Status:
COMPLETED
Inspiratory Muscle Rehabilitation in Children With Obesity
Lead Sponsor:
Duke University
Collaborating Sponsors:
The Derfner Foundation
Conditions:
Pediatric Obesity
Eligibility:
All Genders
8-17 years
Phase:
NA
Brief Summary
This is a single-center, randomized, SHAM-controlled, parallel assignment, double-masked, interventional trial among children aged 8-17 years (not yet 18 years old) of age with obesity (n=30), recruit...
Detailed Description
Improved management of obesity is an urgent public health need. Nearly 40% of US children and adolescents have a body mass index that markedly increases their risk for serious metabolic and cardiopulm...
Eligibility Criteria
Inclusion
- 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) being seen at Duke Healthy Lifestyles clinic.
- 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.
Exclusion
- Prior enrollment in an IMR program.
- Contraindications for IMR including a history of recent lung surgery, recent pulmonary embolism, or history of recurrent spontaneous pneumothorax
- Progressive neurological or neuromuscular disorders or need for chronic O2 therapy.
- Inability to complete baseline measurements in a satisfactory manner according to the judgment of the research coordinator or PI.
- Current self-reported pregnancy or planning to become pregnant.
- Body weight greater than 300 pounds.
- 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, undiagnosed chest pain, pneumothorax in the past 12 months, inner ear surgery in the past 12 months, or undiagnosed syncopal episodes.
Key Trial Info
Start Date :
August 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2023
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT05412134
Start Date
August 23 2022
End Date
March 3 2023
Last Update
April 18 2024
Active Locations (1)
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1
Duke Healthy Lifestyles Clinic
Durham, North Carolina, United States, 27704