Diaphragm Structure and Function in Children

University of Maryland, Baltimore10 enrolled

Overview

The purpose of this research is to study the feasibility of a specific training program for the breathing muscles (inspiratory muscle training) and the effects on how breathing is regulated during exercise in typically developing children.

During the first study visit, participants will undergo a series of pulmonary function and muscle performance tests followed by treadmill walking trials at different speeds with concurrent expired gas analysis via a face mask. The participants will then perform a training program for the breathing muscles at home for 6 weeks. The research team will follow up each week via telehealth visits to support training. After the 6-week training program, participants will return in-person for a follow-up visit and will undergo the same series of assessments as the first visit.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Respiratory Muscle Training

Interventions

POWERbreathe Plus IMTDEVICE

Inspiratory muscle training will be performed using the POWERbreathe Plus IMT (POWERbreathe International Ltd., Warwickshire, UK), a commercially available inspiratory pressure threshold device. In this type of training, airflow is occluded until the generated inspiratory pressure reaches the predetermined threshold, which can be set at increments of 8 cm H2O. During the first week of training, the target intensity will be set at 50% of baseline maximal inspiratory pressure (MIP.) During the second week, the target intensity will be set at 60% of baseline MIP. Beginning at the third week and for the remainder of the training program, the target intensity will be set at 75% of the participant's baseline MIP. The target volume will be 5 sets of 6 breaths per day (total of 30 breaths per day), separated by 1-minute rest breaks between sets. The frequency of training will be 5 days per week, for a duration of 6 weeks.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age range 6-12 years of age Exclusion Criteria: * History of neuromuscular, cardiac, or pulmonary disease * Known intellectual or developmental problems that would preclude the ability to assent * Ruptured eardrum * Recent injury or condition (less than 6 months ago) that precludes strength testing or walking * Recent (less than 2 weeks ago) or current respiratory or other type of illness

Locations (1)

University of Maryland, Baltimore

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Percent completion

Percentage of enrolled participants who complete the 6-week inspiratory muscle training protocol

Time frame: 6 weeks

Adherence to treatment protocol

Number of sets and repetitions of training breaths completed during the 6-week inspiratory muscle training protocol

Time frame: 6 weeks

Secondary Outcomes

Maximal inspiratory pressure (measured in cm H2O)

Maximal pressure generated during an inspiratory maneuver, representing inspiratory muscle strength

Time frame: 6 weeks

Diaphragm thickness (measured in mm)

Thickness of the diaphragm muscle measured by noninvasive ultrasound imaging

Time frame: 6 weeks

Exercise ventilation

Ratio of ventilation to carbon dioxide production (VE/VCO2) during steady-state walking, representing ventilatory drive during exercise

Time frame: 6 weeks

Data from ClinicalTrials.gov

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