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

Trial Summary

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 Pulmonary Rehabilitation Program for COPD?

Research shows that pulmonary rehabilitation helps people with COPD by improving their ability to exercise, reducing symptoms, and enhancing their quality of life. It can also lower the chances of hospital visits and help patients maintain independence. ^{1 2 3 4 5}

Is pulmonary rehabilitation safe for humans?

Research shows that pulmonary rehabilitation is generally safe for people with chronic obstructive pulmonary disease (COPD), even after acute exacerbations (worsening of symptoms). ^{5 6 7 8 9}

How is the Pulmonary Rehabilitation Program treatment different from other treatments for COPD?

The Pulmonary Rehabilitation Program is unique because it is a comprehensive, multidisciplinary approach that includes exercise training, education, nutritional support, and psychosocial support, aiming to improve overall quality of life and reduce healthcare use for COPD patients. Unlike other treatments that may focus solely on medication, this program emphasizes high-intensity exercise and self-management education to enhance physical and mental well-being. ^{5 10 11 12 13}

What is the purpose of this trial?

The purpose of this study is to test the uptake, effectiveness, and patient-caregiver-provider experience of a crucial treatment not provided in rural areas: pulmonary rehabilitation.

Research Team

Teng Moua, M.D.

Principal Investigator

Mayo Clinic

Roberto Benzo, M.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

I am 40 years old or older.

English Speaking

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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 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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

[Rehabilitation in COPD]. [2008]

2. England pubmed.ncbi.nlm.nih.gov

Improving the uptake of pulmonary rehabilitation in patients with COPD: qualitative study of experiences and attitudes. [2018]

3. Japan pubmed.ncbi.nlm.nih.gov

[Efficacy of pulmonary rehabilitation]. [2011]

4. Germany 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]. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Implementation and maintenance of an enhanced pulmonary rehabilitation program in a single centre: An implementation study. [2023]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Outcome of pulmonary rehabilitation in COPD patients with severely impaired health status. [2021]

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

Efficiency and safety of pulmonary rehabilitation in acute exacerbation of chronic obstructive pulmonary disease. [2022]

8. Italy pubmed.ncbi.nlm.nih.gov

Pulmonary rehabilitation and risk of fall in elderly with chronic obstructive pulmonary disease. [2023]

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

Pulmonary Rehabilitation: A Retrospective Study in Eastern North Carolina. [2019]

10. England pubmed.ncbi.nlm.nih.gov

A feasibility trial of pulmonary rehabilitation for patients with COPD in a low resource setting: Jaffna, Sri Lanka. [2022]

11. France pubmed.ncbi.nlm.nih.gov

[Pulmonary rehabilitation in patients with chronic obstructive pulmonary disease]. [2016]

12. New Zealand pubmed.ncbi.nlm.nih.gov

Efficacy of Repeating Pulmonary Rehabilitation in People with COPD: A Systematic Review. [2022]

13. Egypt pubmed.ncbi.nlm.nih.gov

Using Telehealth technology to deliver pulmonary rehabilitation in chronic obstructive pulmonary disease patients. [2021]