Breathing Training for Bronchiectasis

Overseen by Bryan Taylor, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Mayo Clinic

Must not be taking: Antibiotics

Disqualifiers: Advanced heart failure, neurological, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this research is to investigate whether a home-based and health coach supported specific breathing and respiratory muscle training program improves the ability to exercise, the function of the lungs and breathing muscles, and general clinical status in people with non-cystic fibrosis bronchiectasis (non-CFB).

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 data supports the effectiveness of the treatment LungTrainers and similar therapies for bronchiectasis?

Research shows that pulmonary rehabilitation, which includes exercises and breathing training, can improve exercise capacity, quality of life, and reduce symptoms in people with bronchiectasis. These improvements were maintained even six months after stopping the training, suggesting long-term benefits. ^{1 2 3 4 5}

Is breathing training safe for people with bronchiectasis?

Pulmonary rehabilitation, which includes breathing exercises, is generally considered safe for people with bronchiectasis and is recommended by international guidelines. It has been shown to improve exercise capacity and quality of life without significant safety concerns. ^{3 4 5 6 7}

How is the LungTrainers Pulmonary Rehabilitation treatment different from other treatments for bronchiectasis?

The LungTrainers Pulmonary Rehabilitation treatment is unique because it combines breathing exercises with physical activities like treadmill walking and cycle ergometry, which are designed to improve exercise tolerance and quality of life in bronchiectasis patients. This approach is tailored to address the specific needs of bronchiectasis, unlike other treatments that may focus on different respiratory conditions. ^{1 3 4 5 7}

Research Team

Bryan Taylor, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• LungTrainers (Procedure)
• LungTrainers Pulmonary Rehabilitation regime (Behavioral Intervention)

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.

Participant Groups

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 Canada for the following indications:

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+

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

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]

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 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]

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]

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 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]

References

1. New Zealand 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. [2023]

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

Pulmonary Rehabilitation in Individuals With Non-Cystic Fibrosis Bronchiectasis: A Systematic Review. [2018]

3. England pubmed.ncbi.nlm.nih.gov

'Teach me how to look after myself': What people with bronchiectasis want from education in a pulmonary rehabilitation setting. [2023]

4. Italy pubmed.ncbi.nlm.nih.gov

Pulmonary rehabilitation for patients with bronchiectasis: case reports. [2012]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy of pulmonary rehabilitation for bronchiectasis and related factors: which patients should receive the most treatment? [2021]

6. Turkey pubmed.ncbi.nlm.nih.gov

Efficacy of pulmonary rehabilitation on patients with non-cystic bronchiectasis according to disease severity. [2022]

7. Switzerland 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. [2022]