Inspiratory Muscle Rehabilitation in Children With Obesity

NCT05412134 | Completed Results FDA Device

• 1 other identifier: Pro00110494
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Conditions

Pediatric Obesity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

  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

  Baseline, approximately 2 months

• Change in Average Daily Step Count

  Baseline, approximately 2 months

Other Outcomes (1)

• Heart Rate Change During 3-minute Step Test (HRC)

  Baseline, approximately 2 months

Study Arms (2)

Active inspiratory muscle rehabilitation (IMR) group

EXPERIMENTAL

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

SHAM

ACTIVE COMPARATOR

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

Interventions

Pro2 - 75% of participant's MIP DEVICE

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 inspiratory muscle rehabilitation (IMR) group

Pro2 - 15% of participant's MIP DEVICE

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.

SHAM

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• The Derfner Foundation: collaborator

Study Sites (1)

Duke Healthy Lifestyles Clinic

Durham, North Carolina, 27704, United States

Location

Related Publications (1)

• Lang JE, Carrion VM, Bhammar DM, Howard JB, Armstrong SC. A Randomized Trial of Inspiratory Training in Children and Adolescents With Obesity. Child Obes. 2024 Oct;20(7):517-525. doi: 10.1089/chi.2023.0183. Epub 2024 May 2.

  PMID: 38696657 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jason Lang, MD
• Organization: Duke University

jason.lang@duke.edu

919-684-3364

Study Officials

• Jason Lang, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 9, 2022
• Study Start: August 23, 2022
• Primary Completion: February 28, 2023
• Study Completion: March 3, 2023
• Last Updated: April 18, 2024
• Results First Posted: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)