Diaphragm Structure and Function in Children

University of Maryland Baltimore (UMB) logo

University of Maryland Baltimore (UMB)

Status

Enrolling

Conditions

Respiratory Muscle Training

Treatments

Device: POWERbreathe Plus IMT

Study type

Interventional

Funder types

Other

Identifiers

NCT06230692
HP-00108839

Details and patient eligibility

About

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.

Full 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.

Enrollment

13 estimated patients

Sex

All

Ages

6 to 12 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

13 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

Martina Miller

Data sourced from clinicaltrials.gov

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