A Trial Assessing the Safety and Feasibility of Respiratory Muscle Training and Exercise Training in Children and Adolescents With Persistent Asthma
DHBS2
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
1 other identifier
interventional
11
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable asthma
Started Mar 2019
Shorter than P25 for not_applicable asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 5, 2019
CompletedFirst Submitted
Initial submission to the registry
April 9, 2019
CompletedFirst Posted
Study publicly available on registry
April 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 25, 2020
CompletedNovember 4, 2020
March 1, 2020
12 months
April 9, 2019
November 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Study Arms (4)
Arm 1 : Inspirtory muscle training (IMT)
EXPERIMENTALIMT exercises at home will gradually ramp up.
Arm 2: Exercise alone
EXPERIMENTALSubjects 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
EXPERIMENTALa combination of arm 1 and arm 3
Arm 4: Routine care
NO INTERVENTIONno interventions will occur in this group besides testing procedures and offering access to the study team in case asthma-related questions come up.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Duke University
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2019
First Posted
April 11, 2019
Study Start
March 5, 2019
Primary Completion
February 25, 2020
Study Completion
February 25, 2020
Last Updated
November 4, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share