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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06205251
Other study ID # HP-00106329
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 15, 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
Health authority
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 childhood cancer survivors.


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 No
Gender All
Age group 6 Years to 12 Years
Eligibility Inclusion Criteria: - Completed medical treatment (chemotherapy, chemotherapy/surgery, chemotherapy/radiation or any combination of cancer treatment) for any type of cancer, except for cancer of the central nervous system, at least 1 year ago Exclusion Criteria: - History of neuromuscular, cardiac, or pulmonary disease prior to the diagnosis of cancer - Recent injury or condition (less than 6 months ago) that precludes strength testing or walking - Dyspnea with minimal activity (4 on the modified Medical Research Council Dyspnea Scale)

Study Design


Related Conditions & MeSH terms


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
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