- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06230692
Diaphragm Structure and Function in Children
Understanding the Influence of Diaphragm Structure and Function on the Control of Breathing During Exercise in Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Martina Miller
- Phone Number: 410-706-3869
- Email: martina.miller@umaryland.edu
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- Recruiting
- University of Maryland, Baltimore
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Inspiratory Muscle Training (IMT)
Participants will be asked to perform inspiratory muscle training (breathing exercise) 5 days per week for 6 weeks at home.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent completion
Time Frame: 6 weeks
|
Percentage of enrolled participants who complete the 6-week inspiratory muscle training protocol
|
6 weeks
|
Adherence to treatment protocol
Time Frame: 6 weeks
|
Number of sets and repetitions of training breaths completed during the 6-week inspiratory muscle training protocol
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximal inspiratory pressure (measured in cm H2O)
Time Frame: 6 weeks
|
Maximal pressure generated during an inspiratory maneuver, representing inspiratory muscle strength
|
6 weeks
|
Diaphragm thickness (measured in mm)
Time Frame: 6 weeks
|
Thickness of the diaphragm muscle measured by noninvasive ultrasound imaging
|
6 weeks
|
Exercise ventilation
Time Frame: 6 weeks
|
Ratio of ventilation to carbon dioxide production (VE/VCO2) during steady-state walking, representing ventilatory drive during exercise
|
6 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
6-minute walk test distance (measured in m)
Time Frame: 6 weeks
|
Maximal distance walked in 6 minutes
|
6 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Simon Ho, University of Maryland, Baltimore
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HP-00108839
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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