Home-based Pulmonary Rehabilitation for Pulmonary Fibrosis

Recruiting at 2 trial locations

Overseen By Johanna Hoult, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Immobility, Cognitive impairment, Hospice, others

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

Compensation: Varies

Number of Visits: Unknown

460 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how a home-based pulmonary rehabilitation program, combined with health coaching, can improve quality of life and physical activity for individuals with pulmonary fibrosis, a lung disease that causes lung scarring. It compares this approach to the usual care patients receive, seeking better ways to manage symptoms at home. The trial seeks participants diagnosed with lung fibrosis who experience breathlessness during daily activities. As an unphased trial, participants contribute to innovative research that may enhance home care strategies for pulmonary fibrosis.

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 seems like you can continue your existing treatments, as the trial includes patients with active or prior medical treatment.

What prior data suggests that this home-based pulmonary rehabilitation is safe for patients with fibrotic interstitial lung disease?

A previous study found home-based lung rehabilitation safe for people with pulmonary fibrosis. The research showed that patients adhered to the program well and reported no major safety issues. Another study highlighted long-term benefits, such as improved exercise ability and quality of life. Participants generally managed the program well over time. Overall, these findings suggest that home-based lung rehabilitation is a safe option for those with fibrotic interstitial lung disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about home-based pulmonary rehabilitation for pulmonary fibrosis because it offers a new, convenient way to manage the condition. Unlike traditional rehabilitation programs that require visits to a clinic or hospital, this approach allows patients to perform exercises and receive health coaching from the comfort of their own home. This not only makes it more accessible but can also improve adherence and outcomes by fitting into patients' daily lives more easily. Additionally, the integration of health coaching provides personalized support and motivation, which can enhance the effectiveness of the rehabilitation process.

What evidence suggests that home-based pulmonary rehabilitation is effective for pulmonary fibrosis?

Research has shown that pulmonary rehabilitation exercises at home can help people with pulmonary fibrosis breathe and feel better. In one study, participants walked about 50 meters farther after completing the program. Another study found that this rehabilitation increases physical activity and improves health satisfaction. The benefits can last for at least a year, providing long-term relief. In this trial, participants in the Home-based Pulmonary Rehabilitation with Health Coaching Group will receive guidance from health coaches, potentially enhancing the program's effectiveness. These findings suggest that home-based programs can be a promising option for those with fibrotic lung disease. ^{1 2 4 6 7}

Who Is on the Research Team?

Teng Moua

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for people with fibrotic interstitial lung disease, which shows more than 10% fibrosis on a CT scan. Participants can be of any race or ethnicity and must have some difficulty breathing (mMRC score >1). They should be able to walk and follow instructions but haven't done center-based pulmonary rehab in the last 3 months.

Inclusion Criteria

More than 10% fibrosis on CT imaging

I have or had interstitial lung disease and received treatment for it.

I experience shortness of breath when exerting myself.

Exclusion Criteria

I cannot walk due to a health condition.

I can understand and follow instructions.

I completed a rehab program at a center within the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Non-use Waitlist Control Observation

Participants receive usual care during a 12-week waitlist period before transitioning to the intervention group

12 weeks

Home-based Pulmonary Rehabilitation with Health Coaching

Participants undergo a 12-week home-based pulmonary rehabilitation program with health coaching

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after the intervention

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Home-based Pulmonary Rehabilitation

Trial Overview

The study tests a home-based pulmonary rehabilitation program with health coaching against usual care. It aims to see if this approach improves patients' quality of life related to respiratory issues and their physical activity levels.

How Is the Trial Designed?

Group I: Home-based Pulmonary Rehabilitation with Health Coaching Group Experimental Treatment 1 Intervention

Twelve-week intervention with home-based pulmonary rehabilitation and health coaching.

Group II: Non-use Waitlist Control Observation Group Active Control 1 Intervention

12-week non-use usual care waitlist with transition to intervention group at the end of the observation period.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11186438/

Effect of Home-Based Pulmonary Rehabilitation on ...

Our study shows that home-based pulmonary rehabilitation effectively improves pulmonary function, physical functional capacity, and quality of life in patients ...

2.

pcori.org

pcori.org/research-results/2023/comparing-effectiveness-home-based-pulmonary-rehabilitation-and-health-coaching-usual-care-patients-fibrotic-lung-disease

Comparing the Effectiveness of Home-Based Pulmonary ...

This study compares the effectiveness of a home-based, technology-delivered pulmonary rehabilitation (PR) program with health coaching in ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0954611122001925

Effect of a home-based pulmonary rehabilitation program ...

The aims of this study are to evaluate the efficacy of home-based PR on functional capacity and health-related quality of life in people with ILD.

4.

publications.ersnet.org

publications.ersnet.org/content/erjor/5/2/00045-2019

Long-term evaluation of home-based pulmonary rehabilitation ...

Our study shows significant long-term (12 months) benefits of a 2-month home-based pulmonary rehabilitation programme for f-IIP patients with bimonthly visits ...

5.

tandfonline.com

tandfonline.com/doi/full/10.1080/26895293.2021.1898051

Long-term effects of home-based pulmonary rehabilitation ...

It found that the 6MWD results were significantly improved from 348.5 ± 106.1 m at baseline to 403.6 ± 100.3 m on the completion of PR and 443.8 ± 96.5 at 1- ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02600689

Home-Based Pulmonary Rehab for Patients With ...

Outpatient (phase 2) pulmonary rehab is an important, but mostly underutilized intervention to improve physical function in patients with idiopathic pulmonary ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9724887/

Effectiveness of home-based pulmonary rehabilitation

Compared to usual care, home-PR significantly improved exercise capacity (standardised mean difference (SMD) 0.88, 95% CI 0.32–1.44; p=0.002) ...