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Behavioural Intervention

Pro2 - 75% of participant's MIP for Childhood Obesity (BREATHE Fit 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

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 2 months

Awards & highlights

BREATHE Fit Trial Summary

This trial tests whether IMR, an intervention to help with dyspnea, is effective and acceptable among children with obesity.

Eligible Conditions

Childhood Obesity

BREATHE Fit Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence to active IMR

Participant satisfaction among active IMR participants

Prevalence of completer status

Secondary outcome measures

Change in average daily moderate-vigorous physical activity (MVPA) time

Change in average daily sedentary physical activity (SPA) time

Change in average daily step count

+2 more

Other outcome measures

Heart rate change during 3-minute step test

BREATHE Fit Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Active inspiratory muscle rehabilitation (IMR) groupExperimental Treatment1 Intervention

Each participant will be provided a PrO2™ device and trained on its use and 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 at Visit 1 and Visit 2 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 a precise and individualized training target. Successful IMR repetitions will require that subjects achieve a pressure target that is 75% of their MIP.

Group II: SHAMActive Control1 Intervention

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. Participants will perform 3 sets of 50 inspiratory breaths 3 times per week.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pro2 - 75% of participant's MIP

2022

N/A

~30

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Duke UniversityLead Sponsor

2,358 Previous Clinical Trials

3,420,042 Total Patients Enrolled

The Derfner FoundationUNKNOWN

Jason Lang, MDPrincipal InvestigatorDuke University

4 Previous Clinical Trials

196 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age requirement for enrolment in this experiment limited to seventy-five and under?

"This experiment seeks participants aged between 8 and 17. A total of 250 patients under the age limit have enrolled, with 603 people enrolling from the 65+ demographic."

Answered by AI

What is the uppermost limit of patients involved in this clinical experiment?

"Affirmative. The clinicaltrials.gov website displays that this research project, which was opened on August 23rd 2022, is still searching for volunteers. 30 trial participants must be enrolled from a single location."

Answered by AI

Are any openings available to participants in this experiment?

"Affirmative. According to clinicaltrials.gov, the study, which was first posted on August 23rd 2022 is still seeking participants. Thirty people need to be enrolled at a single medical centre."

Answered by AI

Is there any possibility to become involved in this medical research?

"This clinical trial seeks 30 minors between 8-17 years old who are struggling with pediatric obesity (BMI ≥ 95th percentile for age and sex). To be eligible, participants must have a legal guardian that has provided documented informed consent as well as their own assent. Additionally, the child's caregiver must commit to helping them complete all study procedures. Furthermore, access to an internet connection and approved smart device/computer is mandatory while fluency in English is also necessary."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Inspiratory Muscle Rehabilitation in Children With Obesity

2022. "Inspiratory Muscle Rehabilitation in Children With Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05412134.