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Enrolling by invitation NCT06931886

Pulmonary Hypertension Inspiratory Training

No phase Interventional Pulmonary Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Inspiratory Muscle Strength Training.
Who it may be relevant to
Registry conditions: Pulmonary Hypertension. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effects of Inspiratory Muscle Strength Training on Pulmonary Hypertension: A Six Week Study

Overview

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.

Interventions

  • Other 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.

Primary outcome measures

  • Pulmonary arterial pressure [Time frame: 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 [Time frame: 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 [Time frame: 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. .]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Arizona — Tucson

Identifiers

NCT: NCT06931886 · STUDY00005343

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