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Behavioral Intervention
Controlled Breathing for COPD (REST Trial)
N/A
Recruiting
Research Sponsored by University of Texas at Austin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of spirometry confirmed COPD (FEV1/FVC <0.70 + FEV1<80%)
Age >40 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is comparing a breathing exercise program called REST to usual care to see if it helps reduce stress in people with COPD.
Who is the study for?
This trial is for people over 40 with confirmed COPD, who experience significant stress and shortness of breath. Participants must have a certain score on the COPD Assessment Test, be able to attend training sessions in person, and communicate in English.
What is being tested?
The REST trial compares a controlled breathing technique designed to reduce stress against usual care practices for individuals with COPD. It's a pilot study where participants are randomly assigned to one of the two groups.
What are the potential side effects?
Since this intervention involves education and breathing techniques (REST), side effects may be minimal but could include discomfort or fatigue from practicing new breathing exercises.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with COPD confirmed by a breathing test.
Select...
I am over 40 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability (qualitative)
Acceptability (quantitative)
Intervention Feasibility
+1 moreSecondary study objectives
Mindful Attention Awareness Scale
Modified Medical Research Council dyspnea scale
Perceived Stress Scale
Other study objectives
Heart rate variability
Lung Function
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Behavioral Intervention (REST)Experimental Treatment1 Intervention
Participants randomized to this group will receive COPD education, research staff support, and the REST (controlled breath) intervention.
Group II: ControlActive Control1 Intervention
Participants randomized to this group will receive COPD education and research staff support.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
REST
2013
Completed Phase 2
~780
Find a Location
Who is running the clinical trial?
University of Texas at AustinLead Sponsor
374 Previous Clinical Trials
86,139 Total Patients Enrolled
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