Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma

NCT05608668 | Recruiting FDA Device

• 1 other identifier: Pro00111393
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Asthma; Obesity; Pediatric

Outcome Measures

Primary Outcomes (3)

• Adherence to active IMR Adherence to active IMR

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

  approximately 2 months

• Participant satisfaction among active IMR participants

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

  approximately 2 months

• Prevalence of completer status

  Completion of study Visit 3

  approximately 2 months

Secondary Outcomes (2)

• Demonstrate changes in inspiratory muscle function with IMR.

  approximately 2 months

• Demonstrate changes in respiratory symptoms following IMR.

  approximately 2 months

Other Outcomes (1)

• Demonstrate the safety of IMR

  approximately 2 months

Study Arms (2)

Active inspiratory muscle rehabilitation (IMR) group

EXPERIMENTAL

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.

Device: Pro2 - 60% of participant's MIP

SHAM

ACTIVE COMPARATOR

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.

Device: Pro2 - 15% of participant's MIP

Interventions

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.

Active inspiratory muscle rehabilitation (IMR) group

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

SHAM

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• American Lung Association: collaborator

Study Sites (1)

Duke Healthy Lifestyles Clinic

Durham, North Carolina, 27704, United States

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity; Asthma; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jason Lang, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronica Carrion, BS

CONTACT

9197041523; vmp19@duke.edu

Jasong Lang, MD

CONTACT

9196843364; jason.lang@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The only person who will know the arm of each participant will be the study team member in charge of randomization (the clinical research coordinator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: November 8, 2022
• Study Start: July 27, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)