A Trial Assessing the Safety and Feasibility of Respiratory Muscle Training and Exercise Training in Children and Adolescents With Persistent Asthma

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and tolerability of a 6-week Inspiratory Muscle Training and cardiovascular exercise training program in children and adolescents with asthma. To also determine the efficacy of inspiratory muscle training and exercise in increasing respiratory muscle strength and endurance, and to explore relationships between fitness interventions (inspiratory muscle training and exercise), exercise tolerance, airway closure and dyspnea scores.

Official Title
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The Duke Healthy Breathing Study Stage 2 (DHBS): A Randomized Controlled Trial Assessing the Safety and Feasibility of Respiratory Muscle Training and Exercise Training in Children and Adolescents With Persistent Asthma

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: Inspiratory muscle training (IMT)
* Behavioral: Exercise alone
* Behavioral: IMT and Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 10-17 years of age Clinician-diagnosed asthma Sedentary activity defined as having not participated in a sports team or formal activity (dance classes, gym membership, active hobby requiring physical activity) in the past 12 months or have a Body mass index (BMI) ≥85th percentile (adjusted for sex and age) Child must have a designated caregiver who expresses a commitment to encourage the participant to attend weekly clinic-based exercise and also complete additional home exercise. Exclusion Criteria: Previous intubation for asthma, Forced expiratory volume in 1 second (FEV1) < 50% of predicted at enrollment; Any major chronic illness that in the opinion of the PI would interfere with participation in the intervention or completion of the study procedures; Inability to complete baseline measurements in a satisfactory manner according to the judgment of the research coordinator or PI Currently active in sports, vigorous play or planned exercise more than 1 time per week on average over the past month Current Pregnancy as determined by urine pregnancy test. Parent/Caregiver unable to consent in English

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 : Inspirtory muscle training (IMT)<br>IMT exercises at home will gradually ramp up. | Behavioral: Inspiratory muscle training (IMT)<br>* IMT exercises at home will gradually ramp up<br>|
| Experimental: Arm 2: Exercise alone<br>Subjects will be asked to exercise 2x/week for 6 weeks in person at the Duke research facility and again 2x/week at home for 30 minutes. | Behavioral: Exercise alone<br>* Subjects will be asked to exercise 2x/week for 6 weeks in person at the Duke research facility and again 2x/week at home for 30 minutes.<br>|
| Experimental: Arm 3: IMT and Exercise<br>a combination of arm 1 and arm 3 | Behavioral: IMT and Exercise<br>* Combining IMT training and exercise<br>|
| No Intervention: Arm 4: Routine care<br>no interventions will occur in this group besides testing procedures and offering access to the study team in case asthma-related questions come up. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participant's with asthma and not participating in any physical activity |  | 6 weeks | 
| Number of Adverse events reported by participants. |  | 6 weeks | 
| Number of participants that complete respiratory muscle training (IMT) and exercise. |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma