Pulmonary Rehabilitation for COPD

(RISE Trial)

Recruiting at 2 trial locations

Overseen By Valeria M Rojas, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must be taking: COPD medications

Disqualifiers: Pregnancy, Dementia, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: 3

Duration: 10 weeks

387 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore ways to improve the health of people with chronic obstructive pulmonary disease (COPD), focusing on underserved communities. It will compare three groups: standard care, a COPD Wellness program with exercise and rehabilitation, and an enhanced version with additional support from Health Advocates. Individuals diagnosed with COPD, who have frequent flare-ups and can participate in exercise, might be suitable for this study. The trial seeks to determine how effectively these programs manage COPD symptoms and enhance quality of life. As an unphased trial, this study provides a unique opportunity to contribute to research that could lead to better management strategies for COPD.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be currently prescribed COPD medication(s), which suggests you may continue your current COPD medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that pulmonary rehabilitation is generally safe for people with COPD. Studies indicate it can improve quality of life and reduce doctor visits without causing harm. Previous participants found programs like COPD Wellness and COPD Wellness Plus+ to be well-tolerated. These programs focus on gentle exercise and education, which most people manage well. Reports of serious side effects from these programs do not exist. Therefore, participants can expect a safe experience. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the COPD Wellness and COPD Wellness Plus+ programs because they offer a fresh approach to managing COPD. Unlike traditional treatments that primarily focus on medication and standard rehabilitation, COPD Wellness incorporates a low-intensity exercise component specifically designed for individuals with moderate-to-severe COPD. This exercise-based rehabilitation aims to improve the functional status of patients. COPD Wellness Plus+ takes it a step further by integrating Health Advocates to address social needs, potentially enhancing overall health and adherence to the program. This holistic approach could lead to better health outcomes by not only improving physical health but also addressing social factors that impact wellness.

What evidence suggests that this trial's treatments could be effective for COPD?

Research has shown that pulmonary rehabilitation effectively treats chronic obstructive pulmonary disease (COPD). Studies have found that it improves overall health, eases breathing, and boosts mental well-being. In this trial, participants may join the COPD Wellness program, which enhances these benefits by offering gentle exercise alongside pulmonary rehabilitation. Early results suggest that these programs improve life quality for people with moderate-to-severe COPD. Another arm of this trial, the COPD Wellness Plus+ program, includes Health Advocates to assist with social needs, potentially further improving health outcomes. Overall, both programs are well-supported as effective ways to manage COPD symptoms. ^{1 3 6 7 8}

Who Is on the Research Team?

Neeta Thakur, MD, MPH

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults aged 40-90 with physician-diagnosed COPD, a specific lung function score (FEV1/FVC ≤ 0.7 and FEV1% <80%), and a history of exacerbations. They must be on COPD meds, able to exercise with their legs, not have had recent severe illness or rehab, and be SFHN patients.

Inclusion Criteria

I have severe COPD or have had serious flare-ups.

Your lung function test shows a certain ratio and percentage that are below normal.

I am willing to join the COPD Wellness program.

Exclusion Criteria

I have had a worsening of my COPD in the last 6 weeks.

Pregnancy

My heart condition is stable, with no recent severe events.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the 10-week COPD Wellness and Plus+ Program, which includes pulmonary rehabilitation and social navigation through Health Advocates

10 weeks

Follow-up

Participants are monitored for changes in medication adherence, functional status, symptom burden, and quality of life

6 months

3 visits (in-person) at 3-month, 6-month, and 9-month intervals

Long-term Follow-up

Assessment of health system adoption and maintenance of the intervention

24 months

What Are the Treatments Tested in This Trial?

Interventions

• COPD Wellness
• COPD Wellness Plus+
• Usual Care

Trial Overview The RISE study tests two programs: 'COPD Wellness' and 'COPD Wellness Plus+' against usual care over 10 weeks in underserved communities. It includes health advocacy to address social needs alongside the wellness programs.

How Is the Trial Designed?

Group I: COPD Wellness Plus+ Experimental Treatment 1 Intervention

This arm includes COPD Wellness Plus+. This arm is built from COPD Wellness with the addition of Health Advocates (i.e. Plus+). This intervention seeks to understand the effects of addressing social needs on overall health and wellness through Zuckerberg San Francisco General Hospital's (ZSFG) Health Advocate (HA) program; participation and engagement with the HA's will serve as an adherence strategy.

