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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24- and 48-weeks

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

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

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

0 / 6Eligibility criteria met