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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
Must not have
Unable to ambulate without the use of a wheelchair or scooter
Significant medical (e.g., unstable heart disease, uncontrolled high blood pressure, active cancer treatment in past 1 year, end-stage organ failure) or psychiatric (e.g., active bipolar disorder, psychosis) comorbidities
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24- and 48-weeks
Awards & highlights

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am a Black or African-American woman.
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My asthma is not well-controlled, or I've had a severe asthma attack in the last year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need a wheelchair or scooter to move around.
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I do not have severe health or mental health issues.
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I have been diagnosed with COPD or have a significant smoking history.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24- and 48-weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24- and 48-weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Asthma Control Questionnaire
Asthma exacerbations
Daily Steps
+10 more

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
1,034 Previous Clinical Trials
753,470 Total Patients Enrolled
18 Trials studying Asthma
2,190 Patients Enrolled for Asthma
University of Illinois at ChicagoOTHER
632 Previous Clinical Trials
1,567,491 Total Patients Enrolled
6 Trials studying Asthma
7,630 Patients Enrolled for Asthma
University of Texas at AustinOTHER
370 Previous Clinical Trials
82,962 Total Patients Enrolled
4 Trials studying Asthma
1,334 Patients Enrolled for Asthma

Media Library

ACTION Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05726487 — N/A
Asthma Research Study Groups: Education Control, ACTION Intervention
Asthma Clinical Trial 2023: ACTION Intervention Highlights & Side Effects. Trial Name: NCT05726487 — N/A
ACTION Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05726487 — N/A
~108 spots leftby Dec 2025
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