Physical Activity Intervention for Black Women With Asthma (NCT05726487) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Physical Activity Intervention for Black Women With Asthma
United States224 participantsStarted 2023-05-04
Plain-language summary
Physical inactivity is associated with poor asthma control and quality of life, and greater health care utilization. Rates of physical inactivity, asthma, and asthma mortality among Black women are higher than those of their White counterparts. Our formative work identified barriers to PA among Black women with asthma including a lack of social support, self-efficacy, unsafe neighborhood and fear related to experiences with life-threatening asthma exacerbations. Given the unique barriers to PA and high rates of physical inactivity that are associated with poor asthma outcomes in Black women, there is an urgent need to optimize PA interventions for this population. The proposed study uses our theory-driven intervention (ACTION: A lifestyle physiCal acTivity Intervention for minOrity womeN with asthma) to deliver a 24-week lifestyle physical activity intervention designed for and by urban Black women with asthma. Participants will be recruited through two urban health care systems that care for a diverse urban Black populations. Participants will be randomized to one of two groups: 1) ACTION intervention (group sessions, physical activity self-monitoring and text-based support for goal-setting), or 2) education control (an individual asthma education session and text messages related to asthma education). Participants will be followed for an additional 24-weeks after the intervention to assess for the maintenance of intervention effects on asthma health outcomes. We are proposing an efficacy study that focuses on asthma outcomes (Aim 1A/B), explores behavioral mechanisms of the intervention (Aim 2) and assesses factors that influence its reach and implementation potential (Aim 3). This trial will provide the first ever evidence of the efficacy of a lifestyle physical activity intervention among urban Black women with asthma, a population that is understudied yet plagued by low levels of PA and poor health outcomes. Our study has high potential to advance clinical treatment of asthma, and further the mechanistic understanding of physical activity interventions in minority populations living in low-resourced urban environments.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Self-identify as female and Black or African-American
* Age \>/= 18
* Physician-diagnosed persistent asthma that is sub-optimally controlled based on Asthma Control Test (ACT \< 20) OR history in the past year of an asthma exacerbation (a need for systemic corticosteroids or hospital admission or emergency treatment for worsening asthma)
* Willing to enroll and provide written-informed consent
* Willing to be randomly assigned to treatment or control group
* Low- active: engages in less than 150 minutes per week of moderate-to- vigorous physical activity
* Has a smartphone and texts every day or almost everyday
Exclusion Criteria:
* Plans to relocate outside of the Chicagoland area during the study period
* Unable to ambulate without the use of a wheelchair or scooter
* Diagnosis of COPD (emphysema or chronic bronchitis) suggested by patient report of doctor diagnosis or smoking history (≥ 20 pack years)
* Current tobacco smoker
* A contraindication to exercise as indicated by the Physical Activity Readiness Questionnaire unless written permission by a health care provider
* 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
* Participation in another physical activity or asthma research program
* Asthma exacerbation, defined by an urgent care visit for asthma in the last 4 weeks, or…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically designed for Black women with asthma — given my background and asthma history, is this the kind of study my doctor thinks could be a good fit to discuss further?
2The trial is measuring asthma control using something called the Asthma Control Questionnaire — can you explain what that measures and whether my current level of asthma control would make this type of research relevant to my situation?
3Since this is a physical activity intervention, what does that actually involve day-to-day, and are there any concerns about whether my current asthma severity makes increased physical activity safe for me right now?
4The trial is listed as 'active but not recruiting' — does that mean enrollment is closed, and if so, are there similar studies or programs focused on physical activity for asthma management that I might still be able to access?
5Before considering a lifestyle-based research study like this, should I first make sure my asthma is being optimally managed with standard treatments, or could participating in something like this complement what I'm already doing?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.