Inspiratory Muscle Training for Lung Transplant Recovery

Overseen By Cristiane Meirelles, PT, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Regular IMT program, impaired cognition

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

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a special breathing exercise device for people who have had a lung transplant. The device helps strengthen the muscles used for breathing. The goal is to help these patients breathe better, feel less tired, and improve their ability to do everyday activities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is inspiratory muscle training safe for humans?

Inspiratory muscle training, including devices like PowerBreathe, has been studied in various conditions and is generally considered safe for humans. Studies have shown it to be feasible and tolerable in patients recovering from conditions like community-acquired pneumonia, although specific safety data for lung transplant recovery is not detailed. ^{1 2 3 4 5}

How is inspiratory muscle training unique for lung transplant recovery?

Inspiratory muscle training (IMT) is unique for lung transplant recovery because it specifically targets and strengthens the muscles used for breathing, which can improve exercise capacity and respiratory function. Unlike other treatments, IMT is a non-invasive exercise-based therapy that enhances lung function and reduces breathlessness by increasing the strength and endurance of the inspiratory muscles. ^{1 2 4 6 7}

What data supports the effectiveness of the treatment PowerBreathe Medic for lung transplant recovery?

Research shows that inspiratory muscle training can improve exercise capacity, reduce breathlessness, and enhance respiratory function in people waiting for lung transplants. It also helps increase muscle strength in patients recovering from mechanical ventilation, which suggests it could be beneficial for lung transplant recovery. ^{1 8 9 10 11}

Who Is on the Research Team?

Cristiane Meirelles, PT, PhD

Principal Investigator

School of Health and Rehabilitation Sciences- Physical Therapy Division

Are You a Good Fit for This Trial?

This trial is for people waiting for a lung transplant who can walk (even with help) and understand the study. They shouldn't have cognitive issues that make it hard to follow instructions or already be doing inspiratory muscle training.

Inclusion Criteria

I can walk by myself or with help from a device.

Participant has personally signed and dated informed consent form indicating understanding of all pertinent aspects of the study

You are waiting for a lung transplant.

Exclusion Criteria

I struggle to understand or follow instructions due to cognitive issues.

You are currently enrolled in a regular IMT program.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive inspiratory muscle training using the IMT trainer device along with standard physical therapy

8 weeks

Daily sessions

Follow-up

Participants are monitored for changes in inspiratory muscle strength, lung function, physical performance, and quality of life

12 months

Assessments at baseline, 8 weeks, 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• PowerBreathe Medic

Trial Overview The study tests if using an inspiratory muscle trainer right after a lung transplant helps patients breathe better, feel less tired, and improve their daily activities compared to those who only get standard physical therapy.

How Is the Trial Designed?

Group I: Inspiratory Muscle training- Intervention group Experimental Treatment 1 Intervention

Along with standard post-transplant physical therapy, the intervention group will begin daily respiratory exercise training utilizing the IMT trainer device (POWERbreathe Medic Plus®) with weekly incremental increases in respiratory load. Patients will be asked to use the IMT device twice per day, 7 days per week, for 8 weeks.

Group II: Usual care group Active Control 1 Intervention

Patients will only participate in standard post-transplant physical therapy.

Group III: Inspiratory Muscle training - Placebo group Placebo Group 1 Intervention

Along with standard post-transplant physical therapy, the placebo group will begin daily respiratory exercise training utilizing the IMT trainer device (POWERbreathe Medic Plus®) with no increase of respiratory load. Patients will be asked to use the IMT device twice per day, 7 days per week, for 8 weeks.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

In a study of 34 lung transplantation candidates, those who received inspiratory muscle training (IMT) alongside pulmonary rehabilitation showed a significant improvement in exercise capacity, walking an additional 100 meters compared to those who only underwent pulmonary rehabilitation.

The IMT group also experienced a notable increase in maximum inspiratory pressure and carbon monoxide diffusion capacity, indicating enhanced respiratory function, while both groups reported reduced dyspnea scores, although the difference between groups was not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of inspiratory muscle training on exercise capacity, dyspnea and respiratory functions in lung transplantation candidates: a randomized controlled trial. Pehlivan, E., Mutluay, F., Balcı, A., et al.[2019]

Respiratory muscle training (RMT) significantly improved inspiratory muscle strength in patients with restrictive thoracic disorders, with a 27.6% increase in maximal inspiratory mouth pressure after three months of training.

