Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma
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 Start (Actual) 27 July 2023
🗓️ Primary Completion (Estimated) June 2024
✅ Study Completion (Estimated) June 2024
👥 Enrollment (Estimated) 60
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Durham, North Carolina, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 8 Years to 17 Years (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 25 October 2022
  • First Submitted that Met QC Criteria 2 November 2022
  • First Posted 8 November 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 1 August 2023
  • Last Update Posted 2 August 2023
  • Last Verified March 2023