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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, year 3 of study period (end of study activities)
Awards & highlights

RISE Trial 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.Check my eligibility
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.See study design
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.

RISE Trial 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.

RISE Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline 6 Minute Walk Test to end-of-intervention (3-month) visit
Secondary outcome measures
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 outcome measures
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

RISE 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

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,506 Previous Clinical Trials
15,238,168 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,837 Previous Clinical Trials
47,851,207 Total Patients Enrolled
Neeta Thakur, MD, MPHPrincipal InvestigatorUniversity of California, San Francisco
2 Previous Clinical Trials
339 Total Patients Enrolled

Media Library

COPD Wellness Clinical Trial Eligibility Overview. Trial Name: NCT05572632 — N/A
Chronic Obstructive Pulmonary Disease Research Study Groups: COPD Wellness Plus+, Usual Care, COPD Wellness
Chronic Obstructive Pulmonary Disease Clinical Trial 2023: COPD Wellness Highlights & Side Effects. Trial Name: NCT05572632 — N/A
COPD Wellness 2023 Treatment Timeline for Medical Study. Trial Name: NCT05572632 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research applicable for minors?

"This medical study requires patients to be in the age range of 40-90. For those younger than 18, there are 14 studies available and 333 for individuals older than 65 years old."

Answered by AI

Are any additional participants being sought for this research?

"As per the information on clinicaltrials.gov, this investigation is no longer accepting enrollees. The trial began recruiting patients on October 1st 2022 and was last amended five days later. Although its recruitment period has concluded, there are still 337 other studies actively searching for participants at present."

Answered by AI

Are there any criteria that would disqualify me from participating in this clinical investigation?

"This medical trial seeks 387 volunteers between the ages 40 and 90 that suffer from chronic obstructive pulmonary disease. Those interested must provide a signed informed consent form, agree to participate in the COPD Wellness program, be able to speak either English or Spanish, have a COPD Assessment Test score of 10 or higher as well as a history of at least one hospitalization due to exacerbation or two outpatient treatments with steroid therapy; they must also currently be taking prescribed medications for their condition, demonstrate capability to exercise using upper and/or lower extremities without any recent respiratory flare-ups (no exacerbations within 6 weeks), receive care under San"

Answered by AI

Who else is applying?

What site did they apply to?
Maxine Hall Health Center (MHHC)
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Rehabilitation in Safety-net Environments (RISE) to Improve Outcomes in Vulnerable Patients With COPD
2023. "Rehabilitation in Safety-net Environments (RISE) to Improve Outcomes in Vulnerable Patients With COPD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05572632.
~258 spots leftby Dec 2026
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