Diaphragm Structure and Function in Children

Not Applicable

Recruiting

• Conditions: Respiratory Muscle Training
• Interventions: Device: POWERbreathe Plus IMT

• Registration Number: NCT06230692
• Lead Sponsor: University of Maryland, Baltimore

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2024-01-19
• Study First Submitted QC: 2024-01-19
• Study First Posted: 2024-01-30
• Study Start: 2024-03-16
• Status Verified: 2024-04
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Inspiratory Muscle Training (IMT)	POWERbreathe Plus IMT	Participants will be asked to perform inspiratory muscle training (breathing exercise) 5 days per week for 6 weeks at home.

Primary Outcome Measures

Name	Time	Method
Percent completion	6 weeks	Percentage of enrolled participants who complete the 6-week inspiratory muscle training protocol
Adherence to treatment protocol	6 weeks	Number of sets and repetitions of training breaths completed during the 6-week inspiratory muscle training protocol

Secondary Outcome Measures

Name	Time	Method
Maximal inspiratory pressure (measured in cm H2O)	6 weeks	Maximal pressure generated during an inspiratory maneuver, representing inspiratory muscle strength
Diaphragm thickness (measured in mm)	6 weeks	Thickness of the diaphragm muscle measured by noninvasive ultrasound imaging
Exercise ventilation	6 weeks	Ratio of ventilation to carbon dioxide production (VE/VCO2) during steady-state walking, representing ventilatory drive during exercise

Trial Locations

Locations (1)

University of Maryland, Baltimore; 🇺🇸 Baltimore, Maryland, United States