Inspiratory Muscle Training for Lung Transplant

Overseen By Bryan Taylor

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Retransplantation, Multiorgan transplantation, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether training the muscles used for breathing can help lung transplant recipients improve exercise ability and overall quality of life. Participants will use a device called POWERBreathe Plus® at home to strengthen these muscles. There are two groups: one using the active device and another using a placebo version. The trial seeks individuals who have undergone a single or double lung transplant at Mayo Clinic Florida. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance post-transplant recovery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

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

Research shows that using the POWERbreathe Plus® device for inspiratory muscle training is generally safe. Studies have found that people tolerate this device well in various situations. No major reports of problems or side effects have emerged when used as instructed, indicating it is unlikely to cause harm if used correctly. The POWERbreathe Plus® is a drug-free device available for purchase, enhancing its safety, as many people already use it to improve breathing strength and stamina. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about inspiratory muscle training for lung transplant patients because it offers a unique approach to improving recovery post-surgery. Unlike standard cardiopulmonary rehabilitation, which generally focuses on overall exercise and breathing techniques, this method uses the POWERBreathe Plus® device to specifically target and strengthen the inspiratory muscles. This targeted training could lead to better lung function and faster rehabilitation for transplant patients. By allowing patients to perform exercises at home, this approach also adds convenience and accessibility, potentially improving adherence to rehabilitation programs.

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

This trial will compare two approaches for lung transplant patients: one group will undergo 12 weeks of pulmonary rehabilitation training plus inspiratory muscle training using the POWERbreathe Plus® device, while another group will receive 12 weeks of pulmonary rehabilitation plus a placebo (inactive) inspiratory muscle training. Studies have shown that the POWERbreathe Plus® device strengthens breathing muscles. In one study, participants who used the device could breathe in more deeply. This type of training has benefited individuals with weak breathing muscles, such as those recovering from surgery or illness. Research also suggests that stronger breathing muscles can enhance exercise capacity and improve overall quality of life. These findings support the potential benefits of this breathing training for lung transplant patients. ^{5 6 7 8 9}

Who Is on the Research Team?

Bryan Taylor, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for patients at Mayo Clinic Florida who have had a single or double lung transplant. It's not for those who didn't survive the surgery, are getting retransplanted, having multiple organs transplanted, or can't consent.

Inclusion Criteria

I had a lung transplant at Mayo Clinic Florida.

Exclusion Criteria

I am willing and able to give written consent.

I survived the surgery required for my transplant.

I am scheduled for or have had a second organ transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 12 weeks of inspiratory muscle training using the POWERBreathe Plus® device, twice per day, 5 days per week

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cardiopulmonary rehabilitation post lung transplant
• POWERBreathe Plus®

Trial Overview

The study tests if POWERBreathe Plus®, a device to strengthen breathing muscles, along with post-transplant cardiopulmonary rehab improves exercise ability, quality of life and clinical outcomes after lung transplant.

How Is the Trial Designed?

Group I: 12-weeks pulmonary rehabilitation training plus inspiratory muscle training Experimental Treatment 2 Interventions

To assess maximum inspiratory pressure, you will be asked to breathe through a device called POWERBreathe Plus®. This device is commercially available and will be provided to you by the study. You will be asked to use this device twice per day, 5 days per week, for 12 weeks. Each session will require you to breathe into the device 30 times. You can use the device at home.

Group II: 12-weeks pulmonary rehabilitation plus placebo (inactive) inspiratory muscle Placebo Group 2 Interventions

To assess maximum inspiratory pressure with placebo, you will be asked to breathe through a device called POWERBreathe Plus®. This device is commercially available and will be provided to you by the study. You will be asked to use this device twice per day, 5 days per week, for 12 weeks. Each session will require you to breathe into the device 30 times. You can use the device at home. The resistance will be set to about 5% throughout the study.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

A 12-week Nordic walking rehabilitation program for 22 patients referred for lung transplantation resulted in a significant increase in walking distance (from 310.2 m to 372.1 m) and improvements in lung function, indicating its efficacy as a rehabilitation method.

The program was safe, with no adverse events reported, and led to enhanced quality of life, particularly in social functioning, demonstrating that Nordic walking is a feasible exercise option for patients with end-stage lung disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary rehabilitation in patients referred for lung transplantation. Jastrzebski, D., Ochman, M., Ziora, D., et al.[2022]

Inspiratory muscle training (IMT) significantly improved respiratory function in a 13-year-old boy after lung transplantation, increasing his maximal inspiratory pressure by about 60% over 2 months.

