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Completed

NCT Number: NCT05412134

Inspiratory Muscle Rehabilitation in Children With Obesity

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

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Key information

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Healthy Lifestyles Clinic

Durham, North Carolina, 27704, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Number of Participants Who Complete Study Visit 3

    Time frame: approximately 2 months

  2. Adherence to Active IMR (Inspiratory Muscle Rehabilitation)

    Time frame: up to 2 months

    Percentage of IMR completion (actual / planned reps over intervention period x 100)

  3. Participant Satisfaction With IMR (Inspiratory Muscle Rehabilitation)

    Time frame: up to 2 months

    Scored on a 5-point Likert scale where 1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, 5 = strongly agree.

Secondary outcomes

  1. Change in Maximum Inspiratory Pressure (MIP) Over Intervention Period

    Time frame: Baseline, approximately 2 months

  2. Change in Modified Medical Research Council (mMRC) Dyspnea Scores Over Intervention Period

    Time frame: Baseline, approximately 2 months

    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.

  3. Change in Average Daily Moderate-vigorous Physical Activity (MVPA) Time

    Time frame: Baseline, approximately 2 months

  4. Change in Average Daily Sedentary Physical Activity (SPA) Time

    Time frame: Baseline, approximately 2 months

    Determined by the difference in MVPA between the baseline (run-in) value and value taken at the end of the intervention period.

  5. Change in Average Daily Step Count

    Time frame: Baseline, approximately 2 months

Other outcomes

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

    Time frame: Baseline, approximately 2 months

    determined by the change in HRC from baseline to final visit after intervention

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • The Derfner Foundation

Registry information

Official study title

Inspiratory Muscle Rehabilitation in Children With Obesity to Promote Physical Activity

Acronym: BREATHE Fit

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 9, 2022
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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