Inspiratory Muscle Rehabilitation in Children With Obesity

Inspiratory Muscle Rehabilitation in Children With Obesity to Promote Physical Activity

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05412134

Acronym

BREATHE Fit

Enrollment

Registered

2022-06-09

Start date

2022-08-23

Completion date

2023-03-03

Last updated

2024-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Obesity

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.

Interventions

DEVICEPro2 - 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.

DEVICEPro2 - 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes 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)

Eligibility

Sex/Gender

ALL

Age

8 Years to 17 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Change in Average Daily Moderate-vigorous Physical Activity (MVPA) Time	Baseline, approximately 2 months	—
Change in Average Daily Step Count	Baseline, approximately 2 months	—
Change in Average Daily Sedentary Physical Activity (SPA) Time	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.
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	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.

Other

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

Countries

United States

Participant flow

Recruitment details

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.

Participants by arm

Arm	Count
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.	14
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.	13
Total	27

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	2	0

Baseline characteristics

Characteristic	Active Inspiratory Muscle Rehabilitation (IMR) Group	Total	SHAM
Age, Continuous	11.1 years STANDARD_DEVIATION 2.8	11.3 years STANDARD_DEVIATION 2.5	11.5 years STANDARD_DEVIATION 2.2
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants	8 Participants	5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants	19 Participants	8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	9 Participants	19 Participants	10 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants	5 Participants	2 Participants
Race (NIH/OMB) White	2 Participants	3 Participants	1 Participants
Region of Enrollment United States	14 Participants	27 Participants	13 Participants
Sex: Female, Male Female	6 Participants	9 Participants	3 Participants
Sex: Female, Male Male	8 Participants	18 Participants	10 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 14	0 / 13
other Total, other adverse events	0 / 14	0 / 13
serious Total, serious adverse events	0 / 14	0 / 13

Outcome results

Primary

Adherence to Active IMR (Inspiratory Muscle Rehabilitation)

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

Time frame: up to 2 months

Arm	Measure	Value (MEDIAN)
Active Inspiratory Muscle Rehabilitation (IMR) Group	Adherence to Active IMR (Inspiratory Muscle Rehabilitation)	76 percentage of completed repetitions
SHAM	Adherence to Active IMR (Inspiratory Muscle Rehabilitation)	69 percentage of completed repetitions

Comparison: Session adherencep-value: 0.626Chi-squared

Comparison: Repetition adherencep-value: 0.333Chi-squared

Primary

Number of Participants Who Complete Study Visit 3

Time frame: approximately 2 months

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Active Inspiratory Muscle Rehabilitation (IMR) Group	Number of Participants Who Complete Study Visit 3	12 Participants
SHAM	Number of Participants Who Complete Study Visit 3	13 Participants

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.

Time frame: up to 2 months

Arm	Measure	Value (MEDIAN)
Active Inspiratory Muscle Rehabilitation (IMR) Group	Participant Satisfaction With IMR (Inspiratory Muscle Rehabilitation)	5 score on a scale
SHAM	Participant Satisfaction With IMR (Inspiratory Muscle Rehabilitation)	5 score on a scale

p-value: 0.416Wilcoxon (Mann-Whitney)

Secondary