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Inspiratory Muscle Rehabilitation in Children With Obesity (BREATHE Fit)

Primary Purpose

Pediatric Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Pro2 - 75% of participant's MIP

Pro2 - 15% of participant's MIP

About this trial

This is an interventional treatment trial for Pediatric Obesity

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Duke Healthy Lifestyles Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Active inspiratory muscle rehabilitation (IMR) group

SHAM

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Prevalence of completer status

Completion of study Visit 3

Adherence to active IMR

Prevalence of IMR completion (actual / planned reps over intervention period) in active IMR group

Participant satisfaction among active IMR participants

Prevalence of agree or strongly agree to question of satisfaction with active IMR

Secondary Outcome Measures

Change in maximum inspiratory pressure (MIP) over intervention period

Change in dyspnea scores over intervention period

Change in average daily moderate-vigorous physical activity (MVPA) time

Change in average daily sedentary physical activity (SPA) time

Change in average daily step count

Full Information

NCT ID

NCT05412134

First Posted

June 7, 2022

Last Updated

March 30, 2023

Sponsor

Duke University

Collaborators

The Derfner Foundation

1. Study Identification

Unique Protocol Identification Number

NCT05412134

Brief Title

Inspiratory Muscle Rehabilitation in Children With Obesity

Acronym

BREATHE Fit

Official Title

Inspiratory Muscle Rehabilitation in Children With Obesity to Promote Physical Activity

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

August 23, 2022 (Actual)

Primary Completion Date

February 28, 2023 (Actual)

Study Completion Date

March 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

The Derfner Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pediatric Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

The only person who will know the arm of each participant will be the study team member in charge of randomization (the clinical research coordinator)

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active inspiratory muscle rehabilitation (IMR) group

Arm Type

Experimental

Arm Description

Arm Title

SHAM

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Pro2 - 75% of participant's MIP

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Pro2 - 15% of participant's MIP

Intervention Description

Primary Outcome Measure Information:

Title

Prevalence of completer status

Description

Completion of study Visit 3

Time Frame

approximately 2 months

Title

Adherence to active IMR

Description

Prevalence of IMR completion (actual / planned reps over intervention period) in active IMR group

Time Frame

approximately 2 months

Title

Participant satisfaction among active IMR participants

Description

Prevalence of agree or strongly agree to question of satisfaction with active IMR

Time Frame

approximately 2 months

Secondary Outcome Measure Information:

Title

Change in maximum inspiratory pressure (MIP) over intervention period

Time Frame