Breathing Training for Bronchiectasis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Antibiotics

Disqualifiers: Advanced heart failure, neurological, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special home-based breathing and muscle training program benefits people with non-cystic fibrosis bronchiectasis, a lung condition causing coughing and shortness of breath, by improving their exercise capacity and overall lung health. Participants will either receive standard care from their doctors or add the LungTrainers Pulmonary Rehabilitation regime to their usual care. Individuals diagnosed with non-cystic fibrosis bronchiectasis, who are stable without recent changes in treatment, and can commit to the study might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to understanding new ways to manage this condition from home.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using antibiotics.

What prior data suggests that this breathing training program is safe for people with non-cystic fibrosis bronchiectasis?

Research shows that the LungTrainers Pulmonary Rehabilitation program is safe. Studies have found that inspiratory muscle training, a key component of this program, strengthens the muscles used for breathing and usually doesn't cause serious side effects.

One study found that people with bronchiectasis who did breathing exercises improved their exercise capacity and had stronger breathing muscles. These studies reported no major safety issues. Since this treatment focuses on improving breathing, most people tolerate it well.

Overall, this training is considered safe for those seeking to improve lung function, especially individuals with conditions like non-cystic fibrosis bronchiectasis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LungTrainers Pulmonary Rehabilitation regime because it offers a new approach to managing bronchiectasis. Unlike the standard care, which typically involves general pulmonary rehab guided by physicians, this method emphasizes home-based specific breathing and respiratory muscle training. This tailored approach could enhance lung function and quality of life by directly strengthening the respiratory muscles, which is not the primary focus of current treatments. The convenience of a home-based program also increases accessibility and adherence, potentially leading to better patient outcomes.

What evidence suggests that the LungTrainers Pulmonary Rehabilitation regime is effective for non-CFB?

Research has shown that training the muscles used for breathing can benefit people with bronchiectasis. One study found that this training improved lung function and helped clear mucus. Another study demonstrated that combining breathing exercises with arm and leg exercises significantly enhanced patients' exercise capacity. High-intensity breathing muscle training also led to better lung function and reduced shortness of breath. In this trial, participants in the home-based specific breathing and respiratory muscle training group will use the LungTrainers Pulmonary Rehabilitation program. These findings suggest that this program might effectively improve exercise ability and lung health in people with non-cystic fibrosis bronchiectasis. ^{2 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 Mayo Clinic patients with non-cystic fibrosis bronchiectasis (non-CFB), who can consent to participate. They should be stable, without exacerbations or changes in therapy for three weeks and not have heart failure, major diseases, neurological conditions, orthopedic issues affecting exercise, recent pulmonary rehab participation or current antibiotic use.

Inclusion Criteria

I have been diagnosed with Non-Cystic Fibrosis Bronchiectasis and have been stable for the last three weeks.

Able and willing to provide informed consent to participate in the study.

Exclusion Criteria

My condition is advanced heart failure.

I have been part of a lung rehab program in the last 6 months.

I have a health condition that makes it hard for me to exercise.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an 8-week home-based specific breathing and respiratory muscle training program supported by a health coach

8 weeks

Home-based with virtual support

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LungTrainers
• LungTrainers Pulmonary Rehabilitation regime

Trial Overview The study tests a home-based breathing training program supported by health coaches. It aims to see if this LungTrainers Pulmonary Rehabilitation regime improves exercise capacity, lung and respiratory muscle function, and overall clinical status in individuals with non-CFB.

How Is the Trial Designed?

Group I: Home-based specific breathing and respiratory muscle training group Experimental Treatment 2 Interventions

In addition standard of care pulmonary rehabilitation, subjects will participate in an 8-week home-based specific breathing and respiratory muscle training via the LungTrainers Pulmonary Rehabilitation regime (LT-PR).

Group II: Control group of standard physician directed care Active Control 1 Intervention

Subjects will receive pulmonary rehabilitation via standard physician directed care (i.e., 'normal care').

LungTrainers Pulmonary Rehabilitation regime is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Pulmonary Rehabilitation for:

• Chronic Obstructive Pulmonary Disease (COPD)
• Bronchiectasis
• Interstitial Lung Diseases
• Pulmonary Hypertension
• Severe Asthma

Approved in United States as Pulmonary Rehabilitation for:

• Chronic Obstructive Pulmonary Disease (COPD)
• Bronchiectasis
• Interstitial Lung Diseases
• Pulmonary Hypertension
• Severe Asthma

Approved in Canada as Pulmonary Rehabilitation for:

• Chronic Obstructive Pulmonary Disease (COPD)
• Bronchiectasis
• Interstitial Lung Diseases
• Pulmonary Hypertension
• Severe Asthma

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Pulmonary rehabilitation (PR) significantly improves exercise capacity and quality of life in patients with bronchiectasis, regardless of the severity of their disease as assessed by the Bronchiectasis Severity Index (BSI).

The study included 69 patients over an 8-week PR program, and while improvements were noted, the efficacy of PR did not vary significantly among patients with mild, moderate, or severe bronchiectasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of pulmonary rehabilitation on patients with non-cystic bronchiectasis according to disease severity. Deniz, S., Şahin, H., Erbaycu, AE.[2022]

A study involving 21 adults with bronchiectasis revealed that patients desire more clarity on the causes and prognosis of their condition, highlighting a need for tailored educational content in pulmonary rehabilitation programs.

