Pulmonary Rehabilitation for COPD

Recruiting at 1 trial location

Overseen By Johanna Hoult, M.A.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Inability to walk, Cognitive impairment, Hospice, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

306 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a home-based pulmonary rehabilitation program for people with COPD, a lung condition causing breathing problems, in rural areas. The goal is to determine if patients, caregivers, and healthcare providers find the program effective and easy to use. Participants will either begin the rehab program immediately or after a 12-week wait. It suits individuals aged 40 or older who have been diagnosed with COPD and live in rural areas. As an unphased trial, this study provides a unique opportunity for participants to contribute to research that could enhance COPD care in rural communities.

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 pulmonary rehabilitation program is safe for COPD patients?

Research has shown that pulmonary rehabilitation (PR) is safe for people with chronic obstructive pulmonary disease (COPD). Studies demonstrate that PR can enhance patients' exercise capacity and quality of life. It is considered a low-risk treatment and is generally well-tolerated.

One study found that PR was safe and effective even during COPD flare-ups. Another review confirmed its safety during hospital stays for those with worsening symptoms. This suggests that PR is a safe option for managing COPD symptoms in various situations.

Overall, evidence supports PR as a safe treatment choice for improving COPD symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a home-based pulmonary rehabilitation program for COPD, which offers a unique approach compared to traditional, clinic-based rehabilitation. This method allows individuals to engage in rehabilitation exercises from the comfort of their own homes, potentially increasing accessibility and adherence to the program. It also reduces the need for frequent clinic visits, making it more convenient for patients who may have mobility issues or transportation challenges. By providing a flexible and accessible alternative, researchers hope to improve patient outcomes and quality of life for those with COPD.

What evidence suggests that pulmonary rehabilitation is effective for COPD?

Research has shown that pulmonary rehabilitation can greatly help people with COPD (chronic obstructive pulmonary disease). Studies indicate that this treatment enables patients to walk farther and feel more satisfied with their daily activities. It also offers long-term benefits, such as improved lung function and better quality of life. In this trial, participants in the treatment group will begin the home-based pulmonary rehabilitation intervention immediately, while those in the waitlist control group will receive usual care before starting the program after a 12-week control period. Pulmonary rehabilitation can reduce costs and enhance life quality after hospital stays for COPD. Even those with mild symptoms can benefit from this program, making it a valuable option for managing COPD. ^{6 7 8 9 10}

Who Is on the Research Team?

Teng Moua, M.D.

Principal Investigator

Mayo Clinic

Roberto Benzo, M.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for English-speaking people over 40 living in rural areas with physician-diagnosed COPD and some breathlessness. It's not for those nearing end-of-life care, with recent pulmonary rehab, severe cognitive issues, immobility, or acute COPD flare-ups at screening.

Inclusion Criteria

English Speaking

I am 40 years old or older.

Living in a rural area defined by Rural-Urban Commuting Area Codes 4-10

Exclusion Criteria

Transition to hospice or end-of-life care at the time of screening

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

Treatment

Participants in the treatment group begin home-based pulmonary rehabilitation immediately

12 weeks

Waitlist Control

Participants in the waitlist control group receive usual care for 12 weeks before starting pulmonary rehabilitation

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pulmonary Rehabilitation Program

Trial Overview The study tests a pulmonary rehabilitation program tailored for rural patients with COPD to see how well it works and what the experience is like for patients, caregivers, and providers.

How Is the Trial Designed?

Group I: Waitlist Control Experimental Treatment 1 Intervention

Subjects randomized to the waitlist control (usual care) arm will be offered the home-based pulmonary rehabilitation intervention after completing the 12-week control period.

Group II: Treatment Group Experimental Treatment 1 Intervention

Subjects randomized to the treatment arm will begin the home-based pulmonary rehabilitation intervention immediately.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

The pulmonary rehabilitation (PR) program significantly improved exercise capacity in COPD patients, with an average increase of 263.8 feet in the 6-minute walk distance (6MWD) after participation.

The program also led to a reduction in the frequency of COPD exacerbations by 0.3 events per year, indicating a positive impact on overall health, although quality-of-life improvements were mixed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary Rehabilitation: A Retrospective Study in Eastern North Carolina. Chalise, SN., Shaheen, HT., Rizwan, MZ., et al.[2019]

A daily outpatient rehabilitation program for COPD patients showed significant improvements in most measured parameters, particularly in the 6-minute walking distance, which increased from an average of 485.78 m to 527.97 m after 19 days of rehabilitation.

The program was safe, with no adverse events reported, indicating that outpatient rehabilitation can be a viable and effective approach for managing COPD in an acute hospital setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preliminary Short-term Results of an All-day Outpatient Pulmonary Rehabilitation Program in an Acute Hospital on Patients with Mild to Very Severe COPD]. Spielmanns, M., Winkler, A., Priegnitz, C., et al.[2015]

Qualitative interviews with 16 patients with COPD revealed that fears about breathlessness and exercise were significant barriers to accepting pulmonary rehabilitation, while the potential to regain control over their health motivated participation.

