Back to resultsA Trial Assessing the Safety and Feasibility of Respiratory Muscle Training and Exercise Training in Children and Adolescents With Persistent Asthma (DHBS2)
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inspiratory muscle training (IMT)
Exercise alone
IMT and Exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Asthma focused on measuring Asthma
Eligibility Criteria
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
Sites / Locations
- Duke University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
Arm 1 : Inspirtory muscle training (IMT)
Arm 2: Exercise alone
Arm 3: IMT and Exercise
Arm 4: Routine care
Arm Description
IMT exercises at home will gradually ramp up.
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.
a combination of arm 1 and arm 3
no interventions will occur in this group besides testing procedures and offering access to the study team in case asthma-related questions come up.
Outcomes
Primary Outcome Measures
Percentage of Participant's with asthma and not participating in any physical activity
Number of Adverse events reported by participants.
Number of participants that complete respiratory muscle training (IMT) and exercise.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03911206
Brief Title
A Trial Assessing the Safety and Feasibility of Respiratory Muscle Training and Exercise Training in Children and Adolescents With Persistent Asthma
Acronym
DHBS2
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 5, 2019 (Actual)
Primary Completion Date
February 25, 2020 (Actual)
Study Completion Date
February 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1 : Inspirtory muscle training (IMT)
Arm Type
Experimental
Arm Description
IMT exercises at home will gradually ramp up.
Arm Title
Arm 2: Exercise alone
Arm Type
Experimental
Arm Description
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 Title
Arm 3: IMT and Exercise
Arm Type
Experimental
Arm Description
a combination of arm 1 and arm 3
Arm Title
Arm 4: Routine care
Arm Type
No Intervention
Arm Description
no interventions will occur in this group besides testing procedures and offering access to the study team in case asthma-related questions come up.
Intervention Type
Behavioral
Intervention Name(s)
Inspiratory muscle training (IMT)
Intervention Description
IMT exercises at home will gradually ramp up
Intervention Type
Behavioral
Intervention Name(s)
Exercise alone
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
IMT and Exercise
Intervention Description
Combining IMT training and exercise
Primary Outcome Measure Information:
Title
Percentage of Participant's with asthma and not participating in any physical activity
Time Frame
6 weeks
Title
Number of Adverse events reported by participants.
Time Frame
6 weeks
Title
Number of participants that complete respiratory muscle training (IMT) and exercise.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Trial Assessing the Safety and Feasibility of Respiratory Muscle Training and Exercise Training in Children and Adolescents With Persistent Asthma
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