Clinical trial NCT06931886: Pulmonary Hypertension Inspiratory Training
Official title: Effects of Inspiratory Muscle Strength Training on Pulmonary Hypertension: A Six Week Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pulmonary Hypertension
Keywords: Inspiratory Muscle Strength Training
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each individual enrolled will perform six weeks of inspiratory muscle strength training. There will be no control or sham group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is examining the effects of six weeks of inspiratory muscle strength training (IMST) on outcomes related to pulmonary hypertension. This study leverages previous cardiopulmonary exercise test (CPET) results and a pre-existing upcoming CPET to examine the effects of IMST on cardiopulmonary pressures and exercise tolerance and ability.

Detailed description: PH is a condition characterized by abnormally high blood pressure in the lungs (i.e., pulmonary arterial pressure), which impacts heart function and reduces exercise tolerance. This study will assess whether six weeks of a breathing exercise called IMST can improve heart and lung function as well as exercise capacity for individuals with PH.

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.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with PH defined by clinical guideline 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:

* Current smoker or have smoked in the last 10 years
* 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.

Primary outcomes:
measure: Pulmonary arterial pressure
timeFrame: The data will be obtained from previous medical records of patient visits occurring up to 8 months prior to enrollment and at the end of treatment at 6 weeks post enrollment. .
measure: Cardiac Output
timeFrame: The data will be obtained from previous medical records of patient visits occurring up to 8 months prior to enrollment and at the end of treatment, which occurs 6 weeks post-initiation.
measure: Maximal Oxygen Uptake
timeFrame: The data will be obtained from previous medical records of patient visits occurring up to 8 months prior to enrollment and at the end of treatment at 6 weeks post enrollment. .
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
References: