Inspiratory Muscle Rehabilitation in Children With Obesity (BREATHE Fit)

Inspiratory Muscle Rehabilitation in Children With Obesity to Promote Physical Activity

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

Study Overview

• Status: Completed
• Conditions: Pediatric Obesity
• Intervention / Treatment: Device: Pro2 - 75% of participant's MIP; Device: Pro2 - 15% of participant's MIP

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27704
      • Duke Healthy Lifestyles Clinic

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) 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 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
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 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.	Device: Pro2 - 75% 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 75% of their MIP.
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. Participants will perform 3 sets of 50 inspiratory breaths 3 times per week.	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. Participants will perform 3 sets of 50 inspiratory breaths 3 times per week.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Baseline, approximately 2 months
Change in Average Daily Moderate-vigorous Physical Activity (MVPA) Time		Baseline, approximately 2 months
Change in Average Daily Sedentary Physical Activity (SPA) Time	Determined by the difference in MVPA between the baseline (run-in) value and value taken at the end of the intervention period.	Baseline, approximately 2 months
Change in Average Daily Step Count		Baseline, approximately 2 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate Change During 3-minute Step Test (HRC)	determined by the change in HRC from baseline to final visit after intervention	Baseline, approximately 2 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: The Derfner Foundation
• Investigators: Principal Investigator: Jason Lang, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2022
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): March 3, 2023

Study Registration Dates

• First Submitted: June 7, 2022
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (Actual): June 9, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: Pro00110494

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