Inspiratory Muscle Rehabilitation in Children With Obesity

Not Applicable

Completed

Conditions: Pediatric Obesity

Interventions: Device: Pro2 - 15% of participant's MIP
Device: Pro2 - 75% of participant's MIP

Registration Number: NCT05412134

Lead Sponsor: Duke University

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), 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

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 cardiopulmonary sequelae. Current childhood obesity rates, for the first time in US history, predict a decline in life US expectancy. Importantly, childhood obesity is a key driver of health disparities in the US, with obesity disproportionately affecting African-American, Hispanic-Latino, and Native American children. A key contributor to the sequelae of obesity is sedentariness. Thus, best practice in obesity management includes both reducing sedentariness and establishing durable increases in daily physical activity, however, attrition from planned exercise programs remains high. A key challenge to initiating and sustaining physical activity in children with obesity is the extreme dyspnea (breathlessness) they experience. This is due to the altered thoracic mechanics of obesity which lead to enhanced inspiratory muscle fatigue and dyspnea, with even modest physical activity. Our group has confirmed that among adolescents, higher body mass index (BMI) associates with lower inspiratory muscle endurance (r= -0.680, p=0.049, n=14), and that this lower endurance correlates with more frequent dyspnea (r= - 0.672, p=0.023, n=12). Treating obesity-related inspiratory muscle impairment and dyspnea is a promising approach to support physical activity in children with obesity but is yet unproven.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 27

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHAM	Pro2 - 15% of participant's MIP	Participants in the control intervention will also use the same PrO2™ device but at a reduced peak resistance of 15% MIP. The research team will implement biofeedback signals at a specific inspiratory resistance to provide precise and individualized training target. Successful IMR repetitions will require that subjects achieve a pressure target that is 15% of their MIP for each repetition. Participants will perform 3 sets of 50 inspiratory breaths 3 times per week.
Active inspiratory muscle rehabilitation (IMR) group	Pro2 - 75% of participant's MIP	Each participant will be provided a PrO2™ device and trained on its use and its accompanying PrO2 Fit™ app. The PrO2™ is a flow-resistive device that provides inspiratory resistance via a fixed 2mm orifice and has Bluetooth connectivity to most IOS/Android devices or Mac/Windows computers. The PrO2™ device and app allows for both 100% adherence monitoring and immediate user biofeedback. Participants will be instructed at Visit 1 and Visit 2 to inspire forcefully through PrO2™ until the device signals that the user has achieved the target resistance (via audible alarm and visible light signal). The research team will implement biofeedback signals at a specific inspiratory resistance to provide a precise and individualized training target. Successful IMR repetitions will require that subjects achieve a pressure target that is 75% of their MIP.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Complete Study Visit 3	approximately 2 months
Adherence to Active IMR (Inspiratory Muscle Rehabilitation)	up to 2 months	Percentage of IMR completion (actual / planned reps over intervention period x 100)
Participant Satisfaction With IMR (Inspiratory Muscle Rehabilitation)	up to 2 months	Scored on a 5-point Likert scale where 1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, 5 = strongly agree.

Secondary Outcome Measures

Name	Time	Method
Change in Average Daily Sedentary Physical Activity (SPA) Time	Baseline, approximately 2 months	Determined by the difference in MVPA between the baseline (run-in) value and value taken at the end of the intervention period.
Change in Average Daily Moderate-vigorous Physical Activity (MVPA) Time	Baseline, approximately 2 months
Change in Maximum Inspiratory Pressure (MIP) Over Intervention Period	Baseline, approximately 2 months
Change in Modified Medical Research Council (mMRC) Dyspnea Scores Over Intervention Period	Baseline, approximately 2 months	The mMRC scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4: 0, no breathlessness except on strenuous exercise; 1, shortness of breath when hurrying on the level or walking up a slight hill; 2, walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3, stops for breath after walking ∼100 m or after few minutes on the level; and 4, too breathless to leave the house, or breathless when dressing or undressing.
Change in Average Daily Step Count	Baseline, approximately 2 months