A proposed model suggests that framing pulmonary rehabilitation as a means to regain control may help address patients' concerns and improve their willingness to engage in the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the uptake of pulmonary rehabilitation in patients with COPD: qualitative study of experiences and attitudes. Harris, D., Hayter, M., Allender, S.[2018]

Pulmonary rehabilitation (PR) significantly enhances exercise capacity, alleviates symptoms, and improves the quality of life for patients with Chronic Obstructive Pulmonary Disease (COPD), while also contributing to increased survival rates and reduced healthcare usage.

Patients with severe symptoms, low exercise capacity, and poor quality of life benefit the most from PR, which includes a multidisciplinary approach involving exercise training, education, and psychosocial support tailored to individual needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Rehabilitation in COPD]. Villiger, B.[2008]

Pulmonary rehabilitation is effective for patients with COPD, improving exercise tolerance, reducing symptoms like dyspnea, and enhancing quality of life, as confirmed by recent studies.

In a follow-up study of 100 patients, those who exercised at home for more than 30 minutes a day showed a tendency to slow the progression of dyspnea over 19 months, highlighting the importance of continued physical activity post-rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy of pulmonary rehabilitation]. Machida, K.[2011]

In a study of 437 COPD patients undergoing a 12-week intensive pulmonary rehabilitation program, significant improvements were observed in both exercise performance and health-related quality of life, with 68% of patients showing enhanced walking distance and 75% reporting better quality of life post-rehabilitation.

Despite the severe health impairments of the patients, the study indicates that pulmonary rehabilitation can lead to substantial benefits, although individual responses to the program were not easily predictable based on initial health status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of pulmonary rehabilitation in COPD patients with severely impaired health status. van Ranst, D., Otten, H., Meijer, JW., et al.[2021]

The enhanced pulmonary rehabilitation (PR) program was well-received, with 70-75% of referred patients participating, and showed clinically significant improvements in exercise capacity and self-efficacy for many patients over 18 months.

Healthcare professionals demonstrated high engagement in the program, with implementation fidelity ranging from 76% to 95%, indicating that the program was effectively integrated and maintained at the center.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation and maintenance of an enhanced pulmonary rehabilitation program in a single centre: An implementation study. van der Braak, K., Wald, J., Tansey, CM., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10381859/

Effectiveness of Pulmonary Rehabilitation for Chronic ... The results showed that the PD program was able to improve the activity tolerance level and satisfaction of COPD patients and enrich the ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S095461112500277X

Long-term benefits of pulmonary rehabilitation with ... RMT significantly improved FEV1 % and SGRQ scores at 15 months in COPD patients. · Short-term improvements in the RMT group showed no significant group ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2793431

Cost-effectiveness of Pulmonary Rehabilitation Among US ... In this economic evaluation, PR after COPD hospitalization appeared to result in net cost savings along with improvement in QALE.

4. ejb.springeropen.com ejb.springeropen.com/articles/10.1186/s43168-025-00452-9

Evaluation of the effectiveness of pulmonary rehabilitation in ... A pulmonary rehabilitation program of 12-week duration for patients with chronic obstructive lung disease has a great effect on improving 6MWD, ...

5. atsjournals.org atsjournals.org/doi/10.1164/rccm.202306-1066ST

Pulmonary Rehabilitation for Adults with Chronic ... A systematic review demonstrated that people with stable COPD and mild symptoms (mMRC dyspnea scale score, ⩽1) benefit from PR (73), and a cluster analysis of > ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11147635/

Review of the Evidence for Pulmonary Rehabilitation in ... PR has been associated with improvement in exercise capacity, health-related quality of life, and dyspnea in patients living with COPD.

7. atsjournals.org atsjournals.org/doi/full/10.1513/AnnalsATS.202206-545OC

Safety and Efficacy of Inpatient Pulmonary Rehabilitation ... Conclusions: This review suggests that it is safe and effective to provide PR during hospitalization for individuals with AECOPD. In-hospital PR ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0003999322017105

Short-Term Health Outcomes of a Structured Pulmonary ... Pulmonary rehabilitation (PR) is a low-cost therapy shown to improve exercise tolerance and health status in people with chronic obstructive pulmonary disease ( ...

9. resmedjournal.com resmedjournal.com/article/S0954-6111(23)00313-X/fulltext

Pulmonary rehabilitation for acute exacerbations of COPD Compared to usual care, pulmonary rehabilitation probably improves AECOPD-related hospital readmissions (relative risk 0.56, 95% CI 0.36 to 0.86 ...

10. mdpi.com mdpi.com/2077-0383/13/9/2576

The Short-Term Efficacy of a Three-Week Pulmonary ... The study supports the short-term efficacy of the three-week PR program in improving clinical outcomes, exercise tolerance, and quality of life in COPD and ...