Clinical Trials Directory

Trials / Completed

CompletedNCT06205251

Diaphragm Structure and Function in Childhood Cancer Survivors

Understanding the Influence of Diaphragm Structure and Function on the Control of Breathing During Exercise in Childhood Cancer Survivors (2373GCCC)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
7 (actual)
Sponsor
University of Maryland, Baltimore · Academic / Other
Sex
All
Age
6 Years – 12 Years
Healthy volunteers
Not accepted

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 childhood cancer survivors.

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.

Conditions

Interventions

TypeNameDescription
DEVICEPOWERbreathe Plus IMTInspiratory 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.

Timeline

Start date
2024-03-15
Primary completion
2025-01-07
Completion
2025-01-07
First posted
2024-01-12
Last updated
2026-03-30

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06205251. Inclusion in this directory is not an endorsement.