Inspiratory Muscle Rehabilitation in Children With Obesity
Condition: Pediatric Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

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.
    

Intervention name(s): Pro2 - 75% of participant's MIP; Pro2 - 15% of participant's MIP
Intervention type(s): Device; Device
Intervention description(s): Each participant will be provided a PrO2™ device and trained on its use as well as 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 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 precise and individualized training target. Successful IMR repetitions will require that subjects achieve a pressure target that is 75% of their 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment