Clinical trial NCT05412134: Inspiratory Muscle Rehabilitation in Children With Obesity
Official title: Inspiratory Muscle Rehabilitation in Children With Obesity to Promote Physical Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: The Derfner Foundation
First posted: 2022-06-09
Enrollment: 27
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants Who Complete Study Visit 3
timeFrame: approximately 2 months
measure: Adherence to Active IMR (Inspiratory Muscle Rehabilitation)
timeFrame: up to 2 months
measure: Participant Satisfaction With IMR (Inspiratory Muscle Rehabilitation)
timeFrame: up to 2 months
Secondary outcomes:
measure: Change in Maximum Inspiratory Pressure (MIP) Over Intervention Period
timeFrame: Baseline, approximately 2 months
measure: Change in Modified Medical Research Council (mMRC) Dyspnea Scores Over Intervention Period
timeFrame: Baseline, approximately 2 months
measure: Change in Average Daily Moderate-vigorous Physical Activity (MVPA) Time
timeFrame: Baseline, approximately 2 months
measure: Change in Average Daily Sedentary Physical Activity (SPA) Time
timeFrame: Baseline, approximately 2 months
measure: Change in Average Daily Step Count
timeFrame: Baseline, approximately 2 months
Other outcomes:
measure: Heart Rate Change During 3-minute Step Test (HRC)
timeFrame: Baseline, approximately 2 months
Locations:
city: Durham
country: United States
facility: Duke Healthy Lifestyles Clinic
state: North Carolina
Study officials:
affiliation: Duke University
name: Jason Lang, MD
role: PRINCIPAL_INVESTIGATOR
References: