Pulmonary Hypertension Inspiratory Training (PHIT)

University of Arizona

Status

Invitation-only

Conditions

Pulmonary Hypertension

Treatments

Other: Inspiratory Muscle Strength Training

Study type

Interventional

Funder types

Other

Identifiers

NCT06931886

STUDY00005343

Details and patient eligibility

About

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.

Full 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.

Enrollment

4 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.