Pulmonary Rehabilitation for COPD
(RISE Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Overseen byNeeta Thakur, MD, MPH
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, San Francisco
Must be taking: COPD medications
Disqualifiers: Pregnancy, Dementia, Cardiovascular disease, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Chronic obstructive pulmonary disease (COPD), one of the leading causes of death in the US, disproportionately affects low socioeconomic communities. While few interventions effectively modify the course of COPD and improve outcomes, pulmonary rehabilitation is the one notable exception. However, implementation of this resource-intensive program in real-life settings, and in particular, for underserved communities, has proven to be challenging. Safety-net centers that serve primarily under-insured populations lack financial resources to provide pulmonary rehabilitation.
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 leads to the implementation of a Health Advocates program to address participant's social needs and barriers to healthcare.
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.
What data supports the effectiveness of the treatment COPD Wellness, Pulmonary Rehabilitation, COPD Wellness and Plus+ Program, COPD Wellness Plus+, Pulmonary Rehabilitation, COPD Rehabilitation, COPD Wellness and Plus+ Program, Usual Care, Standard Care, Conventional Care for COPD?
Research shows that pulmonary rehabilitation programs can improve exercise capacity, quality of life, and reduce the frequency of COPD flare-ups. These programs are beneficial for managing COPD symptoms and enhancing patients' overall well-being.
12345Is pulmonary rehabilitation safe for people with COPD?
Pulmonary rehabilitation is generally considered safe for people with COPD, as studies show it can improve quality of life and reduce healthcare visits without significant safety concerns.
36789How is the COPD Wellness Plus+ treatment different from other COPD treatments?
The COPD Wellness Plus+ treatment is unique because it integrates pulmonary rehabilitation with a focus on self-management education and includes a domiciliary (home-based) component with regular phone support from a respiratory team, which may help reduce the frequency of acute exacerbations and improve overall quality of life.
110111213Eligibility Criteria
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.
+8 more
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.
+6 more
Trial Timeline
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
Participant Groups
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.
3Treatment groups
Experimental Treatment
Active Control
Group I: COPD Wellness Plus+Experimental Treatment1 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 WellnessExperimental Treatment1 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 CareActive Control1 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, Australia 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)
🇦🇺 Approved in Australia as Pulmonary Rehabilitation for:
- Chronic Obstructive Pulmonary Disease (COPD)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Southeast Health Center (SEHC)San Francisco, CA
Maxine Hall Health Center (MHHC)San Francisco, CA
Zuckerberg San Francisco General (ZSFG) HospitalSan Francisco, CA
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Who Is Running the Clinical Trial?
University of California, San FranciscoLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
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. [2018]BACKGROUND Integrated pulmonary rehabilitation (PR) in chronic obstructive pulmonary disease (COPD) may prevent acute exacerbations of COPD (AECOPD). The aim of this study was to evaluate the effectiveness, before and 12 months after, the use of an integrated PR program in patients discharged from hospital for AECOPD. MATERIAL AND METHODS A retrospective observational clinical study included patients diagnosed with COPD who participated in a domiciliary integrated PR program that included a weekly phone interview supervised by a respiratory team. A six-minute walk test (6MWT), COPD assessment test (CAT), and the modified Medical Research Council scale (mMRC) were evaluated every three months. RESULTS Of the 303 eligible patients, 267 patients (88.1%), with a mean age of 64.9±8.7 years, a mean FEV1 percentage predicted of 48.8±12.9%, successfully completed the 12-month study program and achieved a significant improvement in their clinical performance with a significantly reduced frequency of episodes of EACOPD (3.1±1.7 vs. 2.0±1.4) (p
[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]Positive effects of pulmonary rehabilitation on chronic obstructive pulmonary disease (COPD) are well known, and inpatient rehabilitation programs are the preferred modality in Germany. In this paper, we report on the recent results of a daily outpatient rehabilitation program offered at an acute hospital, the first of this kind in Germany. It is not known whether this kind of rehabilitation is an effective approach.
[The education program for patients with COPD from Bad Reichenhall]. [2009]An education program for patients with COPD is presented. This program was created for inpatient pulmonary rehabilitation at the Klinik Bad Reichenhall. We intend to improve the patients' acceptance of disease and their understanding of therapy. Furthermore we want to impart basic knowledge about COPD and its treatment. The patients should be motivated to manage the disease in an active and more independent way: They should control the natural course of their disease by learning preventive and restorative health care behaviours and self-help activities in case of acute exacerbations. The aim is to attain the acceptance of changing life-style.
Three years of pulmonary rehabilitation: inhibit the decline in airflow obstruction, improves exercise endurance time, and body-mass index, in chronic obstructive pulmonary disease. [2022]Pulmonary rehabilitation is known to be a beneficial treatment for COPD patients. To date, however, there is no agreement for how long a rehabilitation program should be implemented. In addition, current views are that pulmonary rehabilitation does not improve FEV1 or even slow its decline in COPD patients. The aim of the study was to examine the efficacy of a 3 year outpatient pulmonary rehabilitation (PR) program for COPD patients on pulmonary function, exercise capability, and body mass index (BMI).
Pulmonary rehabilitation programs for patients with COPD. [2019]Pulmonary rehabilitation programs are aimed at providing benefits to COPD patients, in various aspects. Our objective was to review the literature on COPD patient rehabilitation. This systematic review involved articles written in English, Spanish, or Portuguese; published between 2005 and 2009; and indexed in national and international databases. Articles were classified in accordance with the Global Initiative for Chronic Obstructive Lung Disease criteria for the determination of the level of scientific evidence (grade of recommendation A, B, or C). The outcome measures were exercise, quality of life, symptoms, exacerbations, mortality, and pulmonary function. Treatments were classified as standard rehabilitation, partial rehabilitation, strength exercises, and resistance exercises. Of the 40 articles selected, 4, 18, and 18 were classified as grades A, B, and C, respectively. Of the 181 analyses made in these articles, 61, 50, 23, 23, 20, and 4, respectively, were related to the outcome measures quality of life, exercise, symptoms, exacerbations, pulmonary function, and mortality. The standard rehabilitation programs showed positive effects on all of the outcomes evaluated, except for mortality (because of the small number of analyses). However, we found no differences among the various rehabilitation programs regarding their effects on the outcomes studied. Rehabilitation programs can be considered important tools for the treatment of COPD. Therefore, health administrators should implement public policies including such programs in the routine of health care facilities.
Evaluation of an Enhanced Pulmonary Rehabilitation Program: A Randomized Controlled Trial. [2021]Rationale: Pulmonary rehabilitation (PR) is the most effective strategy to improve health outcomes in people with chronic obstructive pulmonary disease (COPD), although it has had limited success in promoting sustained physical activity. PR with a strong focus on disease self-management may better facilitate long-term behavior change. Objectives: To compare a newly developed enhanced PR (EPR) program with a traditional PR program on outcome achievement. Methods: In this randomized parallel-group controlled trial, PR classes were block-randomized to EPR or traditional PR and were delivered over 16 sessions each. The EPR program incorporated new and updated "Living Well with COPD" education modules, which had a stronger focus on chronic disease self-management. Fidelity of the intervention for content and delivery was assessed. Physical activity, self-efficacy, exercise tolerance, and health-related quality of life (HRQoL) were collected before, after, and 6 months after PR. Healthcare visits were collected 2 years before PR and 1 year after. Mortality was recorded 1 year after PR. Results: Of the 207 patients with COPD enrolled, 108 received EPR and 99 received traditional PR. Physical activity (steps) and self-efficacy improved from before to after PR in both programs, with no differences between groups. These effects were not sustained at 6 months. Exercise tolerance and HRQoL improved from before to after PR with no between-group differences and were maintained at 6 months. Visits to primary care providers and respiratory specialists decreased in the EPR program relative to the traditional PR program. EPR was delivered as intended, and there was no meaningful cross-contamination between the two programs. Conclusions: Enhancing PR to have a greater emphasis on chronic disease self-management did not result in a superior improvement of physical activity and health outcomes compared with traditional PR except for reduced resource usage from primary and specialist physician visits in the EPR program.Clinical trial registered with ClinicalTrials.gov (NCT02917915).
Patient Profile of Drop-Outs From a Pulmonary Rehabilitation Program. [2022]While the benefits of pulmonary rehabilitation programs (PR) in COPD have been demonstrated, poor adherence, related with worse clinical outcomes, is common.
Magnitude of exercise capacity and quality of life improvement following repeat pulmonary rehabilitation in patients with COPD. [2018]Maintenance and repeated pulmonary rehabilitation programs (PRPs) for patients with COPD have attempted to prolong PRP benefits beyond 12-24 months. However, there is limited evidence as to the magnitude of benefit or the ideal interval between repeating the program under "real-world" conditions in which patients are referred based on clinical necessity. Therefore, we reviewed the effects of repeating PRP in a physician-referred cohort of patients with COPD.
Benefits of a community-hospital pulmonary rehabilitation program. [2019]Pulmonary rehabilitation can be a beneficial and cost-effective mode of therapy for patients with chronic obstructive pulmonary disease (COPD). At St Joseph's Hospital in Stockton, California, we established a multi-disciplinary, 10-week program combining outpatient education with aerobic exercise to promote both improved subjective well-being and increased exercise tolerance in patients with COPD. We studied 74 patients who had completed the program at least 1 year before the study began. Subjective data about the program were collected by use of a questionnaire. Changes in physical work capacity were measured by use of stress tests performed before and after the program was completed. Of the 57 patients responding to the questionnaire, most felt that the program had improved the quality of their lives. After the program was completed, significant decreases were seen in oxygen consumption, minute ventilation, and heart rate during treadmill exercise. The number of days of hospitalization for the group decreased from 497 in the year before completing the program to 34 the year after.
[Rehabilitation in COPD]. [2008]Pulmonary rehabilitation (PR) is an important tool in the treatment of COPD patients. It is now clearly established that PR improves exercise capacity, reduces symptoms and improves quality of life in COPD patients. There is further evidence that the programmes also improve survival and reduce medical consumption. Pulmonary rehabilitation programmes are multidisziplinary and consist of exercise training (endurance, power), chest physiotherapie, education, psychosocial and nutritional support. Patients with poor exercise capacity, peripheral muscle weakness, severe complaints and poor quality of life seem to profit most from in- and outpatients rehab programmes. The type of rehabilitation depends on the severity of symptoms, the competence of the rehab-team and the local possibilities.
[The effect of controlled and uncontrolled dynamic lower extremity training in the rehabilitation of patients with chronic obstructive pulmonary disease]. [2022]Pulmonary rehabilitation has become a part of the integrated management of patients with chronic obstructive pulmonary disease (COPD). The lower extremity dynamic training has been proved to be the most effective element of the program.
Implementation and maintenance of an enhanced pulmonary rehabilitation program in a single centre: An implementation study. [2023]Pulmonary rehabilitation (PR) has major benefits for patients with chronic obstructive pulmonary disease (COPD). An enhanced PR program was developed with a self-management education intervention. The objective of our study was to evaluate the implementation of the enhanced PR program into a single centre.
Predictors of response to pulmonary rehabilitation in stable chronic obstructive pulmonary disease patients: A prospective cohort study. [2020]Pulmonary rehabilitation (PR) has become a standard of care in the management of chronic obstructive pulmonary disease (COPD). However, a significant proportion of the patients do not show benefit after the PR program.