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Pulmonary Rehabilitation for COPD (RISE Trial)

N/A

Recruiting

Led By Neeta Thakur, MD, MPH

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

COPD Assessment Test ≥ 10 or history of 1+ exacerbation requiring hospitalization or 2+ outpatient exacerbations requiring steroid therapy

English or Spanish speaking

Must not have

COPD exacerbation in the past 6 weeks

Unstable cardiovascular disease (includes recent [<6 months] myocardial infarction or pulmonary embolism, uncontrolled arrhythmia, poorly controlled heart failure)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, year 3 of study period (end of study activities)

Awards & highlights

No Placebo-Only Group

Summary

This trial tested a program to bring pulmonary rehabilitation to low income patients with COPD, which included a Health Advocates program to address social needs.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the trial interventions focus on wellness without direct medication, side effects may include fatigue or muscle soreness from increased physical activity. There's also a risk of injury if exercises are performed improperly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I speak English or Spanish.

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My doctor has diagnosed me with COPD.

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I am currently taking medication for COPD.

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I am between 40 and 90 years old.

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I can exercise using my legs.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I do not have an active lung infection like TB or COVID-19.

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I do not have dementia, cognitive issues, or severe mental health problems that would stop me from participating.

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I have limitations that prevent me from doing moderate physical activities.

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I do not have any health conditions expected to cause death within a year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, year 3 of study period (end of study activities)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, year 3 of study period (end of study activities)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, year 3 of study period (end of study activities) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline 6 Minute Walk Test to end-of-intervention (3-month) visit

Secondary study objectives

Change from Baseline 6 Minute Walk Test at 6-month and 9-month visit following end-of-intervention

X-Ray Computed Tomography

Chronic Obstructive Airway Disease

+5 more

Other study objectives

Anxiety

Change from Baseline Medication Adherence at 3-month (End of Intervention), 6-month, and 9-month visit

Change from Baseline Smoking Status at 3-month (End of Intervention) visit, 6-month, and 9-month visit

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

COPD Wellness

2017

N/A

~40

0 / 12Eligibility criteria met