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.
Inspiratory muscle training (IMT)
IMT and Exercise
|Study Type :||Interventional|
|Estimated Enrollment :||11 participants|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||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|
|Actual Study Start Date :||March 5, 2019|
|Estimated Primary Completion Date :||February 25, 2020|
|Estimated Study Completion Date :||February 25, 2020|
Experimental: Arm 1 : Inspirtory muscle training (IMT)
IMT exercises at home will gradually ramp up.
Experimental: Arm 2: Exercise alone
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.
Experimental: Arm 3: IMT and Exercise
a combination of arm 1 and arm 3
No Intervention: Arm 4: Routine care
no interventions will occur in this group besides testing procedures and offering access to the study team in case asthma-related questions come up.
|Ages Eligible for Study:||10 Years to 17 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Durham, North Carolina, United States, 27710