acute study. There is no washout per se. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
|
| ||||||||||||||||||
| Second Intervention |
|
Baseline analysis is shown for all randomized participants including the two participants who did not complete the interval warm-up first arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Albuterol First | Children will complete an exercise induced bronchoconstriction test preceded by: 1) Control, 2) pretreatment with 'Albuterol' and 3) interval warm-up exercise and Control visit was always completed first. The order of albuterol and interval warm-up was randomized. In this arm, albuterol visit was completed first. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum % Change in Forced Expiratory Volume in the First Second (FEV1) | The change in FEV1 from before to after the exercise induced bronchoconstriction test. For the control condition, the change in FEV1 was measured from before the 6min exercise challenge test to up to 30 min after the exercise challenge test. The control condition was completed before participants were randomized to either albuterol or interval warm-up. This "control" condition is our reference condition because any improvement noted with albuterol or interval warm-up exercise should be compared against the control condition. | Two participants did not complete the interval warm-up arm and there results are not reported. | Posted | Mean | Standard Deviation | percentage change | The change in FEV1 will be assessed for up to 30 minutes after completing the exercise induced bronchoconstriction test |
|
For our participants, the five visits were completed within 6.9 ± 2.4 weeks (Range: 3.6-11.1 weeks).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Albuterol Intervention | 180 ug of albuterol given on one day in this acute study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vocal cord dysfunction during exercise | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Complained of shortness of breath towards the end of the exercise challenge test on the day of the interval warm-up visit. Evaluated by pediatric pulmonologist. Resolved spontaneously. Patient taught sniff and blow technique for future. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dharini Bhammar | The Ohio State University | 614-866-9467 | dharini.bhammar@osumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 10, 2021 | Jun 10, 2021 | Prot_SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 11, 2020 | May 14, 2021 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D001250 | Asthma, Exercise-Induced |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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2x3 mixed ANOVA. 2 between groups: children with and without obesity. 3 within groups: control, interval warm-up, pretreatment with bronchodilator
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|
| Interval Warm-up exercise | Behavioral | 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 |
|
| NOT COMPLETED |
|
|
| Interval Warm up First |
Children will complete an exercise induced bronchoconstriction test preceded by: 1) Control, 2) pretreatment with 'Albuterol' and 3) interval warm-up exercise and Control visit was always completed first. The order of albuterol and interval warm-up was randomized. In this arm, interval warm-up visit was completed first. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Albuterol first and then interval warm up
| OG001 | Interval Warm-up First | Interval warm-up first and then albuterol |
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Interval Warm-up Intervention | Interval warm-up exercise completed on one day in this acute study. | 0 | 18 | 0 | 18 | 2 | 18 |
|
| Leg pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001249 | Asthma |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D000092202 | Exercise-Induced Allergies |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000588 |
| Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |