Inspiratory Muscle Training for Lung Transplant

Overseen by Bryan Taylor, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Mayo Clinic

Disqualifiers: Retransplantation, Multiorgan transplantation, others

Trial Summary

What is the purpose of this trial?

The purpose of this research is to study the effect of training the inspiratory muscles (i.e. the muscle that allow you to breath-in) on exercise capacity, quality of life, and short-term clinical outcomes in patients post lung transplant.

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 data supports the effectiveness of the treatment Inspiratory Muscle Training for Lung Transplant?

Inspiratory muscle training (IMT) can improve breathing strength and reduce shortness of breath in children after lung transplants, as shown by a 60% increase in breathing muscle strength and improved lung function in a 13-year-old boy. Additionally, pulmonary rehabilitation, which includes IMT, is known to enhance exercise capacity and quality of life in patients with chronic lung diseases. ^{1 2 3 4 5}

Is inspiratory muscle training safe for humans?

Research on pulmonary rehabilitation, which includes inspiratory muscle training, shows it is generally safe for humans. Studies involving lung transplant patients and those with other chronic lung conditions have not reported any adverse events, indicating that this type of rehabilitation is safe. ^{2 6 7 8 9}

How is inspiratory muscle training different from other treatments for lung transplant patients?

Inspiratory muscle training (IMT) is unique because it specifically targets the strength and endurance of the muscles used for breathing, which can help improve exercise capacity and reduce breathlessness in lung transplant patients. Unlike other treatments, IMT focuses on enhancing respiratory muscle function, which is particularly beneficial for those with respiratory muscle weakness. ^{1 3 10 11 12}

Research Team

Bryan Taylor, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Cardiopulmonary rehabilitation post lung transplant (Behavioural Intervention)
• POWERBreathe Plus® (Behavioural Intervention)

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.

Participant Groups

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+

Dr. Gianrico Farrugia

Mayo Clinic

Chief Executive Officer since 2019

MD from University of Malta Medical School

Dr. Richard Afable

Mayo Clinic

Chief Medical Officer

MD from Loyola Stritch School of Medicine

Findings from Research

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 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]

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]

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]

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]

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]

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 (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]

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]

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]

References

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

Effects of inspiratory muscle training after lung transplantation in children. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

[Pulmonary Rehabilitation]. [2020]

3. 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]

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

Physical rehabilitation for lung transplant candidates and recipients: An evidence-informed clinical approach. [2022]

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

The timing and extent of acute physiotherapy involvement following lung transplantation: An observational study. [2022]

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

Pulmonary rehabilitation following lung transplantation. [2022]

7. England pubmed.ncbi.nlm.nih.gov

How to adapt the pulmonary rehabilitation programme to patients with chronic respiratory disease other than COPD. [2022]

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

Pulmonary rehabilitation in patients referred for lung transplantation. [2022]

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

The Efficacy of Outpatient Pulmonary Rehabilitation After Bilateral Lung Transplantation. [2020]

10. France pubmed.ncbi.nlm.nih.gov

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

11. England pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training, with or without concomitant pulmonary rehabilitation, for chronic obstructive pulmonary disease (COPD). [2023]

12. Romania pubmed.ncbi.nlm.nih.gov

[Respiratory muscle training in pulmonary rehabilitation]. [2013]