Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma

ConditionsPediatric Obesity Pediatric Asthma

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age8-17

SponsorDuke University

About this trial

This is a single-center, randomized, SHAM-controlled, parallel assignment, double-masked,8-week interventional study among children aged 8-17 years (not yet 18 years old) of age with obesity and asthma. (n=60), recruited from Duke Health Center Creekstone, to test the effectiveness of inspiratory muscle rehabilitation (IMR) as an acceptable add-on intervention to reduce dyspnea (feeling short-of-breath or breathless) and to promote greater activity in children with obesity and asthma.

Clinic to test the effectiveness of inspiratory muscle rehabilitation (IMR) as an acceptable add-on intervention to reduce dyspnea (feeling short-of-breath or breathless) and to promote greater activity in children with obesity

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Documented informed consent from legal guardian and assent from participant as appropriate.

Children 8 to 17 years of age with obesity (BMI ≥ 95th percentile for age and sex) and mild asthma.

Participants (or parent/guardian) must have access to the internet and an approved smart device/computer.

Child must have a designated caregiver who expresses a commitment to encourage the participant to complete the study procedures.

Disqualifiers

Prior intubation for asthma

Current self-reported pregnancy or planning to become pregnant.

Have an FEV1 < 50% of predicted at screening

History of lung surgery in the past two years,

Trial design

Design model

Parallel

Treatments tested in this trial

Pro2 - 60% of participant's MIP
Device
Each participant will be provided a PrO2™ device and trained on its use as well as its accompanying PrO2 Fit™ app. The PrO2™ is a flow-resistive device that provides inspiratory resistance via a fixed 2mm orifice and has Bluetooth connectivity to most IOS/Android devices or Mac/Windows computers. The PrO2™ device and app allows for both 100% adherence monitoring and immediate user biofeedback. 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 60% of their MIP.
Pro2 - 15% of participant's MIP
Device
Participants in the control intervention will also use the same PrO2™ device but at a reduced peak resistance of 15% MIP. 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 for each repetition

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Active inspiratory muscle rehabilitation (IMR) groupExperimental treatment 1 intervention

Group B: SHAMActive comparator 1 intervention

Trial outcomes

Primary outcomes

Adherence to active IMR Adherence to active IMR

Prevalence of IMR completion (actual / planned reps over intervention period) in active IMR group

Time frame

approximately 2 months

Participant satisfaction among active IMR participants

Prevalence of agree or strongly agree to question of satisfaction with active IMR

Time frame

approximately 2 months

Prevalence of completer status

Completion of study Visit 3

Time frame

approximately 2 months

Secondary outcomes

Demonstrate changes in inspiratory muscle function with IMR.

Change in maximum inspiratory pressure (MIP) over intervention period

Time frame

approximately 2 months

Demonstrate changes in respiratory symptoms following IMR.

Participants are asked every week during the follow up calls if there are any health improvements

Time frame

approximately 2 months

Other outcomes

Demonstrate the safety of IMR

Participants are asked every week during the follow up calls if there are any adverse events

Time frame

approximately 2 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

American Lung Association

Collaborator

Source ClinicalTrials.gov

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