Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma (iPro)

This is a single-center, randomized, SHAM-controlled, parallel assignment, double-masked,8-week interventional study among children aged 8-17 years (not yet 18 years old) of age with obesity and asthma. (n=60), recruited from Duke Health Center Creekstone, 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 and asthma.

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

Study Overview

• Status: Recruiting
• Conditions: Pediatric Obesity; Pediatric Asthma
• Intervention / Treatment: Device: Pro2 - 15% of participant's MIP; Device: Pro2 - 60% of participant's MIP

Detailed Description

Asthma is a chronic respiratory disease affecting roughly 8% of US children, and is characterized by intermittent symptoms of breathlessness/dyspnea, chest tightness, wheeze, and cough. Although asthma is currently the most common chronic disease in childhood, there are no cures and the underlying etiologies of the various asthma phenotypes still remain unclear. More than half of the 7-8 million pediatric asthma patients in the US have one or more exacerbations each year. A sizable component of asthma's impact on children stems from the recurrent mild-moderate symptoms that cause impaired quality-of-life, activity limitation and exercise avoidance. Uncontrolled asthma frequently disrupts quality of life and is the #1 reason that children miss school and avoid physical activity. Among children with asthma, obesity is a major risk factor for disruptive asthma symptoms. Asthma is conventionally thought to stem from inflammation in the lower airways. However, despite the widespread availability of anti-inflammatory inhaled corticosteroid (ICS) drugs, uncontrolled asthma remains extremely common and appears to be less effective in obese patients.

Pediatric obesity is a risk factor for both new-onset asthma and asthma that has more frequent and refractory symptoms. We found that pediatric obesity increases the risk for spirometry-confirmed asthma by nearly 30%. The mechanistic link between obesity and uncontrolled asthma remains unknown. In general, asthmatic children who are obese experience a reduced response to daily preventative ICS. Pediatric obesity has repeatedly been associated with more frequent and severe asthma symptoms, greater airflow obstruction, need for more frequent albuterol use, and more frequent and severe exacerbations. A consistent finding across most studies of children with both obesity and asthma has been an obesity-related increase in the frequency of chronic asthma symptoms (specifically dyspnea) and asthma-related activity limitation. We found that the greater asthma symptoms seen in obese versus non-obese children were primarily attributable to excess symptoms of dyspnea. Obese adolescents with asthma most commonly report that dyspnea is their most problematic asthma symptom. We hypothesize that the increased asthma symptom reporting in obese asthma, stems not from airway inflammation but rather obesity-related impaired breathing mechanics (i.e. chest restriction). Because of the reduced response to conventional asthma drugs and the resulting excess symptoms, there is a critical need for new treatment approaches for obese children with asthma that is guided by improved mechanistic understanding of this difficult phenotype.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Veronica Carrion, BS; Phone Number: 9197041523; Email: vmp19@duke.edu
• Study Contact Backup: Name: Jasong Lang, MD; Phone Number: 9196843364; Email: jason.lang@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27704
      • Recruiting
      • Duke Healthy Lifestyles Clinic
      • Contact: Veronica Carrion, BS; Phone Number: 919-704-1523; Email: vmp19@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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) and mild asthma.
• 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.
• Child is currently taking prescription medicine for asthma (Any type of albuterol or inhaled steroid)

Exclusion Criteria:

• Prior intubation for asthma
• Current self-reported pregnancy or planning to become pregnant.
• Have an FEV1 < 50% of predicted at screening
• History of lung surgery in the past two years,
• History of pulmonary embolism in the past two years,
• Any history of recurrent spontaneous pneumothorax, or pneumothorax in the past 12 months
• Current undiagnosed chest pain,
• History of inner ear surgery in the past 12 months,
• Undiagnosed syncopal episodes in the past two years,
• Progressive neurological or neuromuscular disorders or need for chronic O2 therapy.
• Inability to complete baseline measurements satisfactorily according to the research coordinator's or PI's judgment.
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SHAM; 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.	Device: 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
Experimental: Active inspiratory muscle rehabilitation (IMR) group; 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 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 60% of their MIP.	Device: Pro2 - 60% of participant's MIP; 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 60% of their MIP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to active IMR Adherence to active IMR	Prevalence of IMR completion (actual / planned reps over intervention period) in active IMR group	approximately 2 months
Participant satisfaction among active IMR participants	Prevalence of agree or strongly agree to question of satisfaction with active IMR	approximately 2 months
Prevalence of completer status	Completion of study Visit 3	approximately 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demonstrate changes in inspiratory muscle function with IMR.	Change in maximum inspiratory pressure (MIP) over intervention period	approximately 2 months
Demonstrate changes in respiratory symptoms following IMR.	Participants are asked every week during the follow up calls if there are any health improvements	approximately 2 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demonstrate the safety of IMR	Participants are asked every week during the follow up calls if there are any adverse events	approximately 2 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: American Lung Association
• Investigators: Principal Investigator: Jason Lang, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: October 25, 2022
• First Submitted That Met QC Criteria: November 2, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Obesity; Asthma; Pediatric
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Obesity; Asthma; Pediatric Obesity
• Other Study ID Numbers: Pro00111393

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No