Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma

Description

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

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Study Overview

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Study Details

Study overview

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

Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma

Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma

Condition
Pediatric Obesity
Intervention / Treatment

-

Contacts and Locations

Durham

Duke Healthy Lifestyles Clinic, Durham, North Carolina, United States, 27704

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

8 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Duke University,

Jason Lang, MD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

2025-06