Group II: COPD Wellness Experimental Treatment 1 Intervention

This arm, COPD Wellness gives low-intensity exercise component with pulmonary rehabilitation for individuals with moderate-to-severe COPD. COPD Wellness is a program that was built from the Better Breathing Program, that is a part of San Francisco Health Network (SFHN) standard care for COPD.

Group III: Usual Care Active Control 1 Intervention

This includes access to comprehensive primary care services. Participants randomized to the usual care arm will be offered referral to the Better Breathing Program that is part of SFHN standard care for COPD. This program consists of an evidence-based curriculum that improves disease knowledge and management skills but has no effect on symptoms or functional status. At end of study enrollment, usual care participants will be offered the COPD Wellness intervention.

COPD Wellness 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)

Approved in United States as Pulmonary Rehabilitation for:

• Chronic Obstructive Pulmonary Disease (COPD)

Approved in Canada as Pulmonary Rehabilitation for:

• Chronic Obstructive Pulmonary Disease (COPD)

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

The education program for COPD patients at Klinik Bad Reichenhall aims to enhance their understanding of the disease and treatment, promoting better disease management and acceptance.

By encouraging active participation in their own care, the program seeks to empower patients to adopt healthier lifestyles and effectively handle acute exacerbations of COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The education program for patients with COPD from Bad Reichenhall]. Spohn, S., Wittmann, M., Petro, W.[2009]

In a study of 141 COPD patients who completed pulmonary rehabilitation programs (PRPs) multiple times over 12 years, significant improvements in functional exercise capacity were observed after each PRP, regardless of the time interval between programs.

Health-related quality of life and mood improved after the first two PRPs, but no significant benefits were noted after the third PRP, suggesting diminishing returns with repeated interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnitude of exercise capacity and quality of life improvement following repeat pulmonary rehabilitation in patients with COPD. Sandoz, JS., Roberts, MM., Cho, JG., et al.[2018]

Pulmonary rehabilitation programs significantly improve various outcomes for COPD patients, including exercise capacity and quality of life, based on a systematic review of 40 studies published between 2005 and 2009.

Standard rehabilitation programs were effective across all evaluated outcomes except mortality, highlighting their importance in COPD management and suggesting that health policies should support their implementation in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary rehabilitation programs for patients with COPD. Wehrmeister, FC., Knorst, M., Jardim, JR., et al.[2019]

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]

In a study of 102 stable COPD patients undergoing an 8-week pulmonary rehabilitation program, 52.5% showed significant improvements in exercise tolerance and quality of life, indicating that PR can be effective for many patients.

Poor baseline lung function (forced expiratory volume in 1 second <50% predicted) was identified as a positive predictor of PR response, while osteoporosis was a negative predictor, suggesting that assessing these factors can help tailor PR programs for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of response to pulmonary rehabilitation in stable chronic obstructive pulmonary disease patients: A prospective cohort study. Ragaselvi, S., Janmeja, AK., Aggarwal, D., et al.[2020]

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]

A 3-year outpatient pulmonary rehabilitation program significantly slowed the decline in lung function (FEV1) in COPD patients, with a decrease of only 74 ml compared to 149 ml in the control group.

The rehabilitation program also improved exercise capability and helped maintain a stable body mass index (BMI) in COPD patients, contrasting with a decrease in BMI observed in the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three years of pulmonary rehabilitation: inhibit the decline in airflow obstruction, improves exercise endurance time, and body-mass index, in chronic obstructive pulmonary disease. Stav, D., Raz, M., Shpirer, I.[2022]

Supervised lower extremity dynamic training in patients with COPD led to greater improvements in exercise capacity and vital capacity compared to unsupervised training, highlighting the importance of professional guidance during rehabilitation.

Both groups experienced improvements in aerobic capacity and quality of life, but the supervised group showed more significant enhancements in anaerobic threshold and reduced dyspnea, suggesting that higher intensity training under supervision may optimize rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effect of controlled and uncontrolled dynamic lower extremity training in the rehabilitation of patients with chronic obstructive pulmonary disease]. Varga, J., Boda, K., Somfay, A.[2022]

A 12-month integrated pulmonary rehabilitation program significantly reduced the frequency of acute exacerbations of COPD (AECOPD) and emergency department visits among 267 patients, demonstrating its effectiveness in managing COPD.

