Pulmonary Hypertension Inspiratory Training

NCT06931886 | Enrolling By Invitation

• 1 other identifier: STUDY00005343
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Keywords

Inspiratory Muscle Strength Training

Outcome Measures

Primary Outcomes (3)

• Pulmonary arterial pressure

  To be eligible for this study, patients must already have an upcoming invasive cardiopulmonary exercise test scheduled for assessment of their PH. Pulmonary arterial pressure will be obtained from this upcoming appointment as well as from previous medical records and an upcoming already scheduled assessment of pulmonary hypertension.

  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. .

• Cardiac Output

  This will be obtained as part of the usual standard assessment of pulmonary hypertension. Patients must already have this scheduled prior to enrollment in this study. Cardiac output, a measure of the volume of blood the heart pumps per minute, will be determined at rest and in response to exercise during the scheduled cardiopulmonary exercise test. This involves a graded maximal cycling protocol on a stationary bike, where resistance progressively increases until the patient reaches their maximum effort or exhaustion .

  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.

• Maximal Oxygen Uptake

  This will be obtained as part of the usual standard assessment of pulmonary hypertension. Patients must already have this scheduled prior to enrollment in this study. Maximal oxygen uptake, a measure of the body's maximum ability to take in, transport, and utilize oxygen during intense exercise, will be determined during the scheduled cardiopulmonary exercise test. This test involves a graded maximal cycling protocol on a stationary bike, where resistance progressively increases until the patient reaches their maximum effort or exhaustion. Throughout the test, patients will wear a mask that is used to analyze gas exchange.

  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. .

Study Arms (1)

Inspiratory Muscle Strength Training

EXPERIMENTAL

This group will perform inspiratory muscle strength training (\~5 min/day) for 5 days a week for 6 weeks.

Other: Inspiratory Muscle Strength Training

Interventions

Inspiratory Muscle Strength Training OTHER

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.

Also known as: IMST, Resisted Breathing Training, Resisted Inspiratory Efforts

Inspiratory Muscle Strength Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85711, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Each individual enrolled will perform six weeks of inspiratory muscle strength training. There will be no control or sham group.

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: April 17, 2025
• Study Start: October 25, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-07

Locations

US (1)