Diaphragm Structure and Function in Children

NCT06230692 | Completed

• 1 other identifier: HP-00108839
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Muscle Training

Keywords

Diaphragm; Control of Breathing; Exercise

Outcome Measures

Primary Outcomes (2)

• Percent completion

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

  6 weeks

• Adherence to treatment protocol

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

  6 weeks

Secondary Outcomes (3)

• Maximal inspiratory pressure (measured in cm H2O)

  6 weeks

• Diaphragm thickness (measured in mm)

  6 weeks

• Exercise ventilation

  6 weeks

Other Outcomes (1)

• 6-minute walk test distance (measured in m)

  6 weeks

Study Arms (1)

Inspiratory Muscle Training (IMT)

EXPERIMENTAL

Participants will be asked to perform inspiratory muscle training (breathing exercise) 5 days per week for 6 weeks at home.

Device: POWERbreathe Plus IMT

Interventions

POWERbreathe Plus IMT DEVICE

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.

Inspiratory Muscle Training (IMT)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age range 6-12 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Simon Ho

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 30, 2024
• Study Start: March 16, 2024
• Primary Completion: January 6, 2025
• Study Completion: January 6, 2025
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)