Participants expressed a strong interest in learning self-management strategies, treatments for extra-pulmonary symptoms, and the role of physiotherapy and exercise, indicating that current educational offerings may not fully meet their needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Teach me how to look after myself': What people with bronchiectasis want from education in a pulmonary rehabilitation setting. Lee, AL., Smith, R., Burr, L., et al.[2023]

Supervised pulmonary rehabilitation (PR) and exercise training (ET) for 8 weeks significantly improved exercise capacity and disease-specific health-related quality of life (HRQOL) in adults with bronchiectasis, but these benefits did not last beyond 6 months.

Only exercise training (ET) reduced the frequency of exacerbations over 12 months, while PR initiated during an acute exacerbation did not affect exacerbation rates or mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary Rehabilitation in Individuals With Non-Cystic Fibrosis Bronchiectasis: A Systematic Review. Lee, AL., Hill, CJ., McDonald, CF., et al.[2018]

A five-month pulmonary rehabilitation program for three patients with bronchiectasis led to significant improvements in exercise tolerance and quality of life, as evidenced by enhanced performance in the 6-minute walk test and other health assessments.

Chest X-rays showed a reduction in bronchial wall thickness after rehabilitation, indicating a decrease in obstructive disease, and these benefits were sustained for six months post-treatment, suggesting the potential long-term efficacy of pulmonary rehabilitation in bronchiectasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary rehabilitation for patients with bronchiectasis: case reports. Santamato, A., Ranieri, M., Panza, F., et al.[2012]

A multidisciplinary pulmonary rehabilitation (PR) program significantly improved various health metrics in 130 patients with bronchiectasis, including dyspnea, exercise capacity, and quality of life, with all measured outcomes showing statistically significant improvements (p < 0.001).

The effectiveness of the PR program was consistent across different patient demographics and conditions, but individual responses varied, indicating a need for further research to identify which patients may benefit the most from such interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of pulmonary rehabilitation for bronchiectasis and related factors: which patients should receive the most treatment? Candemir, I., Ergun, P., Satar, S., et al.[2021]

A study involving 86 patients with bronchiectasis showed that combining respiratory rehabilitation training with limb rehabilitation significantly improved sputum clearance, lung function, and quality of life after three months compared to conventional drug treatment alone.

Patients in the intervention group had better scores on the Barthel index and quality of life assessments, indicating that this combined rehabilitation approach is effective and should be considered for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Respiratory Training Combined with Limb Exercise on Pulmonary Function and Quality of Life in Patients with Bronchiectasis. Ni, R., Cai, L., Xing, Y., et al.[2023]

A retrospective analysis of 135 patients with non-CF bronchiectasis showed significant improvements in exercise capacity, dyspnea, and health-related quality of life after a 3-week pulmonary rehabilitation program, indicating its efficacy for these patients.

Independent predictors of success in improving exercise capacity included male gender, a baseline FEV1/VC ratio of less than 70%, and having more than 2 exacerbations in the previous year, suggesting that certain clinical characteristics can help identify patients who may benefit most from rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Pulmonary Rehabilitation in Patients with Non-Cystic Fibrosis Bronchiectasis: A Retrospective Analysis of Clinical and Functional Predictors of Efficacy. Zanini, A., Aiello, M., Adamo, D., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7019679/

The Efficacy of Therapeutic Respiratory Muscle Training ... The aim of this study was to analyse the effects of therapeutic respiratory muscle training (RMT) interventions on improving sputum clearance, ventilator ...

2. withpower.com withpower.com/trial/phase-bronchiectasis-8-2023-4facf

Breathing Training for Bronchiectasis A study involving 86 patients with bronchiectasis showed that combining respiratory rehabilitation training with limb rehabilitation significantly improved ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11139531/

Incremental Load Respiratory Muscle Training Improves ... According to the results of this study, high-intensity respiratory muscle training significantly and effectively improved the lung function, ...

4. researchgate.net researchgate.net/publication/338507884_The_efficacy_of_therapeutic_respiratory_muscle_training_interventions_in_people_with_bronchiectasis_a_systematic_review

The efficacy of therapeutic respiratory muscle training ... (PDF) The efficacy of therapeutic respiratory muscle training interventions in people with bronchiectasis: a systematic review.

5. journals.lww.com journals.lww.com/nsca-scj/fulltext/2024/12000/practical_application_of_respiratory_muscle.5.aspx

Practical Application of Respiratory Muscle Training in... RMT is associated with improved endurance performance and pulmonary function, and it reduced respiratory fatigue, perceived exertion, or breathlessness.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9817429/

Inspiratory muscle training, with or without concomitant ... Inspiratory muscle training (IMT) aims to improve respiratory muscle strength and endurance. Clinical trials used various training protocols, devices and ...

7. lungtrainers.com lungtrainers.com/

Lung Trainers | Make Every Breath Count! The Lung Trainer is a device that promotes better breathing techniques and strengthens the diaphragm, increasing air exchange.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30209855/

High-intensity inspiratory muscle training in bronchiectasis The H-IMT increased exercise capacity in patients with non-cystic fibrosis bronchiectasis. It has also positive effects on respiratory muscle strength and ...

9. researchgate.net researchgate.net/publication/367051207_Effects_of_Inspiratory_Muscles_Trainer_in_Pulmonary_Rehabilitation_Program_among_COPD_Patients

(PDF) Effects of Inspiratory Muscles Trainer in Pulmonary ... Conclusion: It was concluded that inspiratory muscle trainer group was more effective as compare to standard rehabilitation in improving ...