Actively Recruiting

Phase Not Applicable
Age: 8Years - 17Years
All Genders
NCT05608668

Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma

Led by Duke University · Updated on 2025-08-22

60

Participants Needed

1

Research Sites

148 weeks

Total Duration

On this page

Sponsors

D

Duke University

Lead Sponsor

A

American Lung Association

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma

Who Can Participate

Age: 8Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Documented informed consent from legal guardian and assent from participant as appropriate
  • Children aged 8 to 17 years with obesity (BMI  95th percentile for age and sex) and mild asthma
  • Access to the internet and an approved smart device or computer
  • Child has a designated caregiver committed to supporting study participation
  • Participant and legal guardian can speak and read English
  • Child is currently taking prescription medicine for asthma (such as any type of albuterol or inhaled steroid)
Not Eligible

You will not qualify if you...

  • Prior intubation for asthma
  • Current self-reported pregnancy or planning to become pregnant
  • Forced expiratory volume in one second (FEV1) less than 50% of predicted at screening
  • History of lung surgery in the past two years
  • History of pulmonary embolism in the past two years
  • 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 fainting episodes in the past two years
  • Progressive neurological or neuromuscular disorders or need for chronic oxygen therapy
  • Inability to complete baseline measurements satisfactorily
  • Any condition that in the opinion of the principal investigator would not allow safe conduct of study procedures such as physical disability, recent musculoskeletal injury or illness, or ongoing evaluation for undiagnosed cardiopulmonary or neurologic symptoms

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Duke Healthy Lifestyles Clinic

Durham, North Carolina, United States, 27704

Actively Recruiting

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Research Team

V

Veronica Carrion, BS

CONTACT

J

Jasong Lang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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