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

4 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Inspiratory Muscle Strength Training for Pulmonary Hypertension?

Research shows that Inspiratory Muscle Training (IMT) can improve respiratory muscle strength, exercise capacity, and quality of life in patients with pulmonary hypertension. It also helps reduce feelings of breathlessness and fatigue, making it a beneficial treatment for those with this condition. ^{1 2 3 4 5}

Is inspiratory muscle training safe for humans?

Inspiratory muscle training has been studied in various conditions, including pulmonary hypertension, and is generally considered safe for humans. Studies have shown improvements in muscle strength and exercise capacity without significant adverse effects. ^{1 2 3 4 6}

How does inspiratory muscle training differ from other treatments for pulmonary hypertension?

Inspiratory muscle training (IMT) is unique because it focuses on strengthening the muscles used for breathing, which can help improve exercise capacity and reduce feelings of breathlessness and fatigue in patients with pulmonary hypertension. Unlike medications, it is a physical therapy that can be used as a standalone treatment or as a complement to other exercise programs. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Inspiratory Muscle Training Improves Inspiratory Muscle Strength and Functional Exercise Capacity in Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension: A Pilot Randomised Controlled Study. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of Inspiratory Muscle Training in Patients With Pulmonary Hypertension. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Benefits of skeletal-muscle exercise training in pulmonary arterial hypertension: The WHOLEi+12 trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training in pulmonary arterial hypertension. [2015]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of inspiratory muscle training in patients with pulmonary hypertension: A systematic review and meta-analysis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A multi-trial, retrospective analysis of the antihypertensive effects of high-resistance, low-volume inspiratory muscle strength training. [2023]