A Trial Assessing the Safety and Feasibility of Respiratory Muscle Training and Exercise Training in Children and Adolescents With Persistent Asthma
NCT ID: NCT03911206
Last Updated: 2020-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
11 participants
INTERVENTIONAL
2019-03-05
2020-02-25
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Arm 1 : Inspirtory muscle training (IMT)
IMT exercises at home will gradually ramp up.
Inspiratory muscle training (IMT)
IMT exercises at home will gradually ramp up
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.
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.
Arm 3: IMT and Exercise
a combination of arm 1 and arm 3
IMT and Exercise
Combining IMT training and exercise
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.
No interventions assigned to this group
Interventions
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Inspiratory muscle training (IMT)
IMT exercises at home will gradually ramp up
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.
IMT and Exercise
Combining IMT training and exercise
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
10 Years
17 Years
ALL
No
Sponsors
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Duke University
OTHER
Responsible Party
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Locations
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Duke University
Durham, North Carolina, United States
Countries
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Other Identifiers
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Pro00100666
Identifier Type: -
Identifier Source: org_study_id