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Behavioural Intervention
Inspiratory Muscle Training for Childhood Asthma (MICA Trial)
N/A
Waitlist Available
Led By Jason Lang, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Either obese (≥95th percentile BMI and less than 170% of the 95th CDC percentile) or have a normal BMI (BMI 5th to 84th CDC percentile)
Currently requiring 2 or more controller prescriptions to treat disease (i.e. moderate to severe persistent disease)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights
MICA Trial Summary
This trial will study the differences between obese and non-obese children with moderate-severe asthma, testing how inspiratory muscle dysfunction and small airway dysfunction affect them. 6-17 year olds will train at different intensity levels for 8 weeks, with the aim of understanding asthma better.
Who is the study for?
The MICA study is for children aged 6-17 with moderate to severe asthma, who need multiple medications. It includes those with normal weight or obesity but not extreme obesity. Kids can't join if they've been intubated for asthma, have very low lung function, are pregnant, have poor asthma control or another major illness.Check my eligibility
What is being tested?
This trial tests Inspiratory Training (IT) in lean and obese asthmatic kids. They'll do breathing exercises at different intensities: SHAM (very easy), low dose, and high dose compared to their maximum ability. The goal is to see how these exercises affect muscle and small airway function over 8 weeks.See study design
What are the potential side effects?
Since the intervention involves breathing exercises without medication, side effects might include temporary breathlessness or fatigue during training sessions. However, significant side effects are unlikely given the nature of the intervention.
MICA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is either in the obese range or normal according to CDC standards.
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I need 2 or more medications to manage my condition.
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I am between 6 and 17 years old.
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I have been diagnosed with asthma by a doctor.
MICA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with inspiratory muscle dysfunction in obesity-related versus non-obesity-related asthma
Number of participants with small airway dysfunction in obesity-related versus non-obesity-related asthma
Secondary outcome measures
Inspiratory muscle endurance (sustained maximal inspiratory pressure)
Other outcome measures
Small airway dysfunction as measured by impulse oscillometry
Small airway dysfunction as measured by residual volume
MICA Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Active Low Dose inspiratory muscle rehabilitation (IMR) groupExperimental Treatment1 Intervention
Each participant will be provided a PrO2™ device and trained on its use as well as its accompanying PrO2 Fit™ app. Participants will be instructed to inspire forcefully through PrO2™ until the device signals that the user has achieved the target resistance (via audible alarm and visible light signal). The research team will implement biofeedback signals at a specific inspiratory resistance to provide precise and individualized training target. Successful IMR repetitions will require that subjects achieve a pressure target that is 40% of their MIP (maximum inspiratory pressure).
Group II: Active High Dose inspiratory muscle rehabilitation (IMR) groupExperimental Treatment1 Intervention
Each participant will be provided a PrO2™ device and trained on its use as well as its accompanying PrO2 Fit™ app. Participants will be instructed to inspire forcefully through PrO2™ until the device signals that the user has achieved the target resistance (via audible alarm and visible light signal). The research team will implement biofeedback signals at a specific inspiratory resistance to provide precise and individualized training target. Successful IMR repetitions will require that subjects achieve a pressure target that is 75% of their MIP (maximum inspiratory pressure).
Group III: SHAMActive Control1 Intervention
Each participant will be provided a PrO2™ device and trained on its use as well as its accompanying PrO2 Fit™ app. Participants will be instructed to inspire forcefully through PrO2™ until the device signals that the user has achieved the target resistance (via audible alarm and visible light signal). The research team will implement biofeedback signals at a specific inspiratory resistance to provide precise and individualized training target. Successful IMR repetitions will require that subjects achieve a pressure target that is 15% of their MIP (maximum inspiratory pressure).
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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,360 Previous Clinical Trials
3,420,254 Total Patients Enrolled
81 Trials studying Obesity
31,693 Patients Enrolled for Obesity
National Institutes of Health (NIH)NIH
2,697 Previous Clinical Trials
7,492,243 Total Patients Enrolled
103 Trials studying Obesity
25,780 Patients Enrolled for Obesity
Jason Lang, MDPrincipal InvestigatorDuke University
4 Previous Clinical Trials
147 Total Patients Enrolled
2 Trials studying Obesity
87 Patients Enrolled for Obesity
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My BMI is either in the obese range or normal according to CDC standards.I need 2 or more medications to manage my condition.I am between 6 and 17 years old.Your lung function is less than half of what would be expected for someone your age and size.My legal guardian cannot consent in English or Spanish.Your asthma control test score is less than 17.I have been diagnosed with asthma by a doctor.I have been put on a ventilator for asthma before.I am under 6 years old.
Research Study Groups:
This trial has the following groups:- Group 1: SHAM
- Group 2: Active High Dose inspiratory muscle rehabilitation (IMR) group
- Group 3: Active Low Dose inspiratory muscle rehabilitation (IMR) group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals still able to join this clinical investigation at this time?
"The trial's page on clinicaltrials.gov reveals that, as of July 6th 2023, the medical study is no longer seeking participants. As an alternative, there are 1388 other studies actively recruiting patients for their research currently available."
Answered by AI
Is the age threshold for enrolment in this medical experiment below seventy years?
"The minimum age for participation in this trial is 6 years old and the maximum age is 17. Clinicialtrials.gov has 392 studies that are available to minors as well 828 clinical trials catered towards senior citizens aged 65 or above."
Answered by AI
Am I eligible to become a participant in this medical experiment?
"To be eligible, the trial is accepting individuals between 6 and 17 years old with a BMI of 30 or higher. Currently, 76 patients are able to join this study."
Answered by AI
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