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Diaphragm Structure and Function in Children

Understanding the Influence of Diaphragm Structure and Function on the Control of Breathing During Exercise in Children

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06230692
Enrollment
10
Registered
2024-01-30
Start date
2024-03-16
Completion date
2025-01-06
Last updated
2026-03-30

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

Conditions

Respiratory Muscle Training

Keywords

Diaphragm, Control of Breathing, Exercise

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.

Interventions

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.

Sponsors

University of Maryland, Baltimore
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Percent completion6 weeksPercentage of enrolled participants who complete the 6-week inspiratory muscle training protocol
Adherence to treatment protocol6 weeksNumber of sets and repetitions of training breaths completed during the 6-week inspiratory muscle training protocol

Secondary

MeasureTime frameDescription
Maximal inspiratory pressure (measured in cm H2O)6 weeksMaximal pressure generated during an inspiratory maneuver, representing inspiratory muscle strength
Diaphragm thickness (measured in mm)6 weeksThickness of the diaphragm muscle measured by noninvasive ultrasound imaging
Exercise ventilation6 weeksRatio of ventilation to carbon dioxide production (VE/VCO2) during steady-state walking, representing ventilatory drive during exercise

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSimon Ho

University of Maryland, Baltimore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 12, 2026