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Physical Activity Program for Asthma (ACTION E2I Trial)
N/A
Recruiting
Led By Sharmilee Nyenhuis, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >/= 18
Self-identify as female and Black or African-American
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24- and 48-weeks
Awards & highlights
ACTION E2I Trial Summary
This trial will test if a physical activity intervention designed for Black women with asthma can improve asthma health outcomes.
Who is the study for?
This trial is for Black or African-American women over 18 with persistent asthma that isn't well-controlled. They should be physically able to walk, not smoke tobacco, and engage in less than 150 minutes of moderate exercise weekly. Participants must not have severe medical/psychiatric conditions, plans to move from the Chicagoland area during the study, recent severe asthma issues, current pregnancy or intention to become pregnant soon.Check my eligibility
What is being tested?
The ACTION Intervention aims to increase physical activity among urban Black women with asthma through group sessions, self-monitoring and text support for goal-setting over a period of 24 weeks. The control group receives individual education on asthma management. The study will measure how these approaches affect asthma health outcomes.See study design
What are the potential side effects?
Since this intervention focuses on increasing physical activity rather than medication or medical procedures, side effects are minimal but may include typical exercise-related discomforts such as muscle soreness or fatigue.
ACTION E2I Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am a Black or African-American woman.
Select...
My asthma is not well-controlled, or I've had a severe asthma attack in the last year.
ACTION E2I Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24- and 48-weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24- and 48-weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Asthma Control Questionnaire
Asthma exacerbations
Daily Steps
+10 moreACTION E2I Trial Design
2Treatment groups
Experimental Treatment
Group I: Education ControlExperimental Treatment1 Intervention
Orientation (week 0): 1 individual asthma education session Education texts: weekly (weeks 1-8), then bi-weekly (week 9-12), then monthly (weeks 13-24) Outcome assessments (12-, 24-, 48-weeks)
Group II: ACTION InterventionExperimental Treatment1 Intervention
Orientation (week 0): 1 group session Induction phase (weeks 1-12): 8 weekly then 2 bi-weekly goal setting via text with health coach + 2 group sessions (week 5, 9) Adoptive phase (weeks 13-24): 2 monthly goal setting with remote health coach + 3 group sessions (week 13, 17, 21) Maintenance phase (weeks 25-48): 1 group session Outcome assessment (12-, 24-, and 48-weeks)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ACTION Intervention
2017
N/A
~60
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
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819,553 Total Patients Enrolled
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Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am a Black or African-American woman.You do not exercise for at least 150 minutes per week at a moderate or vigorous level.I have had a severe asthma attack or needed steroids for asthma in the last month.My asthma is not well-controlled, or I've had a severe asthma attack in the last year.I need a wheelchair or scooter to move around.You are currently smoking tobacco.I do not have severe health or mental health issues.I am not currently participating in any other physical activity or asthma studies.I have been diagnosed with COPD or have a significant smoking history.You should not exercise, unless a doctor gives you written permission.
Research Study Groups:
This trial has the following groups:- Group 1: Education Control
- Group 2: ACTION Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients currently being accepted for enrollment in this experiment?
"Affirmative. According to information accessible on clinicaltrials.gov, this research study is actively recruiting individuals as of April 27th 2023. It was first posted on the tenth day of April in 2023 and requires 224 participants from 2 distinct sites."
Answered by AI
How many individuals have enrolled in this clinical investigation?
"Affirmative. The trial, which was launched on April 10th 2023 and has since been updated on the 27th of the same month, is still recruiting participants. Specifically, 224 individuals need to be enrolled at 2 sites according to clinicaltrials.gov records."
Answered by AI
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