N/A
N=27
Inspiratory Muscle Rehabilitation in Children With Obesity
Pediatric Obesity
Bottom Line
View on ClinicalTrials.gov: NCT05412134 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Number of Participants Who Complete Study Visit 3 — 12; 13 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pro2 - 75% of participant's MIP (Device); Pro2 - 15% of participant's MIP (Device)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Complete Study Visit 3 |
12; 13 | — |
| PRIMARY Adherence to Active IMR (Inspiratory Muscle Rehabilitation) |
76; 69 | 0.333 |
| PRIMARY Participant Satisfaction With IMR (Inspiratory Muscle Rehabilitation) |
5; 5 | 0.416 |
| SECONDARY Change in Maximum Inspiratory Pressure (MIP) Over Intervention Period |
14; 7 | 0.581 |
| SECONDARY Change in Modified Medical Research Council (mMRC) Dyspnea Scores Over Intervention Period |
-2.2; -1.1 | 0.071 |
| SECONDARY Change in Average Daily Moderate-vigorous Physical Activity (MVPA) Time |
7; -16 | 0.356 |
| SECONDARY Change in Average Daily Sedentary Physical Activity (SPA) Time |
— | — |
| SECONDARY Change in Average Daily Step Count |
865; -51 | 0.079 |
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), 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
Eligibility Criteria
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) 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05412134). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.