Inspiratory Muscle Training for Pulmonary Hypertension

(PHIT Trial)

Overseen By Josie Mazzone, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Disqualifiers: Smoking, COPD, Severe asthma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a specific breathing exercise, called inspiratory muscle strength training (IMST), can help individuals with pulmonary hypertension (PH) improve their breathing and exercise abilities. Participants will practice this exercise for about five minutes daily, five days a week, for six weeks. It suits those diagnosed with PH who haven't had major changes in their PH treatment recently and are already scheduled for a PH check-up soon. As an unphased trial, this study offers an opportunity to contribute to research that may enhance breathing techniques for PH patients.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, since participants must not have had major changes in their pulmonary hypertension management or medication in the last 18 months, it seems likely that you can continue your current medications.

What prior data suggests that this technique is safe for pulmonary hypertension patients?

Research shows that Inspiratory Muscle Strength Training (IMST) is generally easy for people to handle. In past studies, participants experienced very few side effects during this training. Most find it safe and manageable, even over several weeks.

IMST involves breathing exercises that strengthen the muscles used for inhaling. This non-invasive training does not involve surgery or medication, often making it a safer option with fewer side effects compared to drugs.

Overall, IMST is considered safe for most people, especially since it is often used to aid breathing in various conditions. However, like any exercise, following guidelines and consulting a healthcare professional is important to ensure it is appropriate.

Why are researchers excited about this trial?

Inspiratory Muscle Strength Training is unique because it focuses on strengthening the breathing muscles, which is a different approach compared to the standard medications for pulmonary hypertension like vasodilators or endothelin receptor antagonists. This method involves a simple, non-drug technique that participants can perform at home, which makes it accessible and less invasive. Researchers are excited about this treatment because it has the potential to improve breathing efficiency and overall quality of life without the side effects associated with many current drug therapies.

What evidence suggests that inspiratory muscle strength training is effective for pulmonary hypertension?

Studies have shown that inspiratory muscle strength training (IMST) can help individuals with breathing problems enhance their breathing and exercise abilities. Research indicates that IMST strengthens the muscles used for breathing, which can lower blood pressure and improve heart health. This is especially promising for those with pulmonary hypertension, a condition characterized by high blood pressure in the lungs' arteries. Participants in this trial will perform IMST, and previous findings suggest that those who have used IMST experienced better exercise tolerance and fewer symptoms. These findings suggest that IMST could effectively manage pulmonary hypertension by easing breathing and improving overall heart and lung health.

Are You a Good Fit for This Trial?

This trial is for individuals diagnosed with pulmonary hypertension (PH) who are scheduled for a clinical PH assessment within 8 weeks and have had stable PH management in the past 18 months. It's not for those with certain lung diseases, high blood pressure, neurological issues, organ transplants, HIV/autoimmune diseases, smokers of the last decade or those unable to undergo PH testing.

Inclusion Criteria

I am scheduled for a pulmonary hypertension assessment within 2 months.

My pulmonary hypertension has been stable with no medication changes in the last 18 months.

I have been diagnosed with pulmonary hypertension.

Exclusion Criteria

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

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform inspiratory muscle strength training (IMST) for 6 weeks

6 weeks

5 sessions per week (home-based)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Inspiratory Muscle Strength Training

Trial Overview The study tests inspiratory muscle strength training (IMST) over six weeks to see its effects on cardiopulmonary pressures and exercise tolerance in people with pulmonary hypertension. Participants' progress will be measured using results from routine cardiopulmonary exercise tests.

How Is the Trial Designed?

Group I: Inspiratory Muscle Strength Training Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Published Research Related to This Trial

Inspiratory muscle training (IMT) significantly improved respiratory muscle strength and functional capacity in 29 patients with pulmonary arterial hypertension (PAH) over a 6-week program, leading to better performance in activities like walking.

Patients undergoing IMT reported reduced fatigue and dyspnea, indicating that this training is a safe and effective treatment option for enhancing quality of life in PAH patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training in pulmonary arterial hypertension. Saglam, M., Arikan, H., Vardar-Yagli, N., et al.[2015]

Inspiratory muscle training (IMT) significantly improves respiratory muscle strength, as shown by increases in maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP), in a systematic review of four studies involving 80 patients with pulmonary hypertension.

IMT also enhances exercise capacity, evidenced by a notable increase in the 6-minute walk distance (6MWD), but does not show significant improvements in pulmonary function or quality of life, indicating that while IMT is beneficial, more research is needed to fully understand its effects on dyspnea and fatigue in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of inspiratory muscle training in patients with pulmonary hypertension: A systematic review and meta-analysis. Luo, Z., Qian, H., Zhang, X., et al.[2022]

High-resistance inspiratory muscle strength training (IMST) significantly lowers systolic blood pressure (SBP) by 9 mmHg and diastolic blood pressure (DBP) by 4 mmHg in adults over 6 weeks, with effects noticeable as early as week 2.

IMST also improves inspiratory muscle strength, as indicated by increased maximal inspiratory pressure (PIMAX), and is effective across a wide range of adult ages and health statuses, making it a promising intervention for managing blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multi-trial, retrospective analysis of the antihypertensive effects of high-resistance, low-volume inspiratory muscle strength training. Craighead, DH., Tavoian, D., Freeberg, KA., et al.[2023]

Citations