AsthmaDHBS2NCT03911206
A Trial Assessing the Safety and Feasibility of Respiratory Muscle Training and Exercise Training in Children and Adolescents With Persistent Asthma
A study testing Inspiratory muscle training (IMT), Exercise alone and IMT and Exercise in people with Asthma, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- Inspiratory muscle training (IMT), Exercise alone and IMT and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2019to 25 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Asthma
- Being tested
- Inspiratory muscle training (IMT), Exercise alone, IMT and Exercise
- Keywords
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle training (IMT)Behavioural
IMT exercises at home will gradually ramp up
Exercise aloneBehavioural
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 ExerciseBehavioural
Combining IMT training and exercise
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 : Inspirtory muscle training (IMT) | Experimental | IMT exercises at home will gradually ramp up. Receives: Behavioral: Inspiratory muscle training (IMT) |
| Arm 2: Exercise alone | Experimental | 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. Receives: Behavioral: Exercise alone |
| Arm 3: IMT and Exercise | Experimental | a combination of arm 1 and arm 3 Receives: Behavioral: IMT and Exercise |
| Arm 4: Routine care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participant's with asthma and not participating in any physical activity
Measured: 6 weeks
Number of Adverse events reported by participants.
Measured: 6 weeks
Number of participants that complete respiratory muscle training (IMT) and exercise.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start5 Mar 2019
- Primary completion25 Feb 2020
- Study completion25 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911206
- Sponsor's protocol ID
- Pro00100666
- Acronym
- DHBS2
- Status last verified
- Mar 2020
- First submitted
- 9 Apr 2019
- Last updated
- 4 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03911206
- Acronym / sponsor ID
- DHBS2 / Pro00100666
- Conditions
- Asthma
- Keywords
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 11 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 : Inspirtory muscle training (IMT) | Experimental | Behavioral: Inspiratory muscle training (IMT)IMT exercises at home will gradually ramp up. |
| Arm 2: Exercise alone | Experimental | Behavioral: Exercise aloneSubjects 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 | Experimental | Behavioral: IMT and Exercisea combination of arm 1 and arm 3 |
| Arm 4: Routine care | No intervention | –no interventions will occur in this group besides testing procedures and offering access to the study team in case asthma-related questions come up. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory muscle training (IMT)IMT exercises at home will gradually ramp up | Behavioural | Arm 1 : Inspirtory muscle training (IMT) |
| Exercise aloneSubjects 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. | Behavioural | Arm 2: Exercise alone |
| IMT and ExerciseCombining IMT training and exercise | Behavioural | Arm 3: IMT and Exercise |
Primary outcome
Percentage of Participant's with asthma and not participating in any physical activity
Time frame: 6 weeks
Number of Adverse events reported by participants.
Time frame: 6 weeks
Number of participants that complete respiratory muscle training (IMT) and exercise.
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training (IMT), Exercise alone and IMT and Exercise in people with Asthma, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participant's with asthma and not participating in any physical activity (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.