Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
4 participants
INTERVENTIONAL
2025-10-25
2026-10-31
Brief Summary
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Detailed Description
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For this study, patients will be asked to perform IMST for the six weeks prior to their next scheduled clinical standard of care assessment of their PH. The goal of this study is to determine whether IMST reduces pulmonary arterial pressure and improves exercise tolerance in individuals with PH. This study will be minimally invasive, as it simply adds a safe, well-tolerated, non-invasive respiratory training to the participants' standard of care and leverages their existing PH assessment data to evaluate the impact of IMST on PH.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Inspiratory Muscle Strength Training
This group will perform inspiratory muscle strength training (\~5 min/day) for 5 days a week for 6 weeks.
Inspiratory Muscle Strength Training
Participants will be asked to inhale against a resistance. This resistance will be set to \~55% of their maximal inspiratory ability. Participants will complete 5 sets of 6 breaths (30 total) a day for 5 days a week for 6 weeks.
Interventions
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Inspiratory Muscle Strength Training
Participants will be asked to inhale against a resistance. This resistance will be set to \~55% of their maximal inspiratory ability. Participants will complete 5 sets of 6 breaths (30 total) a day for 5 days a week for 6 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must already be scheduled for a clinical assessment of their PH within 8 weeks of enrolling in the study.
* Must have undergone an assessment of their PH in the last 18 months with no major changes in PH management or medication within that period.
Exclusion Criteria
* Unable or unwilling to undergo routine functional testing of their PH (i.e., 6-minute walk distance).
* Presence of significant cardiovascular or respiratory conditions other than PH, including but not limited to:
* Chronic obstructive pulmonary disease
* Severe asthma
* Severe ischemic heart disease
* Left-sided heart failure
* History of a major cardiovascular event, such as a myocardial infarction or stroke, within the last 6 months
* Individuals with an implanted pacemaker or other significant cardiac devices
* History of neurological, respiratory, head and neck, or thoracic surgeries, or conditions such as a collapsed lung or perforated eardrum
* Pregnant individuals or those actively trying to become pregnant
* Individuals with any of the following: chronic laryngitis, chronic bronchitis, emphysema, pneumonia, tuberculosis, chronic cough, extremely high blood pressure (\>170/100), neurological problems, scoliosis, organ transplants, HIV or other immunocompromising conditions, or autoimmune disease.
18 Years
ALL
No
Sponsors
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University of Arizona
OTHER
Responsible Party
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Elizabeth Fiona Bailey, PhD
Professor
Locations
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University of Arizona
Tucson, Arizona, United States
Countries
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Other Identifiers
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STUDY00005343
Identifier Type: -
Identifier Source: org_study_id