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| Name | Class |
|---|---|
| The Derfner Foundation | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Lang, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Healthy Lifestyles Clinic | Durham | North Carolina | 27704 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38696657 | Derived | 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. |
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The Breathe-Fit trial was a single-center, partially-blinded, randomized 6-week parallel group intervention trial of inspiratory muscle training in youths with obesity being seen at the Duke Healthy Lifestyles childhood obesity treatment clinic. In brief, study staff screened the clinic schedule for initial eligibility and then approached potential patients to for recruitment and to confirm eligibility criteria and obtain consent/assent.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Complete Study Visit 3 | Posted | Count of Participants | Participants | approximately 2 months |
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Approximately 2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Lang, MD | Duke University | 919-684-3364 | jason.lang@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 26, 2022 | Feb 28, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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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)
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| 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. |
|
| 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 |
| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | 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. 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. |
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| Primary | Adherence to Active IMR (Inspiratory Muscle Rehabilitation) | Percentage of IMR completion (actual / planned reps over intervention period x 100) | Posted | Median | Inter-Quartile Range | percentage of completed repetitions | up to 2 months |
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| Primary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | up to 2 months |
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| Secondary | Change in Maximum Inspiratory Pressure (MIP) Over Intervention Period | Posted | Mean | Standard Deviation | cm water | Baseline, approximately 2 months |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, approximately 2 months |
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| Secondary | Change in Average Daily Moderate-vigorous Physical Activity (MVPA) Time | Posted | Mean | Standard Deviation | minutes per day | Baseline, approximately 2 months |
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| Secondary | 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. | Data not collected. | Posted | Baseline, approximately 2 months |
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| Secondary | Change in Average Daily Step Count | Posted | Mean | Standard Deviation | steps per day | Baseline, approximately 2 months |
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| Other Pre-specified | Heart Rate Change During 3-minute Step Test (HRC) | determined by the change in HRC from baseline to final visit after intervention | Not Posted | Baseline, approximately 2 months | Participants |
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | 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. 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. | 0 | 13 | 0 | 13 | 0 | 13 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 0.626 |
| Other |