Inspiratory Muscle Rehabilitation in Children With Obesity
Completed · Not applicable · Has a placebo group
Conditions studied: Pediatric Obesity
In brief
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), recruited from the Duke Healthy Lifestyles 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
Key facts
- Study ID
- NCT05412134
- Run by
- Duke University
- People needed
- 27
- Starts
- 2022-08-23
- Expected to finish
- 2023-03-03
- Last updated by the study team
- 2024-04-18
Who can join
Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
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) 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.
You may not qualify if…
- 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.
Where it is running
- Duke Healthy Lifestyles Clinic — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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