Patients showed marked improvements in their overall well-being and clinical performance, as measured by the COPD assessment test (CAT) and modified Medical Research Council scale (mMRC), indicating the program's positive impact on quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of a Domiciliary Integrated Pulmonary Rehabilitation Program for Patients with a History of Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Retrospective 12-Month Observational Study. Li, Y., Feng, J., Li, Y., et al.[2018]

In a 12-week pulmonary rehabilitation program for COPD involving 83 patients, a significant drop-out rate of 38.5% was observed, primarily due to low motivation and transportation issues.

Non-adherent patients exhibited worse functional characteristics, including lower forced vital capacity and poorer performance on exercise tests, as well as higher usage of oral steroids, indicating that those with more severe disease may struggle to adhere to rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Profile of Drop-Outs From a Pulmonary Rehabilitation Program. Almadana Pacheco, V., Pavón Masa, M., Gómez-Bastero Fernández, AP., et al.[2022]

A 10-week pulmonary rehabilitation program for 74 patients with COPD significantly improved their quality of life, as reported by 57 participants who completed a questionnaire.

The program also led to a remarkable reduction in hospitalizations, with the number of days spent in the hospital dropping from 497 to just 34 in the year following the program, indicating its effectiveness in managing COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of a community-hospital pulmonary rehabilitation program. Wright, RW., Larsen, DF., Monie, RG., et al.[2019]

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 207 patients with COPD, an enhanced pulmonary rehabilitation (EPR) program focused on chronic disease self-management did not lead to greater improvements in physical activity or health outcomes compared to traditional pulmonary rehabilitation, although both programs showed similar benefits in exercise tolerance and health-related quality of life.

The EPR program resulted in fewer visits to primary care providers and respiratory specialists, indicating a potential for reduced healthcare resource usage, despite no significant differences in sustained physical activity between the two rehabilitation approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an Enhanced Pulmonary Rehabilitation Program: A Randomized Controlled Trial. Selzler, AM., Jourdain, T., Wald, J., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05572632

Study Details | NCT05572632 | Rehabilitation in Safety-net ... The proposed study will directly test the benefit of the 10-week COPD Wellness and Plus+ Program relative to usual care and estimate the added benefit of the HA ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7515680/

Pulmonary Rehabilitation for Chronic Obstructive Pulmonary ... PR is well supported by the literature, and has been shown to improve health status, reduce dyspnea, improve psychological well-being, and reduce healthcare ...

3. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05572632

Rehabilitation in Safety-net Environments (RISE) to Improve ... The proposed study will directly test the benefit of the 10-week COPD Wellness and Plus+ Program relative to usual care and estimate the added benefit of the ...

4. atsjournals.org atsjournals.org/doi/full/10.1513/AnnalsATS.202203-214OC

A Clinical Trial | Annals of the American Thoracic Society Pulmonary rehabilitation is the most effective intervention in improving QoL but has low uptake and adherence. Home-based programs are a ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0954611121001840

Benefits of pulmonary rehabilitation in COPD patients with ... PR is an effective treatment in COPD for both CI and CN patients. · A 3-week PR program has favorable effects on health status in both CI and CN COPDs. · A 3-week ...

6. reporter.nih.gov reporter.nih.gov/project-details/11141059

Rehabilitation in Safety-Net Environments (RISE) for COPD COPD Wellness Plus+ was designed to specifically address barriers to rehabilitation and function within low-resourced healthcare settings. If effective, the ...

7. trial.medpath.com trial.medpath.com/clinical-trial/e36fe5dbbbf256a7/nct05572632-community-based-pulmonary-rehabilitation-copd-wellness-social-navigation-health-advocates

Rehabilitation in Safety-net Environments (RISE) to Improve ... The 10-week COPD Wellness and Plus+ Program directly addresses this gap, and yet, programs like these do not automatically lead to improved outcomes, which ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10704228/

INSIGHT COPD Randomized Clinical Trial - PubMed Central The intervention did lead to clinically meaningful weight loss and appeared to prevent the loss of exercise tolerance. Preventing decline is an ...