The patient's forced vital capacity improved from 74.6% to 83.4% of the predicted normal value, along with a reduction in dyspnoea, suggesting that IMT can be beneficial for children experiencing respiratory muscle weakness post-transplant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of inspiratory muscle training after lung transplantation in children. Yamaga, T., Yamamoto, S., Sakai, Y., et al.[2023]

Pulmonary rehabilitation is effective in improving symptoms like dyspnoea and fatigue, not just in COPD but also in other chronic respiratory conditions such as interstitial lung disease and bronchiectasis, enhancing exercise capacity and quality of life.

Exercise training within pulmonary rehabilitation is safe and beneficial for patients with pulmonary arterial hypertension, provided they are stable on medication and closely monitored, highlighting the program's versatility across various respiratory disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to adapt the pulmonary rehabilitation programme to patients with chronic respiratory disease other than COPD. Holland, AE., Wadell, K., Spruit, MA.[2022]

Inspiratory muscle training (IMT) combined with pulmonary rehabilitation (PR) did not show significant improvements in dyspnea, functional exercise capacity, or health-related quality of life in COPD patients, based on a review of 55 randomized controlled trials involving 4,467 participants.

However, IMT alone may lead to better outcomes in these areas, suggesting that while IMT can be beneficial, its effectiveness may be diminished when combined with PR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training, with or without concomitant pulmonary rehabilitation, for chronic obstructive pulmonary disease (COPD). Ammous, O., Feki, W., Lotfi, T., et al.[2023]

Pulmonary rehabilitation significantly reduces breathlessness, increases exercise capacity, and improves quality of life for patients with advanced chronic lung diseases.

Incorporating self-management education into pulmonary rehabilitation not only enhances physical activity levels but also reduces hospitalizations, making it a comprehensive and effective treatment approach that is supported by Swiss insurance programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pulmonary Rehabilitation]. Frey, M.[2020]

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]

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]

A comprehensive pulmonary rehabilitation program significantly improved exercise capacity and respiratory muscle strength in 74% of the 23 lung transplant recipients studied, with notable increases in shuttle walk test distances and muscle strength after participating in the program.

Participants also reported better quality of life and reduced anxiety and depressive symptoms, indicating that early pulmonary rehabilitation post-lung transplantation can enhance both physical and psychological well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of Outpatient Pulmonary Rehabilitation After Bilateral Lung Transplantation. Candemir, I., Ergun, P., Kaymaz, D., et al.[2020]

Inspiratory muscle training significantly benefits COPD patients by enhancing the strength and endurance of respiratory muscles, which leads to reduced dyspnea and improved quality of life.

This type of training can be effectively used alone or alongside general physical training, particularly for patients experiencing weakness in their inspiratory muscles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Respiratory muscle training in pulmonary rehabilitation]. Croitoru, A., Bogdan, MA.[2013]

A study involving 36 lung transplant patients showed significant improvements in functional exercise capacity, lung function, and quality of life after participating in a standard outpatient pulmonary rehabilitation program for 12 weeks.

Patients demonstrated large gains in their 6-minute walk distance and lung function measurements within the first month, with continued but smaller improvements in the second month, suggesting that early rehabilitation is crucial for recovery post-transplant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary rehabilitation following lung transplantation. Munro, PE., Holland, AE., Bailey, M., et al.[2022]

Lung transplant recipients began exercising just 2 days after surgery, with physiotherapy sessions averaging about 108 minutes, of which approximately 23 minutes were dedicated to exercise in the initial phase.

Over the course of treatment, the time spent exercising increased to about 28 minutes in the final phase, indicating a progressive approach to rehabilitation that emphasizes the importance of early mobilization post-transplant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The timing and extent of acute physiotherapy involvement following lung transplantation: An observational study. Tarrant, BJ., Holland, A., Le Maitre, C., et al.[2022]

Physical rehabilitation is crucial for lung transplant candidates and recipients, as it helps improve physical function before the transplant and aids in recovery afterward.

The review emphasizes tailored rehabilitation strategies based on the evolving demographics of lung transplant patients, including older individuals and those with multiple health issues, to meet their specific rehabilitation needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical rehabilitation for lung transplant candidates and recipients: An evidence-informed clinical approach. Wickerson, L., Rozenberg, D., Janaudis-Ferreira, T., et al.[2022]

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