Recruiting

Pulmonary Rehabilitation

Sponsor:

Duke University

Code:

NCT05608668

Conditions

Pediatric Obesity

Pediatric Asthma

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Not accepted

Interventions

Pro2 - 60% of participant's MIP

Pro2 - 15% of participant's MIP

Study Details

Brief summary:

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

Conditions

Pediatric Obesity

Pediatric Asthma

Study ID

NCT05608668

Start date

Jul 27, 2023

Status verified date

Jun, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.
  • Participant and legal guardian must speak and read English.
  • Child is currently taking prescription medicine for asthma (Any type of albuterol or inhaled steroid)

Exclusion Criteria:

  • 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,
  • History of pulmonary embolism in the past two years,
  • Any history of recurrent spontaneous pneumothorax, or pneumothorax in the past 12 months
  • Current undiagnosed chest pain,
  • History of inner ear surgery in the past 12 months,
  • Undiagnosed syncopal episodes in the past two years,
  • Progressive neurological or neuromuscular disorders or need for chronic O2 therapy.
  • Inability to complete baseline measurements satisfactorily according to the research coordinator's or PI's judgment.
  • Any condition in the opinion of the PI that would not allow safe conduct of study procedures (including IMR, MIP testing or step-test), such as a physical disability, recent musculoskeletal injury or illness, current and ongoing evaluation for undiagnosed cardiopulmonary or neurologic symptoms

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active inspiratory muscle rehabilitation (IMR) group

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 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 60% of their MIP.

active comparator: SHAM

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.

Interventions

Pro2 - 60% of participant's MIP

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

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

Primary outcome measure

  • Adherence to active IMR Adherence to active IMR [ Time Frame: approximately 2 months ]
  • Participant satisfaction among active IMR participants [ Time Frame: approximately 2 months ]
  • Prevalence of completer status [ Time Frame: approximately 2 months ]

Central Contacts and Locations

Central contacts

Veronica Carrion, BS

9197041523vmp19@duke.edu

Jasong Lang, MD

9196843364jason.lang@duke.edu

Locations

Duke Healthy Lifestyles Clinic

Recruiting

Durham, North Carolina, United States, 27704

Contacts

Veronica Carrion, BS

9197041523vmp19@duke.edu

More Information

Sponsor

Duke University

Last update posted

Aug 22, 2025

Last verified

Jun, 2025

Keywords

  • Asthma
  • Obesity
  • Pediatric

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2025-08-22.