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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how inspiratory muscle training (IMT) can aid recovery in lung transplant patients. The researchers aim to determine if using a special breathing device, the PowerBreathe Medic, alongside regular physical therapy, can improve breathing strength, reduce fatigue, and enhance daily activities. Participants will be divided into groups: one using the device with increasing resistance, one using it without resistance, and one receiving standard care. The trial seeks individuals on the lung transplant waiting list who can move independently, even with a walking aid.

As an unphased trial, this study provides a unique opportunity to contribute to pioneering research that could improve recovery for future lung transplant patients.

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.

What prior data suggests that this inspiratory muscle training is safe for lung transplant recovery?

Research has shown that inspiratory muscle training (IMT) is generally safe and well-tolerated. Studies have found that devices like the POWERbreathe Medic are practical and acceptable for patients. People with asthma and chronic obstructive pulmonary disease (COPD) often use these devices without experiencing harmful side effects. The POWERbreathe Medic is a drug-free device, meaning it doesn't involve medication, which reduces the risk of side effects.

Other studies have demonstrated that IMT is practical and tolerable for patients with serious conditions, such as those recovering from pneumonia. Although limited safety data exists for lung transplant patients, evidence from similar groups suggests that the treatment is likely safe.

Overall, while IMT devices like the POWERbreathe Medic are generally considered safe, using them as directed is important to avoid potential issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about inspiratory muscle training (IMT) using the POWERbreathe Medic Plus® because it offers a new way to support recovery after lung transplants. Unlike standard treatments that focus mainly on physical therapy, this method involves using a specialized device to strengthen the muscles we use to breathe. By gradually increasing the resistance, this technique aims to boost lung function more effectively. The placebo group uses the same device but without increased resistance, helping to clearly show the benefits of muscle strengthening. This approach could potentially improve recovery outcomes and help patients get back to their daily lives more quickly.

What evidence suggests that inspiratory muscle training is effective for lung transplant recovery?

Research has shown that inspiratory muscle training (IMT) benefits people with lung problems. Studies have found that IMT can improve exercise capacity, ease breathing, and enhance quality of life for those with severe lung conditions. Specifically, IMT strengthens the muscles used for breathing and reduces breathlessness. In this trial, participants in the intervention group will use the PowerBreathe Medic device with increasing respiratory load, while the placebo group will use the device without increasing the load. This evidence suggests that IMT might aid lung transplant patients in recovery by strengthening their breathing muscles and reducing fatigue. ^{2 3 6 7 8}

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 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]

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]

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]

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]

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]

Citations

1. powerbreathe.com powerbreathe.com/wp-content/uploads/2025/02/life-15-00296.pdf

Effectiveness of Inspiratory Muscle Training in Individuals ... A newly published study found that IMT and compression therapy had a significant healing effect on disease severity and respiratory muscle ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05309551

Inspiratory Muscle Training Immediately After Lung ... The aim of this randomized controlled study is to investigate the benefits of providing inspiratory muscle training via use of an inspiratory muscle trainer ...

3. withpower.com withpower.com/trial/phase-rehabilitation-3-2022-b1a36

Inspiratory Muscle Training for Lung Transplant Recovery In a study involving 12 normal subjects, the Powerbreathe inspiratory muscle trainer showed a significant improvement in maximal static inspiratory mouth ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10726745/

Effectiveness of a respiratory rehabilitation program ... The results of this study support the use of specific inspiration training devices for respiratory rehabilitation in COVID-19 sequels.

5. powerbreathe.com powerbreathe.com/pb_medical_kb_category/powerbreathe-research-2020-2029/

POWERbreathe in Research 2020-2029 Archives A randomized clinical trial: immediate respiratory warm-up effect on dynamic inspiratory muscle strength in cardiac surgery candidates.

6. powerbreathe.com powerbreathe.com/us/precautions-contraindications/

Precautions & Contraindications POWERbreathe breathing training devices (both IMT and EMT) are drug free, suitable for almost anyone and should cause no harmful side effects when used properly ...

7. powerbreathe.com powerbreathe.com/product/powerbreathe-medic/

POWERbreathe Medic Breathing Device The POWERbreathe Medic is a medical grade inspiratory muscle trainer. The device is proven to alleviate symptoms of asthma, COPD and other lung conditions.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1036731423000620

Feasibility, safety, and patient acceptability of electronic ... Electronic IMT is feasible and acceptable to complete with critically ill participants who require prolonged mechanical ventilation.