Patients who underwent RMT also showed enhanced exercise performance and health-related quality of life, evidenced by increased peak oxygen consumption and improved physical performance scores compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory muscle training in restrictive thoracic disease: a randomized controlled trial. Budweiser, S., Moertl, M., Jörres, RA., et al.[2006]

In a study involving 12 normal subjects, the Powerbreathe inspiratory muscle trainer showed a significant improvement in maximal static inspiratory mouth pressure, but no significant difference in diaphragm strength or other respiratory measures after 6 weeks of training.

The results suggest that the Powerbreathe device does not provide sufficient evidence to justify its continued sale and use, highlighting the need for larger studies to confirm its efficacy in improving diaphragm strength.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an inspiratory muscle trainer in healthy humans. Hart, N., Sylvester, K., Ward, S., et al.[2004]

Using the PowerBreath® device for respiratory muscle training can lead to significant improvements in maximum inspiratory pressure (54% increase) within just 4 weeks of training.

After 6 weeks of training, participants also showed notable enhancements in their maximum volume of oxygen (VO2max) and a decrease in blood lactate concentration, indicating improved athletic performance and pulmonary function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory Muscle Training Program Using the PowerBreath®: Does It Have Ergogenic Potential for Respiratory and/or Athletic Performance? A Systematic Review with Meta-Analysis. Fernández-Lázaro, D., Gallego-Gallego, D., Corchete, LA., et al.[2021]

High-intensity inspiratory muscle training (IMT) at 80% of maximal effort significantly improved inspiratory muscle function, lung volumes, work capacity, and power output in healthy individuals, based on a study involving 40 participants over 8 weeks.

IMT at 60% of maximal effort also enhanced work capacity and power output, but lower intensities (40%) did not yield any measurable improvements, indicating that higher training intensities are crucial for achieving functional benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of inspiratory muscle training intensities on pulmonary function and work capacity in people who are healthy: a randomized controlled trial. Enright, SJ., Unnithan, VB.[2011]

Inspiratory muscle training (IMT) improves the strength and endurance of inspiratory muscles, reduces dyspnoea during daily activities, and enhances quality of life, but does not offer additional benefits when combined with standard pulmonary rehabilitation programs.

IMT is beneficial for patients who cannot engage in full exercise training, and it shows promise in pre-operative programs, suggesting it may be a useful intervention in specific contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Inspiratory muscle training during pulmonary rehabilitation]. Beaumont, M., Le Tallec, F., Villiot-Danger, E.[2021]

Citations

1. England pubmed.ncbi.nlm.nih.gov

The effects of inspiratory muscle training on exercise capacity, dyspnea and respiratory functions in lung transplantation candidates: a randomized controlled trial. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Pre- and postoperative inspiratory muscle training in patients undergoing cardiac surgery: systematic review and meta-analysis. [2018]

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

Inspiratory muscle training increases inspiratory muscle strength in patients weaning from mechanical ventilation: a systematic review. [2018]

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

High-intensity inspiratory muscle training in patients with chronic obstructive pulmonary disease and severely reduced function. [2019]

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

Respiratory muscle training in restrictive thoracic disease: a randomized controlled trial. [2006]

6. England pubmed.ncbi.nlm.nih.gov

Evaluation of an inspiratory muscle trainer in healthy humans. [2004]

7. Switzerland pubmed.ncbi.nlm.nih.gov

The feasibility and tolerability of using inspiratory muscle training with adults discharged from the hospital with community-acquired pneumonia. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Inspiratory Muscle Training Program Using the PowerBreath®: Does It Have Ergogenic Potential for Respiratory and/or Athletic Performance? A Systematic Review with Meta-Analysis. [2021]

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

Respiratory muscle training in patients recovering recent open cardiothoracic surgery: a randomized-controlled trial. [2022]

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

Effect of inspiratory muscle training intensities on pulmonary function and work capacity in people who are healthy: a randomized controlled trial. [2011]

11. France pubmed.ncbi.nlm.nih.gov

[Inspiratory muscle training during pulmonary rehabilitation]. [2021]