Diaphragm Structure and Function in Children

Respiratory Muscle Training Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06230692
• Other study ID #: HP-00108839
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2024
• Est. completion date: October 2024

Study information

• Verified date: April 2024
• Source: University of Maryland, Baltimore
• Contact: Martina Miller
• Phone: 410-706-3869
• Email: martina.miller[@]umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 13
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Muscle Training

Intervention

Device:
• POWERbreathe Plus IMT
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.

Locations

Country	Name	City	State
United States	University of Maryland, Baltimore	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	6-minute walk test distance (measured in m)	Maximal distance walked in 6 minutes	6 weeks
Primary	Percent completion	Percentage of enrolled participants who complete the 6-week inspiratory muscle training protocol	6 weeks
Primary	Adherence to treatment protocol	Number of sets and repetitions of training breaths completed during the 6-week inspiratory muscle training protocol	6 weeks
Secondary	Maximal inspiratory pressure (measured in cm H2O)	Maximal pressure generated during an inspiratory maneuver, representing inspiratory muscle strength	6 weeks
Secondary	Diaphragm thickness (measured in mm)	Thickness of the diaphragm muscle measured by noninvasive ultrasound imaging	6 weeks
Secondary	Exercise ventilation	Ratio of ventilation to carbon dioxide production (VE/VCO2) during steady-state walking, representing ventilatory drive during exercise	6 weeks